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#23547 From: PozHealth@yahoogroups.com
Date: Sat Dec 1, 2007 10:00 pm
Subject: File - LIST RULES YOU HAVE AGREED TO FOLLOW
PozHealth@yahoogroups.com
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This is a monthly reminder to all

This is a group created to share information about HIV related lipodystrophy,
facial wasting, nutrition, side effects, exercise, latest treatments and
metabolic disorders and other emerging HIV health issues. It is run solely by
volunteers. Please read the following and make sure you understand what you
agree to do when joining this group.

By joining, I will abide by the following:

1- I will refrain from engaging in personal attacks on others--even if I
strongly disagree with their views.
2- I will respect the confidentiality of others.
3- I have read the mission of the list and I will post messages only on issues
that are pertinent to the list
4- I will respect people's gender, ethnicity, sexual orientation,religion, HIV
status, political affiliations, etc.
5- I will not spam the list with for profit information
6- I believe HIV is the cause of AIDS
7- I will include subject lines so others can determine the content of my
posting, and not "I have a question" or "Digest #456"
8- As a new member, I will read the previous postings on the website (using the
search feature) before I post the same question again.
9- My messages may or may not get approved by the moderator. I will accept the
moderator's best judgement and will not argue about it with him/her.
  10 - I will make every effort to snip off and edit the extraneous junk, like
yahoo ads, off of the copied text. I will edit and remove anything that doesn't
refer to the reply

I understand that if I do not comply with these requirements I may be expelled
from this list by the administrator. The administrator will not send a warning
in many cases.

IF YOU DO NOT AGREE WITH THESE TERMS , PLEASE UNSUBSCRIBE BY SENDING AN EMAIL TO
POZHEALTH-UNSUBSCRIBE@YAHOOGROUPS.COM

Thanks

#23546 From: PoWeRTX@...
Date: Fri Nov 30, 2007 5:44 pm
Subject: 80 nice people shared their experiences with doctors for lipodystrophy treatment
nelsonvergel
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 80 nice people shared their experiences with doctors for lipodystrophy treatments
 
 
 
You still have time to contribute to this data base if you want
 
 
 
 
 

Regards,

Nelson Vergel
powerusa dot org




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#23545 From: PoWeRTX@...
Date: Fri Nov 30, 2007 5:51 pm
Subject: Text Messaging in the Fight Against HIV/AIDS
nelsonvergel
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HHS and Kaiser Family Foundation Team Up to Promote Text Messaging in the Fight Against HIV/AIDS

CONTACTS

Rob Graham, KFF, (650) 854-9400

HHS Press Office, (202) 690-6343

In the United States, an estimated 1 million people are living with HIV; of these, approximately 25 percent are unaware of their HIV infection and at increased risk for infecting others. The earlier people know they have HIV, the sooner they can benefit from life-extending treatment, and reduce the risk of infecting their partners.

Despite the thousands of HIV testing locations around the United States, many of which offer free and anonymous HIV testing, many people do not know where they can find an HIV test site.

In observance of this World A IDS Day, December 1, the U.S. Department of Health and Human Services, through the Centers for Disease Control and Prevention (CDC) and the HHS Office of HIV/AIDS Policy is working with the Kaiser Family Foundation to promote text messaging to help people identify nearby HIV testing locations.

Mobile phone users can send a text message with their zip code to “KNOWIT” (566948). Within seconds, they will receive a text message containing information on HIV testing sites near them. This mobile phone service connects users with CDC’s testing database found at www.HIVtest.org.

As of December 2006, over 18.5 billion text messages were being sent every month – and that number has grown by 250% each year for the last two years.

“The growing use of text messaging provides an important opportunity to link people with simple and portable health information,” according to Dr. Kevin Fenton, Director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC. This World AIDS Day, Dr. Fenton encourages “cell phone users to text their zip codes to KNOWIT to find an HIV testing center near them.”

“For years, popular media has proven to be an effective way to engage the public on important health issues, including HIV/AIDS,” said Tina Hoff, Vice President and Director of Entertainment Media Partnerships at the Kaiser Family Foundation. “Given the tremendous growth of text messaging among mobile phone users in the United States, our new KNOWIT service will more easily connect Americans with local HIV testing center information using a media platform that’s both convenient and confidential.”

For more information, please see www.hivtest.org and www.AIDS.gov.

 

Regards,

Nelson Vergel
powerusa dot org




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#23544 From: PoWeRTX@...
Date: Fri Nov 30, 2007 5:50 pm
Subject: Gay men's HIV prevention in the US and Europe is 'faltering'
nelsonvergel
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Gay men's HIV prevention in the US and Europe is 'faltering'

Gay men’s HIV prevention in the United States is faltering and renewed efforts to stop the transmission of the infection requires leadership from gay community and public health officials, as well as the acceptance of the need for behaviour change at a personal level, according to a commentary in the November 28th edition of the Journal of the American Medical Association.

Read More >>

 

Regards,

Nelson Vergel
powerusa dot org




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#23543 From: PoWeRTX@...
Date: Fri Nov 30, 2007 5:36 pm
Subject: Treatment for Depression Reduces Mortality by Half in Older Diabetics
nelsonvergel
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Treatment for Depression Reduces Mortality by Half in Older Diabetics


Pauline Anderson

November 29, 2007 — Older depressed patients with diabetes who receive additional intervention for their depression are half as likely to die within 5 years as similar patients who not provided this intervention, according to a new study appearing in the December issue of Diabetes Care, published by the American Diabetes Association.

“These results indicate that a depression care management intervention can significantly reduce all-cause mortality among depressed patients with diabetes,” the authors conclude.

“There’s a policy statement here,” lead author Hillary R. Bogner, MD, assistant professor in the department of family practice and community medicine at the University of Pennsylvania, in Philadelphia, told Medscape Psychiatry. “We need more resources in primary care settings to treat depression.”

A Daunting PROSPECT

The researchers used data from the randomized Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT), which included a mix of 20 primary care practices from New York City, Philadelphia, and Pittsburgh and compared a primary care-based intervention with usual care in improving the outcome of depression.

This latest study sample included 599 depressed patients, of whom 396 (66.1%) met Diagnostic and Statistical Manual of Mental Disorders, 4th ed (DSM-IV) criteria for major depression. Because of missing data on 15 of these patients, the sample size for analysis was reduced to 584 patients, whose mean age was 70.3 years. Of these participants, 123 (21.2%) reported a history of diabetes.

The intervention group had access to trained depression care managers, who collaborated with physicians by offering guidelines-based treatment recommendations, monitoring clinical status of patients, and providing appropriate follow-up, said Dr. Bogner. “These managers met with the patients in person or talked with them over the phone when clinically necessary or at scheduled intervals, in some cases as often as once a week. “

The depression care managers asked the patients questions regarding depressive symptoms, medication adverse effects, and adherence to medications, Dr. Bogner said. “Basically, they found out how the patient was feeling and whether their symptoms had improved. They also assessed whether the patient was having any trouble taking medications. For some patients, the depression care managers provided interpersonal therapy.”

The fact that a person trained in depression management was available to address any problems or concerns that arose likely made a difference to the outcome for those in the intervention group, said Dr. Bogner. “It was an extra resource.”

In the usual-care group, physicians were informed of a patient’s depression diagnosis but did not receive specific treatment recommendations, said Dr. Bogner. “We know that patients in the usual-care group were often receiving depression treatment; the difference was that there was nobody in the practice who could make recommendations to the physician, such as increasing the dose” of medication, she said.

Mortality Cut By Half

After 5 years, 110 patients had died. Depressed patients with diabetes in the intervention group were about half as likely to die during that 5-year follow-up as were depressed patients with diabetes receiving usual care (adjusted hazard ratio, 0.49). Although researchers have not completed an analysis of the exact causes of these deaths, they do know that suicide was not a major contributor; there was only 1 suicide — a depressed patient with diabetes who was in the intervention group. According to Dr. Bogner, cardiovascular disease appears to be a likely cause of many of the other deaths.

In contrast to the patients with diabetes, depressed patients without diabetes in the intervention group had about the same risk of dying as similar patients in the usual-care group.

Although there has been much research on depression and diabetes, they write, “To our knowledge, this is the first study to report on the relationship between diabetes and mortality in a depression intervention trial.”

The study suggests more attention should be paid to treating depression in patients with diabetes, they conclude. The need is all the more pressing due to the prevalence of depression and diabetes. These conditions represent 2 of the most common problems seen in primary care settings today, the authors note. The 2 are intimately related; depression is a risk factor for diabetes, and depression is increased by a factor of 2 in patients with diabetes, they write. Depression also contributes to poor adherence to medication and dietary regimens.

PROSPECT was funded by the National Institute of Mental Health (NIMH). Participation of Drs. Bogner, Post, and Bruce was supported by NIMH awards. The authors report no potential conflicts of Interest.

Diabetes Care. 2007;30:3005-3010. Abstract

 

Regards,

Nelson Vergel
powerusa dot org




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#23542 From: PoWeRTX@...
Date: Fri Nov 30, 2007 5:35 pm
Subject: High Testosterone Levels Linked to Reduced Mortality in Men
nelsonvergel
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Publication Logo

High Testosterone Levels Linked to Reduced Mortality in Men



By Anthony J. Brown, MD

NEW YORK (Reuters Health) Nov 28 - As testosterone levels increase in men, the risk of death from cardiovascular disease and other causes drops, according to a report in the December 4th issue of Circulation.

"To our knowledge, our study is the first large population-based study to find that higher endogenous testosterone levels appear to be associated with lower risk of death from all causes, cardiovascular disease and cancer in men," lead author Dr. Kay-Tee Khaw told Reuters Health. "This may be because past studies have been much smaller in size with limited statistical power to detect or exclude a moderate relationship with cardiovascular disease events."

The current research involved an analysis of data for 2314 men enrolled in the European Prospective Investigation into Cancer (EPIC) in Norfolk study.

The men were between 40 and 79 years of age and were cancer- and cardiovascular disease-free when they enrolled in the study between 1993 and 1997; they were followed through 2003. The main focus was a comparison of baseline testosterone levels between the 825 men who died during follow-up and the 1489 men who did not.

Testosterone levels were inversely related to the risk of death from all causes, cardiovascular disease, and cancer.

On multivariate analysis, men in the highest testosterone quartile were 41% less likely to die during follow-up than those in the lowest quartile. In terms of specific testosterone levels, each 6 nmol/L increase was associated with a 19% reduction in mortality risk.

Dr. Khaw, from Addenbrooke's Hospital, Cambridge, UK, said that her team was somewhat surprised by the finding that elevated testosterone levels were not associated with increased cancer mortality.

"Reduction of testosterone levels is a recognized treatment for prostate cancer and there has been concern that high levels of testosterone may be a risk factor for prostate cancer. We did not have enough cases of prostate cancer in this study to examine the question specifically but at least for total cancer there was no evidence of increased risk," she said.

The message for clinicians is that "low blood testosterone levels may help identify men at increased risk of cardiovascular disease who may be most likely to benefit from established preventive interventions such as cholesterol or blood pressure lowering medication," Dr. Khaw emphasized.

Circulation 2007;116.



Reuters Health Information 2007. 2007 Reuters Ltd.
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

 

Regards,

Nelson Vergel
powerusa dot org




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#23541 From: John Barrow <pozbod@...>
Date: Fri Nov 30, 2007 3:09 pm
Subject: Re: Swallowing POZ Pre-cum
johnftl59
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I totaly understand your doubts and concerns...
I was diagnosed HIV+ 2 years ago and my boyfriend was negative (he still is but whe broke 2 months ago). Even that he works investigating HIV in Mexico, he is a very good scientist that travels all around the world, we usually had a lot of questions. It is not the same reading or hearing about the ways you can get infected as living it every day.


There is a tendency to think that giving blow jobs is not a significant risk for transmitting HIV, and while it is lower risk than getting fucked, it is still a real risk.  The following study is old, but there are few good studies, and it's an area where you have to assume things haven't changed too much.



HIV risk of sex practices calculated
 Lisa Keen
 The Washington Blade - August 13, 1999
 ----------------------------------------------

 

 Researchers from the U.S. Centers for Disease Control and
 Prevention and several universities report this month that their
 research into the relative HIV hazards of various sex practices
 confirms earlier reports -- unprotected anal intercourse as a
 bottom partner is the highest risk, while oral sex is the lowest.

 

 The researchers surveyed 2,189 Gay and bisexual men in three
 cities (San Francisco, Chicago, and Denver) every six months over
 a period of two years to determine what sexual practices they
 engaged in and whether the men had become HIV-infected.
 Specifically, the researchers were looking for men who were
 engaging in high-risk sexual behaviors, and they eventually
 analyzed data from 1,583 men.

 

 Of these 1,583 men, 49 men (3 percent) began testing positive for
 HIV infection during the course of the study. The researchers
 then compared the sexual practices of these men to the men who
 did not test positive.

 

 What they found was that the men who tested positive were much
 more likely to have been the passive partner in anal intercourse
 without a condom and with a partner they knew to be HIV-positive.
 Fourteen percent of the men who tested positive were bottoms in
 unprotected anal sex with HIV-positive partners, compared to only
 1 percent of the men who did not test positive.

 

 Forty-five percent of the men who tested positive said they had
 been bottoms in unprotected anal intercourse with a partner whose
 HIV status they did not know, compared to 27 percent of the men
 who did not test positive.

 

 But what interested the researchers more was the fact that, if 45
 percent of the men who tested positive were likely infected
 through sexual practices known to have a high risk, then 55
 percent become infected through "other types of contact."

 

 "Provided the [participants'] reporting was accurate," noted the
 researchers, "this implies that a majority of new infections took
 place via other types of contact, which may have included
 episodes in which condoms were used but failed."

 

 The most common sexual practice engaged in by the group of men
 who became infected was anal intercourse with a condom -- as
 either the top or bottom partner. Following that, the most common
 sexual practices were anal intercourse as the top partner and not
 using a condom, and being the receptive partner in oral sex in
 which the insertive partner did not use a condom.

 

 Applying a number to quantify the risk of each practice, the
 researchers identified anal intercourse as the bottom with a top
 partner known to be HIV-infected and not using a condom (the
 highest risk) at 0.82 percent per contact. (The study's authors
 noted that nine men became infected after only one or two
 contacts of unprotected anal intercourse as the bottom.)

 

 The same intercourse with the top using a condom was identified
 at 0.18 percent per contact. Being the receptive partner in oral
 sex in which the top does not use a condom was identified at 0.04
 percent per contact, a risk that was the lowest for all sexual
 practices but "not without risk."

 

 The study is reported in the Aug. 1 issue of the American Journal
 of Epidemiology.

 

 

 


#23540 From: PoWeRTX@...
Date: Fri Nov 30, 2007 9:37 am
Subject: Fwd: NATAP: Polylactic Acid for Lipoatrophy Randomized Study
nelsonvergel
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No surprise here
 
NATAP http://natap.org/
_______________________________________________


A Randomized, Multicenter, Open-Label Study of Poly-L-Lactic Acid for HIV-1 Facial Lipoatrophy

JAIDS Journal of Acquired Immune Deficiency Syndromes:Volume 46(5)15 December 2007pp 581-589

Carey, Dianne L MPH*; Baker, David MB, ChB†; Rogers, Gary D MBBS, PhD‡; Petoumenos, Kathy PhD*; Chuah, John MBBS, BSc (Med) Hons§; Easey, Nicole BApplSc (Med Imaging)
; Machon, Kirsty BA (Hons), MA¶; Cooper, David A DSc, MD*; Emery, Sean PhD*; Carr, Andrew MD; for the Facial LipoAtrophy Study in HIV Investigators

>From the *National Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, Sydney, Australia; †407 Doctors, Sydney, Australia; ‡Secretariat of the Pacific Community, Noumea, New Caledonia; §Gold Coast Sexual Health Clinic, Miami, Australia;
St. Vincent's Hospital, Sydney, Australia; and the ¶National Association of People Living with HIV/AIDS, Sydney, Australia.

In summary, we showed in a multicenter, open-label, randomized controlled trial with objective endpoints that PLA treatment in HIV-infected adults with moderate or severe facial lipoatrophy achieved only modest increases in facial thickness but not in facial volume. In contrast, patient-perceived benefits were significant in terms of aesthetic improvement and increased well-being, social functioning, and quality of life. PLA does not address fat loss in other body regions. Restoration of lost fat mass is gradual. In the interim, further well-designed comparative studies with objectively assessed endpoints are needed to ascertain the optimal treatment for HIV facial lipoatrophy.”


Abstract
Background: Facial lipoatrophy can stigmatize and can reduce quality of life, self esteem, and antiretroviral adherence. Poly-L-lactic acid (PLA) injections seem safe and effective, but no randomized study has included objective endpoints.

Methods: HIV-positive adults with moderate/severe facial lipoatrophy were randomized to 4 open-label PLA treatments administered every 2 weeks from week 0 (immediate group, n = 51) or after week 24 (deferred group, n = 50). The primary endpoint was mean change in facial soft tissue volume (FSTV), as assessed by spiral computed tomography. Analyses were by intention to treat.

Results: At week 24, mean changes in FSTV were 0 cm3 in the intermediate group and -10 cm3 in the deferred group (between-group difference of 10 [95% confidence interval (CI): -7 to 28] cm3; P = 0.24). The immediate group had a greater mean change in soft tissue depth at the maxilla (2.2 mm [95% CI: 1.6 to 2.9]; P < 0.0001) and base of the nasal septum (1.0 mm [95% CI: 0.3 to 1.6]; P = 0.003) levels. PLA did not have an impact on peripheral fat mass, viral load, or antiretroviral adherence. Patient and physician subjectively assessed facial lipoatrophy severity (P < 0.0001), 2 of 8 Short Form-36 Health Survey and 2 of 5 Multidimensional Body-Self Relations Questionnaire-Appearance Scales, scores improved significantly. The median duration of treatment-related adverse events was 2 (interquartile range: 1 to 3) days.

Conclusions: PLA did not increase FSTV, although tissue thickness in injection planes increased modestly, an improvement observed by patients. PLA was safe and well tolerated. Facial lipoatrophy severity and some quality-of-life domains improved.

HIV lipodystrophy (peripheral lipoatrophy and relative central fat accumulation) can be disfiguring and socially stigmatizing and may result in reduced antiretroviral adherence.1,2 Facial lipoatrophy is the most distressing manifestation.3 Apart from the modest benefits of thymidine-based nucleoside analogue cessation, there is no proven therapy for lipoatrophy.4-10 Even with nucleoside analogue cessation, changes in facial lipoatrophy were not observed with standard methods.6,11

Plastic surgery and cosmetic procedures may restore facial fat volume. Permanent and biodegradable soft tissue filling agents have been investigated.12,13 Poly-L-lactic acid (PLA; Sculptra; Dermik Laboratories, Berwyn, PA), which has been approved in Europe and the United States for use in HIV facial lipoatrophy, is used most commonly. PLA is a synthetic, biodegradable, immunologically inert, resorbable polymer. It has been widely and safely used for many years in surgical devices such as resorbable sutures, surgical meshes, and plate and pin implants in craniofacial and orthopedic surgery and as vectors for injectable slow-release drug delivery systems.14,15 After injection, PLA microparticles may stimulate collagen production, which leads to a gradual and progressive increase in volume of the lipoatrophic area.16

Open-label studies have demonstrated the safety of PLA injections in HIV-infected adults.17-25 PLA efficacy is less clear, because all studies were single site, most were small, and all were uncontrolled or had subjective efficacy endpoints.17-19,21-25 We undertook a randomized, multicenter, open-label, 24-week study with a 96-week total follow-up comparing immediate versus deferred deep subcutaneous injections of PLA in adults with antiretroviral-induced facial lipoatrophy. The primary objective was to determine the effect of 4 bilateral PLA treatments administered every 2 weeks on facial soft tissue volume (FSTV) over 24 weeks with volumetric computed tomography (CT). Other endpoints comprised safety, body composition measures, quality of life, and antiretroviral adherence.

DISCUSSION
Four bilateral PLA treatments administered by deep subcutaneous injection every 2 weeks did not increase FSTV after 24 weeks in HIV-infected lipodystrophic adults with extensive antiretroviral exposure and moderate or severe facial lipoatrophy. Small improvements in objectively assessed facial soft tissue thickness around the planes of injection were demonstrated. Clinicians and patients perceived significant treatment benefits with reductions in facial lipoatrophy severity assessed in treated subjects relative to controls. Some quality-of-life scores also improved.

There is no validated measure of facial thickness. FSTV had not been used previously but was chosen because it is an unbiased objective measure. The lack of improvement in FSTV at week 24 may be attributable to several factors. First, the study may have not been adequately powered. Because there were no normative data, we were uncertain of the expected change, and thus based our sample size calculation on the results of an earlier randomized study,18 where a statistically significant difference in improvement in patient visual analog assessment of 47% in the treatment arm versus 7% in the placebo arm was demonstrated at week 12. We chose a more conservative estimate of 50 subjects per arm, which gave 80% power to detect a difference in the proportion with a clinically relevant improvement in cheek volume to 10% in the placebo arm versus 35% in the treatment arm. At week 24, however, only 16% of treated subjects and 10% of deferred subjects had a >10% increase in FSTV. If the observed differences were accurate, we would have required 525 subjects per arm to detect a significant between-group difference in FSTV at week 24. Second, the procedure may be more variable than envisaged. Because subjects were spread geographically, 9 CT scanning sites were required. At each imaging site, a single operator acquired the data using the same equipment and software at each visit. Although baseline scans were quality assessed, failure to reconstruct the data set at week 24 to reflect baseline image parameters could produce measurement error. Finally, it is possible that PLA is not as efficacious as previously believed. At week 24, FSTV remained unchanged in PLA recipients but had decreased in untreated subjects, suggesting that PLA benefits may lie in its ability to prevent further deterioration in treated areas.

The heterogeneity of studies that have investigated the use of PLA in HIV facial lipoatrophy makes efficacy comparisons difficult. Treatment numbers vary enormously, with many studies adjusting vial numbers based on subjectively assessed baseline facial lipoatrophy severity or to achieve a subjectively assessed satisfactory result or predefined outcome.17,19-25 Only 1 study administered a fixed number of treatments.18 Across studies, the number of treatments ranged from 1 to 8, with mean/medians of 4 or 5. Heterogeneity of study subjects, facial lipoatrophy severity and its assessment, or lack of these data adds additional complexity. Although most subjects were white men aged 41 to 49 years, only 1 study used a validated lipodystrophy assessment tool27 to assess facial lipoatrophy severity.18 Apart from an ultrasound-assessed facial fat thickness threshold,17 the remaining studies utilized a site-specific scale with patient and/or clinician assessment. Because these open-label studies all lacked objective lipodystrophy data, comparisons are problematic.

