AIDS TREATMENT NEWS Issue #390, April 4, 2003
phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Treatment Interruption; Advanced HIV; New Ideas: Dr. Cal
Cohen Interview on Retroviruses Conference (part 2 of 2)
The conclusion of Dr. Cohen's interview includes an in-depth
look at current thinking on treatment interruption, strategies
for highly treatment-experienced patients, and other topics from
the recent Retroviruses conference.

** SARS Web Information
Where to find current information about Severe Acute Respiratory
Syndrome (SARS), a new disease that can cause severe or fatal
pneumonia.

** Abacavir Arm Stopped in Clinical Trial
A government clinical trial stopped treatment with abacavir plus
AZT plus 3TC, due to more viral rebound than other treatments in
the study. Many unknowns remain.

** Huge Medicaid Cuts Weighed in Washington
A $92 billion Medicaid cut passed by the U.S. House of
Representatives, and a plan by the Bush Administration to reduce
entitlement funding of medical care for the poor and elderly and
give states more power to choose whose benefits are ended, could
seriously reduce HIV care in the coming decade.

** Africa Activism: Money for AIDS Not for War; South Africa
Antiretrovirals
Africa Action seeks organizational endorsements for prioritizing
an epidemic that has already killed 25 million people.
Separately, South Africa's Treatment Action Campaign seeks
international support for government cooperation in making
antiretroviral treatment available there.

** PRISON HEALTH NEWS First Issue Available
AIDS TREATMENT NEWS helped start this new publication on HIV,
hepatitis C, and other major illnesses in U.S. prisons.
Subscriptions are free.


***** Treatment Interruption; Advanced HIV; New Ideas: Dr. Cal
Cohen Interview on Retroviruses Conference (part 2 of 2)

by John S. James

In our last issue Cal Cohen, M.D., discussed starting
antiretroviral treatment, new information on protease
inhibitors, and antiretroviral toxicity. Here he looks at
treatment interruption, and treatment of patients with advanced
illness who have already received many antiretrovirals. We also
asked about an early experiment with a human monoclonal
antibody, which might lead to a different kind of treatment
given by injection every two or three weeks.

The interview took place on February 21.

Treatment Interruptions

Dr. Cohen: There were a couple of very important presentations
on treatment interruptions [see abstracts #64 through #68lb on
this topic]. I would summarize them as follows:

We continue to learn from studies that in some cases people can
safely stop their medications. If somebody has had a good CD4
rise and then stops medication, CD4 counts do not plummet
rapidly, on average. The viral load, even as it goes up, may
leave most people able to tolerate some time off antiretrovirals
if that is their choice. The risks include a few percent who can
have symptoms associated with HIV rebound -- similar to what
some have when first exposed to HIV. We have also learned at
past meetings that the other risk of stopping -- rapidly falling
CD4 counts -- is greatest in those who have a history of very
low counts -- suggesting that immune reconstitution is not
always complete for those who have ever had very low CD4 counts.
But even this is a generalization -- there are some with low
counts in the past who have stopped and had some time off with
stable counts -- they just need more frequent monitoring if they
do stop.

New data at this meeting highlighted a caution -- that a few
percent of people will develop viral resistance when stopping
antiretrovirals. Understanding of why and when that happens is
still evolving. But it appears that if your viral load is higher
than 50 and you stop your antiretrovirals, that is when you are
more likely to develop resistance. And this resistance is most
likely to drugs with a "low genetic barrier" to the development
of resistance - especially 3TC and the non-nukes [efavirenz and
nevirapine].

We are seeing results of studies showing that people can take
weeks or even months off antiretrovirals (long-cycle approaches
to treatment interruption). For example, a Thai trial compared
short treatment cycles (7 days on and 7 days off), vs.
continuous treatment, vs. a strategy of stopping when the CD4
counts are above 350 and starting only after a 30% drop in the
counts.(1) The researchers noted that their volunteers needed to
be on medications only 33% of the time with this CD4-guided
strategy. This approach is promising to reduce drug exposure.
And it is similar to the strategy being tested in the
international "SMART" trial -- the largest trial ever attempted
in our field. (SMART compares long-cycle interruptions to
continuous therapy. It is tackling a key issue in structured
treatment interruption, which is whether it makes a difference
in the long term. Readers can learn more about the SMART study
at http://www.smart-trial.org )

But an important caution about treatment interruption also came
from this trial,(1) which showed that the 7-day-on-7-day-off
antiretroviral regimen for people with well-suppressed virus did
not always work. This trial had 73 volunteers, of whom about a
third did 7 days on and 7 days off, and there were virologic
escapes. There may be reasons that explain it, including
underlying resistance, or these volunteers not always having
less than 50 when they stopped. These are just conjectures, as
the research team did not fully explain why their results
differed so much from other studies that showed successful
suppression even after 7 days off. The bottom line is that the
7-7 regimen is still a research approach with rules yet to be
understood, which is why we remind people that this is still
research and not a recommendation. If everybody looked at the 7-
7 data from Dr. Dybul at the National Institutes of Health and
started doing it, the Thai data suggests that as many as half of
the people trying it could have virologic escape. Researchers
and doctors are cautious because sometimes we learn later on
that problems occur. We need time and experience to understand
the newer strategies in order to know how to apply our findings.

