AIDS TREATMENT NEWS Issue #383, September 6, 2002
phone 800-TREAT-1-2, or 215-546-3776

Contents

** HIV Medicine After Barcelona Conference: Interview with Howard Grossman,
M.D.
We asked a leading HIV physician to summarize some of the treatment issues
that clinicians are now looking at after the Barcelona conference. Topics in
this interview include:
* Tenofovir, including for first-line therapy;
* The shift from protease inhibitors to non-nucleoside RT inhibitors, for
many but not all patients;
* Benefits of once-a-day regimens;
* Lipodystrophy, and strategies for avoiding or reducing it;
* Viral resistance testing;
* T-20
* Prevention -- including danger of superinfection with a new HIV strain

** Pan-African AIDS Treatment Movement Launched
Activists from 21 African countries have launched a movement to organize the
different sectors of societies, along with international institutions, to
address the epidemic more successfully.

** Chinese Activist Detained by Police, Immediate Action Needed
Dr. Wan Yanhai, widely considered one of China's leading AIDS activists, was
detained by police in Beijing August 24. Amnesty International and AIDS
organizations have called for immediate letters and email on his behalf.

** Philadelphia, New York: Dr. Jon Kaiser's Treatment Update, September 17,
18
A San Francisco physician who has long used both standard and natural
treatments in HIV will speak at a free public meeting in Philadelphia Sept.
17, and New York Sept. 18.


***** HIV Medicine After Barcelona Conference: Interview with Howard
Grossman, M.D.

by John S. James

Howard A. Grossman, M.D., is a leading HIV physician who has practiced HIV
medicine in New York City since 1987. He is also Assistant Clinical
Professor of Medicine at Columbia University and Associate Attending
Physician at St. Luke's Roosevelt Hospital. With his associate and a
physician assistant, his clinic works with approximately 850 people living
with HIV. AIDS TREATMENT NEWS interviewed Dr. Grossman on August 16, 2002.

ATN: Let's start with new regimens. How do you approach treatment options
today? For example, what do you think of tenofovir [VIREAD(R)], both for
treatment-experienced patients, and for those starting antiretrovirals?

GROSSMAN: It has been poorly communicated to patients that our great desire
would be to put everybody on therapy when we first find out they were
infected, if we had therapies that were not toxic, easy to take, and
long-lasting. But given the fact that we don't, we settled on the 350 T-cell
count as a general guideline for starting antiretrovirals. It keeps bearing
up in study after study that it is a pretty good place to set that line.

But when you start looking at much less toxic drugs like tenofovir, or at
somebody who could take a triple nucleoside regimen that does not have
really bad toxicity, and might be able to take that treatment for years, it
reopens the question of when to start. Nothing is set in stone in HIV
medicine. No question is forever closed.

ATN: What are doctors combining tenofovir with?

GROSSMAN: Tenofovir with abacavir [ZIAGEN(R)] and 3TC [EPIVIR(R)] is a good
regimen, all once-a-day. Or tenofovir with ddI [VIDEX(R)] and 3TC, although
some people worry that you might be more likely to develop a K65R mutation,
which could affect other nucleoside analogs. Or use a non-nucleoside that
does not have major side effects. Less toxic regimens re-open the question
about when is the best time to start antiretrovirals.

ATN: For the non-nucleoside, would you choose efavirenz [SUSTIVA(R)], for
someone who does not have a big problem with the mood changes or other
mental effects?

GROSSMAN: I like efavirenz, but we are using more nevirapine [VIRAMUNE(R)].
I think with once-a-day therapy, morning dosing works better than nighttime
dosing. Most patients are more likely to forget to take a dose at night.

ATN: You haven't had viral breakthroughs with nevirapine?

GROSSMAN: No, we have seen good efficacy. And a number of studies at the
Barcelona international conference showed pretty comparable efficacy between
nevirapine and efavirenz. The problem is that Boehringer-Ingelheim has not
done the studies. Those at the international conference were done by private
investigators, and not supported by Boehringer Ingelheim. The company
dropped the ball on getting answers to the questions.