Significant increases in facial thickness were observed at 2 planes, the maxilla and base of the nasal septum, which were the approximate planes of injection, but the increases were less than those recorded using sonography in previous studies.17,18,23,24 In these studies, measurements were made predominantly at the nasolabial folds and showed broad interstudy variability with changes of 4.4 mm at 2 months23 and 3.5 to 6.4 mm at 24 weeks17,18,24 after 4 or 6, 4 to 5, 3, and a median of 5 (range: 2 to 8) bilateral PLA treatments, respectively. Our results are similar to those obtained using 3-D photographs with 3-D computerized reconstruction of the face to measure dermal thickness.22 In 49 patients who received a median of 5 (range: 1 to 7) PLA treatments, the median increase in dermal thickness from baseline to the end of treatment (median = 2.3 [range: 0.5 to 7] months) was 1.9 (range: 0.4 to 5.5) mm. At the last follow-up assessment, a median of 12 (range: 1 to 27) months after the first PLA injection, the maximal increase in dermal thickness was 2.4 (range: 0.7 to 6.1) mm in the right cheek and 2.2 (range: 0.9 to 5.9) mm in the left.22 Calipers were used to assess skin thickness changes in the malar region (n = 99); however, because the authors reported only mean percent change from baseline at 6 months (59.2%), comparison with other studies is difficult.19 None of these measurement methods has been validated, perhaps assisting to explain the broad interstudy variability in outcomes. Because measurement reproducibility is operator dependent, it requires consistency in measurement positioning, which is made more difficult by the absence of facial landmarks. The shortcomings of facial sonography were highlighted in an earlier study, which showed it to be a poor measure of facial lipoatrophy.11

Despite only modest improvements in objectively assessed facial thickness, patients and clinicians perceived significant improvements. This observer bias results from the open-label design of the study and was observed in an earlier lipodystrophy study, where despite significant reductions in limb fat as assessed by DEXA, lipoatrophy severity was perceived to have improved significantly.35 In the current study, these perceptions were supported by a significant association between perceived improvements and objectively assessed increases in facial thickness. The lack of change in subjectively assessed lipodystrophy and its severity was supported by no difference in other objectively assessed body composition parameters. Additionally, the lack of between-group differences in limb fat mass and limb fat percent suggests that the observed facial differences were attributable to PLA treatment and not to a change in overall lipoatrophy.

The associations observed between the objectively assessed linear measures and patient subjective assessment, and between patient and physician subjective assessments, suggest that there is a treatment benefit. The lack of correlation between change in the objective primary endpoint, FSTV, and the secondary subjective endpoints is therefore of interest. The scanning landmarks (midorbit and angle of mandible) produced a volume substantially greater than the area where PLA was injected. Because increases in tissue depth in the injection plane were modest, it is possible that the resultant volumetric increases may not have been detected, particularly if, as mentioned previously, the procedure was more variable than anticipated.

The psychosocial impact of lipodystrophy is well described.36 This study used well-validated quality-of-life tools to assess the impact of PLA treatment on participants' health status and body image. Improvements in social function and mental health scores of the SF-36 provided additional evidence of patient-perceived treatment benefits. Our results contrast with those of an earlier study in which the SF-36 mental health score did not change after PLA treatment.22 Interesting, all SF-36 scores in the control group were reduced, perhaps reflecting despondency at being randomized to deferred treatment. Improvements in body self-image subscales of the MBSRQ-AS were also observed. Treated patients reported less dissatisfaction with their overall physical appearance and with most body areas at week 24 than control subjects.

PLA injections were safe and well tolerated. Although most patients experienced at least 1 procedure/product-related adverse event, most were of low grade and transient consistent with those observed in previous clinical studies.17,18,22 The incidence of injection-site nodules (12%) is comparable to that reported in other HIV studies.19,22,25 Although considerably lower than the incidences of 31% to 52% reported previously,17,24,37 it is higher than that found by other investigators (0% to 6%).19,21,23 Onset times for nodules of 2 to 9 months22 and a median of 7 months26 after the first injection have been reported; therefore, it is possible that with longer follow-up, the incidence reported here may increase.

There are limitations to this study. Most participants were white men, reflecting the HIV epidemic in Australia. There are no data describing normal FSTV in men; thus, we could not determine to what extent facial lipoatrophy normalized. Nevertheless, FSTV did not change, suggesting that additional PLA treatments might provide some benefit.

In summary, we showed in a multicenter, open-label, randomized controlled trial with objective endpoints that PLA treatment in HIV-infected adults with moderate or severe facial lipoatrophy achieved only modest increases in facial thickness but not in facial volume. In contrast, patient-perceived benefits were significant in terms of aesthetic improvement and increased well-being, social functioning, and quality of life. PLA does not address fat loss in other body regions. Restoration of lost fat mass is gradual. In the interim, further well-designed comparative studies with objectively assessed endpoints are needed to ascertain the optimal treatment for HIV facial lipoatrophy.


METHODS
Participants
Participants were recruited at 18 clinical sites (primary care, n = 11; hospital outpatient, n = 7) around Australia. Eligible participants had documented HIV-1 infection, were aged at least 18 years, had received combination antiretroviral therapy (ART), and had moderate or severe facial lipoatrophy with lipodystrophy at 1 or more other sites (arms, legs, abdomen, or buttocks). Current ART had to be unchanged for at least 12 weeks, or for subjects not on therapy, there should be no intent to recommence before week 24. Women of child-bearing potential had a negative pregnancy test result and were using contraception. Patients were ineligible if they had an active AIDS-defining illness, HIV wasting syndrome, active herpes labialis, any facial skin disorder, any coagulopathy, or previous treatment for facial lipoatrophy. Anabolic steroids (except testosterone replacement for hypogonadism), oral glucocorticosteroids at greater than replacement dose (7.5 mg of prednisolone daily or equivalent), anticoagulant therapies, growth hormone, or other agents to increase appetite or improve weight were not permitted.

All participants provided written informed consent after approval by each site's local human research ethics committee.

Interventions
The study randomized 100 eligible patients to receive 4 open-label PLA treatments (1 vial [150 mg] per cheek) every 2 weeks with a minimum 14-day interval between treatments commencing at week 0 (immediate group) or after a delay period of 24 weeks (deferred group). The immediate group received bilateral PLA injections at weeks 0, 2, 4, and 6 administered at a single surgical site in each of the 4 participating Australian states according to a common protocol. PLA vials were reconstituted to 5 mL;26 after an infraorbital nerve block (1 mL of lignocaine 2% with adrenaline), aliquots of 0.1 to 0.3 mL were deposited deep into the subcutaneous tissue in a predefined buccal area below the orbital margin (Fig. 1). After administration of the contents of 1 vial into each cheek, the injected areas were massaged firmly to promote even distribution of PLA. Participants were instructed to repeat the massage procedure 3 times daily for at least 3 days after each treatment. Management guidelines for PLA-related adverse events included treatment delay or termination. PLA cessation was mandatory for grade 4 (very severe or life-threatening) events considered definitely, probably, or possibly related to PLA. Antiretroviral drug substitution was permitted for on-study adverse events or virologic failure. Randomization using minimization was performed by a single statistician at the National Centre in HIV Epidemiology and Clinical Research (NCHECR), Sydney, Australia, and was stratified by age, facial lipoatrophy severity, current protease inhibitor (PI) use, current thymidine analogue reverse transcriptase inhibitor (tNRTI) use, and surgeon. Lipoatrophy severity was assessed and scored by physical examination and patient report.27,28 Additionally, patient and physician assessment of facial lipoatrophy severity was made using a validated facial lipodystrophy picture scale (0 = normal, 1 = mild, 2 = moderate, and 3 = severe) with accompanying descriptions and facial diagrams,18 as described previously.27,28

Assessments
At screening, demographic details, ART, and concomitant medication were recorded. Participants were seen at week -1, at weeks 1, 3, 5, and 7 for postprocedure and safety review if in the immediate arm, and at weeks 12 and 24. Safety assessments included clinical adverse events, physical examination, concomitant drugs, complete blood cell count and coagulation screen, plasma HIV-1 RNA and T-lymphocyte subsets, and serum _-human chorionic gonadotrophin (pregnancy test) in women. At screening and week 24, spiral CT of the head was performed to quantify total FSTV of the region defined superiorly by the midorbit and inferiorly by the angle of mandible according to a common protocol. Participants were positioned supine and scanned parallel to the hard palate without gantry tilt. After spiral acquisition, 61 symmetric images were created in the axial plane at 1-mm thickness such that the middle image (image 31) was parallel to and at the level of the hard palate. Using the axial data and protocol-defined bony landmarks, 4 images were identified; using the measurement tool, bilateral baselines were then drawn on them as follows: symphysis mentis to the lateral aspect of each temporomandibular joint; anterior nasal spine to the lateral aspect of the ramus of each mandible; most anterior part of the bony nasal septum to the anterior aspect of the maxillary antrum; and lateral aspect of the temporal bone at the level of the optic nerve. The maximum distance from each baseline to the skin line was recorded as the mandible, base of nasal septum, maxilla, and orbit measurements, respectively (see Fig. 1). Volumetric assessment was performed using 3-dimensional (3-D) postprocessing software. A protocol-defined rectangular region of interest was defined on image 31 (midslice) and by use of appropriate Hounsfield units volumetric soft tissue measurements obtained. All baseline CT scans, linear measurements, and soft tissue volumes were quality reviewed at a single radiology site to ensure adherence to the common protocol, and any not considered adequate were repeated.

Body composition was measured by dual-energy x-ray absorptiometry (DEXA) at screening and week 24 to determine total and regional body fat and lean tissue (apart from the head) according to a standard protocol.4,28 Other objective body composition measures were weight, body mass index (BMI), and hip and waist circumferences. Subjective measures of lipodystrophy severity were recorded independently by clinicians and patients at screening and weeks 12 and 24. For each body region, a standardized scoring system (0 = none, 1 = mild, 2 = moderate, and 3 = severe) was assigned.28,29

Health-related quality of life was self-reported at week -1 and then at weeks 12 and 24 using the Short Form (SF)-36v2 Health Survey.30 The Multidimensional Body-Self Relations Questionnaire-Appearance Scales (MBSRQ-AS), a standardized measure of body image attitudes, assessed self-satisfaction with appearance and weight.31 Antiretroviral adherence was assessed using a standardized self-report form.32 Participants recorded whether they took all, most, about half, very few, or none of their pills during the preceding 7 days.

Statistical Analysis
The study had 80% power to detect an absolute difference of 25% in the proportion of participants with a clinically relevant change in FSTV between the immediate and deferred arms at 24 weeks using intention-to-treat analysis. We hypothesized that no more than 10% of deferred participants would show a clinically relevant improvement in soft tissue volume over 24 weeks, a more conservative estimate than earlier data.18 Analysis of the randomized comparison was performed when all randomized participants had completed 24 weeks of follow-up or had permanently withdrawn from follow-up. Baseline characteristics were summarized without formal comparison of the randomized groups.

All efficacy analyses compared the randomized treatment groups in terms of change from baseline to week 24 on an intention-to-treat basis and included all participants with baseline data and at least 1 follow-up assessment. Primary efficacy analyses adopted a last-value-carried-forward approach for participants lost to follow-up. Secondary analyses used only available data. Continuous endpoints were investigated using analysis of variance or nonparametric equivalents and binary endpoints assessed by _2 tests or logistic regression. All significance tests were 2-sided and not adjusted for multiple comparisons.

Serious adverse events, adverse events associated with PLA or leading to changes in ART, and all grade 3 or 4 clinical adverse events were summarized by treatment group. Events associated with PLA modification or cessation were summarized. An antiretroviral adherence score was calculated as described previously.33 Subgroup analyses were based on the following strata: age, patient-assessed facial lipoatrophy severity, baseline PI and thymidine nucleoside analogue use, and surgeon. Differences in outcome between the randomized treatment arms were assessed with tests of interaction between treatment and strata.

Univariate linear regression and multivariate linear regression were used to determine predictors of efficacy in PLA recipients, as assessed by change in facial volume at week 24, and predictors of safety, as determined by PLA cessation for toxicity or grade 3 or 4 adverse events. Post hoc analysis was performed to assess additional predictors of efficacy assessed by change in facial linear measurements at the maxilla and base of nasal septum levels at week 24. The following variables were assessed as predictors: baseline demographic characteristics, antiretroviral treatment, baseline CD4 cell count and HIV-1 viral load, smoking status, skin tanning type (Fitzpatrick scale),34 baseline limb fat mass and percent, and change in limb fat mass and percent at week 24 as assessed by DEXA. The final predictive model was determined using forward-stepwise regression. Variables with a univariate P value ≤0.1 were assessed in multivariate analysis.

RESULTS
Over a 6-week period during December 2005, and January 2006, 104 patients were screened and 101 participants randomized (see Fig. 2). One participant withdrew consent (patient choice) after randomization and was excluded from analysis. Most (92%) participants were men, 35 (35%) had AIDS, all were receiving ART, 65 were receiving a PI, and 14 were receiving a tNRTI (Table 1). Almost all (96%) participants rated their antiretroviral adherence as optimal (>95%). Self-assessed facial lipoatrophy was severe in 51 (26 immediate and 25 deferred) participants. Agreement between physical examination and self-assessed facial lipoatrophy severity was moderate (_ = 0.50). Mean baseline FSTV was 388 ± 71 cm3 in the immediate group and 393 ± 69 cm3 in the deferred group (see Table 1).

Safety bloods (complete blood cell count and coagulation screen) collected within 7 days of treatment initiation indicated that all immediate participants could proceed safely with PLA injections. Of the 50 immediate participants, 49 (98%) received 4 bilateral PLA treatments. One participant required only 1 treatment (2 vials) for adequate facial correction. Twenty-one antiretroviral drugs were stopped in 15 (15%) participants (6 immediate and 9 deferred). Most (62%) changes were within-class substitutions; 60% of these were for regimen simplification, with lamivudine (8 participants [5 immediate and 3 deferred]) and didanosine (3 participants [1 immediate and 2 deferred]) most commonly ceased. No participant ceased PI therapy or tNRTI therapy. There was no death or new AIDS-defining event. There was 1 screening protocol violation in the control arm. The patient had an HIV-1 RNA viral load in excess of 750,000 (5.88 log) copies/mL immediately before screening and commenced a new PI-containing regimen at week 6. No participant commenced any prohibited concomitant medication. Data for 100 participants (50 immediate and 50 deferred) were available for the intention-to-treat-analysis.

Efficacy: Objective Measures
PLA did not increase FSTV (Table 2). At week 24, the mean change in FSTV was 0 (95% confidence interval [CI]: -14 to 13) cm3 in the immediate group and -10 (95% CI: -22 to 1) cm3 in the deferred group, a difference of 10 (95% CI: -7 to 28) cm3 (P = 0.24). These represent changes of 0% and -3%, respectively, in FSTV. At week 24, 16% of the immediate group and 10% of the deferred group had a >10% increase in FSTV (P = 0.37). Treatment efficacy assessed by change in FSTV at week 24 did not differ significantly between any subgroup (data not shown).

The immediate group had a significantly greater mean change in tissue depth at the maxilla and base of nasal septum levels relative to the deferred group (2.2 [95% CI: 1.6 to 2.9] mm, P < 0.0001 and 1.0 [95% CI: 0.3 to 1.6] mm, P = 0.003, respectively). Facial thickness at the untreated orbit and mandibular levels was not increased by PLA. PLA therapy did not significantly affect any other objective body composition parameter, plasma viral load, or CD4 lymphocyte counts (see Table 2). Self-reported ART adherence was not different, with 96% of both groups reporting >95% adherence at week 24 (P = 1.0).

Analyses to investigate predictors of efficacy yielded inconsistent data. In multivariate analysis, significant predictors of a greater increase in FSTV at week 24 were prior AIDS (P = 0.002) and current PI therapy (P < 0.0001). Predictors of a greater increase in facial thickness at the maxillary level were Fitzpatrick skin types IV to VI (P = 0.035) and an improvement in limb fat from baseline to week 24 (P = 0.072). At the base of the nasal septum level, there was a trend for a greater increase in facial thickness to be associated with a limb fat increase between baseline and week 24 (P = 0.059).

Efficacy: Subjective Measures
Facial lipoatrophy severity was perceived as improved in 45 (90%) PLA recipients compared with 18% in the deferred group (P < 0.0001) at week 12 and in 84% and 18%, respectively, at week 24 (P < 0.0001). At week 12, clinicians perceived a reduction in severity in 90% of the immediate group, with no change or a worsening in 80% of deferred participants (P < 0.0001). At week 24, 86% of PLA recipients were perceived to have improved compared with 20% in the deferred group (P < 0.0001; Fig. 3). There was a significant association between self-assessed change in facial lipoatrophy severity and objectively assessed change in facial thickness at the maxilla level (P = 0.026) and a borderline association with change in thickness at the base of nasal septum (P = 0.079) (Fig. 4). There was no difference in any other clinician- or patient-assessed subjective measure of lipodystrophy or its severity at week 12 or 24.

At week 12, the mean change from baseline in the score for the Mental Health scale of the SF-36 Health Survey scale in PLA recipients was significantly different from the mean change in the deferred group (2.8 and -3.2, respectively; P = 0.026). At week 24, the mean change in scores for Social Functioning and Mental Health in the immediate group differed significantly from mean changes in the deferred group (P = 0.031 and P = 0.047, respectively; Fig. 5). Although the mean score for 5 SF-36 scales increased in the immediate group, the mean score for all 8 scales decreased in the deferred group. Additionally, the mean change in the Mental Health Component Summary score differed significantly in the immediate group relative to the deferred group (P = 0.048), but there was no difference in the Physical Component Summary score (P = 0.98) or in any of the scales associated with physical functioning. Body self-image assessed using the MBSRQ-AS showed that the mean change in appearance evaluation and body areas satisfaction subscale scores in the immediate group was significantly different from scores in the deferred group (0.19 and -0.03, P = 0.040 and 0.29 and -0.12, P < 0.0001, respectively) at week 12 and at week 24 (0.15 and -0.15, P = 0.010 and 0.19 and -0.11, P = 0.0004, respectively).

Safety/Tolerability
Forty-eight (96%) PLA recipients experienced at least 1 procedure/product-related adverse event, with pain/discomfort (76%), localized edema (64%), and erythema (53%) reported most commonly (Table 3). Most events were grade 1 or 2 and were of short duration (median = 2 [interquartile range [IQR]: 1 to 3] days). No treatment was delayed or terminated for adverse events, surgical or clinical discretion, or patient wish. At week 24, there were 4 palpable and 1 visible ongoing subcutaneous noninflammatory nodules and 1 papule at the injection site in 6 participants (12%). These events were noted at the injection site 5 to 19 weeks after the first injection. Five serious adverse events were reported in 4 participants: 3 events (epidural abscess, surgery to resect renal tumor, and hospitalization for lower lobe pneumonia) in the immediate group (2 participants) and 2 events (surgery for perianal abscess and acute renal retention) in the deferred group (2 participants). None of these events was associated with PLA. Additionally, no other grade 4 event was considered definitely, probably, or possibly related to PLA.



 

Regards,

Nelson Vergel
powerusa dot org




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A Randomized, Multicenter, Open-Label Study of Poly-L-Lactic Acid for HIV-1 Facial Lipoatrophy

JAIDS Journal of Acquired Immune Deficiency Syndromes:Volume 46(5)15 December 2007pp 581-589

Carey, Dianne L MPH*; Baker, David MB, ChB†; Rogers, Gary D MBBS, PhD‡; Petoumenos, Kathy PhD*; Chuah, John MBBS, BSc (Med) Hons§; Easey, Nicole BApplSc (Med Imaging)
; Machon, Kirsty BA (Hons), MA¶; Cooper, David A DSc, MD*; Emery, Sean PhD*; Carr, Andrew MD; for the Facial LipoAtrophy Study in HIV Investigators

>From the *National Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, Sydney, Australia; †407 Doctors, Sydney, Australia; ‡Secretariat of the Pacific Community, Noumea, New Caledonia; §Gold Coast Sexual Health Clinic, Miami, Australia;
St. Vincent's Hospital, Sydney, Australia; and the ¶National Association of People Living with HIV/AIDS, Sydney, Australia.

“In summary, we showed in a multicenter, open-label, randomized controlled trial with objective endpoints that PLA treatment in HIV-infected adults with moderate or severe facial lipoatrophy achieved only modest increases in facial thickness but not in facial volume. In contrast, patient-perceived benefits were significant in terms of aesthetic improvement and increased well-being, social functioning, and quality of life. PLA does not address fat loss in other body regions. Restoration of lost fat mass is gradual. In the interim, further well-designed comparative studies with objectively assessed endpoints are needed to ascertain the optimal treatment for HIV facial lipoatrophy.”


Abstract
Background: Facial lipoatrophy can stigmatize and can reduce quality of life, self esteem, and antiretroviral adherence. Poly-L-lactic acid (PLA) injections seem safe and effective, but no randomized study has included objective endpoints.

Methods: HIV-positive adults with moderate/severe facial lipoatrophy were randomized to 4 open-label PLA treatments administered every 2 weeks from week 0 (immediate group, n = 51) or after week 24 (deferred group, n = 50). The primary endpoint was mean change in facial soft tissue volume (FSTV), as assessed by spiral computed tomography. Analyses were by intention to treat.

Results: At week 24, mean changes in FSTV were 0 cm3 in the intermediate group and -10 cm3 in the deferred group (between-group difference of 10 [95% confidence interval (CI): -7 to 28] cm3; P = 0.24). The immediate group had a greater mean change in soft tissue depth at the maxilla (2.2 mm [95% CI: 1.6 to 2.9]; P < 0.0001) and base of the nasal septum (1.0 mm [95% CI: 0.3 to 1.6]; P = 0.003) levels. PLA did not have an impact on peripheral fat mass, viral load, or antiretroviral adherence. Patient and physician subjectively assessed facial lipoatrophy severity (P < 0.0001), 2 of 8 Short Form-36 Health Survey and 2 of 5 Multidimensional Body-Self Relations Questionnaire-Appearance Scales, scores improved significantly. The median duration of treatment-related adverse events was 2 (interquartile range: 1 to 3) days.

Conclusions: PLA did not increase FSTV, although tissue thickness in injection planes increased modestly, an improvement observed by patients. PLA was safe and well tolerated. Facial lipoatrophy severity and some quality-of-life domains improved.

HIV lipodystrophy (peripheral lipoatrophy and relative central fat accumulation) can be disfiguring and socially stigmatizing and may result in reduced antiretroviral adherence.1,2 Facial lipoatrophy is the most distressing manifestation.3 Apart from the modest benefits of thymidine-based nucleoside analogue cessation, there is no proven therapy for lipoatrophy.4-10 Even with nucleoside analogue cessation, changes in facial lipoatrophy were not observed with standard methods.6,11

Plastic surgery and cosmetic procedures may restore facial fat volume. Permanent and biodegradable soft tissue filling agents have been investigated.12,13 Poly-L-lactic acid (PLA; Sculptra; Dermik Laboratories, Berwyn, PA), which has been approved in Europe and the United States for use in HIV facial lipoatrophy, is used most commonly. PLA is a synthetic, biodegradable, immunologically inert, resorbable polymer. It has been widely and safely used for many years in surgical devices such as resorbable sutures, surgical meshes, and plate and pin implants in craniofacial and orthopedic surgery and as vectors for injectable slow-release drug delivery systems.14,15 After injection, PLA microparticles may stimulate collagen production, which leads to a gradual and progressive increase in volume of the lipoatrophic area.16

Open-label studies have demonstrated the safety of PLA injections in HIV-infected adults.17-25 PLA efficacy is less clear, because all studies were single site, most were small, and all were uncontrolled or had subjective efficacy endpoints.17-19,21-25 We undertook a randomized, multicenter, open-label, 24-week study with a 96-week total follow-up comparing immediate versus deferred deep subcutaneous injections of PLA in adults with antiretroviral-induced facial lipoatrophy. The primary objective was to determine the effect of 4 bilateral PLA treatments administered every 2 weeks on facial soft tissue volume (FSTV) over 24 weeks with volumetric computed tomography (CT). Other endpoints comprised safety, body composition measures, quality of life, and antiretroviral adherence.