So these days if someone is considering a treatment
interruption, and they want to be as conservative as possible --
meaning to conserve the drugs they are on now for use next time
-- some of the studies suggested treatment interruption may be safe,
but it is also important to do so in a way that minimizes
creating resistance. Resistance occurs while the drugs are
leaving the bloodstream and are present in concentrations too
low to stop the virus from growing. So we can take advantage of
the higher genetic barrier to resistance of boosted protease
inhibitors. One approach I use is a week of boosted dual
protease inhibitors to avoid resistance. If someone is on, say,
AZT plus 3TC plus efavirenz, I may substitute a dual boosted
protease inhibitor combination, Kaletra plus saquinavir, for
example, for a week. This allows the AZT, 3TC, and efavirenz to
leave the bloodstream while continuing viral suppression. Then
you can stop the protease inhibitors, and these drugs have a
high enough genetic barrier that you are quite unlikely to lose
them to resistance. Otherwise, you might lose 3TC or efavirenz -
- and it seems to me a good use of that week on an alternative
regimen to not risk losing those very precious drugs. Get them
out of your system while the virus is suppressed.

James: As a practical matter, do you have trouble with
reimbursement if you prescribe these drugs for just one week?

Dr. Cohen: In my experience, no, because it appears the same as
if I am just switching to this combination; no insurance refuses
to pay for medication switches. And certainly our pharmacies
here in Massachusetts are enlightened enough that if I want to
give somebody a week's supply instead of a month's supply they
are OK with that. It may be different elsewhere.

Choosing Drugs for Highly Treatment Experienced Patients ("Deep
Salvage")

James: What was new at this meeting for people who have had
extensive antiretroviral treatment, and have already developed
resistance to a number of the drugs?

Dr. Cohen: At this meeting we saw two very important pieces of
the puzzle. One area is new drugs. Another is an idea on how to
wait instead of switching antiretrovirals too soon.

Given that there are important new drugs coming, the question is
what to do if somebody is on a combination now that is holding
them at some acceptable viral load. If they do not have enough
new drugs that can work for them to create an effective, potent
regimen that makes it likely they will re-establish suppression,
we have seen that if you switch too early they will lose those
drugs and be back where they started, only worse since they now
have even fewer options. So there has always been an interest in
postponing the switch until you have a good switch. The
difficult question for a couple of years has been, what do you
do while you wait? Because keeping someone on a regimen allowing
partial suppression, but unfortunately also allowing the virus
to create more and more mutations, creates more and more cross
resistance, potentially losing options you've been trying to
save somebody for.

No one has a great answer, but Steve Deeks presented some very
preliminary but creative work, that for many was one of the
highlights of the meeting for innovativeness.(2) Since after
resistance non-nukes are generally useless, he has people on a
combination of nucleoside analogs and protease inhibitors, as
most of us do. He then focused on a group who were still
receiving benefit from the antivirals -- those whose current
viral load on meds was lower than their set point -- suggesting
that at least some of the meds were working. Then he thought,
maybe we could "save" a class -- and keep people on just
nucleoside analogs, or just protease inhibitors, minimizing
creating more resistance to either one class or the other -- and
minimizing toxicity from one class as well.

He showed that when he stopped the protease inhibitors,
maintaining the nucleosides only, at least for weeks if not
months, the viral load stayed suppressed; he could maintain this
viral load even without the protease inhibitors for months. Five
patients did the reverse, and stayed on the protease inhibitors,
and he did see a viral load increase of a little over half a log --
suggesting that, at least for now, stopping the protease
inhibitors and maintaining nucleosides may be a better way to
postpone switching and preserve the protease inhibitors for the
future. If you are off the protease inhibitors you will not
develop new PI mutations, so drugs like tipranavir may stay more
active for you. That's the logic.

Dr. Deeks also pointed out that this approach does not last
forever. It may be a stalling maneuver. It does provide food for
thought, and maybe another option for a while. But he noted that
in time the nucleoside-inhibitor-only approach will lead to
rebound -- so it might be necessary to restart the protease
inhibitors for some period of time, to take advantage of the
fact that the protease inhibitors can reduce the blood level of
even resistant virus. The key is to emphasize that these
observations are the beginning of a story -- and we have much to
learn about when these observations hold true, as well as when
we will see different outcomes. But it has some relevance for
some people now.