ATN: I had the impression that people were choosing efavirenz as their first
choice.

GROSSMAN: I don't think that is necessary. Efavirenz is certainly a fine
choice for people who can tolerate it, and I do have lots of patients on it.
But again, with once-a-day, I think that morning dosing works better.

ATN: What do you typically combine with nevirapine in a starting regimen?

GROSSMAN: Often I put people on nevirapine, 3TC, and tenofovir. With this
regimen few patients will have major side effects. There can be problems,
but not as much as with other drugs.

ATN: And with nevirapine, it's the rash, and you have to watch the liver
enzymes?

GROSSMAN: Right. And nobody can tell who is going to have the acute hepatic
syndrome. Today that is totally unpredictable. But it is rare. There have
only been a handful of cases reported of acute hepatic necrosis. This seems
to be an unpredictable, rare, and very acute syndrome that has happened in
some people with very high CD4 counts.

The liver toxicity that is more common is an asymptomatic rise in liver
enzymes that occurs in the first 6 weeks of treatment. If people develop
elevated liver enzymes and symptoms, they can stop the drug and the symptoms
disappear. And if they make it past the six weeks they probably won't get
this problem. That is why Boehringer-Ingelheim has recommended that people
starting Nevirapine get their liver function tests done every 2 weeks for
the first 6 weeks.

ATN: Any other thoughts about regimens for starting antiretroviral therapy?

GROSSMAN: I strongly believe in once-a-day therapy. I consider it the big
breakthrough of the last year and next year.

It is being accepted in a reverse of the usual way. Usually in HIV, the
first people to develop new strategies are investigators and academics. In
this case, however, the investigators have been holding back on once-a-day
therapy. But it has caught on in a huge way in the community. For the
doctors in the trenches who have patients who are difficult to treat, it has
been a no-brainer that once-a-day is the way to go.

In Barcelona there were two posters about patients preferring once-a-day
therapy. Both were studies sponsored by Bristol-Myers Squibb, which has a
big stake in promoting once-a-day. But many of the research physicians have
been holding back.

For my patients it has made a tremendous difference. We offer once-a-day to
everybody who has a possibility of taking it -- even if that means changing
their regimen, because I think it makes such a difference in terms of
increased adherence, increased efficacy and patient satisfaction.

At Barcelona I presented a poster on once-a-day, looking at the first 50
patients we treated, and it was successful. But there was not much
information at the conference about qd [once-a-day] therapy.

There was interesting information about ritonavir/saquinavir. One poster
compared it vs. indinavir/ritonavir, both twice a day in this trial [P. Cahn
and others, abstract #WeOrB1265], and the number of adverse events, change
in LDL cholesterol, and change in triglycerides, was lower in the
ritonavir/saquinavir group. Yet they did just as well virologically.

Another poster looked at switching patients from another protease inhibitor
regimen that failed to a ritonavir/saquinavir protease inhibitor regimen
[J.G. Baril and others, #WePeB5902]. This retrospective chart review of 12
patients found generally good results.

But so far I have not had good success with once-a-day protease inhibitors.
I had a couple patients on amprenavir/ritonavir once-a-day, and a couple
patients on saquinavir/ritonavir once-a-day, but that takes lots of pills.
When we get newer protease inhibitors, like atazanavir and GSK908,
once-a-day PIs will become practical.

There was also a followup to the Kaletra (lopinavir/ritonavir) once-a-day
vs. twice a day trial in treatment-naive patients [J. Feinberg and others,
#TuPeB4445]. Now they are reporting at 72 weeks, and there was no
significant difference between the arms in virologic suppression.

But in this study, trough levels on the twice-daily Kaletra regimen cluster
very close to 100 times the IC-50 [meaning that the lowest drug level in the
blood, usually just before the patient takes the next dose, is about 100
times the amount needed to inhibit 50% of the virus] -- a good place. Trough
levels on once-a-day have much more variation. Some patients are much closer
to the IC-50.