DISCUSSION
Four bilateral PLA treatments administered by deep subcutaneous injection every 2 weeks did not increase FSTV after 24 weeks in HIV-infected lipodystrophic adults with extensive antiretroviral exposure and moderate or severe facial lipoatrophy. Small improvements in objectively assessed facial soft tissue thickness around the planes of injection were demonstrated. Clinicians and patients perceived significant treatment benefits with reductions in facial lipoatrophy severity assessed in treated subjects relative to controls. Some quality-of-life scores also improved.

There is no validated measure of facial thickness. FSTV had not been used previously but was chosen because it is an unbiased objective measure. The lack of improvement in FSTV at week 24 may be attributable to several factors. First, the study may have not been adequately powered. Because there were no normative data, we were uncertain of the expected change, and thus based our sample size calculation on the results of an earlier randomized study,18 where a statistically significant difference in improvement in patient visual analog assessment of 47% in the treatment arm versus 7% in the placebo arm was demonstrated at week 12. We chose a more conservative estimate of 50 subjects per arm, which gave 80% power to detect a difference in the proportion with a clinically relevant improvement in cheek volume to 10% in the placebo arm versus 35% in the treatment arm. At week 24, however, only 16% of treated subjects and 10% of deferred subjects had a >10% increase in FSTV. If the observed differences were accurate, we would have required 525 subjects per arm to detect a significant between-group difference in FSTV at week 24. Second, the procedure may be more variable than envisaged. Because subjects were spread geographically, 9 CT scanning sites were required. At each imaging site, a single operator acquired the data using the same equipment and software at each visit. Although baseline scans were quality assessed, failure to reconstruct the data set at week 24 to reflect baseline image parameters could produce measurement error. Finally, it is possible that PLA is not as efficacious as previously believed. At week 24, FSTV remained unchanged in PLA recipients but had decreased in untreated subjects, suggesting that PLA benefits may lie in its ability to prevent further deterioration in treated areas.

The heterogeneity of studies that have investigated the use of PLA in HIV facial lipoatrophy makes efficacy comparisons difficult. Treatment numbers vary enormously, with many studies adjusting vial numbers based on subjectively assessed baseline facial lipoatrophy severity or to achieve a subjectively assessed satisfactory result or predefined outcome.17,19-25 Only 1 study administered a fixed number of treatments.18 Across studies, the number of treatments ranged from 1 to 8, with mean/medians of 4 or 5. Heterogeneity of study subjects, facial lipoatrophy severity and its assessment, or lack of these data adds additional complexity. Although most subjects were white men aged 41 to 49 years, only 1 study used a validated lipodystrophy assessment tool27 to assess facial lipoatrophy severity.18 Apart from an ultrasound-assessed facial fat thickness threshold,17 the remaining studies utilized a site-specific scale with patient and/or clinician assessment. Because these open-label studies all lacked objective lipodystrophy data, comparisons are problematic.

Significant increases in facial thickness were observed at 2 planes, the maxilla and base of the nasal septum, which were the approximate planes of injection, but the increases were less than those recorded using sonography in previous studies.17,18,23,24 In these studies, measurements were made predominantly at the nasolabial folds and showed broad interstudy variability with changes of 4.4 mm at 2 months23 and 3.5 to 6.4 mm at 24 weeks17,18,24 after 4 or 6, 4 to 5, 3, and a median of 5 (range: 2 to 8) bilateral PLA treatments, respectively. Our results are similar to those obtained using 3-D photographs with 3-D computerized reconstruction of the face to measure dermal thickness.22 In 49 patients who received a median of 5 (range: 1 to 7) PLA treatments, the median increase in dermal thickness from baseline to the end of treatment (median = 2.3 [range: 0.5 to 7] months) was 1.9 (range: 0.4 to 5.5) mm. At the last follow-up assessment, a median of 12 (range: 1 to 27) months after the first PLA injection, the maximal increase in dermal thickness was 2.4 (range: 0.7 to 6.1) mm in the right cheek and 2.2 (range: 0.9 to 5.9) mm in the left.22 Calipers were used to assess skin thickness changes in the malar region (n = 99); however, because the authors reported only mean percent change from baseline at 6 months (59.2%), comparison with other studies is difficult.19 None of these measurement methods has been validated, perhaps assisting to explain the broad interstudy variability in outcomes. Because measurement reproducibility is operator dependent, it requires consistency in measurement positioning, which is made more difficult by the absence of facial landmarks. The shortcomings of facial sonography were highlighted in an earlier study, which showed it to be a poor measure of facial lipoatrophy.11

Despite only modest improvements in objectively assessed facial thickness, patients and clinicians perceived significant improvements. This observer bias results from the open-label design of the study and was observed in an earlier lipodystrophy study, where despite significant reductions in limb fat as assessed by DEXA, lipoatrophy severity was perceived to have improved significantly.35 In the current study, these perceptions were supported by a significant association between perceived improvements and objectively assessed increases in facial thickness. The lack of change in subjectively assessed lipodystrophy and its severity was supported by no difference in other objectively assessed body composition parameters. Additionally, the lack of between-group differences in limb fat mass and limb fat percent suggests that the observed facial differences were attributable to PLA treatment and not to a change in overall lipoatrophy.

The associations observed between the objectively assessed linear measures and patient subjective assessment, and between patient and physician subjective assessments, suggest that there is a treatment benefit. The lack of correlation between change in the objective primary endpoint, FSTV, and the secondary subjective endpoints is therefore of interest. The scanning landmarks (midorbit and angle of mandible) produced a volume substantially greater than the area where PLA was injected. Because increases in tissue depth in the injection plane were modest, it is possible that the resultant volumetric increases may not have been detected, particularly if, as mentioned previously, the procedure was more variable than anticipated.

The psychosocial impact of lipodystrophy is well described.36 This study used well-validated quality-of-life tools to assess the impact of PLA treatment on participants' health status and body image. Improvements in social function and mental health scores of the SF-36 provided additional evidence of patient-perceived treatment benefits. Our results contrast with those of an earlier study in which the SF-36 mental health score did not change after PLA treatment.22 Interesting, all SF-36 scores in the control group were reduced, perhaps reflecting despondency at being randomized to deferred treatment. Improvements in body self-image subscales of the MBSRQ-AS were also observed. Treated patients reported less dissatisfaction with their overall physical appearance and with most body areas at week 24 than control subjects.

PLA injections were safe and well tolerated. Although most patients experienced at least 1 procedure/product-related adverse event, most were of low grade and transient consistent with those observed in previous clinical studies.17,18,22 The incidence of injection-site nodules (12%) is comparable to that reported in other HIV studies.19,22,25 Although considerably lower than the incidences of 31% to 52% reported previously,17,24,37 it is higher than that found by other investigators (0% to 6%).19,21,23 Onset times for nodules of 2 to 9 months22 and a median of 7 months26 after the first injection have been reported; therefore, it is possible that with longer follow-up, the incidence reported here may increase.

There are limitations to this study. Most participants were white men, reflecting the HIV epidemic in Australia. There are no data describing normal FSTV in men; thus, we could not determine to what extent facial lipoatrophy normalized. Nevertheless, FSTV did not change, suggesting that additional PLA treatments might provide some benefit.

In summary, we showed in a multicenter, open-label, randomized controlled trial with objective endpoints that PLA treatment in HIV-infected adults with moderate or severe facial lipoatrophy achieved only modest increases in facial thickness but not in facial volume. In contrast, patient-perceived benefits were significant in terms of aesthetic improvement and increased well-being, social functioning, and quality of life. PLA does not address fat loss in other body regions. Restoration of lost fat mass is gradual. In the interim, further well-designed comparative studies with objectively assessed endpoints are needed to ascertain the optimal treatment for HIV facial lipoatrophy.


METHODS
Participants
Participants were recruited at 18 clinical sites (primary care, n = 11; hospital outpatient, n = 7) around Australia. Eligible participants had documented HIV-1 infection, were aged at least 18 years, had received combination antiretroviral therapy (ART), and had moderate or severe facial lipoatrophy with lipodystrophy at 1 or more other sites (arms, legs, abdomen, or buttocks). Current ART had to be unchanged for at least 12 weeks, or for subjects not on therapy, there should be no intent to recommence before week 24. Women of child-bearing potential had a negative pregnancy test result and were using contraception. Patients were ineligible if they had an active AIDS-defining illness, HIV wasting syndrome, active herpes labialis, any facial skin disorder, any coagulopathy, or previous treatment for facial lipoatrophy. Anabolic steroids (except testosterone replacement for hypogonadism), oral glucocorticosteroids at greater than replacement dose (7.5 mg of prednisolone daily or equivalent), anticoagulant therapies, growth hormone, or other agents to increase appetite or improve weight were not permitted.

All participants provided written informed consent after approval by each site's local human research ethics committee.

Interventions
The study randomized 100 eligible patients to receive 4 open-label PLA treatments (1 vial [150 mg] per cheek) every 2 weeks with a minimum 14-day interval between treatments commencing at week 0 (immediate group) or after a delay period of 24 weeks (deferred group). The immediate group received bilateral PLA injections at weeks 0, 2, 4, and 6 administered at a single surgical site in each of the 4 participating Australian states according to a common protocol. PLA vials were reconstituted to 5 mL;26 after an infraorbital nerve block (1 mL of lignocaine 2% with adrenaline), aliquots of 0.1 to 0.3 mL were deposited deep into the subcutaneous tissue in a predefined buccal area below the orbital margin (Fig. 1). After administration of the contents of 1 vial into each cheek, the injected areas were massaged firmly to promote even distribution of PLA. Participants were instructed to repeat the massage procedure 3 times daily for at least 3 days after each treatment. Management guidelines for PLA-related adverse events included treatment delay or termination. PLA cessation was mandatory for grade 4 (very severe or life-threatening) events considered definitely, probably, or possibly related to PLA. Antiretroviral drug substitution was permitted for on-study adverse events or virologic failure. Randomization using minimization was performed by a single statistician at the National Centre in HIV Epidemiology and Clinical Research (NCHECR), Sydney, Australia, and was stratified by age, facial lipoatrophy severity, current protease inhibitor (PI) use, current thymidine analogue reverse transcriptase inhibitor (tNRTI) use, and surgeon. Lipoatrophy severity was assessed and scored by physical examination and patient report.27,28 Additionally, patient and physician assessment of facial lipoatrophy severity was made using a validated facial lipodystrophy picture scale (0 = normal, 1 = mild, 2 = moderate, and 3 = severe) with accompanying descriptions and facial diagrams,18 as described previously.27,28

Assessments
At screening, demographic details, ART, and concomitant medication were recorded. Participants were seen at week -1, at weeks 1, 3, 5, and 7 for postprocedure and safety review if in the immediate arm, and at weeks 12 and 24. Safety assessments included clinical adverse events, physical examination, concomitant drugs, complete blood cell count and coagulation screen, plasma HIV-1 RNA and T-lymphocyte subsets, and serum _-human chorionic gonadotrophin (pregnancy test) in women. At screening and week 24, spiral CT of the head was performed to quantify total FSTV of the region defined superiorly by the midorbit and inferiorly by the angle of mandible according to a common protocol. Participants were positioned supine and scanned parallel to the hard palate without gantry tilt. After spiral acquisition, 61 symmetric images were created in the axial plane at 1-mm thickness such that the middle image (image 31) was parallel to and at the level of the hard palate. Using the axial data and protocol-defined bony landmarks, 4 images were identified; using the measurement tool, bilateral baselines were then drawn on them as follows: symphysis mentis to the lateral aspect of each temporomandibular joint; anterior nasal spine to the lateral aspect of the ramus of each mandible; most anterior part of the bony nasal septum to the anterior aspect of the maxillary antrum; and lateral aspect of the temporal bone at the level of the optic nerve. The maximum distance from each baseline to the skin line was recorded as the mandible, base of nasal septum, maxilla, and orbit measurements, respectively (see Fig. 1). Volumetric assessment was performed using 3-dimensional (3-D) postprocessing software. A protocol-defined rectangular region of interest was defined on image 31 (midslice) and by use of appropriate Hounsfield units volumetric soft tissue measurements obtained. All baseline CT scans, linear measurements, and soft tissue volumes were quality reviewed at a single radiology site to ensure adherence to the common protocol, and any not considered adequate were repeated.

Body composition was measured by dual-energy x-ray absorptiometry (DEXA) at screening and week 24 to determine total and regional body fat and lean tissue (apart from the head) according to a standard protocol.4,28 Other objective body composition measures were weight, body mass index (BMI), and hip and waist circumferences. Subjective measures of lipodystrophy severity were recorded independently by clinicians and patients at screening and weeks 12 and 24. For each body region, a standardized scoring system (0 = none, 1 = mild, 2 = moderate, and 3 = severe) was assigned.28,29

Health-related quality of life was self-reported at week -1 and then at weeks 12 and 24 using the Short Form (SF)-36v2 Health Survey.30 The Multidimensional Body-Self Relations Questionnaire-Appearance Scales (MBSRQ-AS), a standardized measure of body image attitudes, assessed self-satisfaction with appearance and weight.31 Antiretroviral adherence was assessed using a standardized self-report form.32 Participants recorded whether they took all, most, about half, very few, or none of their pills during the preceding 7 days.

Statistical Analysis
The study had 80% power to detect an absolute difference of 25% in the proportion of participants with a clinically relevant change in FSTV between the immediate and deferred arms at 24 weeks using intention-to-treat analysis. We hypothesized that no more than 10% of deferred participants would show a clinically relevant improvement in soft tissue volume over 24 weeks, a more conservative estimate than earlier data.18 Analysis of the randomized comparison was performed when all randomized participants had completed 24 weeks of follow-up or had permanently withdrawn from follow-up. Baseline characteristics were summarized without formal comparison of the randomized groups.

All efficacy analyses compared the randomized treatment groups in terms of change from baseline to week 24 on an intention-to-treat basis and included all participants with baseline data and at least 1 follow-up assessment. Primary efficacy analyses adopted a last-value-carried-forward approach for participants lost to follow-up. Secondary analyses used only available data. Continuous endpoints were investigated using analysis of variance or nonparametric equivalents and binary endpoints assessed by _2 tests or logistic regression. All significance tests were 2-sided and not adjusted for multiple comparisons.

Serious adverse events, adverse events associated with PLA or leading to changes in ART, and all grade 3 or 4 clinical adverse events were summarized by treatment group. Events associated with PLA modification or cessation were summarized. An antiretroviral adherence score was calculated as described previously.33 Subgroup analyses were based on the following strata: age, patient-assessed facial lipoatrophy severity, baseline PI and thymidine nucleoside analogue use, and surgeon. Differences in outcome between the randomized treatment arms were assessed with tests of interaction between treatment and strata.

Univariate linear regression and multivariate linear regression were used to determine predictors of efficacy in PLA recipients, as assessed by change in facial volume at week 24, and predictors of safety, as determined by PLA cessation for toxicity or grade 3 or 4 adverse events. Post hoc analysis was performed to assess additional predictors of efficacy assessed by change in facial linear measurements at the maxilla and base of nasal septum levels at week 24. The following variables were assessed as predictors: baseline demographic characteristics, antiretroviral treatment, baseline CD4 cell count and HIV-1 viral load, smoking status, skin tanning type (Fitzpatrick scale),34 baseline limb fat mass and percent, and change in limb fat mass and percent at week 24 as assessed by DEXA. The final predictive model was determined using forward-stepwise regression. Variables with a univariate P value ≤0.1 were assessed in multivariate analysis.

RESULTS
Over a 6-week period during December 2005, and January 2006, 104 patients were screened and 101 participants randomized (see Fig. 2). One participant withdrew consent (patient choice) after randomization and was excluded from analysis. Most (92%) participants were men, 35 (35%) had AIDS, all were receiving ART, 65 were receiving a PI, and 14 were receiving a tNRTI (Table 1). Almost all (96%) participants rated their antiretroviral adherence as optimal (>95%). Self-assessed facial lipoatrophy was severe in 51 (26 immediate and 25 deferred) participants. Agreement between physical examination and self-assessed facial lipoatrophy severity was moderate (_ = 0.50). Mean baseline FSTV was 388 ± 71 cm3 in the immediate group and 393 ± 69 cm3 in the deferred group (see Table 1).

Safety bloods (complete blood cell count and coagulation screen) collected within 7 days of treatment initiation indicated that all immediate participants could proceed safely with PLA injections. Of the 50 immediate participants, 49 (98%) received 4 bilateral PLA treatments. One participant required only 1 treatment (2 vials) for adequate facial correction. Twenty-one antiretroviral drugs were stopped in 15 (15%) participants (6 immediate and 9 deferred). Most (62%) changes were within-class substitutions; 60% of these were for regimen simplification, with lamivudine (8 participants [5 immediate and 3 deferred]) and didanosine (3 participants [1 immediate and 2 deferred]) most commonly ceased. No participant ceased PI therapy or tNRTI therapy. There was no death or new AIDS-defining event. There was 1 screening protocol violation in the control arm. The patient had an HIV-1 RNA viral load in excess of 750,000 (5.88 log) copies/mL immediately before screening and commenced a new PI-containing regimen at week 6. No participant commenced any prohibited concomitant medication. Data for 100 participants (50 immediate and 50 deferred) were available for the intention-to-treat-analysis.

Efficacy: Objective Measures
PLA did not increase FSTV (Table 2). At week 24, the mean change in FSTV was 0 (95% confidence interval [CI]: -14 to 13) cm3 in the immediate group and -10 (95% CI: -22 to 1) cm3 in the deferred group, a difference of 10 (95% CI: -7 to 28) cm3 (P = 0.24). These represent changes of 0% and -3%, respectively, in FSTV. At week 24, 16% of the immediate group and 10% of the deferred group had a >10% increase in FSTV (P = 0.37). Treatment efficacy assessed by change in FSTV at week 24 did not differ significantly between any subgroup (data not shown).

The immediate group had a significantly greater mean change in tissue depth at the maxilla and base of nasal septum levels relative to the deferred group (2.2 [95% CI: 1.6 to 2.9] mm, P < 0.0001 and 1.0 [95% CI: 0.3 to 1.6] mm, P = 0.003, respectively). Facial thickness at the untreated orbit and mandibular levels was not increased by PLA. PLA therapy did not significantly affect any other objective body composition parameter, plasma viral load, or CD4 lymphocyte counts (see Table 2). Self-reported ART adherence was not different, with 96% of both groups reporting >95% adherence at week 24 (P = 1.0).

Analyses to investigate predictors of efficacy yielded inconsistent data. In multivariate analysis, significant predictors of a greater increase in FSTV at week 24 were prior AIDS (P = 0.002) and current PI therapy (P < 0.0001). Predictors of a greater increase in facial thickness at the maxillary level were Fitzpatrick skin types IV to VI (P = 0.035) and an improvement in limb fat from baseline to week 24 (P = 0.072). At the base of the nasal septum level, there was a trend for a greater increase in facial thickness to be associated with a limb fat increase between baseline and week 24 (P = 0.059).

Efficacy: Subjective Measures
Facial lipoatrophy severity was perceived as improved in 45 (90%) PLA recipients compared with 18% in the deferred group (P < 0.0001) at week 12 and in 84% and 18%, respectively, at week 24 (P < 0.0001). At week 12, clinicians perceived a reduction in severity in 90% of the immediate group, with no change or a worsening in 80% of deferred participants (P < 0.0001). At week 24, 86% of PLA recipients were perceived to have improved compared with 20% in the deferred group (P < 0.0001; Fig. 3). There was a significant association between self-assessed change in facial lipoatrophy severity and objectively assessed change in facial thickness at the maxilla level (P = 0.026) and a borderline association with change in thickness at the base of nasal septum (P = 0.079) (Fig. 4). There was no difference in any other clinician- or patient-assessed subjective measure of lipodystrophy or its severity at week 12 or 24.

At week 12, the mean change from baseline in the score for the Mental Health scale of the SF-36 Health Survey scale in PLA recipients was significantly different from the mean change in the deferred group (2.8 and -3.2, respectively; P = 0.026). At week 24, the mean change in scores for Social Functioning and Mental Health in the immediate group differed significantly from mean changes in the deferred group (P = 0.031 and P = 0.047, respectively; Fig. 5). Although the mean score for 5 SF-36 scales increased in the immediate group, the mean score for all 8 scales decreased in the deferred group. Additionally, the mean change in the Mental Health Component Summary score differed significantly in the immediate group relative to the deferred group (P = 0.048), but there was no difference in the Physical Component Summary score (P = 0.98) or in any of the scales associated with physical functioning. Body self-image assessed using the MBSRQ-AS showed that the mean change in appearance evaluation and body areas satisfaction subscale scores in the immediate group was significantly different from scores in the deferred group (0.19 and -0.03, P = 0.040 and 0.29 and -0.12, P < 0.0001, respectively) at week 12 and at week 24 (0.15 and -0.15, P = 0.010 and 0.19 and -0.11, P = 0.0004, respectively).

Safety/Tolerability
Forty-eight (96%) PLA recipients experienced at least 1 procedure/product-related adverse event, with pain/discomfort (76%), localized edema (64%), and erythema (53%) reported most commonly (Table 3). Most events were grade 1 or 2 and were of short duration (median = 2 [interquartile range [IQR]: 1 to 3] days). No treatment was delayed or terminated for adverse events, surgical or clinical discretion, or patient wish. At week 24, there were 4 palpable and 1 visible ongoing subcutaneous noninflammatory nodules and 1 papule at the injection site in 6 participants (12%). These events were noted at the injection site 5 to 19 weeks after the first injection. Five serious adverse events were reported in 4 participants: 3 events (epidural abscess, surgery to resect renal tumor, and hospitalization for lower lobe pneumonia) in the immediate group (2 participants) and 2 events (surgery for perianal abscess and acute renal retention) in the deferred group (2 participants). None of these events was associated with PLA. Additionally, no other grade 4 event was considered definitely, probably, or possibly related to PLA.



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#23539 From: JuLev@...
Date: Fri Nov 30, 2007 4:08 am
Subject: NATAP: Polylactic Acid for Lipoatrophy Randomized Study
jules72orange
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A Randomized, Multicenter, Open-Label Study of Poly-L-Lactic Acid for HIV-1 Facial Lipoatrophy

JAIDS Journal of Acquired Immune Deficiency Syndromes:Volume 46(5)15 December 2007pp 581-589

Carey, Dianne L MPH*; Baker, David MB, ChB†; Rogers, Gary D MBBS, PhD‡; Petoumenos, Kathy PhD*; Chuah, John MBBS, BSc (Med) Hons§; Easey, Nicole BApplSc (Med Imaging)
; Machon, Kirsty BA (Hons), MA¶; Cooper, David A DSc, MD*; Emery, Sean PhD*; Carr, Andrew MD; for the Facial LipoAtrophy Study in HIV Investigators

From the *National Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, Sydney, Australia; †407 Doctors, Sydney, Australia; ‡Secretariat of the Pacific Community, Noumea, New Caledonia; §Gold Coast Sexual Health Clinic, Miami, Australia;
St. Vincent's Hospital, Sydney, Australia; and the ¶National Association of People Living with HIV/AIDS, Sydney, Australia.