There are new drugs coming. We saw data on tipranavir that shows
that the company now has a dose worth using, and that it works
well against many protease-inhibitor-resistant mutations. T-20
is already well established and approved for sale at least in
the U.S. as of March 2003; in this meeting we saw data to show
that T-1249 works if you have T-20 resistance, and it works
quite well. We also saw data about other new classes of drugs,
including many other entry inhibitors, CCR-5 inhibitors, and one
drug from a completely new class that may be a viral assembly
inhibitor. Many of these new drugs are still only in the test
tube; there is a little clinical data. But it was promising that
people are finding new drugs and new drug classes that work
against resistant viruses.

Human Monoclonal Antibody

James: What do you think about the early test of the anti-HIV
antibody TNX-355 -- a new kind of possible treatment that was
injected once, and still inhibited HIV two weeks later?(3)

Dr. Cohen: It's not clear ultimately where this drug will go --
but there might be an injectable treatment given every two weeks
or so. In the trial so far they gave only one dose, and two
weeks later the virus reached its lowest point. We have never
before seen a drug that a single dose took two weeks to reach
its maximum response; it is not entirely clear why that
happened. This finding was curious but suggests that this drug
binds to the cells for a prolonged period and maintains the
effects for far longer than our usual oral medication. It raises
a host of questions because we have not used drugs with these
characteristics before.

James: Activists were disappointed that there was no human data
on TMC125, a new and very powerful non-nucleoside.(4)

Dr. Cohen: Yes, there may be issues with the formulation. This
drug has been burdened by a formulation that requires many pills
per day, and the company is working hard to improve on that
before moving ahead. As I understand it, they are closer to
proceeding to the next phase of research.

There are many drugs we will hear about over time -- some will
be developed more slowly than others. We are hearing less data
about some potential drugs since many trials are just under way.
Because we do not hear about something does not necessarily mean
there is no new information about it. Sometimes the trials are
being planned or have started, but are not mature enough to be
presented at scientific meetings.

Summary

James: Could you summarize some of your main take-home points
from the meeting?

Dr. Cohen:

(1) We continue to learn that we are far from preventing HIV
infection with a vaccine. Therefore prevention through behavior
changes that are maintained is critical to protecting oneself
reducing the size of the epidemic. We also don't know much more
about the risk from re-exposure to HIV, so for now we suggest
caution as more is learned.

(2) We know that treatment works, and we are learning more about
the tradeoffs with different approaches. There is no perfect
regimen for everyone, but clearly some choices have well-
established advantages over others.

(3) We must continue to be vigilant about side effects. While
searching for ways to both prevent and reverse them, we must
also be alert for newer side effects that we do not yet know
much about. We are only six years into the "HAART" era -- and
without a cure in place, we have decades to go.

(4) Starting treatment is no longer a single decision to be made
once -- people can stop and restart multiple times in different
patterns. The benefits and risks of these approaches are finally
beginning to be defined. And through longer-term studies finally
underway, we hope to be able to move from the era of knowing
that we can stop medications in some cases, to knowing whether
we should stop medications. It will take many people in long-
term studies to answer this question.

(5) The only way forward is more research. We all need to be
vigilant about supporting HIV research, as well as advocating
for our own field.

References

Note: These references are to the 10th Conference on
Retroviruses and Opportunistic Infections, Boston February 10-
14, 2003. They are available at http://www.retroconference.org
and will remain there for about a year. The abstracts should be
readable on all computers, but the browser's Internet security
setting should not be too high, or the software to search the
abstracts will not work.

1. J Ananworanich, P Cardiello, P Srasuebkul, and others. HIV-
NAT 001.4: A Prospective Randomized Trial of Structured
Treatment Interruption in Patients with Chronic HIV Infection.
[Abstract #64]

2. SG Deeks, JN Martin, R Hoh, T Wrin, C Petropoulos, and RM
Grant. Continued reverse transcriptase inhibitor therapy is
sufficient to maintain short-term partial suppression of multi-
drug resistant viremia. [Abstract #640]

3. DR Kuritzkes, JM Jacobson, W Powderly and others. Safety and
preliminary anti-HIV activity of an anti-CD4 mAb (TNX-355;
formerly HU5A8) in HIV-infected patients. [Abstract #13]

4. K Das, AD Clark, and PL Boyer. Could multiple modes of
binding of a potent NNRTI TMC125-R165335 explain its potency
against common drug-resistant mutants? [Abstract #613 - Poster
available]


***** SARS Web Information

by John S. James

Almost everyone has now heard of SARS (severe acute respiratory
syndrome), a new disease that can cause a serious and sometimes
fatal pneumonia. As we go to press (April 2, 2003) the news is
changing very rapidly. Just a week ago it looked like SARS might
be dying out -- but then Hong Kong reported over 50 new cases in
one day. Conferences and other public events are being postponed
or cancelled in that city and some other parts of Asia. This
disease could end on its own, or it could become a worldwide
pandemic and kill many people. Currently there are over 80
suspected cases in the U.S., most acquired from travel abroad.