I tried this Kaletra regimen in 5 patients who were not treatment-naive, and
we measured their lopinavir trough levels after 2 weeks, and all 5 were
below the IC-50. So I took everybody off once-a-day Kaletra. While the trial
seems to be achieving good results, I am not sure that it is expandable
beyond naive patients. I don't think people should try this outside of a
study.

ATN: What do you think about continuing antiretroviral therapy in heavily
treated patients who cannot control the virus with any currently available
drugs?

GROSSMAN: I have advanced patients who have a viral load over 750,000 copies
-- they are definitely not controlling the virus. I think they still get
some benefit from the drugs. But their T-cells are too low to show if there
is a response. Usually if they do not have overwhelming side effects, I
recommend that they stay on the drugs.

I think from Steve Deeks' data a couple years ago and some other studies,
that patients get some benefit from antiretrovirals even if the virus is
resistant and cannot be well controlled with the drugs.


Lipodystrophy

ATN: On lipodystrophy, what are you seeing? What drugs or combinations seem
to be associated more with the problem?

GROSSMAN: I see both fat accumulation and fat wasting. Fat accumulation is
sometimes hard to diagnose. I use what I call the pinch test. If the patient
says they are getting a big stomach, I ask if they can pinch it. If you can
pinch it, it's probably not lipodystrophy, but just fat. Lipodystrophy is
visceral fat -- it is deep, and hard, and different from the subcutaneous
fat you get because you are eating too much, or not getting enough exercise,
or getting older. This is one way to help people feel more comfortable.

But I also see many patients with fat accumulation that is lipodystophy.
Often the prominent belly, if it is muscular, is not as big a problem for
them as facial wasting is for many people.

In the gay community some people have eroticized the lipodystrophy look --
facial wasting, prominent cheekbone, veins showing everywhere. But a
collapsed-in face is usually much harder for people to deal with than a big
abdomen.

And doctors who do not ask patients to take their clothes off in the office
may not see it. I know many doctors who don't.

While there probably is some HIV-related lipodystrophy, and some related to
the nucleoside analogs in general, clearly we are seeing something different
now than in the past. You sit in a room with 400 patients, and look around,
and think, "This is unbelievable."

If you live in New York, or San Francisco, or West Hollywood, or probably
Philadelphia, where many people walk on the street, you see it. If you live
in places where people travel in cars, you don't see how pervasive it is.

ATN: What are you using for it? What regimen changes, or treatments?

GROSSMAN: Clearly d4T and the protease inhibitors seem to be the bad drugs.
Which one causes more, whether it happens mainly with one or the other or is
worst with both, we are not sure. My response has been to avoid both, until
researchers figure out what is going on. We start almost nobody on protease
inhibitors -- unless they come in with a virus with the K-103 mutation, due
to transmitted resistance to non-nucleoside drugs. Otherwise I don't touch
the protease inhibitors, and I stay away from d4T. Why take that risk for
patients when we have other choices?

ATN: On resistance testing, what is new that people should be thinking
about?

GROSSMAN: Sax at Harvard showed that in places where resistant virus is
common, as in most of the major cities in the U.S., resistance testing
before beginning treatment becomes cost effective [P.E. Sax, #MoPeB3129]. In
cost for good outcome, it is comparable to other medical treatments that are
well accepted.

We started doing resistance testing before treating people who were
chronically infected -- which goes against conventional wisdom. But I think
there are enough mutations in the community from AZT, and some of the
non-nucleoside and protease inhibitor mutations, that will hang around years
after somebody is infected with a resistant virus. This makes it worthwhile
to test for resistance, if they were infected in an area with a fairly high
prevalence of resistant virus (around 7%). I test them before starting
therapy to see if we come up with any antiretrovirals we should avoid.

After patients are on therapy, we test everybody who fails. I do both
genotyping and phenotyping, because in many patients the picture is complex.
You get enough discordance between the genotype and phenotype that having
both kinds of resistance testing can be very useful.

ATN: Do you use the new ViroLogic service that combines both?

GROSSMAN: Yes, the Phenosense GT. Virco has a good test too, but I like the
amount of data ViroLogic has on their report. And now they are doing their
experimental replicative capacity test as well, looking at the "fitness" of
the virus.