“In summary, we showed in a multicenter, open-label, randomized controlled trial with objective endpoints that PLA treatment in HIV-infected adults with moderate or severe facial lipoatrophy achieved only modest increases in facial thickness but not in facial volume. In contrast, patient-perceived benefits were significant in terms of aesthetic improvement and increased well-being, social functioning, and quality of life. PLA does not address fat loss in other body regions. Restoration of lost fat mass is gradual. In the interim, further well-designed comparative studies with objectively assessed endpoints are needed to ascertain the optimal treatment for HIV facial lipoatrophy.”


Abstract
Background: Facial lipoatrophy can stigmatize and can reduce quality of life, self esteem, and antiretroviral adherence. Poly-L-lactic acid (PLA) injections seem safe and effective, but no randomized study has included objective endpoints.

Methods: HIV-positive adults with moderate/severe facial lipoatrophy were randomized to 4 open-label PLA treatments administered every 2 weeks from week 0 (immediate group, n = 51) or after week 24 (deferred group, n = 50). The primary endpoint was mean change in facial soft tissue volume (FSTV), as assessed by spiral computed tomography. Analyses were by intention to treat.

Results: At week 24, mean changes in FSTV were 0 cm3 in the intermediate group and -10 cm3 in the deferred group (between-group difference of 10 [95% confidence interval (CI): -7 to 28] cm3; P = 0.24). The immediate group had a greater mean change in soft tissue depth at the maxilla (2.2 mm [95% CI: 1.6 to 2.9]; P < 0.0001) and base of the nasal septum (1.0 mm [95% CI: 0.3 to 1.6]; P = 0.003) levels. PLA did not have an impact on peripheral fat mass, viral load, or antiretroviral adherence. Patient and physician subjectively assessed facial lipoatrophy severity (P < 0.0001), 2 of 8 Short Form-36 Health Survey and 2 of 5 Multidimensional Body-Self Relations Questionnaire-Appearance Scales, scores improved significantly. The median duration of treatment-related adverse events was 2 (interquartile range: 1 to 3) days.

Conclusions: PLA did not increase FSTV, although tissue thickness in injection planes increased modestly, an improvement observed by patients. PLA was safe and well tolerated. Facial lipoatrophy severity and some quality-of-life domains improved.

HIV lipodystrophy (peripheral lipoatrophy and relative central fat accumulation) can be disfiguring and socially stigmatizing and may result in reduced antiretroviral adherence.1,2 Facial lipoatrophy is the most distressing manifestation.3 Apart from the modest benefits of thymidine-based nucleoside analogue cessation, there is no proven therapy for lipoatrophy.4-10 Even with nucleoside analogue cessation, changes in facial lipoatrophy were not observed with standard methods.6,11

Plastic surgery and cosmetic procedures may restore facial fat volume. Permanent and biodegradable soft tissue filling agents have been investigated.12,13 Poly-L-lactic acid (PLA; Sculptra; Dermik Laboratories, Berwyn, PA), which has been approved in Europe and the United States for use in HIV facial lipoatrophy, is used most commonly. PLA is a synthetic, biodegradable, immunologically inert, resorbable polymer. It has been widely and safely used for many years in surgical devices such as resorbable sutures, surgical meshes, and plate and pin implants in craniofacial and orthopedic surgery and as vectors for injectable slow-release drug delivery systems.14,15 After injection, PLA microparticles may stimulate collagen production, which leads to a gradual and progressive increase in volume of the lipoatrophic area.16

Open-label studies have demonstrated the safety of PLA injections in HIV-infected adults.17-25 PLA efficacy is less clear, because all studies were single site, most were small, and all were uncontrolled or had subjective efficacy endpoints.17-19,21-25 We undertook a randomized, multicenter, open-label, 24-week study with a 96-week total follow-up comparing immediate versus deferred deep subcutaneous injections of PLA in adults with antiretroviral-induced facial lipoatrophy. The primary objective was to determine the effect of 4 bilateral PLA treatments administered every 2 weeks on facial soft tissue volume (FSTV) over 24 weeks with volumetric computed tomography (CT). Other endpoints comprised safety, body composition measures, quality of life, and antiretroviral adherence.

DISCUSSION
Four bilateral PLA treatments administered by deep subcutaneous injection every 2 weeks did not increase FSTV after 24 weeks in HIV-infected lipodystrophic adults with extensive antiretroviral exposure and moderate or severe facial lipoatrophy. Small improvements in objectively assessed facial soft tissue thickness around the planes of injection were demonstrated. Clinicians and patients perceived significant treatment benefits with reductions in facial lipoatrophy severity assessed in treated subjects relative to controls. Some quality-of-life scores also improved.

There is no validated measure of facial thickness. FSTV had not been used previously but was chosen because it is an unbiased objective measure. The lack of improvement in FSTV at week 24 may be attributable to several factors. First, the study may have not been adequately powered. Because there were no normative data, we were uncertain of the expected change, and thus based our sample size calculation on the results of an earlier randomized study,18 where a statistically significant difference in improvement in patient visual analog assessment of 47% in the treatment arm versus 7% in the placebo arm was demonstrated at week 12. We chose a more conservative estimate of 50 subjects per arm, which gave 80% power to detect a difference in the proportion with a clinically relevant improvement in cheek volume to 10% in the placebo arm versus 35% in the treatment arm. At week 24, however, only 16% of treated subjects and 10% of deferred subjects had a >10% increase in FSTV. If the observed differences were accurate, we would have required 525 subjects per arm to detect a significant between-group difference in FSTV at week 24. Second, the procedure may be more variable than envisaged. Because subjects were spread geographically, 9 CT scanning sites were required. At each imaging site, a single operator acquired the data using the same equipment and software at each visit. Although baseline scans were quality assessed, failure to reconstruct the data set at week 24 to reflect baseline image parameters could produce measurement error. Finally, it is possible that PLA is not as efficacious as previously believed. At week 24, FSTV remained unchanged in PLA recipients but had decreased in untreated subjects, suggesting that PLA benefits may lie in its ability to prevent further deterioration in treated areas.

The heterogeneity of studies that have investigated the use of PLA in HIV facial lipoatrophy makes efficacy comparisons difficult. Treatment numbers vary enormously, with many studies adjusting vial numbers based on subjectively assessed baseline facial lipoatrophy severity or to achieve a subjectively assessed satisfactory result or predefined outcome.17,19-25 Only 1 study administered a fixed number of treatments.18 Across studies, the number of treatments ranged from 1 to 8, with mean/medians of 4 or 5. Heterogeneity of study subjects, facial lipoatrophy severity and its assessment, or lack of these data adds additional complexity. Although most subjects were white men aged 41 to 49 years, only 1 study used a validated lipodystrophy assessment tool27 to assess facial lipoatrophy severity.18 Apart from an ultrasound-assessed facial fat thickness threshold,17 the remaining studies utilized a site-specific scale with patient and/or clinician assessment. Because these open-label studies all lacked objective lipodystrophy data, comparisons are problematic.

Significant increases in facial thickness were observed at 2 planes, the maxilla and base of the nasal septum, which were the approximate planes of injection, but the increases were less than those recorded using sonography in previous studies.17,18,23,24 In these studies, measurements were made predominantly at the nasolabial folds and showed broad interstudy variability with changes of 4.4 mm at 2 months23 and 3.5 to 6.4 mm at 24 weeks17,18,24 after 4 or 6, 4 to 5, 3, and a median of 5 (range: 2 to 8) bilateral PLA treatments, respectively. Our results are similar to those obtained using 3-D photographs with 3-D computerized reconstruction of the face to measure dermal thickness.22 In 49 patients who received a median of 5 (range: 1 to 7) PLA treatments, the median increase in dermal thickness from baseline to the end of treatment (median = 2.3 [range: 0.5 to 7] months) was 1.9 (range: 0.4 to 5.5) mm. At the last follow-up assessment, a median of 12 (range: 1 to 27) months after the first PLA injection, the maximal increase in dermal thickness was 2.4 (range: 0.7 to 6.1) mm in the right cheek and 2.2 (range: 0.9 to 5.9) mm in the left.22 Calipers were used to assess skin thickness changes in the malar region (n = 99); however, because the authors reported only mean percent change from baseline at 6 months (59.2%), comparison with other studies is difficult.19 None of these measurement methods has been validated, perhaps assisting to explain the broad interstudy variability in outcomes. Because measurement reproducibility is operator dependent, it requires consistency in measurement positioning, which is made more difficult by the absence of facial landmarks. The shortcomings of facial sonography were highlighted in an earlier study, which showed it to be a poor measure of facial lipoatrophy.11

Despite only modest improvements in objectively assessed facial thickness, patients and clinicians perceived significant improvements. This observer bias results from the open-label design of the study and was observed in an earlier lipodystrophy study, where despite significant reductions in limb fat as assessed by DEXA, lipoatrophy severity was perceived to have improved significantly.35 In the current study, these perceptions were supported by a significant association between perceived improvements and objectively assessed increases in facial thickness. The lack of change in subjectively assessed lipodystrophy and its severity was supported by no difference in other objectively assessed body composition parameters. Additionally, the lack of between-group differences in limb fat mass and limb fat percent suggests that the observed facial differences were attributable to PLA treatment and not to a change in overall lipoatrophy.

The associations observed between the objectively assessed linear measures and patient subjective assessment, and between patient and physician subjective assessments, suggest that there is a treatment benefit. The lack of correlation between change in the objective primary endpoint, FSTV, and the secondary subjective endpoints is therefore of interest. The scanning landmarks (midorbit and angle of mandible) produced a volume substantially greater than the area where PLA was injected. Because increases in tissue depth in the injection plane were modest, it is possible that the resultant volumetric increases may not have been detected, particularly if, as mentioned previously, the procedure was more variable than anticipated.

The psychosocial impact of lipodystrophy is well described.36 This study used well-validated quality-of-life tools to assess the impact of PLA treatment on participants' health status and body image. Improvements in social function and mental health scores of the SF-36 provided additional evidence of patient-perceived treatment benefits. Our results contrast with those of an earlier study in which the SF-36 mental health score did not change after PLA treatment.22 Interesting, all SF-36 scores in the control group were reduced, perhaps reflecting despondency at being randomized to deferred treatment. Improvements in body self-image subscales of the MBSRQ-AS were also observed. Treated patients reported less dissatisfaction with their overall physical appearance and with most body areas at week 24 than control subjects.

PLA injections were safe and well tolerated. Although most patients experienced at least 1 procedure/product-related adverse event, most were of low grade and transient consistent with those observed in previous clinical studies.17,18,22 The incidence of injection-site nodules (12%) is comparable to that reported in other HIV studies.19,22,25 Although considerably lower than the incidences of 31% to 52% reported previously,17,24,37 it is higher than that found by other investigators (0% to 6%).19,21,23 Onset times for nodules of 2 to 9 months22 and a median of 7 months26 after the first injection have been reported; therefore, it is possible that with longer follow-up, the incidence reported here may increase.

There are limitations to this study. Most participants were white men, reflecting the HIV epidemic in Australia. There are no data describing normal FSTV in men; thus, we could not determine to what extent facial lipoatrophy normalized. Nevertheless, FSTV did not change, suggesting that additional PLA treatments might provide some benefit.

In summary, we showed in a multicenter, open-label, randomized controlled trial with objective endpoints that PLA treatment in HIV-infected adults with moderate or severe facial lipoatrophy achieved only modest increases in facial thickness but not in facial volume. In contrast, patient-perceived benefits were significant in terms of aesthetic improvement and increased well-being, social functioning, and quality of life. PLA does not address fat loss in other body regions. Restoration of lost fat mass is gradual. In the interim, further well-designed comparative studies with objectively assessed endpoints are needed to ascertain the optimal treatment for HIV facial lipoatrophy.


METHODS
Participants
Participants were recruited at 18 clinical sites (primary care, n = 11; hospital outpatient, n = 7) around Australia. Eligible participants had documented HIV-1 infection, were aged at least 18 years, had received combination antiretroviral therapy (ART), and had moderate or severe facial lipoatrophy with lipodystrophy at 1 or more other sites (arms, legs, abdomen, or buttocks). Current ART had to be unchanged for at least 12 weeks, or for subjects not on therapy, there should be no intent to recommence before week 24. Women of child-bearing potential had a negative pregnancy test result and were using contraception. Patients were ineligible if they had an active AIDS-defining illness, HIV wasting syndrome, active herpes labialis, any facial skin disorder, any coagulopathy, or previous treatment for facial lipoatrophy. Anabolic steroids (except testosterone replacement for hypogonadism), oral glucocorticosteroids at greater than replacement dose (7.5 mg of prednisolone daily or equivalent), anticoagulant therapies, growth hormone, or other agents to increase appetite or improve weight were not permitted.

All participants provided written informed consent after approval by each site's local human research ethics committee.

Interventions
The study randomized 100 eligible patients to receive 4 open-label PLA treatments (1 vial [150 mg] per cheek) every 2 weeks with a minimum 14-day interval between treatments commencing at week 0 (immediate group) or after a delay period of 24 weeks (deferred group). The immediate group received bilateral PLA injections at weeks 0, 2, 4, and 6 administered at a single surgical site in each of the 4 participating Australian states according to a common protocol. PLA vials were reconstituted to 5 mL;26 after an infraorbital nerve block (1 mL of lignocaine 2% with adrenaline), aliquots of 0.1 to 0.3 mL were deposited deep into the subcutaneous tissue in a predefined buccal area below the orbital margin (Fig. 1). After administration of the contents of 1 vial into each cheek, the injected areas were massaged firmly to promote even distribution of PLA. Participants were instructed to repeat the massage procedure 3 times daily for at least 3 days after each treatment. Management guidelines for PLA-related adverse events included treatment delay or termination. PLA cessation was mandatory for grade 4 (very severe or life-threatening) events considered definitely, probably, or possibly related to PLA. Antiretroviral drug substitution was permitted for on-study adverse events or virologic failure. Randomization using minimization was performed by a single statistician at the National Centre in HIV Epidemiology and Clinical Research (NCHECR), Sydney, Australia, and was stratified by age, facial lipoatrophy severity, current protease inhibitor (PI) use, current thymidine analogue reverse transcriptase inhibitor (tNRTI) use, and surgeon. Lipoatrophy severity was assessed and scored by physical examination and patient report.27,28 Additionally, patient and physician assessment of facial lipoatrophy severity was made using a validated facial lipodystrophy picture scale (0 = normal, 1 = mild, 2 = moderate, and 3 = severe) with accompanying descriptions and facial diagrams,18 as described previously.27,28

Assessments
At screening, demographic details, ART, and concomitant medication were recorded. Participants were seen at week -1, at weeks 1, 3, 5, and 7 for postprocedure and safety review if in the immediate arm, and at weeks 12 and 24. Safety assessments included clinical adverse events, physical examination, concomitant drugs, complete blood cell count and coagulation screen, plasma HIV-1 RNA and T-lymphocyte subsets, and serum _-human chorionic gonadotrophin (pregnancy test) in women. At screening and week 24, spiral CT of the head was performed to quantify total FSTV of the region defined superiorly by the midorbit and inferiorly by the angle of mandible according to a common protocol. Participants were positioned supine and scanned parallel to the hard palate without gantry tilt. After spiral acquisition, 61 symmetric images were created in the axial plane at 1-mm thickness such that the middle image (image 31) was parallel to and at the level of the hard palate. Using the axial data and protocol-defined bony landmarks, 4 images were identified; using the measurement tool, bilateral baselines were then drawn on them as follows: symphysis mentis to the lateral aspect of each temporomandibular joint; anterior nasal spine to the lateral aspect of the ramus of each mandible; most anterior part of the bony nasal septum to the anterior aspect of the maxillary antrum; and lateral aspect of the temporal bone at the level of the optic nerve. The maximum distance from each baseline to the skin line was recorded as the mandible, base of nasal septum, maxilla, and orbit measurements, respectively (see Fig. 1). Volumetric assessment was performed using 3-dimensional (3-D) postprocessing software. A protocol-defined rectangular region of interest was defined on image 31 (midslice) and by use of appropriate Hounsfield units volumetric soft tissue measurements obtained. All baseline CT scans, linear measurements, and soft tissue volumes were quality reviewed at a single radiology site to ensure adherence to the common protocol, and any not considered adequate were repeated.

Body composition was measured by dual-energy x-ray absorptiometry (DEXA) at screening and week 24 to determine total and regional body fat and lean tissue (apart from the head) according to a standard protocol.4,28 Other objective body composition measures were weight, body mass index (BMI), and hip and waist circumferences. Subjective measures of lipodystrophy severity were recorded independently by clinicians and patients at screening and weeks 12 and 24. For each body region, a standardized scoring system (0 = none, 1 = mild, 2 = moderate, and 3 = severe) was assigned.28,29

Health-related quality of life was self-reported at week -1 and then at weeks 12 and 24 using the Short Form (SF)-36v2 Health Survey.30 The Multidimensional Body-Self Relations Questionnaire-Appearance Scales (MBSRQ-AS), a standardized measure of body image attitudes, assessed self-satisfaction with appearance and weight.31 Antiretroviral adherence was assessed using a standardized self-report form.32 Participants recorded whether they took all, most, about half, very few, or none of their pills during the preceding 7 days.

Statistical Analysis
The study had 80% power to detect an absolute difference of 25% in the proportion of participants with a clinically relevant change in FSTV between the immediate and deferred arms at 24 weeks using intention-to-treat analysis. We hypothesized that no more than 10% of deferred participants would show a clinically relevant improvement in soft tissue volume over 24 weeks, a more conservative estimate than earlier data.18 Analysis of the randomized comparison was performed when all randomized participants had completed 24 weeks of follow-up or had permanently withdrawn from follow-up. Baseline characteristics were summarized without formal comparison of the randomized groups.

All efficacy analyses compared the randomized treatment groups in terms of change from baseline to week 24 on an intention-to-treat basis and included all participants with baseline data and at least 1 follow-up assessment. Primary efficacy analyses adopted a last-value-carried-forward approach for participants lost to follow-up. Secondary analyses used only available data. Continuous endpoints were investigated using analysis of variance or nonparametric equivalents and binary endpoints assessed by _2 tests or logistic regression. All significance tests were 2-sided and not adjusted for multiple comparisons.

Serious adverse events, adverse events associated with PLA or leading to changes in ART, and all grade 3 or 4 clinical adverse events were summarized by treatment group. Events associated with PLA modification or cessation were summarized. An antiretroviral adherence score was calculated as described previously.33 Subgroup analyses were based on the following strata: age, patient-assessed facial lipoatrophy severity, baseline PI and thymidine nucleoside analogue use, and surgeon. Differences in outcome between the randomized treatment arms were assessed with tests of interaction between treatment and strata.

Univariate linear regression and multivariate linear regression were used to determine predictors of efficacy in PLA recipients, as assessed by change in facial volume at week 24, and predictors of safety, as determined by PLA cessation for toxicity or grade 3 or 4 adverse events. Post hoc analysis was performed to assess additional predictors of efficacy assessed by change in facial linear measurements at the maxilla and base of nasal septum levels at week 24. The following variables were assessed as predictors: baseline demographic characteristics, antiretroviral treatment, baseline CD4 cell count and HIV-1 viral load, smoking status, skin tanning type (Fitzpatrick scale),34 baseline limb fat mass and percent, and change in limb fat mass and percent at week 24 as assessed by DEXA. The final predictive model was determined using forward-stepwise regression. Variables with a univariate P value ≤0.1 were assessed in multivariate analysis.

RESULTS
Over a 6-week period during December 2005, and January 2006, 104 patients were screened and 101 participants randomized (see Fig. 2). One participant withdrew consent (patient choice) after randomization and was excluded from analysis. Most (92%) participants were men, 35 (35%) had AIDS, all were receiving ART, 65 were receiving a PI, and 14 were receiving a tNRTI (Table 1). Almost all (96%) participants rated their antiretroviral adherence as optimal (>95%). Self-assessed facial lipoatrophy was severe in 51 (26 immediate and 25 deferred) participants. Agreement between physical examination and self-assessed facial lipoatrophy severity was moderate (_ = 0.50). Mean baseline FSTV was 388 ± 71 cm3 in the immediate group and 393 ± 69 cm3 in the deferred group (see Table 1).

Safety bloods (complete blood cell count and coagulation screen) collected within 7 days of treatment initiation indicated that all immediate participants could proceed safely with PLA injections. Of the 50 immediate participants, 49 (98%) received 4 bilateral PLA treatments. One participant required only 1 treatment (2 vials) for adequate facial correction. Twenty-one antiretroviral drugs were stopped in 15 (15%) participants (6 immediate and 9 deferred). Most (62%) changes were within-class substitutions; 60% of these were for regimen simplification, with lamivudine (8 participants [5 immediate and 3 deferred]) and didanosine (3 participants [1 immediate and 2 deferred]) most commonly ceased. No participant ceased PI therapy or tNRTI therapy. There was no death or new AIDS-defining event. There was 1 screening protocol violation in the control arm. The patient had an HIV-1 RNA viral load in excess of 750,000 (5.88 log) copies/mL immediately before screening and commenced a new PI-containing regimen at week 6. No participant commenced any prohibited concomitant medication. Data for 100 participants (50 immediate and 50 deferred) were available for the intention-to-treat-analysis.

Efficacy: Objective Measures
PLA did not increase FSTV (Table 2). At week 24, the mean change in FSTV was 0 (95% confidence interval [CI]: -14 to 13) cm3 in the immediate group and -10 (95% CI: -22 to 1) cm3 in the deferred group, a difference of 10 (95% CI: -7 to 28) cm3 (P = 0.24). These represent changes of 0% and -3%, respectively, in FSTV. At week 24, 16% of the immediate group and 10% of the deferred group had a >10% increase in FSTV (P = 0.37). Treatment efficacy assessed by change in FSTV at week 24 did not differ significantly between any subgroup (data not shown).

The immediate group had a significantly greater mean change in tissue depth at the maxilla and base of nasal septum levels relative to the deferred group (2.2 [95% CI: 1.6 to 2.9] mm, P < 0.0001 and 1.0 [95% CI: 0.3 to 1.6] mm, P = 0.003, respectively). Facial thickness at the untreated orbit and mandibular levels was not increased by PLA. PLA therapy did not significantly affect any other objective body composition parameter, plasma viral load, or CD4 lymphocyte counts (see Table 2). Self-reported ART adherence was not different, with 96% of both groups reporting >95% adherence at week 24 (P = 1.0).

Analyses to investigate predictors of efficacy yielded inconsistent data. In multivariate analysis, significant predictors of a greater increase in FSTV at week 24 were prior AIDS (P = 0.002) and current PI therapy (P < 0.0001). Predictors of a greater increase in facial thickness at the maxillary level were Fitzpatrick skin types IV to VI (P = 0.035) and an improvement in limb fat from baseline to week 24 (P = 0.072). At the base of the nasal septum level, there was a trend for a greater increase in facial thickness to be associated with a limb fat increase between baseline and week 24 (P = 0.059).