ATN: What do you think of the fitness test?

GROSSMAN: I am going to try it and see. At this point [August 2002] we are
just looking to see if it is useful or not. There need to be prospective
studies.

ATN: What else should patients know about using antiretrovirals?

GROSSMAN: It is very important to come back to the doctor for testing when
starting certain drugs. With the nevirapine regimens, for example, the
company recommends clearly that people get their liver functions tested
every two weeks in the first 6 weeks on therapy. We must be careful and
catch serious toxicities early.

Many patients who start antiretrovirals are used to seeing the doctor every
three months. When you start these meds, you need to follow up with the
doctor much more frequently at first. Unless the practitioner specifically
makes the appointments, patients may not show up again for three months. And
in addition to safety, we really want to see viral responses at 4 weeks and
8 weeks and 12 weeks [after starting antiretrovirals].

Especially when someone starts taking antiretroviral medication, I think
they should be seen two weeks after they start, to make sure they are doing
it right, if nothing else. If they are taking the drugs improperly for
months, the chance of developing resistance is high.

ATN: Is there anything else you would like to add on antiretroviral therapy?

GROSSMAN: The tenofovir data is excellent. The 48 week data from Gilead's
trial where it was added to failing therapy had remarkable results [A.L.
Pozniak and others, #WeOrB1266]. People maintained their decrease in viral
load after 48 weeks, even though their initial baseline therapy had failed
to maintain undetectable virus. And Gilead finally released their data in
treatment-naive patients, which also shows good efficacy. I am very willing
to use tenofovir for first-line therapy. I think it makes so much sense.


T-20

On T-20, people need to understand that it takes 30 minutes to mix this
drug, which is injected twice a day. You have to put a little bit of fluid
in and shake it very carefully, a little bit more and shake very carefully
again; you cannot get any bubbles, you cannot bruise the drug because
otherwise you denature the protein. It is very complicated to mix, and
almost everybody gets injection-site reactions. In studies they found only a
3% drop-out rate due to injection-site reactions; but these were desperate
patients who were highly treatment experienced and failing pretty much their
last regimen, and T-20 was their last chance.

I am not sure what will happen when T-20 comes into wide use. People need to
know that while it is a good drug it is certainly not a wonder drug, and it
will be very difficult for those people who take it. The company is well
aware of that. But the press has not covered how long it takes to mix it; I
have not read that anywhere. People need to know that taking T-20 will have
an impact on their lives, and they need to think about how they will handle
this. You cannot use a mixer or anything that speeds up the process.

New data show that both of the day's doses can be mixed in the morning, with
the afternoon dose left in the refrigerator. This, at least, will make it a
bit easier for those who take it.


Prevention

ATN: On superinfection -- people with HIV getting infected again with
another strain of HIV -- are changes needed in counseling people?

GROSSMAN: There were two cases at Barcelona -- the one from Bruce Walker
that got all the publicity, and another one from Geneva that was even more
impressive because of the testing they did. Clearly both of these people
became superinfected with another virus, even though they were doing well
with their STI (strategic treatment interruption) regimens, being patients
who had been picked up during seroconversion. They suddenly had a burst of
virus, and it turned out to be a different virus than they had before. When
scientists looked back at their stored samples, the second virus was not
there. In the Geneva case the man had been to Brazil and had unprotected
sex, and three or four weeks later he had the burst of virus -- and that
virus was one typically found in Brazil, not one typical for Geneva. [S.
Jost and others, #ThOrA1381]

I think it is very worrisome. We were trying to come up with some more
personalized sex guidelines for people in the early 90s -- rules that would
help people have more protected sex, but that were also more reasonable and
individual. So we said, if both of you were positive, maybe it did not
matter as much that you use a condom. But I think people got carried away.
In New York, San Francisco, Paris, and Los Angeles, many people are not
using condoms anymore at all! Many bathhouses are not giving them out; they
are not around. We are seeing a rise in new HIV infections across the board
in men, especially young men, and we are seeing a rise in other STDs. It is
amazing to me how little younger men know about STDs these days. We have
been so focused on HIV that we have forgotten to teach about good old
syphilis, gonorrhea, warts, etc.

And clearly there is a risk of HIV superinfection even if you are both
HIV-positive. It may not be a huge, high risk, but the risk is that you
could get a second HIV virus and do worse medically.

The implications for vaccines are tremendous, because it means that even a
well-controlled person who has good CTL immune responses and good responses
to the initial virus can be infected with another HIV.

ATN: What about oral sex?

The HOT (HIV Oral Transmission) study, out of San Francisco, is following
over 200 men who have sex with men and are believed to have no risk except
receptive oral sex [K. Page-Shafer and others, #TuPeC4872]. So far they have
found no recent HIV cases.

Clearly there have been reported cases. But this is a large study and seems
to show that though it does happen, the rate is low. Over the years,
Europeans and Australians have focused their prevention messages totally on
unprotected anal intercourse, and their HIV incidence rates have dropped
tremendously. We gave the mixed messages that we don't know about oral sex,
we are not sure, and we've totally confused everyone. As a result, our
incidence is high. I think people get frustrated and say, "Nothing is going
to protect me, I might as well just do what I'm going to do." Focusing on
unprotected anal intercourse is where I think we should be.

An epidemiology study in San Francisco found continuing increases in
unprotected anal intercourse, including with multiple partners [S. Gibson
and others, #MoPeC3430]. There was a big increase in rectal gonorrhea, and a
huge increase in early syphilis -- 17 cases in 1997, 10 in 1998, 29 in 1999,
47 in 2000, and 140 in 2001 [figures from the abstract]. HIV incidence also
increased greatly, although it may have peaked in 1999.

ATN: Overall, what do you think will be most important from the Barcelona
conference for treatment of patients with HIV?

The main messages from Barcelona were:

* The global epidemic is still a total disaster, but some individual people
have been making great progress.

* What I call the 'PI Paradigm" -- that protease inhibitors are stronger;
that people with high viral loads need them (or boosted PIs); that they are
the only drugs that control lymph node viral proliferation, etc. -- took a
big hit at this conference. The best performing regimen we have seen to date
has been efavirenz/Combivir(R) given every 12 hours. These are the drugs
that have been studied. It is my belief, however, that what we are seeing
here is not really drug specific; rather it is an indicator that NNRTI/2NRTI
regimens work as well, or better, than PI-containing regimens. And they are
much better tolerated.

* We still don't know what causes lipodystrophy and elevated lipids.

* We still don't know for sure whether there is an increased incidence of
cardiac disease in people on long-term therapy.

*STDs and new HIV infections are on the rise in young gay men of all races
and ethnicities in the U.S. and Europe. Here in the US they are
disproportionately affecting young gay men of color.


***** Pan-African AIDS Treatment Movement Launched

On August 26, 2002, AIDS activists from 21 African countries announced the
Pan-African HIV/AIDS Treatment Access Movement (PHATAM). They had met for
three days in South Africa, during the World Summit on Sustainable
Development. Twelve AIDS, health, and religious organizations convened the
PHATAM organizing meeting. The new group will focus primarily on treatment,
including antiretrovirals, but will also work on prevention and other ways
to control the epidemic.

From the PHATAM Declaration of Action, published August 25:

"Without treatment, the 28 million people living with HIV/AIDS (PLWAs) on
our continent today will die predictable and avoidable deaths over the next
decade. More than 2 million have died of HIV/AIDS in Africa just this year.
This constitutes a crime against humanity. Governments, multilateral
institutions, the private sector, and civil society must intervene without
delay to prevent a holocaust against the poor. We must ensure access to
antiretroviral (ARV) treatment as part of a comprehensive continuum of care
for all people with HIV who need it. In this regard, at a minimum, we call
for the immediate implementation of the World Health Organization goal to
ensure antiretroviral (ARV) treatment for at least three million people in
the developing world by 2005. Together with our international allies, we
will hold governments, international agencies, donors and the private sector
accountable to meet this target."