Efficacy: Subjective Measures
Facial lipoatrophy severity was perceived as improved in 45 (90%) PLA recipients compared with 18% in the deferred group (P < 0.0001) at week 12 and in 84% and 18%, respectively, at week 24 (P < 0.0001). At week 12, clinicians perceived a reduction in severity in 90% of the immediate group, with no change or a worsening in 80% of deferred participants (P < 0.0001). At week 24, 86% of PLA recipients were perceived to have improved compared with 20% in the deferred group (P < 0.0001; Fig. 3). There was a significant association between self-assessed change in facial lipoatrophy severity and objectively assessed change in facial thickness at the maxilla level (P = 0.026) and a borderline association with change in thickness at the base of nasal septum (P = 0.079) (Fig. 4). There was no difference in any other clinician- or patient-assessed subjective measure of lipodystrophy or its severity at week 12 or 24.

At week 12, the mean change from baseline in the score for the Mental Health scale of the SF-36 Health Survey scale in PLA recipients was significantly different from the mean change in the deferred group (2.8 and -3.2, respectively; P = 0.026). At week 24, the mean change in scores for Social Functioning and Mental Health in the immediate group differed significantly from mean changes in the deferred group (P = 0.031 and P = 0.047, respectively; Fig. 5). Although the mean score for 5 SF-36 scales increased in the immediate group, the mean score for all 8 scales decreased in the deferred group. Additionally, the mean change in the Mental Health Component Summary score differed significantly in the immediate group relative to the deferred group (P = 0.048), but there was no difference in the Physical Component Summary score (P = 0.98) or in any of the scales associated with physical functioning. Body self-image assessed using the MBSRQ-AS showed that the mean change in appearance evaluation and body areas satisfaction subscale scores in the immediate group was significantly different from scores in the deferred group (0.19 and -0.03, P = 0.040 and 0.29 and -0.12, P < 0.0001, respectively) at week 12 and at week 24 (0.15 and -0.15, P = 0.010 and 0.19 and -0.11, P = 0.0004, respectively).

Safety/Tolerability
Forty-eight (96%) PLA recipients experienced at least 1 procedure/product-related adverse event, with pain/discomfort (76%), localized edema (64%), and erythema (53%) reported most commonly (Table 3). Most events were grade 1 or 2 and were of short duration (median = 2 [interquartile range [IQR]: 1 to 3] days). No treatment was delayed or terminated for adverse events, surgical or clinical discretion, or patient wish. At week 24, there were 4 palpable and 1 visible ongoing subcutaneous noninflammatory nodules and 1 papule at the injection site in 6 participants (12%). These events were noted at the injection site 5 to 19 weeks after the first injection. Five serious adverse events were reported in 4 participants: 3 events (epidural abscess, surgery to resect renal tumor, and hospitalization for lower lobe pneumonia) in the immediate group (2 participants) and 2 events (surgery for perianal abscess and acute renal retention) in the deferred group (2 participants). None of these events was associated with PLA. Additionally, no other grade 4 event was considered definitely, probably, or possibly related to PLA.



**************************************
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#23538 From: PoWeRTX@...
Date: Thu Nov 29, 2007 11:51 pm
Subject: World AIDS Day Never About Gays; JAMA Slams Gays for Alleged Silence
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I donot  agree with a lot of this, but interesting reading

Regards,

Nelson Vergel
powerusa dot org




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#23537 From: PoWeRTX@...
Date: Thu Nov 29, 2007 11:43 pm
Subject: Having preoblems with Sustiva (Atripla) nightmares? Get genetic testing!
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Genetic testing helps tailor efavirenz dose in HIV-infected patients
Tuesday, November 27, 2007
Certain patients with HIV infection who are carriers of cytochrome P450 2B6 6* and *26 can successfully reduce their efavirenz dose to diminish adverse effects but still maintain high plasma concentrations of the drug.

NEW YORK (Reuters Health) Nov 27 - Certain patients with HIV infection who are carriers of cytochrome P450 2B6 6* and *26 can successfully reduce their efavirenz dose to diminish adverse effects but still maintain high plasma concentrations of the drug, Japanese researchers report in the November 1st issue of Clinical Infectious Diseases.

"Our study shows that CYP2B6 genotype-based personalized therapy can reduce patients' adverse effects induced by efavirenz," lead investigator Dr. Hiroyuki Gatanaga told Reuters Health. "Actually," he added, "many of our patients who reduced their efavirenz dosage realized that their quality of life has been improved dramatically and they hate to re-increase the dosage."

Dr. Gatanaga of the International Medical Center of Japan, Tokyo and colleagues determined CYP2B6 genotypes in 456 HIV-positive patients receiving or scheduled to receive the agent.

Patients with the polymorphisms who had high plasma concentrations of efavirenz on the standard 600-mg dose had that dosage reduced. Treatment-naive patients with the polymorphisms were started on reduced doses.

The investigators observed that 17.9% of the subjects were carriers of CYP2B6 *6/*6 and 1.3% carried the novel CYB2B6 *6/*26. All had extremely high concentrations on standard drug dosages. In patients with persistently suppressed viral loads, dosage was successfully reduced to as low as 200 mg.

CNS related symptoms, such as dizziness, strange dreams, depression and irritability were reduced in 10 of 14 patients, although a number of patients were initially unaware of having such symptoms.

Along with relieving symptoms, the researchers suggest that an efavirenz dose reduction may also decrease the risk of developing resistance after mandatory treatment discontinuations.

However, the team stresses that along with dose reduction, "careful monitoring is necessary until larger studies confirm the safety of reduced dose in such specific genotype carriers."

Clin Infect Dis 2007;45:1230-1237.

 

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#23536 From: PoWeRTX@...
Date: Thu Nov 29, 2007 11:37 pm
Subject: Check out AIDSVote
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#23535 From: PoWeRTX@...
Date: Thu Nov 29, 2007 11:35 pm
Subject: TMC 125+ Prezista+ Celsentry interactions
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Some of you may be thinking about this combo with or without  Isentress
 
 
An Open, Randomized, Two-Period, Crossover Study in Two Cohorts to Investigate the Effect of Steady-State TMC125 (etravirine) and the Combination of TMC125/Darunavir/Ritonavir on the Steady-State Pharmacokinetics of Oral Maraviroc in Healthy Subjects
 
 
  Reported by Jules Levin
11th European AIDS Conference / EACS
Madrid, Spain, 24-27 October 2007
 
J Davis1, M Sch_ller-Gyyre2, TN Kakuda3, C Ridgway1, S Tweedy1, N Ndongo4, W Petit4 1Pfizer Global Research and Development, Sandwich, UK; 2Tibotec BVBA, Mechelen, Belgium; 3Tibotec, Inc., Yardley, PA, USA; 4Pfizer Clinical Research Unit, Brussels, Belgium
 
BACKGROUND
The MOTIVATE 1 and 2 studies showed that combining maraviroc (CELSENTRI¨), a novel CCR5 antagonist, with optimized background therapy significantly enhances virological suppression and the increase in CD4+ cell count in treatment-experienced patients at 48 weeks.1,2 However, co-administration of maraviroc with other drugs carries a risk of drug-drug interactions.
⋅ Preclinical data suggest that maraviroc is a substrate for cytochrome P450 (CYP3A4) and P-glycoproteins (P-gp).3,4 Therefore, modulators of these enzymes/transporters can affect the pharmacokinetics of maraviroc.5,6
⋅ TMC125 (etravirine; developed by Tibotec), a next generation non-nucleoside reverse transcriptase inhibitor, is an inducer of CYP3A4 and has P-gp inhibitory properties. Therefore, TMC125 may reduce maraviroc exposure.
⋅ The protease inhibitor (PI) darunavir (DRV; developed by Tibotec) is a potent inhibitor of CYP3A4 and is co-prescribed with low-dose ritonavir (/r), itself a potent inhibitor and inducer of several cytochrome P450 enzymes and a P-gp inhibitor. When such combinations of inducers and inhibitors are co-administered in humans, the net effect is CYP3A4 inhibition. As such, a 50% dose reduction of maraviroc (i.e. 150 mg BID) is currently recommended in the presence of boosted PIs and other potent CYP3A4 inhibitors.
 
OBJECTIVES
The primary objectives of this study were to investigate the effects of TMC125 at steady-state on the steady-state pharmacokinetics of maraviroc, either alone or in combination with DRV/r at steady-state, in order to provide optimal dose recommendations for maraviroc when these drugs are co-administered in clinical practice.
 
Author Summary of findings
⋅ Analysis of maraviroc pharmacokinetics suggests that TMC125 reduces maraviroc exposure but when co-administered with DRV/r, the exposure of maraviroc is increased.
⋅ The exposures of TMC125, DRV and ritonavir were similar to historical data, suggesting maraviroc has no effect on either TMC125 or DRV/r.7-9
⋅ There were few treatment-related adverse events, all of which were mild to moderate in severity, and no clinically significant changes in laboratory tests, vital signs or ECGs
 
Author Conclusions
⋅ Short-term co-administration of maraviroc with TMC125 and DRV/r was well tolerated and no safety concerns were raised.
⋅ When maraviroc is co-administered with TMC125 in the absence of potent CYP3A4 inhibitors such as boosted Pls (i.e. DRV/r) exposure is reduced and the recommended maraviroc dose is 600 mg BID.
⋅ Maraviroc exposure is increased when co-administered with TMC125 and DRV/r, and as such, the recommended dose of maraviroc is 150 mg BID, consistent with previous reported data for boosted PIs.7
 
METHODS
⋅ This study was an open, randomized, two-period, crossover study in two cohorts, each of 14 healthy subjects aged 18-55 years. The protocol and informed consent documentation were reviewed and approved by the Independent Ethics Committee and all subjects gave written informed consent.
 
⋅ For each cohort, the study consisted of:
_ a screening visit up to 28 days before the start of dosing
_ two treatment periods (one lasting 20 days, the other lasting 10 days)
_ a minimum wash-out period of 14 days between treatment periods
_ a follow-up visit 7-10 days after the last dose of study drug.
 
Cohort 1a (n=7) recd TMC125mg bid for 10 days, then TMC125 200mg bid+ MVC 300mg bid for 10 days. There was a 14-day washout, then MVC 300mg bid.
 
Cohort 2a (n=7) recd TMC125 200mg bid+ DRV 600/100 mg bid for 10 days, then TMC125 200mg bid+ DRV 600/100mg bid+ MVC 150mg bid. There was a 14-day washout, then MVC 150mg bid.
 
Cohort 1b (n=7) recd MVC 300mg bid. There was a 14 day washout, then TMC125 200mg bid for 10 days; then, TMC125 200mg bid+ MVC 300mg bid.
 
Cohort 2b (n=7) recd MVC 150mg bid. There was a 14-day washout, then TMC125 200mg bid+ DRV 600/100mg bid for 10 days; then, TMC125 200mg bid+ DRV 600/100mg bid+ MVC 150mg bid.
 
⋅ All subjects were fasted for at least 2 hours prior to, and 1 hour after, maraviroc dosing. All TMC125, DRV and ritonavir doses were administered 15 minutes after a standard meal and no more than 5 minutes apart. Subjects were not allowed to consume grapefruit-containing products from 7 days prior to the first dose of study drug until collection of the blood sample.
 
⋅ Serial blood samples were collected for maraviroc pharmacokinetics analysis prior to dosing on Days 11-19 and then from 0-12 hours following maraviroc dosing on Day 20 in the 20-day treatment period; or on Days 1-9 and then from 0-12 hours following maraviroc dosing on Day 10 in the 10-day treatment period. Blood samples for TMC125, DRV and ritonavir pharmacokinetics analysis were collected on Days 6-9 prior to maraviroc dosing and from 0-12 hours post maraviroc dosing on Days 16-19.
 
⋅ Urine samples were collected just prior to maraviroc dosing on Day 10 or 20, depending on the study period, in order to assess urine maraviroc pharmacokinetic parameters.
 
⋅ Cmax, Tmax, Cmin and AUC12 (AUC of the dosing interval) were calculated for maraviroc, TMC125, DRV and ritonavir on Day 10 or 20, as appropriate. ⋅ Safety and tolerability data were collected throughout the study.
 
Results
 
⋅ Co-administration of TMC125 decreased the exposure of maraviroc by 53%, 60% and 39% for AUC12, Cmax and Cmin, respectively, compared with maraviroc alone (Figure 2, Tables 1 & 2).
 
⋅ Analysis of maraviroc pharmacokinetics suggests that co-administration of TMC125 + DRV/r with maraviroc increased the exposure of maraviroc (Figure 1, Tables 1 & 3); maraviroc AUC12, Cmax and Cmin increased by 210%, 77% and 427%, respectively, compared with maraviroc alone (Figure 2, Table 1).
 
⋅ Mean Tmax were similar for all treatments (Table 1).
 
⋅ Maraviroc did not affect TMC125 (Table 4), DRV or ritonavir pharmacokinetics (data not shown).
 
⋅ The amount of maraviroc in the urine was reduced when co-administered with TMC125 and increased when co-administered with TMC125 + DRV/r (Table 5).
 
⋅ There were no deaths or serious adverse events. Treatment-related adverse events were most common in subjects receiving maraviroc (150 mg) with TMC125 + DRV/r. All reported adverse events were mild to moderate in severity.
 
⋅ Four subjects discontinued treatment with maraviroc (150 mg) + TMC125 + DRV/r due to maculopapular rash of moderate severity, which was not seen when maraviroc was given alone or in combination with only TMC125. Discontinuation was permanent in two of these subjects; in the other two cases, the outcome was resolved and discontinuation was therefore only temporary.
 
⋅ There were no clinically significant changes in laboratory tests, vital signs or ECGs.
 

Maravo-1.gif

Stat-2.gif

Mean5-3.gif

renal-4.gif

References
1. Lalezari J, et al. 47th ICAAC, Chicago, USA, 17-20 September 2007. Presentation H-718a.
2. Fatkenheuer G, et al. 11th EACS, Madrid, Spain, 24-27 October 2007. Presentation PS3/5.
3. Abel S, et al. 6th Int Workshop Clin Pharmacol HIV Ther, Quebec, Canada, 28-30 April 2005. Abstract 76.
4. Abel S, et al. 7th Int Workshop Clin Pharmacol HIV Ther, Lisbon, Portugal, 20-22 April 2006. Abstract 77.
5. Jenkins T, et al. 5th Int Workshop Clin Pharmacol HIV Ther, Rome, Italy, 1-3 April 2004. Abstract 5.4.
6. Abel S, et al. 5th Int Workshop Clin Pharmacol HIV Ther, Rome, Italy, 1-3 April 2004. Abstract 5.8.
7. Abel S, et al. 8th Int Workshop Clin Pharmacol HIV Ther, Budapest, Hungary, 16-18 April 2007. Abstract 55.
8. Scholler-Gyure M, et al. 47th ICAAC, Chicago, USA, 17-20 September 2007. Poster A-1427.
9. Scholler-Gyure M, et al. Antiv Ther 2007; 12:789-796.
 
 

Regards,

Nelson Vergel
powerusa dot org




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#23534 From: PoWeRTX@...
Date: Thu Nov 29, 2007 6:43 pm
Subject: AFH Fundraiser in Houston
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HIV/AIDS Prevention Education
prepared me for life.

- ANONYMOUS

World AIDS Day Graphic

 We invite you
to an
Opening World AIDS Day Champagne Reception
Featuring Guest Speaker
Carson Kressley
from "Queer Eye for the Straight Guy"

The Corinthian
202 Fannin Street
Friday, November 30
10:45 a.m
. Champagne Reception
11:30 a.m. Luncheon

Complimentary valet parking will be available at 10:15 a.m.

Please RSVP to  Lydia Murray  via email or by calling (713) 623-6796 x 278.

AFH Logo

 

 




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#23533 From: PoWeRTX@...
Date: Thu Nov 29, 2007 6:45 pm
Subject: Fwd: NATAP: Worlds AIDS Day Statement from NIH/OAR
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_______________________________________________


Joint Statement from Drs. Elias Zerhouni, Jack Whitescarver, and Anthony Fauci of the National Institutes of Health on World AIDS Day
NIH Announces 2007 World AIDS Day Award Recipients

Thursday, November 29, 2007

On December 1, the National Institutes of Health (NIH) joins with people around the globe in commemorating World AIDS Day. More than 25 million men, women and children have already died, and an estimated 33.2 million people around the world are currently living with HIV infection. Last year alone, an estimated 2.5 million new HIV infections occurred worldwide, and 2.1 million people died from AIDS.

Dr. Jack Whitescarver, NIH Associate Director for AIDS Research and director of the Office of AIDS Research (OAR), states, "On World AIDS Day, we confirm our commitment to the global fight against HIV/AIDS. This pandemic continues to wreak devastating consequences in every sector of society, affecting the stability of families and entire communities with profound economic and national security consequences."

This year, the U.S. Department of Health and Human Services has adopted the World AIDS Day theme of "The Power of Partnerships" to remind us all - scientists, clinicians, policymakers, activists, communities, families, clinical study volunteers and individuals living with HIV - that only by working together can we bring an end to HIV/AIDS. NIH has established research partnerships with research institutions, non-governmental organizations, governments, industry, foundations, and representatives of affected communities in the United States and around the world.

"On World AIDS Day, we applaud the heroic efforts of researchers and clinical trial participants who have devoted their time and energy to helping us find effective ways to prevent HIV/AIDS and new treatments to help those already infected," says National Institutes of Health (NIH) Director Elias Zerhouni, M.D. "Although much work remains to be done in the fight against HIV, we remain committed to developing new and improved strategies to control and defeat this virus."

Since the first cases of what is now known as AIDS were first reported in the United States more than a quarter century ago, the NIH has established the largest and most significant AIDS research program in the world, a comprehensive trans-NIH research effort. NIH supports and conducts basic, clinical and behavioral research designed to better understand the biology of HIV and how it affects the body, develop effective new therapies to treat and control the virus, and design interventions aimed at preventing new infections.

"The world is at a pivotal stage in combating HIV/AIDS," says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), a component of the NIH. "Although there have been substantial scientific advances in terms of effective HIV treatments and methods to prevent HIV transmission, the virus continues to spread, and many people still die needlessly."

NIH-funded research established the foundation for the discovery and development of antiretroviral therapies and regimens that have resulted in improved quality of life and life expectancy for those with access to these drugs. In addition, NIH research has developed treatments for HIV-associated co-infections and co-morbidities, including malignancies, neurological complications, tuberculosis, and other clinical manifestations. NIH research has also made a number of advances in HIV prevention, including the demonstration that medically supervised circumcision of adult men can reduce risk of heterosexual HIV acquisition. Although HIV vaccine research experienced a recent setback with the failure of the Merck vaccine candidate in the STEP clinical study, NIH remains committed to developing a safe and effective HIV vaccine.

"Vaccines have always been the cornerstone in fighting infectious diseases," says Dr. Fauci. "We will continue a vigorous vaccine research agenda despite the fact that a promising vaccine candidate recently did not work. Other vaccine strategies are in development, and we are learning from the STEP study and using those findings to move HIV vaccine research forward."

In addition to a continued NIH commitment to finding an HIV vaccine, researchers are also examining new, evidence-based approaches to HIV prevention, including topical anti-HIV gels or creams that could be applied prior to sexual intercourse, as well as preventive regimens of antiretroviral medicines. The intent is to create a toolbox of effective HIV preventive measures, including a vaccine, which can stop the global scourge of HIV/AIDS.

NIH World AIDS Day Awards

To recognize the important contributions that NIH scientists have made to AIDS research, the OAR and NIAID established the NIH World AIDS Day Awards. The recipients of the second annual NIH World AIDS Day Awards were announced today. These scientists and managers have made exceptional contributions to the AIDS research efforts at NIH - either for original scientific research or for programmatic support for research. The individuals selected for the 2007 honor are:

Daniel Douek, M.D., Ph.D. and Richard Koup, M.D., of the Dale and Betty Bumpers Vaccine Research Center of the National Institute of Allergy and Infectious Diseases - a joint award for their original scientific research that significantly contributed to determining the mechanisms that control HIV pathogenesis and immune reconstitution. Their landmark findings have led the field in understanding the role of HIV-specific T cells in the control of HIV infection and helped to establish the immunological basis for the future development of an AIDS vaccine.

Kenneth Bridbord, M.D., M.P.H., of the Fogarty International Center - for his efforts to develop innovative programs to build a cadre of international research scientists and clinicians trained to join the global fight against the AIDS pandemic. These programs have played a significant role in building research infrastructure and capacity for the conduct of basic and clinical biomedical and behavioral AIDS research in more than 100 nations around the world.

"These awards demonstrate the NIH commitment to supporting a multifaceted research effort in HIV/AIDS, with the goal of fostering the best minds to work together as partners to develop new medical tools to stop the devastating effects of the disease around the world," says Dr. Zerhouni.

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies. NIAID AIDS Information can be found at <http://www3.niaid.nih.gov/healthscience/healthtopics/HIVAIDS/publications.htm>.

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices, which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at <http://www.nih.gov/icd/od/>.
The Office of AIDS Research, part of the Office of the Director, is responsible for coordinating the scientific, budgetary and policy elements of the NIH AIDS program.

Federal HIV/AIDS treatment and prevention guidelines and clinical trials information can be found at <http://aidsinfo.nih.gov/>. Additional information about AIDS research can be found at <http://aids.gov/research/index.html>. <AIDS.gov> is the information gateway to Federal domestic HIV/AIDS information and resources.

The National Institutes of Health (NIH) - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.


 

Regards,

Nelson Vergel
powerusa dot org




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NATAP http://natap.org/
_______________________________________________
Joint Statement from Drs. Elias Zerhouni, Jack Whitescarver, and Anthony Fauci of the National Institutes of Health on World AIDS Day
NIH Announces 2007 World AIDS Day Award Recipients

Thursday, November 29, 2007

On December 1, the National Institutes of Health (NIH) joins with people around the globe in commemorating World AIDS Day. More than 25 million men, women and children have already died, and an estimated 33.2 million people around the world are currently living with HIV infection. Last year alone, an estimated 2.5 million new HIV infections occurred worldwide, and 2.1 million people died from AIDS.

Dr. Jack Whitescarver, NIH Associate Director for AIDS Research and director of the Office of AIDS Research (OAR), states, "On World AIDS Day, we confirm our commitment to the global fight against HIV/AIDS. This pandemic continues to wreak devastating consequences in every sector of society, affecting the stability of families and entire communities with profound economic and national security consequences."

This year, the U.S. Department of Health and Human Services has adopted the World AIDS Day theme of "The Power of Partnerships" to remind us all - scientists, clinicians, policymakers, activists, communities, families, clinical study volunteers and individuals living with HIV - that only by working together can we bring an end to HIV/AIDS. NIH has established research partnerships with research institutions, non-governmental organizations, governments, industry, foundations, and representatives of affected communities in the United States and around the world.

"On World AIDS Day, we applaud the heroic efforts of researchers and clinical trial participants who have devoted their time and energy to helping us find effective ways to prevent HIV/AIDS and new treatments to help those already infected," says National Institutes of Health (NIH) Director Elias Zerhouni, M.D. "Although much work remains to be done in the fight against HIV, we remain committed to developing new and improved strategies to control and defeat this virus."