Three international action dates were announced:

"* A Global Day of Action on the Global Fund to Fight AIDS, Tuberculosis and
Malaria on 9 October 2002 to demand more money from donor countries,
prioritization of treatment in national proposals and funding decisions,
increased transparency and monitoring of fund disbursements, and active
involvement of PLWAs in Country Coordinating Mechanisms

"* A Global Day of Action Against Coca-Cola, the largest private employer in
Africa, and other multinationals on 17 October 2002 to demand ARV treatment
for all HIV-positive workers and their families

"* A Global Day for Access to HIV/AIDS Treatment on 1 December, World AIDS
Day, 2002"

For more information see the Declaration of Action, which is available at
http://www.tac.org.za. (Documents on this site are organized by date, and
the Declaration of Action was added on September 3.


***** Chinese Activist Detained by Police, Immediate Action Needed

Dr. Wan Yanhai, China's foremost AIDS activist, disappeared in Beijing on
August 24. According to Liang Yen Yen, one of the coordinators of Dr. Wan's
Aizhi (AIDS) Action Project, he has been detained and is being "examined" by
the Chinese Ministry of State Security. He is accused of exposing state
secrets; namely the AIDS epidemic in China's Henan province brought on by
blood selling.

Dr. Wan's wife Su Zhaosheng has called on AIDS activists and other allies to
help in the effort to expedite his release.

Dr. Wan, 38, is a noted free speech advocate who founded the first AIDS
telephone hotline in China and operates an important AIDS information web
site. A current Fulbright scholar, Dr. Wan is studying the effectiveness of
abstinence-only programs in the U.S. and China.

For the past decade, Dr.Wan has been working on HIV prevention education,
gay & lesbian rights, mental health issues, the rights of people with HIV,
and religious issues. He is the 2002 winner of the Human Rights Watch Award
for Action on HIV and Human Rights.

According to the Committee to Protect Journalists:

"Wan has also been an outspoken opponent of new Internet regulations,
enacted August 1, which require publishers of all China-based Web sites to
register with the government and censor their content or risk being shut
down. In late July, Wan and 17 others initiated a "Declaration of Internet
Citizens' Rights," which called for freedom of expression, association, and
information on the Internet.

"Reporting on AIDS is strictly censored in China's press, and Chinese and
foreign journalists who investigate the topic have faced harassment or
detention. Because of this, Wan Yanhai's Web site has become one of the only
independent sources of information on the disease in China."

In July, Aizhi Action Project was shut down and stripped of its legal
registration by the Chinese government.

Dr. Wan's disappearance, which has been covered extensively by THE NEW YORK
TIMES, National Public Radio and other news outlets, has prompted an
international reaction. On September 2, activists held a protest in Hong
Kong.

Amnesty International issued an international appeal for immediate letters
on his behalf, and U.S. AIDS activists have issued their own appeals.

On September 2, 2002, Amnesty International asked that letters and emails
for Dr. Wan's release be sent immediately to Chinese officials in Beijing
and to Chinese embassies throughout the world. To a send such a message,
check:

http://www.amnestyusa.org/outfront, or
http://www.iglhrc.org/world/ne_asia/China2002Sep.html, or
http://www.whereiswan.org.


***** Philadelphia, New York: Dr. Jon Kaiser's Treatment Update, September
17, 18

Jon Kaiser, M.D., who combines standard HIV antiretroviral treatment with
nutrition, exercise, and other natural treatment approaches will be speaking
in Philadelphia on Tuesday, Sept. 17, at Graduate Hospital Auditorium, 18th
and Lombard St., 6-9 p.m. A light dinner will be served. For more
information, see http://www.jonkaiser.com.

There is no charge for this program, which is sponsored by Action AIDS,
MANNA, Philadelphia Health Alternatives, and Philadelphia FIGHT.

As we went to press the New York talk was set for Sept. 18, St. Vincent's
Hospital, Cronin Auditorium, 10th floor, Cronin Bldg., 170 W. 12th St., 6-9
p.m. Light dinner will be served, and no admission charged. Sponsors are St.
Vincent's AIDS Education and Training, and FIAR (Foundation for Integrative
AIDS Research).


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