Since the first cases of what is now known as AIDS were first reported in the United States more than a quarter century ago, the NIH has established the largest and most significant AIDS research program in the world, a comprehensive trans-NIH research effort. NIH supports and conducts basic, clinical and behavioral research designed to better understand the biology of HIV and how it affects the body, develop effective new therapies to treat and control the virus, and design interventions aimed at preventing new infections.

"The world is at a pivotal stage in combating HIV/AIDS," says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), a component of the NIH. "Although there have been substantial scientific advances in terms of effective HIV treatments and methods to prevent HIV transmission, the virus continues to spread, and many people still die needlessly."

NIH-funded research established the foundation for the discovery and development of antiretroviral therapies and regimens that have resulted in improved quality of life and life expectancy for those with access to these drugs. In addition, NIH research has developed treatments for HIV-associated co-infections and co-morbidities, including malignancies, neurological complications, tuberculosis, and other clinical manifestations. NIH research has also made a number of advances in HIV prevention, including the demonstration that medically supervised circumcision of adult men can reduce risk of heterosexual HIV acquisition. Although HIV vaccine research experienced a recent setback with the failure of the Merck vaccine candidate in the STEP clinical study, NIH remains committed to developing a safe and effective HIV vaccine.

"Vaccines have always been the cornerstone in fighting infectious diseases," says Dr. Fauci. "We will continue a vigorous vaccine research agenda despite the fact that a promising vaccine candidate recently did not work. Other vaccine strategies are in development, and we are learning from the STEP study and using those findings to move HIV vaccine research forward."

In addition to a continued NIH commitment to finding an HIV vaccine, researchers are also examining new, evidence-based approaches to HIV prevention, including topical anti-HIV gels or creams that could be applied prior to sexual intercourse, as well as preventive regimens of antiretroviral medicines. The intent is to create a toolbox of effective HIV preventive measures, including a vaccine, which can stop the global scourge of HIV/AIDS.

NIH World AIDS Day Awards

To recognize the important contributions that NIH scientists have made to AIDS research, the OAR and NIAID established the NIH World AIDS Day Awards. The recipients of the second annual NIH World AIDS Day Awards were announced today. These scientists and managers have made exceptional contributions to the AIDS research efforts at NIH - either for original scientific research or for programmatic support for research. The individuals selected for the 2007 honor are:

Daniel Douek, M.D., Ph.D. and Richard Koup, M.D., of the Dale and Betty Bumpers Vaccine Research Center of the National Institute of Allergy and Infectious Diseases - a joint award for their original scientific research that significantly contributed to determining the mechanisms that control HIV pathogenesis and immune reconstitution. Their landmark findings have led the field in understanding the role of HIV-specific T cells in the control of HIV infection and helped to establish the immunological basis for the future development of an AIDS vaccine.

Kenneth Bridbord, M.D., M.P.H., of the Fogarty International Center - for his efforts to develop innovative programs to build a cadre of international research scientists and clinicians trained to join the global fight against the AIDS pandemic. These programs have played a significant role in building research infrastructure and capacity for the conduct of basic and clinical biomedical and behavioral AIDS research in more than 100 nations around the world.

"These awards demonstrate the NIH commitment to supporting a multifaceted research effort in HIV/AIDS, with the goal of fostering the best minds to work together as partners to develop new medical tools to stop the devastating effects of the disease around the world," says Dr. Zerhouni.

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies. NIAID AIDS Information can be found at <http://www3.niaid.nih.gov/healthscience/healthtopics/HIVAIDS/publications.htm>.

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices, which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at <http://www.nih.gov/icd/od/>.
The Office of AIDS Research, part of the Office of the Director, is responsible for coordinating the scientific, budgetary and policy elements of the NIH AIDS program.

Federal HIV/AIDS treatment and prevention guidelines and clinical trials information can be found at <http://aidsinfo.nih.gov/>. Additional information about AIDS research can be found at <http://aids.gov/research/index.html>. <AIDS.gov> is the information gateway to Federal domestic HIV/AIDS information and resources.

The National Institutes of Health (NIH) - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.



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#23532 From: PoWeRTX@...
Date: Thu Nov 29, 2007 6:28 pm
Subject: LGV, something you guys should know about
nelsonvergel
Offline Offline
Send Email Send Email
 
 
 
I have met several people that have had gut problems for months not knowing it was LGV. Check your lymph nodes close to your crotch and if you have any swelling of your anal area. If left untreated, the lymph nodes erupt like big boils...not pretty.  It is treated with heavy-duty antibiotics.
CATIE News – After LGV treatment—STIs return
 
In 2003, reports emerged from the Netherlands about a strain of Chlamydia that causes a disease called LGV—lymphogranuloma venereum.
 
Before this, LGV was uncommon in high-income countries. But the initial report from the Netherlands was followed by similar cases in other Western European countries and later Australia, the United States and Canada. Nearly all of the cases have been among men who had sex with men (MSM), many of whom also had HIV.
 
If left untreated, LGV can cause serious, painful complications because of scarring inside the penis, scrotum and rectum. LGV can also damage lymph nodes and vessels. The sores caused by LGV in the rectum can also allow other germs—such as those that cause hepatitis, syphilis and gonorrhea—to invade the body.
 
The current outbreak of LGV in high-income countries seems to be spread by unprotected anal sex. Further details about LGV transmission appear later in this bulletin.
 
Signs and symptoms
Initially, a small, painless sore on the genitals may appear within 3 to 30 days after exposure to LGV. This quickly disappears. Later, the germs that cause LGV spread from the genitals to nearby lymph nodes, causing some to swell painfully.
 
In other cases, persistent rectal ulcers and inflammation can occur. This can lead to rectal bleeding and painful bowel movements, constipation and rectal discharge.
 
In addition to these symptoms, LGV germs can travel beyond the genitals, causing the following:
 
* headache
* lack of energy
* fever
weight loss
 
Because symptoms of LGV can mimic those of inflammatory bowel disease, some cases of LGV have been misdiagnosed. The Public Health Agency of Canada (PHAC) notes that routine tests for Chlamydia may come back positive in people with LGV, but these tests do not specifically identify LGV-causing germs.
 
The agency advises that doctors need to request that specific testing for LGV be done on the samples they send. The availability of this type of testing varies across Canada; physicians can contact their local public health unit or provincial laboratory to find out more.
 
Treatment
To help wipe out LGV-causing germs, the recommended first-line treatment is a three-week course of the antibiotic doxycycline 100 mg twice daily. An alternative antibiotic is erythromycin 500 mg four times daily, also for three weeks. Some doctors have used another antibiotic, azithromycin (Zithromax), in cases where doxycycline could not be taken. However, there is no consensus as to the correct dose, schedule and length of therapy for the use of azithromycin against LGV.
 
Focus on infection
To find out exactly how LGV may have been transmitted, several research teams have conducted intensive investigation and questioning of people with LGV. Here are the routes of transmission:
 
* unprotected anal sex
* unprotected insertion of fingers or hands (fisting) into the anus
* sharing of sex toys
 
Also note the following:
 
* HIV positive men seem to be very susceptible to LGV, perhaps because immune defenses in the gut are dysfunctional.
* The use of HAART or having relatively high CD4+ cell counts does not provide protection from LGV.
 
Re-infection
Now researchers in Rotterdam, the Netherlands, have reported some disturbing news:
 
* Some men who have recovered from LGV have been engaging in unprotected intercourse again and catching new sexually transmitted infections (STIs).
 
Study details and results
The Dutch study team reviewed medical records of men who were treated for LGV between 2002 and 2005. The purpose of the study was to assess STIs that may have occurred after treatment for LGV.
 
The team found that out of 26 men who had recovered from LGV, 17 (65%) acquired a new STI shortly after treatment for LGV. Most of these men were already co-infected with HIV and hepatitis B. The most common STI that they later acquired was syphilis.
 
The Dutch team had hoped that since LGV was a serious illness these men would have begun to have protected intercourse after their LGV diagnosis. However, after being treated for LGV some of the men had new rectal infections with other germs, including syphilis.
 
The Dutch doctors stated that these new STIs suggest that “health education efforts need to be stepped up vigorously.” Australian doctors also treating a cluster of LGV cases in Sydney noted that “counselling about healthy sexual practices is [important in the fight against STIs].” Hopefully, reports of STIs in people recovering from LGV are not a harbinger of events to come in Canada and other high-income countries.
 
LGV in Canada
According to PHAC, there have been 88 cases of LGV reported to that agency since 2001. Most of the Canadian cases of LGV occurred after January 2005 and all involved unprotected sex between men who generally did not appear to acquire the infection overseas. Risk behaviours included the following:
 
* unprotected anal sex
* fisting
* sharing of sex toys
* rectal use of crystal meth (crystal methamphetamine)
 
Canadian LGV cases have commonly reported co-infection with the following:
 
* HIV
* hepatitis C virus
* syphilis
 
Recently, reports of LGV in Canada appear to be declining, a trend that will hopefully continue.
 
—Sean R. Hosein
 
REFERENCES:
 
1. Tinmouth J, Rachlis A, Wesson T, et al. Lymphogranuloma venereum in North America: case reports and an update for gastroenterologists. Clinical Gastroenterology and Hepatology 2006 Apr;4(4):469-73.
 
2. Hamill M, Benn P, Carder C, et al. The clinical manifestations of anorectal infection with lymphogranuloma venereum (LGV) versus non-LGV strains of Chlamydia trachomatis: a case-control study in homosexual men. International Journal of STD and AIDS 2007 Jul;18(7):472-5.
 
3. van den Bos RR and van der Meijden WI. Persistent high-risk sexual behaviour in men who have sex with men after symptomatic lymphogranuloma venereum proctitis. International Journal of STD and AIDS 2007 Oct;18(10):715-6.
 
4. van Hal S, Hillman R, Stark DJ, et al. Lymphogranuloma venereum: an emerging anorectal disease in Australia. Medical Journal of Australia 2007 Sep 3;187(5):309-10.
 
5. Public Health Agency of Canada. Lymphogranuloma venereum (LGV) Epi update. 1 September 2007.
 
6. van Nieuwkoop C, Gooskens J, Smit VT, et al. Lymphogranuloma venereum proctocolitis: mucosal T cell immunity of the rectum associated with chlamydial clearance and clinical recovery. Gut 2007 Oct;56(10):1476-7.
 
7. Chase AJ, Sedaghat AR, German JR, et al. Severe Depletion of CD4+ CD25+ Regulatory T Cells from the Intestinal Lamina Propria but Not Peripheral Blood or Lymph Nodes during Acute Simian Immunodeficiency Virus Infection. Journal of Virology 2007 Dec;81(23):12748-57.
 
 
 
 
 
 

Regards,

Nelson Vergel
powerusa dot org




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CATIE News – After LGV treatment—STIs return
 
In 2003, reports emerged from the Netherlands about a strain of Chlamydia that causes a disease called LGV—lymphogranuloma venereum.
 
Before this, LGV was uncommon in high-income countries. But the initial report from the Netherlands was followed by similar cases in other Western European countries and later Australia, the United States and Canada. Nearly all of the cases have been among men who had sex with men (MSM), many of whom also had HIV.
 
If left untreated, LGV can cause serious, painful complications because of scarring inside the penis, scrotum and rectum. LGV can also damage lymph nodes and vessels. The sores caused by LGV in the rectum can also allow other germs—such as those that cause hepatitis, syphilis and gonorrhea—to invade the body.
 
The current outbreak of LGV in high-income countries seems to be spread by unprotected anal sex. Further details about LGV transmission appear later in this bulletin.
 
Signs and symptoms
Initially, a small, painless sore on the genitals may appear within 3 to 30 days after exposure to LGV. This quickly disappears. Later, the germs that cause LGV spread from the genitals to nearby lymph nodes, causing some to swell painfully.
 
In other cases, persistent rectal ulcers and inflammation can occur. This can lead to rectal bleeding and painful bowel movements, constipation and rectal discharge.
 
In addition to these symptoms, LGV germs can travel beyond the genitals, causing the following:
 
* headache
* lack of energy
* fever
weight loss
 
Because symptoms of LGV can mimic those of inflammatory bowel disease, some cases of LGV have been misdiagnosed. The Public Health Agency of Canada (PHAC) notes that routine tests for Chlamydia may come back positive in people with LGV, but these tests do not specifically identify LGV-causing germs.
 
The agency advises that doctors need to request that specific testing for LGV be done on the samples they send. The availability of this type of testing varies across Canada; physicians can contact their local public health unit or provincial laboratory to find out more.
 
Treatment
To help wipe out LGV-causing germs, the recommended first-line treatment is a three-week course of the antibiotic doxycycline 100 mg twice daily. An alternative antibiotic is erythromycin 500 mg four times daily, also for three weeks. Some doctors have used another antibiotic, azithromycin (Zithromax), in cases where doxycycline could not be taken. However, there is no consensus as to the correct dose, schedule and length of therapy for the use of azithromycin against LGV.
 
Focus on infection
To find out exactly how LGV may have been transmitted, several research teams have conducted intensive investigation and questioning of people with LGV. Here are the routes of transmission:
 
* unprotected anal sex
* unprotected insertion of fingers or hands (fisting) into the anus
* sharing of sex toys
 
Also note the following:
 
* HIV positive men seem to be very susceptible to LGV, perhaps because immune defenses in the gut are dysfunctional.
* The use of HAART or having relatively high CD4+ cell counts does not provide protection from LGV.
 
Re-infection
Now researchers in Rotterdam, the Netherlands, have reported some disturbing news:
 
* Some men who have recovered from LGV have been engaging in unprotected intercourse again and catching new sexually transmitted infections (STIs).
 
Study details and results
The Dutch study team reviewed medical records of men who were treated for LGV between 2002 and 2005. The purpose of the study was to assess STIs that may have occurred after treatment for LGV.
 
The team found that out of 26 men who had recovered from LGV, 17 (65%) acquired a new STI shortly after treatment for LGV. Most of these men were already co-infected with HIV and hepatitis B. The most common STI that they later acquired was syphilis.
 
The Dutch team had hoped that since LGV was a serious illness these men would have begun to have protected intercourse after their LGV diagnosis. However, after being treated for LGV some of the men had new rectal infections with other germs, including syphilis.
 
The Dutch doctors stated that these new STIs suggest that “health education efforts need to be stepped up vigorously.” Australian doctors also treating a cluster of LGV cases in Sydney noted that “counselling about healthy sexual practices is [important in the fight against STIs].” Hopefully, reports of STIs in people recovering from LGV are not a harbinger of events to come in Canada and other high-income countries.
 
LGV in Canada
According to PHAC, there have been 88 cases of LGV reported to that agency since 2001. Most of the Canadian cases of LGV occurred after January 2005 and all involved unprotected sex between men who generally did not appear to acquire the infection overseas. Risk behaviours included the following:
 
* unprotected anal sex
* fisting
* sharing of sex toys
* rectal use of crystal meth (crystal methamphetamine)
 
Canadian LGV cases have commonly reported co-infection with the following:
 
* HIV
* hepatitis C virus
* syphilis
 
Recently, reports of LGV in Canada appear to be declining, a trend that will hopefully continue.
 
—Sean R. Hosein
 
REFERENCES:
 
1. Tinmouth J, Rachlis A, Wesson T, et al. Lymphogranuloma venereum in North America: case reports and an update for gastroenterologists. Clinical Gastroenterology and Hepatology 2006 Apr;4(4):469-73.
 
2. Hamill M, Benn P, Carder C, et al. The clinical manifestations of anorectal infection with lymphogranuloma venereum (LGV) versus non-LGV strains of Chlamydia trachomatis: a case-control study in homosexual men. International Journal of STD and AIDS 2007 Jul;18(7):472-5.
 
3. van den Bos RR and van der Meijden WI. Persistent high-risk sexual behaviour in men who have sex with men after symptomatic lymphogranuloma venereum proctitis. International Journal of STD and AIDS 2007 Oct;18(10):715-6.
 
4. van Hal S, Hillman R, Stark DJ, et al. Lymphogranuloma venereum: an emerging anorectal disease in Australia. Medical Journal of Australia 2007 Sep 3;187(5):309-10.
 
5. Public Health Agency of Canada. Lymphogranuloma venereum (LGV) Epi update. 1 September 2007.
 
6. van Nieuwkoop C, Gooskens J, Smit VT, et al. Lymphogranuloma venereum proctocolitis: mucosal T cell immunity of the rectum associated with chlamydial clearance and clinical recovery. Gut 2007 Oct;56(10):1476-7.
 
7. Chase AJ, Sedaghat AR, German JR, et al. Severe Depletion of CD4+ CD25+ Regulatory T Cells from the Intestinal Lamina Propria but Not Peripheral Blood or Lymph Nodes during Acute Simian Immunodeficiency Virus Infection. Journal of Virology 2007 Dec;81(23):12748-57.
 
 
 
 
 
 
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#23531 From: "algeron_72" <algeron_72@...>
Date: Thu Nov 29, 2007 8:16 pm
Subject: poz health magazine
algeron_72
Offline Offline
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hi everyone i had some silly qustions about poz magazine like does
anyone know how u can ask them if you can be featured in it like pose
for a picture and a story..? and do you all know if they will pay you
if they like you and whant to put you in the mag..

#23530 From: LvrOfNatur@...
Date: Thu Nov 29, 2007 7:52 pm
Subject: re: correction on falling cd4 cells
rachelsmename
Offline Offline
Send Email Send Email
 
I forgot that I did use Selenomax for the first two months and then another less expensive brand from the store for another couple of months.
 
Rachel

#23529 From: LvrOfNatur@...
Date: Thu Nov 29, 2007 7:37 pm
Subject: re: falling cd4 cells
rachelsmename
Offline Offline
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Mike,
 
Did you see the article on this listserv about a study which showed 200 mcg of selenium significantly increased the t-cells of people with HIV?  It's working for me and I'm not even using the expensive Selenomax that was used in the study. My t-cells went from 645 to 808 in a few months. My t-cells have not been that high in the 21 years I was diagnosed. See the link below for an article on it.
 
Rachel
 
 

#23528 From: "Jonathan Goldman" <yangzpa@...>
Date: Thu Nov 29, 2007 6:54 pm
Subject: gynecomastia
yangzpa
Offline Offline
Send Email Send Email
 
Hi All,
 
People here have posted about Butt 4 You underwear with padding for men to fillout the behinds when wearing jeans. through stumbling along several links I read an article on Newsweek.com about this condition of 'manboobs' that many men get regardless of HIV status, generally related to hormones. And, while exercise certainly can help- some men have resorted to plastic surgery for reduction. And, as a reader cited this product, a 'special' lyrca-based athletic tee shirt to help compress the manboobs for $20, I'm passing along this non-invasive option/info for those interested.
 
 
Jonathan Goldman
San Francisco


#23527 From: Mathias Alexei <androginia2002@...>
Date: Thu Nov 29, 2007 2:11 pm
Subject: Re: Swallowing POZ Pre-cum
androginia2002
Offline Offline
Send Email Send Email
 

 
 
Hi! 
I totaly understand your doubts and concerns...
I was diagnosed HIV+ 2 years ago and my boyfriend was negative (he still is but whe broke 2 months ago). Even that he works investigating HIV in Mexico, he is a very good scientist that travels all around the world, we usually had a lot of questions. It is not the same reading or hearing about the ways you can get infected as living it every day. We found a lot of information regarding discordant couples because it is hard to get a list on what u are you aloud to do or not.
I can tell you that the cases of infection trough mouth is very, very low but i agree with the person who told you that pre-cum is a body fluid and it has the virus in it, so you both have to be carefull and when he feels his mouth is hurt you should better do it with condom. Try to loose yourselves, after some months we could get used to it and we made the whole "careing for the infection" monster a side. We just did everything automatically. Tell him he should not swallow your precum and he should spit and wash his mouth when feeling some precum is in his mouth...
 
WISH YOU BOTH LOVE AND LUCK!!!
SOrry about my bad english but it is not my mothe tongue.
 

Regards,

Nelson Vergel
powerusa dot org




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#23526 From: "Jonathan Goldman" <yangzpa@...>
Date: Thu Nov 29, 2007 1:17 am
Subject: NYS Medicaid to review inclusion of HGH (somatropin) in their drug formulary at Albany meeting in December
yangzpa
Offline Offline
Send Email Send Email
 
Hi All,
 

Jonathan Goldman
San Francisco, CA

#23525 From: "Mike" <mcinlosangeles@...>
Date: Wed Nov 28, 2007 11:20 pm
Subject: falling CD4 cells
mcinlosangeles
Offline Offline
Send Email Send Email
 
Over the last year my CD4 cells have dropped almost 400 points, yet I continue
to have an
undetectable viral load.  So far my doc has been reluctant to change meds due to
the stable
undectable viral load and the fact that until recently there weren't any active
agents available
for me.  I would very much appreciate any wisdom or recommendations that any one
can
provide.  I will be seeing my doc to discuss my treatment strategy soon and I
would like to
have some arguments to present so that something can be done.  Thanks.

#23524 From: tim pearce <munkybizness37@...>
Date: Wed Nov 28, 2007 11:13 pm
Subject: (No subject)
munkybizness37
Offline Offline
Send Email Send Email
 
Does anyone know if Serostim has been taken off the market?
 
Any other name brands of HGH you guys prefer?
 
Tim
Lafayette LA


Be a better sports nut! Let your teams follow you with Yahoo Mobile. Try it now.

#23523 From: George Carter <fiar@...>
Date: Wed Nov 28, 2007 10:32 pm
Subject: Re: Re: Flavanoid rich chocolate improves vasodilation
lalzephyr
Offline Offline
Send Email Send Email
 
Dark chocolate is heaven! And more data are coming out about it's health benefits.

Those of us who are chocaholics may have intestinal bugs that helps us to like it (see below). (Funny, an email exchange with a friend at the Park Slope Food Co-Op.) (On the political front, screw Nestle's - if you can get FAIR trade coffee, chocolate, etc., I think it is much better; won't find children's fingers in it...)

And a recent study showed 2.5 cups of coffee is good for those of us with hep C.

And microbrewed beer (OK, NO alcohol is good for me waaah) is good for those with good livers. A little bit. Red wine.

You realize what all this means, of course?

Woody Allen was right! (See Sleepersfor the appropriate references....)
George M. Carter

***
The New Yorkerhad a great article, also on the history of Dagoba. I tend to like the Fair Trade VERY DARK chocolate...tend to like, of course, does not really reflect the grisly and lurid truth of the way I eat the stuff....snort, grunt...
check out this link--and another article attached!
george




#23522 From: PoWeRTX@...
Date: Wed Nov 28, 2007 4:58 pm
Subject: butt pics
nelsonvergel
Offline Offline
Send Email Send Email
 
For those who emailed me saying they could not see the pic
 
 
 

Regards,

Nelson Vergel
powerusa dot org




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#23521 From: PoWeRTX@...
Date: Wed Nov 28, 2007 5:00 pm
Subject: Fwd: NATAP: Hillary Clinton HIV/AIDS Announced Plan
nelsonvergel
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She will probably be nominated.  I am supporting her candidacy and will spend a lot of energy on that when the time comes. God knows we need help!
 
 
NATAP http://natap.org/
_______________________________________________


Press release - HillaryClinton.com  11/27/2007

Clinton Announces Plan to Fight HIV/AIDS At Home And Abroad
Will Double Research Funding & Support Evidence-Based Prevention Programs

The Clinton campaign unveiled its plan to fight the HIV/AIDS epidemic in the U.S. and around the world. The comprehensive approach addresses the multiple challenges that HIV/AIDS has presented for over 25 years and includes investments for increased research, prevention and education, and access to treatment and other services. Hillary's plan would especially help groups in the U.S. that have seen HIV infection rates rise over the past several years, including African Americans and gay men, and address the continued risk in Latino communities and among women. In addition, Clinton has pledged to increase funding for the global HIV/AIDS fight to at least $50 billion by 2013.

"In many ways, our fight against HIV/AIDS is at a crossroads. While we have made progress in education and developing medicine that keeps those living with HIV/AIDS healthier, we need to be vigilant in ensuring that people are getting the information and care they need,” said Clinton. “I believe with leadership and smart investments we can significantly reduce the number of new infections, develop treatments that turn HIV/AIDS into a chronic but manageable condition, and expand toward an eventual vaccine."

On the domestic front, Clinton proposes doubling the HIV/AIDS research budget within the National Institutes of Health (NIH) to $5.2 billion annually, including the U.S. contribution towards finding a vaccine. Clinton's American Health Choices Plan will ensure that all Americans living with HIV/AIDS have access to care. Hillary will end the Bush administration's abstinence-only prevention policy, and instead, fund evidence-based HIV/AIDS prevention programs including, but not limited to, abstinence education as part of a comprehensive prevention message.

Hillary will address the disproportionate burden of HIV/AIDS among minority communities. African Americans account for almost 50% of new infections and Hillary will partner with stakeholders in the community to reverse this trend immediately. She is also concerned about the high rates of infection in the Latino community and will take action to improve prevention among Hispanics. Hillary will increase funding for the Minority AIDS Initiative and support the prevention and treatment efforts of minority-run community based organizations. Her plan also increases federal funding for substance abuse treatment, which often leads to high-risk behavior that can lead to infection. By taking steps to crack down on substance abuse and help users seek treatment, the chance that people will contract HIV can be greatly reduced.

Hillary is taking a bold stand to fight HIV/AIDS globally as well. She has committed to providing at least $50 billion over five years to combat HIV/AIDS around the world. This commitment will establish the U.S. as a leader in galvanizing the global community around meeting the Millennium Development Goal of halting and beginning to reverse the spread of HIV and other diseases by 2015. She will lead the world in achieving universal access to treatment by doubling the number of people that the U.S. supports with treatment. The Clinton plan will increase the number of health workers in training or in place in Africa by at least one million over a decade and ensure access to medications for all.

HILLARY CLINTON'S PLAN TO FIGHT HIV/AIDS IN THE U.S. AND AROUND THE WORLD

Today, Hillary Clinton unveiled her plan to combat HIV/AIDS globally through U.S. leadership and effective investments in research, prevention, and treatment. There are 33 million people living with HIV/AIDS around the world. Every day, about 6,800 people become newly infected and 5,700 die because of AIDS. Here in the U.S., while we have made tremendous strides in combating HIV/AIDS, about 40,000 people are newly diagnosed with HIV each year - an estimate which is expected to increase. More than 16,000 Americans die from AIDS annually and AIDS is the leading cause of death among African-American women aged 25-34.

AIDS has had a devastating impact on the continent of Africa, where more than two-thirds of all people with HIV/AIDS live, more than three-quarters of AIDS-related deaths occur and where the epidemic has orphaned 11 million children.

With a coordinated and comprehensive effort, Hillary knows we can significantly reduce the number of new infections annually and help provide coordinated care and treatment to the more than one million Americans currently living with HIV/AIDS in the U.S. and the millions living with HIV/AIDS around the world. As President, Hillary will:

Fight HIV/AIDS in the U.S. by:

    * Developing and Implementing a Comprehensive National AIDS Strategy;
    * Guaranteeing Health Insurance for Individuals Living with HIV/AIDS;
    * Doubling the U.S. Contribution Towards Researching a Vaccine for HIV/AIDS and Increasing Commitments to Research;
    * Ensuring Access to Care for All Americans Living with HIV;
    * Increasing Funding for Evidence-Based HIV/AIDS Prevention;
    * Addressing High Risk Behaviors that Often Lead to HIV/AIDS;
    * Improving Opportunities for Substance Abuse Treatment;
    * Providing Housing Opportunities and Supportive Services for People with AIDS;
    * Increasing Funding for the Ryan White CARE Act; and
    * Halting and Reversing the Burden of AIDS Among African-Americans and Latinos.

Fight HIV/AIDS Globally by:

    * Providing at Least $50 Billion for Global HIV/AIDS by 2013;
    * Ensuring Universal Access to Treatment and Care;
    * Committing to Access to Medications for All;
    * Expanding Prevention Efforts and Targeted Outreach;
    * Championing Universal Basic Education as a "Social Vaccine" to Combat HIV/AIDS;
    * Increasing Flexibility and Improving Accountability in Use of HIV/AIDS Funds;
    * Addressing the Disproportionate Impact of HIV Among Women; and
    * Helping Children Gain Access to Treatment and Care.


This plan builds on Hillary's long history of working to address the HIV/AIDS epidemic. As Senator, Hillary has introduced legislation to expand access to treatment for low-income individuals living with HIV; pushed to make scientific, evidence-based prevention programs more available to youth; sought to increase coordination in combating global AIDS; championed legislation to provide universal basic education that would help prevent the spread of AIDS, and consistently supported increased funding for federal efforts against the epidemic both in the U.S. and around the world.

HILLARY CLINTON'S PLAN TO FIGHT HIV/AIDS IN THE U.S.

As President, Hillary Clinton will continue her commitment to providing care and support for people living with HIV, as well as stopping the spread of the virus by:

Developing and Implementing a Comprehensive National AIDS Strategy - Federal efforts to tackle HIV/AIDS are diffuse and uncoordinated today, failing to maximize coordination among agencies providing treatment, support and care, and limiting our efforts to engage in effective prevention. Hillary will tie all of the federal efforts together into a single comprehensive national strategy. She will bring together federal agencies, such as the Centers for Disease Control and Prevention, the Health Resources and Services Administration, and the Centers for Medicare and Medicaid Services, state and local governments, community-based organizations, providers, academic experts, and Americans living with HIV, among others, to devise a plan to better coordinate the overall response to this epidemic in the U.S., with the goals of significantly reducing the number of new infections, particularly among populations with increases in infection rates, improving the health of people living with HIV, and reducing disparities in care. This plan will include measurable goals, targets, and timelines for increasing evidence-based prevention and expanding effective treatment interventions, so that we can monitor and evaluate our efforts, expand what is working, and correct what is not. This single, comprehensive strategy will allow for better cooperation and more efficient and effective allocation of resources, so that we can stop and reverse the increases in HIV infection among vulnerable populations.

Guaranteeing Health Insurance for Individuals Living with HIV/AIDS - Hillary has proposed the American Health Choices Plan, which ensures that every American will have access to affordable, quality health insurance. Under her plan, insurers will not be able to deny coverage based on preexisting conditions, such as HIV infection. Safety net care options, like Medicaid, will be strengthened, while individuals will be able to choose from an array of plans with benefits at least as good as the typical plan offered to Members of Congress, which includes mental health parity. Health care will be made affordable through the provision of a premium affordability tax credit, which will be designed to ensure that health care premiums never exceed a reasonable portion of a person's income. With the American Health Choices Plan, individuals with HIV/AIDS will have access to chronic care management, helping ensure that their providers are coordinating care for the best outcomes.

Doubling the U.S. Contribution Towards Researching a Vaccine for HIV/AIDS and Increasing Commitments to Research - Hillary believes we should never stop working to achieve the end goal of a cure for AIDS, and recent setbacks in vaccine trials do not mitigate the need to develop a vaccine to combat this disease. During the 1990s, new drugs helped people with HIV and AIDS live longer, healthier lives. In addition to increasing access to these drugs, the federal government must also research new treatments to simplify regimens, increase adherence, and address issues of drug resistance. We must also focus on funding for prevention - whether it is through efforts to fund microbicide research, or efforts to evaluate the best behavioral health strategies for preventing HIV and AIDS. In order to achieve these goals, Hillary would increase our investments in HIV/AIDS research at the National Institutes of Health to $5.2 billion annually, and ensure that researchers in all areas have the resources necessary to continue and expand their valuable efforts.

Ensuring Access to Care for All Americans Living with HIV - Hillary will extend Medicaid eligibility to low-income Americans living with HIV by the end of her first year in office. Today, too many low-income Americans with HIV have to wait until they become sick in order to receive health care through Medicaid. Delaying care in this manner hurts those who could have avoided illness through preventive care and treatment, and increases the costs associated with their care over the long-term. Hillary will change the Medicaid rules so that early treatment and intervention is guaranteed. This proposal builds on Hillary's record as the lead Democratic sponsor of the Early Treatment for HIV/AIDS Act, and helps to strengthen the affordable options available for those living with HIV as part of her America's Health Choices Plan.

Increasing Funding for Evidence-Based Prevention Efforts - As President, Hillary will work to give individuals the tools needed to protect themselves against HIV by supporting proven strategies and targeting those efforts to the populations most vulnerable to HIV infection. Hillary supports giving young people age-appropriate information about HIV/AIDS and how to protect themselves against the disease, including by delaying sexual activity. But she rejects the Bush Administration approach of investing exclusively in abstinence-only sex education. She supports federal funding for needle exchange programs. And she will work to target culturally competent prevention efforts towards vulnerable populations that account for a disproportionate number of new infections. In addition, she will ensure that women, who account for more than one-quarter of all new HIV/AIDS infections in the U.S., have the knowledge and tools necessary to protect themselves against HIV.

Addressing High Risk Behaviors That Often Lead to HIV/AIDS - Hillary will work to halt and reverse the recent increase in infection rates among gay men, young people, and people of color. In addition, Hillary will seek to address the factors that contribute to high risk behavior, such as the use of drugs like crystal meth, which is impacting both rural and urban areas, and the use of which is on the rise in the gay community. Hillary was a proud co-sponsor of the Combat Meth Act of 2005, which was signed into law on March 9, 2006. This law tightens restrictions on how pseudoephedrine is sold to ensure that it is not being trafficked, and provides resources for prevention, education, and treatment. As President, Hillary will work to see that this law is implemented effectively.

Improving Opportunities for Substance Abuse Treatment Services - Providing federal funding for needle exchange programs will help increase referrals and entry into treatment programs and reduce overall HIV incidence, but there is much more we can do to address the connections between substance use and HIV infection. Hillary will expand available treatment services and provide additional federal assistance for such services by increasing funding for SAMHSA, the Substance Abuse and Mental Health Services Administration. In a 2006 SAMHSA study more than 23 million Americans were identified as needing specialty treatment for substance or alcohol abuse, yet only about 10% of them accessed such services. A major barrier to receiving such services is the cost of treatment.

Providing Housing Opportunities and Supportive Services for People with AIDS - As many as half of all people living with HIV/AIDS will need housing assistance at some point in their illness. For many of those, short-term assistance with rent, mortgage or utility costs alone will provide the necessary support to remain healthy and in stable housing. But for others, more intensive supportive services are needed. Hillary will increase funding for the Housing Opportunities for People with AIDS (HOPWA) program to serve about 90,000 households. In addition, Hillary recognizes the importance of supportive services for individuals living with HIV and their families. With stable housing and supportive services, individuals are more likely to be able to access comprehensive health care and adhere to HIV/AIDS treatments, improving their medical outcomes and reducing health care costs.

Increasing Funding for the Ryan White CARE Act - The Ryan White CARE Act is an important mechanism through which to deliver treatment and supportive services to individuals living with HIV and AIDS. As President, Hillary will support increasing Ryan White funding, especially in underserved areas and areas where the epidemic is growing, and working to make sure the increases are coordinated with other federal programs. She will also work to increase flexibility of funding to be used for supportive services - such as nutrition assistance and case management - that increase treatment adherence and improve the health and well-being of Americans living with AIDS.

Halting and Reversing the Burden of AIDS Among African-Americans and Latinos - Hillary will increase funding for the Minority AIDS Initiative, and work to ensure that it helps to foster and support the prevention and treatment efforts of minority-run community based organizations. This effort is particularly important in the African American community, as African Americans in the U.S. account for approximately 13% of the population, yet make up almost half of the new HIV/AIDS diagnoses. Hillary will work to end the disproportionate impact of AIDS on this community and seek to halt the growth of HIV in other minority communities as well. In addition, she will seek to increase cooperation with the clergy and other religious leaders in the black and Hispanic communities, to determine how churches can play a role in reducing the number of new infections. Finally, she will work to reduce and eliminate racial and ethnic disparities throughout our entire health care system, to ensure that African Americans and Latinos living with HIV and AIDS have access to quality care and treatment.

HILLARY CLINTON'S PLAN TO FIGHT HIV/AIDS WORLDWIDE

As First Lady, Hillary Clinton saw the impact of HIV and AIDS in her travels around the globe. As Senator from New York, she has worked to secure funding and improve coordination for global AIDS programs. As President, she will continue our efforts to secure universal access for treatment, prevention, and care by focusing on the following:

Providing at Least $50 Billion for Global HIV/AIDS by 2013 - Hillary has a long record of advocating for funding for both U.S. and multilateral efforts to fight HIV/AIDS around the world. While we have made important progress on funding over the past decade, Hillary believes that we must go beyond the President's request to flat-line global HIV/AIDS funding over the next 5 years. She is currently fighting in the Senate to reauthorize and improve PEPFAR - the President's Emergency Plan For AIDS Relief. And as President, Hillary will commit at least $50 billion for global HIV/AIDS efforts by 2013. This investment will allow the U.S. to increase our commitment to the Global Fund to Fight AIDS, Tuberculosis and Malaria, which leverages additional donor commitments to support coordinated national approaches to fighting disease. It will establish the U.S. as a leader in galvanizing the global community around meeting the Millennium Development Goal of halting and beginning to reverse the spread of HIV and other diseases by 2015.

Ensuring Universal Access to Treatment and Care - With increased funding, Hillary Clinton will expand access to treatment in developing countries. The U.S. will take the lead in ensuring that we reach universal access to medications by doubling the number of people that the U.S. supports with treatment over the next several years. Hillary will also invest in building the health infrastructure of developing countries that is critical to achieving effective treatment and prevention of HIV/AIDS and other diseases. This will include working with international partners to increase the number of health workers in place or in training in Africa by at least one million over the next several years, improve the self-sufficiency of local health networks, and reduce global disparities in care.

Committing to Access to Medications for All - Hillary understands that in order to meet our goals for universal access to treatment, we must make available the life-extending medications we have in the U.S. to resource-poor countries. The World Health Organization estimates that 10 million lives could be saved each year by improving access to medicines already in existence. As President, Hillary will ensure the U.S. lives up to its Doha Declaration commitments and allow countries to access the treatments necessary to address public health crises like HIV/AIDS. She will support trade policies that protect and expand poor countries' right to affordable, quality-assured generic drugs for important health needs. As President, she will also work with institutions that receive federal funding to ensure that drugs developed with taxpayer resources are made available off-patent in developing countries.

Expanding Prevention Efforts and Targeted Outreach - Hillary wants to maximize the impact of new U.S. funding in prevention efforts at the local level. She believes that effective prevention models should be tailored to the needs of communities, without requirements that limit the ability to provide accurate information and relevant comprehensive services to as many individuals as possible. To that end, she supports striking the current requirement that 33% of prevention funding be spent on abstinence-only programs, to ensure that prevention efforts can be tailored to local needs and populations most at-risk. She also supports using U.S. funding to support proven harm reduction efforts - including needle exchange - to help hard-to-reach populations, and will continue to support new evidence-based prevention methods as additional scientific research helps us understand how to best address this epidemic. Hillary will also work to support efforts to reduce stigma and improve outreach and education around testing. When people get tested, and they discover they are positive, we can help them access treatment, medical care, and information about the virus before they become sick. If people get tested and they are negative, counselors can help them understand how they can avoid infection.

Championing Universal Basic Education as a "Social Vaccine" to Combat HIV/AIDS - Hillary is the original Senate sponsor of the Education For All Act, which calls for a dramatic increase in US funding and leadership in achieving universal basic education. In addition to reducing poverty and improving child and maternal health, education is a key form of prevention - a "social vaccine"- against the spread of HIV/AIDS. Compared to peers who are out of school, girls enrolled in secondary education are more likely to resist early marriage and remain abstinent, while also being five times more likely to know the basic facts of prevention and three times less likely to contract HIV/AIDS. With strong peer support programs, life skills training, and prevention curricula that address HIV/AIDS, gender-based violence and other health concerns, education can be even more effective in combating HIV/AIDS.

Increasing Flexibility and Improving Accountability in Use of Funds - Hillary Clinton wants to work with both donors and recipient governments to ensure that U.S. investments are made as effectively as possible. Donors must work to improve coordination and reduce the burden placed on poor country ministries of multiple, overlapping and sometimes conflicting reporting requirements. Developing countries must work with donors to identify the impact of the epidemic on a localized basis and help target prevention and treatment efforts to vulnerable populations that are often overlooked, including orphans, displaced persons and individuals who have been trafficked. Doing so will allow the U.S., at the country level, to better identify needs, eliminate duplication, and establish monitoring and evaluation systems to better track funding. In addition, Hillary will increase funding for operations research to identify and replicate best practices in prevention, care and treatment. Finally, Hillary will work to improve outreach and coordination with nonprofit organizations, businesses, faith-based groups, people living with HIV and AIDS and other nongovernmental entities to ensure that civil society is engaged and active in efforts to prevent and treat HIV/AIDS.

Addressing the Disproportionate Impact of HIV Among Women - Worldwide, adult women account for almost half of all new infections, and in certain areas, like sub-Saharan Africa, women account for more than 60% of those living with HIV. As President, Hillary Clinton will work to reduce infections among women, improve their access to care and treatment, and give them the tools needed to protect themselves against infection. She will require our government to develop a comprehensive plan to address the needs of girls and women and integrate these needs into our efforts to address HIV/AIDS. This plan will identify and address factors, such as gender-based violence and economic insecurity, which are linked with increased vulnerability to HIV. It will also work to improve services for women, in order to integrate HIV and AIDS care into existing health service delivery, including sexual and reproductive health services and family planning. In addition to working to ensure that the health needs of women are addressed in our global AIDS policies, Hillary Clinton will also improve access to overall women's health services that help provide treatment, care and education. She would restore U.S. funding for UNFPA, which provides vital reproductive health services to women around the world, and rescind the Global Gag Rule, which prevents U.S. funding from assisting nongovernmental organizations in other countries that provide information about or access to abortion services.

Helping Children Gain Access to Treatment and Care - The majority of children living with HIV worldwide die before the age of three. As First Lady and Senator, Hillary worked to increase the number of medications specifically manufactured for children, including those that would treat AIDS. As President, she will work to ensure that the gains we have made in increasing treatment options are extended to children around the world. As she moves to improve needs assessments and expand treatment across the lifespan, she will work to ensure that children's needs are included in strategies for fighting AIDS, including plans for the care and treatment of orphans and other vulnerable children who have lost their families to the AIDS epidemic.




 

Regards,

Nelson Vergel
powerusa dot org




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Press release - HillaryClinton.com  11/27/2007

Clinton Announces Plan to Fight HIV/AIDS At Home And Abroad
Will Double Research Funding & Support Evidence-Based Prevention Programs

The Clinton campaign unveiled its plan to fight the HIV/AIDS epidemic in the U.S. and around the world. The comprehensive approach addresses the multiple challenges that HIV/AIDS has presented for over 25 years and includes investments for increased research, prevention and education, and access to treatment and other services. Hillary's plan would especially help groups in the U.S. that have seen HIV infection rates rise over the past several years, including African Americans and gay men, and address the continued risk in Latino communities and among women. In addition, Clinton has pledged to increase funding for the global HIV/AIDS fight to at least $50 billion by 2013.

"In many ways, our fight against HIV/AIDS is at a crossroads. While we have made progress in education and developing medicine that keeps those living with HIV/AIDS healthier, we need to be vigilant in ensuring that people are getting the information and care they need,” said Clinton. “I believe with leadership and smart investments we can significantly reduce the number of new infections, develop treatments that turn HIV/AIDS into a chronic but manageable condition, and expand toward an eventual vaccine."

On the domestic front, Clinton proposes doubling the HIV/AIDS research budget within the National Institutes of Health (NIH) to $5.2 billion annually, including the U.S. contribution towards finding a vaccine. Clinton's American Health Choices Plan will ensure that all Americans living with HIV/AIDS have access to care. Hillary will end the Bush administration's abstinence-only prevention policy, and instead, fund evidence-based HIV/AIDS prevention programs including, but not limited to, abstinence education as part of a comprehensive prevention message.

Hillary will address the disproportionate burden of HIV/AIDS among minority communities. African Americans account for almost 50% of new infections and Hillary will partner with stakeholders in the community to reverse this trend immediately. She is also concerned about the high rates of infection in the Latino community and will take action to improve prevention among Hispanics. Hillary will increase funding for the Minority AIDS Initiative and support the prevention and treatment efforts of minority-run community based organizations. Her plan also increases federal funding for substance abuse treatment, which often leads to high-risk behavior that can lead to infection. By taking steps to crack down on substance abuse and help users seek treatment, the chance that people will contract HIV can be greatly reduced.

Hillary is taking a bold stand to fight HIV/AIDS globally as well. She has committed to providing at least $50 billion over five years to combat HIV/AIDS around the world. This commitment will establish the U.S. as a leader in galvanizing the global community around meeting the Millennium Development Goal of halting and beginning to reverse the spread of HIV and other diseases by 2015. She will lead the world in achieving universal access to treatment by doubling the number of people that the U.S. supports with treatment. The Clinton plan will increase the number of health workers in training or in place in Africa by at least one million over a decade and ensure access to medications for all.

HILLARY CLINTON'S PLAN TO FIGHT HIV/AIDS IN THE U.S. AND AROUND THE WORLD

Today, Hillary Clinton unveiled her plan to combat HIV/AIDS globally through U.S. leadership and effective investments in research, prevention, and treatment. There are 33 million people living with HIV/AIDS around the world. Every day, about 6,800 people become newly infected and 5,700 die because of AIDS. Here in the U.S., while we have made tremendous strides in combating HIV/AIDS, about 40,000 people are newly diagnosed with HIV each year - an estimate which is expected to increase. More than 16,000 Americans die from AIDS annually and AIDS is the leading cause of death among African-American women aged 25-34.

AIDS has had a devastating impact on the continent of Africa, where more than two-thirds of all people with HIV/AIDS live, more than three-quarters of AIDS-related deaths occur and where the epidemic has orphaned 11 million children.

With a coordinated and comprehensive effort, Hillary knows we can significantly reduce the number of new infections annually and help provide coordinated care and treatment to the more than one million Americans currently living with HIV/AIDS in the U.S. and the millions living with HIV/AIDS around the world. As President, Hillary will:

Fight HIV/AIDS in the U.S. by:

    * Developing and Implementing a Comprehensive National AIDS Strategy;
    * Guaranteeing Health Insurance for Individuals Living with HIV/AIDS;
    * Doubling the U.S. Contribution Towards Researching a Vaccine for HIV/AIDS and Increasing Commitments to Research;
    * Ensuring Access to Care for All Americans Living with HIV;
    * Increasing Funding for Evidence-Based HIV/AIDS Prevention;
    * Addressing High Risk Behaviors that Often Lead to HIV/AIDS;
    * Improving Opportunities for Substance Abuse Treatment;
    * Providing Housing Opportunities and Supportive Services for People with AIDS;
    * Increasing Funding for the Ryan White CARE Act; and
    * Halting and Reversing the Burden of AIDS Among African-Americans and Latinos.

Fight HIV/AIDS Globally by:

    * Providing at Least $50 Billion for Global HIV/AIDS by 2013;
    * Ensuring Universal Access to Treatment and Care;
    * Committing to Access to Medications for All;
    * Expanding Prevention Efforts and Targeted Outreach;
    * Championing Universal Basic Education as a "Social Vaccine" to Combat HIV/AIDS;
    * Increasing Flexibility and Improving Accountability in Use of HIV/AIDS Funds;
    * Addressing the Disproportionate Impact of HIV Among Women; and
    * Helping Children Gain Access to Treatment and Care.


This plan builds on Hillary's long history of working to address the HIV/AIDS epidemic. As Senator, Hillary has introduced legislation to expand access to treatment for low-income individuals living with HIV; pushed to make scientific, evidence-based prevention programs more available to youth; sought to increase coordination in combating global AIDS; championed legislation to provide universal basic education that would help prevent the spread of AIDS, and consistently supported increased funding for federal efforts against the epidemic both in the U.S. and around the world.

HILLARY CLINTON'S PLAN TO FIGHT HIV/AIDS IN THE U.S.

As President, Hillary Clinton will continue her commitment to providing care and support for people living with HIV, as well as stopping the spread of the virus by:

Developing and Implementing a Comprehensive National AIDS Strategy - Federal efforts to tackle HIV/AIDS are diffuse and uncoordinated today, failing to maximize coordination among agencies providing treatment, support and care, and limiting our efforts to engage in effective prevention. Hillary will tie all of the federal efforts together into a single comprehensive national strategy. She will bring together federal agencies, such as the Centers for Disease Control and Prevention, the Health Resources and Services Administration, and the Centers for Medicare and Medicaid Services, state and local governments, community-based organizations, providers, academic experts, and Americans living with HIV, among others, to devise a plan to better coordinate the overall response to this epidemic in the U.S., with the goals of significantly reducing the number of new infections, particularly among populations with increases in infection rates, improving the health of people living with HIV, and reducing disparities in care. This plan will include measurable goals, targets, and timelines for increasing evidence-based prevention and expanding effective treatment interventions, so that we can monitor and evaluate our efforts, expand what is working, and correct what is not. This single, comprehensive strategy will allow for better cooperation and more efficient and effective allocation of resources, so that we can stop and reverse the increases in HIV infection among vulnerable populations.

Guaranteeing Health Insurance for Individuals Living with HIV/AIDS - Hillary has proposed the American Health Choices Plan, which ensures that every American will have access to affordable, quality health insurance. Under her plan, insurers will not be able to deny coverage based on preexisting conditions, such as HIV infection. Safety net care options, like Medicaid, will be strengthened, while individuals will be able to choose from an array of plans with benefits at least as good as the typical plan offered to Members of Congress, which includes mental health parity. Health care will be made affordable through the provision of a premium affordability tax credit, which will be designed to ensure that health care premiums never exceed a reasonable portion of a person's income. With the American Health Choices Plan, individuals with HIV/AIDS will have access to chronic care management, helping ensure that their providers are coordinating care for the best outcomes.

Doubling the U.S. Contribution Towards Researching a Vaccine for HIV/AIDS and Increasing Commitments to Research - Hillary believes we should never stop working to achieve the end goal of a cure for AIDS, and recent setbacks in vaccine trials do not mitigate the need to develop a vaccine to combat this disease. During the 1990s, new drugs helped people with HIV and AIDS live longer, healthier lives. In addition to increasing access to these drugs, the federal government must also research new treatments to simplify regimens, increase adherence, and address issues of drug resistance. We must also focus on funding for prevention - whether it is through efforts to fund microbicide research, or efforts to evaluate the best behavioral health strategies for preventing HIV and AIDS. In order to achieve these goals, Hillary would increase our investments in HIV/AIDS research at the National Institutes of Health to $5.2 billion annually, and ensure that researchers in all areas have the resources necessary to continue and expand their valuable efforts.

Ensuring Access to Care for All Americans Living with HIV - Hillary will extend Medicaid eligibility to low-income Americans living with HIV by the end of her first year in office. Today, too many low-income Americans with HIV have to wait until they become sick in order to receive health care through Medicaid. Delaying care in this manner hurts those who could have avoided illness through preventive care and treatment, and increases the costs associated with their care over the long-term. Hillary will change the Medicaid rules so that early treatment and intervention is guaranteed. This proposal builds on Hillary's record as the lead Democratic sponsor of the Early Treatment for HIV/AIDS Act, and helps to strengthen the affordable options available for those living with HIV as part of her America's Health Choices Plan.

Increasing Funding for Evidence-Based Prevention Efforts - As President, Hillary will work to give individuals the tools needed to protect themselves against HIV by supporting proven strategies and targeting those efforts to the populations most vulnerable to HIV infection. Hillary supports giving young people age-appropriate information about HIV/AIDS and how to protect themselves against the disease, including by delaying sexual activity. But she rejects the Bush Administration approach of investing exclusively in abstinence-only sex education. She supports federal funding for needle exchange programs. And she will work to target culturally competent prevention efforts towards vulnerable populations that account for a disproportionate number of new infections. In addition, she will ensure that women, who account for more than one-quarter of all new HIV/AIDS infections in the U.S., have the knowledge and tools necessary to protect themselves against HIV.

Addressing High Risk Behaviors That Often Lead to HIV/AIDS - Hillary will work to halt and reverse the recent increase in infection rates among gay men, young people, and people of color. In addition, Hillary will seek to address the factors that contribute to high risk behavior, such as the use of drugs like crystal meth, which is impacting both rural and urban areas, and the use of which is on the rise in the gay community. Hillary was a proud co-sponsor of the Combat Meth Act of 2005, which was signed into law on March 9, 2006. This law tightens restrictions on how pseudoephedrine is sold to ensure that it is not being trafficked, and provides resources for prevention, education, and treatment. As President, Hillary will work to see that this law is implemented effectively.

Improving Opportunities for Substance Abuse Treatment Services - Providing federal funding for needle exchange programs will help increase referrals and entry into treatment programs and reduce overall HIV incidence, but there is much more we can do to address the connections between substance use and HIV infection. Hillary will expand available treatment services and provide additional federal assistance for such services by increasing funding for SAMHSA, the Substance Abuse and Mental Health Services Administration. In a 2006 SAMHSA study more than 23 million Americans were identified as needing specialty treatment for substance or alcohol abuse, yet only about 10% of them accessed such services. A major barrier to receiving such services is the cost of treatment.

Providing Housing Opportunities and Supportive Services for People with AIDS - As many as half of all people living with HIV/AIDS will need housing assistance at some point in their illness. For many of those, short-term assistance with rent, mortgage or utility costs alone will provide the necessary support to remain healthy and in stable housing. But for others, more intensive supportive services are needed. Hillary will increase funding for the Housing Opportunities for People with AIDS (HOPWA) program to serve about 90,000 households. In addition, Hillary recognizes the importance of supportive services for individuals living with HIV and their families. With stable housing and supportive services, individuals are more likely to be able to access comprehensive health care and adhere to HIV/AIDS treatments, improving their medical outcomes and reducing health care costs.

Increasing Funding for the Ryan White CARE Act - The Ryan White CARE Act is an important mechanism through which to deliver treatment and supportive services to individuals living with HIV and AIDS. As President, Hillary will support increasing Ryan White funding, especially in underserved areas and areas where the epidemic is growing, and working to make sure the increases are coordinated with other federal programs. She will also work to increase flexibility of funding to be used for supportive services - such as nutrition assistance and case management - that increase treatment adherence and improve the health and well-being of Americans living with AIDS.

Halting and Reversing the Burden of AIDS Among African-Americans and Latinos - Hillary will increase funding for the Minority AIDS Initiative, and work to ensure that it helps to foster and support the prevention and treatment efforts of minority-run community based organizations. This effort is particularly important in the African American community, as African Americans in the U.S. account for approximately 13% of the population, yet make up almost half of the new HIV/AIDS diagnoses. Hillary will work to end the disproportionate impact of AIDS on this community and seek to halt the growth of HIV in other minority communities as well. In addition, she will seek to increase cooperation with the clergy and other religious leaders in the black and Hispanic communities, to determine how churches can play a role in reducing the number of new infections. Finally, she will work to reduce and eliminate racial and ethnic disparities throughout our entire health care system, to ensure that African Americans and Latinos living with HIV and AIDS have access to quality care and treatment.

HILLARY CLINTON'S PLAN TO FIGHT HIV/AIDS WORLDWIDE

As First Lady, Hillary Clinton saw the impact of HIV and AIDS in her travels around the globe. As Senator from New York, she has worked to secure funding and improve coordination for global AIDS programs. As President, she will continue our efforts to secure universal access for treatment, prevention, and care by focusing on the following:

Providing at Least $50 Billion for Global HIV/AIDS by 2013 - Hillary has a long record of advocating for funding for both U.S. and multilateral efforts to fight HIV/AIDS around the world. While we have made important progress on funding over the past decade, Hillary believes that we must go beyond the President's request to flat-line global HIV/AIDS funding over the next 5 years. She is currently fighting in the Senate to reauthorize and improve PEPFAR - the President's Emergency Plan For AIDS Relief. And as President, Hillary will commit at least $50 billion for global HIV/AIDS efforts by 2013. This investment will allow the U.S. to increase our commitment to the Global Fund to Fight AIDS, Tuberculosis and Malaria, which leverages additional donor commitments to support coordinated national approaches to fighting disease. It will establish the U.S. as a leader in galvanizing the global community around meeting the Millennium Development Goal of halting and beginning to reverse the spread of HIV and other diseases by 2015.

Ensuring Universal Access to Treatment and Care - With increased funding, Hillary Clinton will expand access to treatment in developing countries. The U.S. will take the lead in ensuring that we reach universal access to medications by doubling the number of people that the U.S. supports with treatment over the next several years. Hillary will also invest in building the health infrastructure of developing countries that is critical to achieving effective treatment and prevention of HIV/AIDS and other diseases. This will include working with international partners to increase the number of health workers in place or in training in Africa by at least one million over the next several years, improve the self-sufficiency of local health networks, and reduce global disparities in care.

Committing to Access to Medications for All - Hillary understands that in order to meet our goals for universal access to treatment, we must make available the life-extending medications we have in the U.S. to resource-poor countries. The World Health Organization estimates that 10 million lives could be saved each year by improving access to medicines already in existence. As President, Hillary will ensure the U.S. lives up to its Doha Declaration commitments and allow countries to access the treatments necessary to address public health crises like HIV/AIDS. She will support trade policies that protect and expand poor countries' right to affordable, quality-assured generic drugs for important health needs. As President, she will also work with institutions that receive federal funding to ensure that drugs developed with taxpayer resources are made available off-patent in developing countries.

Expanding Prevention Efforts and Targeted Outreach - Hillary wants to maximize the impact of new U.S. funding in prevention efforts at the local level. She believes that effective prevention models should be tailored to the needs of communities, without requirements that limit the ability to provide accurate information and relevant comprehensive services to as many individuals as possible. To that end, she supports striking the current requirement that 33% of prevention funding be spent on abstinence-only programs, to ensure that prevention efforts can be tailored to local needs and populations most at-risk. She also supports using U.S. funding to support proven harm reduction efforts - including needle exchange - to help hard-to-reach populations, and will continue to support new evidence-based prevention methods as additional scientific research helps us understand how to best address this epidemic. Hillary will also work to support efforts to reduce stigma and improve outreach and education around testing. When people get tested, and they discover they are positive, we can help them access treatment, medical care, and information about the virus before they become sick. If people get tested and they are negative, counselors can help them understand how they can avoid infection.

Championing Universal Basic Education as a "Social Vaccine" to Combat HIV/AIDS - Hillary is the original Senate sponsor of the Education For All Act, which calls for a dramatic increase in US funding and leadership in achieving universal basic education. In addition to reducing poverty and improving child and maternal health, education is a key form of prevention - a "social vaccine"- against the spread of HIV/AIDS. Compared to peers who are out of school, girls enrolled in secondary education are more likely to resist early marriage and remain abstinent, while also being five times more likely to know the basic facts of prevention and three times less likely to contract HIV/AIDS. With strong peer support programs, life skills training, and prevention curricula that address HIV/AIDS, gender-based violence and other health concerns, education can be even more effective in combating HIV/AIDS.

Increasing Flexibility and Improving Accountability in Use of Funds - Hillary Clinton wants to work with both donors and recipient governments to ensure that U.S. investments are made as effectively as possible. Donors must work to improve coordination and reduce the burden placed on poor country ministries of multiple, overlapping and sometimes conflicting reporting requirements. Developing countries must work with donors to identify the impact of the epidemic on a localized basis and help target prevention and treatment efforts to vulnerable populations that are often overlooked, including orphans, displaced persons and individuals who have been trafficked. Doing so will allow the U.S., at the country level, to better identify needs, eliminate duplication, and establish monitoring and evaluation systems to better track funding. In addition, Hillary will increase funding for operations research to identify and replicate best practices in prevention, care and treatment. Finally, Hillary will work to improve outreach and coordination with nonprofit organizations, businesses, faith-based groups, people living with HIV and AIDS and other nongovernmental entities to ensure that civil society is engaged and active in efforts to prevent and treat HIV/AIDS.

Addressing the Disproportionate Impact of HIV Among Women - Worldwide, adult women account for almost half of all new infections, and in certain areas, like sub-Saharan Africa, women account for more than 60% of those living with HIV. As President, Hillary Clinton will work to reduce infections among women, improve their access to care and treatment, and give them the tools needed to protect themselves against infection. She will require our government to develop a comprehensive plan to address the needs of girls and women and integrate these needs into our efforts to address HIV/AIDS. This plan will identify and address factors, such as gender-based violence and economic insecurity, which are linked with increased vulnerability to HIV. It will also work to improve services for women, in order to integrate HIV and AIDS care into existing health service delivery, including sexual and reproductive health services and family planning. In addition to working to ensure that the health needs of women are addressed in our global AIDS policies, Hillary Clinton will also improve access to overall women's health services that help provide treatment, care and education. She would restore U.S. funding for UNFPA, which provides vital reproductive health services to women around the world, and rescind the Global Gag Rule, which prevents U.S. funding from assisting nongovernmental organizations in other countries that provide information about or access to abortion services.

Helping Children Gain Access to Treatment and Care - The majority of children living with HIV worldwide die before the age of three. As First Lady and Senator, Hillary worked to increase the number of medications specifically manufactured for children, including those that would treat AIDS. As President, she will work to ensure that the gains we have made in increasing treatment options are extended to children around the world. As she moves to improve needs assessments and expand treatment across the lifespan, she will work to ensure that children's needs are included in strategies for fighting AIDS, including plans for the care and treatment of orphans and other vulnerable children who have lost their families to the AIDS epidemic.




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#23520 From: PoWeRTX@...
Date: Wed Nov 28, 2007 4:29 pm
Subject: Fwd: Mark King's New Book, "A Place Like This"
nelsonvergel
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In a message dated 11/28/2007 3:04:44 P.M. Central Standard Time, MarkSKing writes:
Hey friends,
 
I'm proud to announce that my web site is up, which is cool, and which also includes a link to Amazon.com where you can buy my book, "A Place Like This."  It is a first person account of Los Angeles in the 1980's, from phone sex to AIDS to Hollywood to cocaine to assisted suicide.  And just in time for Christmas shopping!
 
Seriously, I'm extremely proud of the book and happy to see it published. 
 
Go to www.MarkSKing.com to check it out.
 
Mark
 
p.s. I'm in Newsweek!  Today on the Newsweek.com web site they have published my essay about crystal meth and HIV.  This special editorial package on World AIDS Day is only available on their web site.

 

Regards,

Nelson Vergel
powerusa dot org




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Hey friends,
 
I'm proud to announce that my web site is up, which is cool, and which also includes a link to Amazon.com where you can buy my book, "A Place Like This."  It is a first person account of Los Angeles in the 1980's, from phone sex to AIDS to Hollywood to cocaine to assisted suicide.  And just in time for Christmas shopping!
 
Seriously, I'm extremely proud of the book and happy to see it published. 
 
Go to www.MarkSKing.com to check it out.
 
Mark
 
p.s. I'm in Newsweek!  Today on the Newsweek.com web site they have published my essay about crystal meth and HIV.  This special editorial package on World AIDS Day is only available on their web site.




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#23519 From: Butch <longjohnmaniac@...>
Date: Wed Nov 28, 2007 7:32 pm
Subject: Re: swallowing poz pre-cum
longjohnmaniac
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Yes indeed, risk permeates everything in life, so trying to quantify relative risk makes sense to me.   I take a certain risk when I decide to fly in an airplane, and that risk is statistically much less than the risk I take when I drive on the freeway.  Not all risks can be quantified with a great degree of accuracy because, as you state, there are many variables, both general and individual.   However, we do have some idea that certain sex acts carry less relative risk than others.   These are statistical ideas, and just because I stand a better chance statistically of surviving my airplane ride as opposed to my cross country car trip means little to me personally if I happen to be killed in the one horrible plane crash that year.  When people talk about risk, they  need to understand that reality.   You can be  very unlucky even  if you limit yourself to relatively safe sex practices.   However,  one should also acknowledge that life is full of risks.  You can't live without some risk taking.   You have to balance what risks you're willing to take with what the risk taking behavior has to offer you.  Life would be quite dull if we limited ourselves to totally safe behaviors.   Some people think there should be no risk, but they are not being realistic.   If someone wants to engage in the joys of sex, and it involves a certain amount of risk, they should be well-informed (along with their partners) about the relative risks.  If something bad happens, in my opinion they shouldn't be pointing fingers unless the partner clearly failed to tell them, for example, that they were poz or otherwise posed some obvious threat that a reasonable person should be aware of..  Of course, in our imperfect legal system, even if you tell somebody you're poz you can end up in a bad legal situation, because usually sex acts are not well documented and also because of prejudice against HIV+ people which permeates into the courtroom.   But I think asking about relative risk is a perfectly reasonable thing to do.
Butch

Re: Swallowing POZ Pre-cum
Posted by: "Jack Coppola" jack.coppola@... signalshift01
Date: Tue Nov 27, 2007 1:57 pm ((PST))

No offense, but I don't really think you understand the situation, and

I would like to know what kind of answer you would expect the doctor
to give? Maybe I'm just jaded, but asking an online doctor if
swallowing his partner's "precum", but not his "load" seems a bit
trite at best.

To the doctor's defense, he did make it clear that pre-ejaculate is an

infectious fluid, and to swallow it, or to have it enter the mouth is
indeed exposing an individual to HIV. Period. There's no grey area.
Whether that person becomes infected, is another story which includes
MANY variables that are impossible to statistically analyze,
especially given the constraints of 10 values.

Pre-ejaculate carries the virus, AND even with an undetectable blood
viral load, it is still present in semen and pre-ejaculate. So much
so, that there are sufficient quantities to cause infection of another

individual for a long time, possibly years, after ART has effectively
controlled the virus. There is some data that suggests 3 - 5 years.

Now, I personally, don't use a condom for oral sex, and I am positive,

but I understand my risks, and I make sure my sexual partners are also

aware of the risks attributed to those sex acts.


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#23518 From: Butch <longjohnmaniac@...>
Date: Wed Nov 28, 2007 7:09 pm
Subject: Re: Flavanoid rich chocolate improves vasodilation
longjohnmaniac
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I realize most people think of chocolate - even dark chocolate - as a "candy" but this article points out flavanoid rich cocoa is what it's all about, even though presumably they fed their patients dark chocolate bars.  But you don't have to ingest cocoa as candy, with all the extra fat and sugar.  You can dump cocoa powder into lots of things, and it's a lot cheaper.  It's naturally bitter so adding just enough sweetener, whether natural or artificial, to counteract the bitterness, is all it takes.  As with salt, you can re-sensitize yourself to sweets to the point where most sweet treats seem sickeningly sweet.  Just start avoiding unnecessary sugars.   I can hardly stand eating commercial sweets or  commercial granola anymore.  They could easily reduce the sugar content by 2/3.    Same with chocolate.  I got some Nestle "special dark" chocolate on sale and it's way too sweet for my taste.  I add cocoa to lots of stuff - even chicken.  Mole, after all, is made with cocoa.   You can put a  tablespoon of cocoa into a blueberry/banana smoothie.  In winter make your own hot chocolate with cocoa in hot water and a little milk or soy milk and a teaspoon or less of sugar or honey,  etc etc.   It's amazing how jaded our taste buds can become with sugar, salt and fat.
Flavonoid-Rich Chocolate Improves Vasodilation, Reduces Platelet Adh
Posted by: "PoWeRTX@..." PoWeRTX@... nelsonvergel
Date: Tue Nov 27, 2007 7:10 am ((PST))


Flavonoid-Rich Chocolate Improves Vasodilation, Reduces Platelet
Adhesion
from _Heartwire_ (http://www.theheart.org/) — a professional news
service of
WebMD

Shelley Wood

November 23, 2007 (Zurich, Switzerland) - Another study--this time
randomized and double-blind--has found that flavonoid-rich dark
chocolate might be
good for the heart [1]. Writing in the November 20, 2007 issue of
Circulation,
Dr Andreas J Flammer (Cardiovascular Center, Zurich, Switzerland) and
colleagues report that compared with "cocoa-free" chocolate, a dark
chocolate rich in
flavonoids induced coronary vasodilation and reduced platelet adhesion
in
heart transplant recipients, even on top of standard secondary
prevention CVD
drugs.
The authors say the findings suggest a role for this type of chocolate
in
preventing graft atherosclerosis in transplant recipients, and possibly
in
reducing the risk of atherosclerosis in a wider population.
"This beneficial potential provides a strong rationale to further
investigate
the clinical effects of cocoa in cardiovascular disease," the authors
write.
Commenting on the study for heartwire, Dr Franz H Messerli (Columbia
University, New York) said the results were an important part of an
ongoing story.
"I don't think we can conclude that dark chocolate is going to be the
next
nitroglycerin, but still. . . . This is the first study that shows
that,
indeed, chocolate improves coronary blood flow, and significantly so,
in patients
who already were on vasodilators--ACE inhibitors and beta blockers,"
he said.
"So over and above conventional therapy, when you give dark chocolate
at the
dose it was given in this study, you get improved coronary blood
flow."
Vascular Benefits
Flammer and colleagues assessed coronary vasomotion using quantitative

coronary angiography and cold-pressor testing before and two hours
after giving 22
heart transplant recipients 40 g of dark chocolate (70% cocoa) or
cocoa-free
chocolate. On the second measurement, coronary artery diameter
increased
significantly from baseline, endothelium-dependent coronary vasomotion
improved,
and platelet adhesion decreased in the flavonoid-rich group. No
significant
changes were seen in the group eating the control chocolate.


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