SARS is believed to be caused by a previously unknown virus.
Some but not all patients have severe breathing difficulties and
need a respirator. So far the fatality rate has been about 4%.
Recently Hong Kong physicians reported success in treating
seriously ill patients with antibodies from those who had
recovered -- a well-known technique that has been used
successfully with other infectious diseases.

At this time experts believe that SARS is spread mostly by close
personal contact, as in hospitals or homes, especially by
coughing or sneezing. Some patients appear to be much more
contagious than others. No one knows how well the infection can
travel through the air in public places. It might also be spread
by objects recently handled by an infected person.

For Current Information

One place to start is a Web page by the U.S. National Library of
Medicine:
http://www.nlm.nih.gov/medlineplus/severeacuterespiratorysyndroe.html

For more detailed information, see the U.S. Centers for Disease
Control and Prevention (CDC) page:
http://www.cdc.gov/ncidod/sars/

We have not yet seen any HIV-specific information about SARS.

Comment

We suggest that more be done to support people in complying with
public-health directives -- especially travelers far from home
who are asked not to fly if they have possible symptoms. If they
fear being stranded in a foreign country thousands of miles from
home with no place to stay, uncertain medical care, and problems
getting a flight home when they recover, they will have strong
incentive to lie and conceal their illness. It would cost little
for public-health systems to help make arrangements for the few
travelers affected at this time.

New diseases will become increasingly serious due to crowded
populations, massive air travel, and possibly bioterrorism.
Proper support for public health, long neglected by governments
that care only for the rich (who can afford private medicine),
will become a life-or-death issue for everyone.


***** Abacavir Arm Stopped in Clinical Trial

by John S. James

A major government clinical trial comparing three HIV treatments
stopped the arm using abacavir plus AZT plus 3TC (Trizivir(R))
alone, after patients in that arm "experienced virologic failure
earlier and more frequently than patients who were randomized to
receive either of the other two treatment regimens being
evaluated in the study." However, all three of the study arms
seemed to do well virologically, given the relatively advanced
HIV infection the volunteers started with. And "there were no
concerns about the toxicity of the study drugs."

This trial (known as AACTG protocol A5095) compared abacavir
plus AZT plus 3TC vs. efavirenz (Sustiva(R)) plus AZT plus 3TC,
vs. all four drugs (abacavir plus efavirenz plus AZT plus 3TC).
In this study the volunteers were antiretroviral naive, but
started with a high viral load (median over 78,000 copies, with
43% of the volunteers having over 100,000) and low CD4 count
(median 238). A data review at 32 weeks found that 21% of those
randomly assigned to the Trizivir alone still had a viral load
over 200 copies after at least 16 weeks of treatment (which was
defined as "virologic failure" in this study), compared to 10%
of the volunteers in the other two groups combined. The
difference was seen both in the group with viral load over
100,000 copies when they started the trial, and the group with
lower viral load. Because the difference was statistically
significant and met the pre-determined standard for stopping a
treatment arm, the Data Safety Monitoring Board (DSMB) had no
choice but to stop abacavir plus AZT plus 3TC and offer the
participants other treatment. A March 10, 2003, letter from the
U.S. Division of AIDS to the researchers, containing all the
information initially available, is at:
http://www.niaid.nih.gov/daids/default.htm

Because the other two arms of this trial are continuing, the
DSMB released the least amount of information necessary, to
avoid any risk of biasing study results. For example, we do not
know if the virologic "failure" usually meant a viral load
barely above 200, or considerably higher. Also, we have no
information about adherence and missing doses. The study was
double-blinded and placebo controlled, so all volunteers took
five pills at night and two in the morning, and if some were
more careless about missing the morning than the evening dose,
that could have biased the result in the direction seen, since
all the efavirenz was in the evening dose, but every drug in the
Trizivir-only arm would have been affected by missing the
medicine in the morning.

Some additional information will be submitted to the
International AIDS Society conference, July 13-17 in Paris;
however, the other two study arms will still be ongoing, so full
information may not be available even then. Continuing the two
remaining arms will help address the question of whether adding
a fourth drug to certain 3-drug HAART combination regimens
provides enough additional virologic benefit to be worth the
added cost in side effects and expense.

Comment

There is no perfect HIV treatment, and we have not seen any rush
to change drug regimens because this Trizivir arm was stopped.
The new information does have doctors' attention, and will be
reflected in medical consensus as more is learned.


***** Huge Medicaid Cuts Weighed in Washington

by John S. James

In March 2003 the U.S. House of Representatives voted to cut $92
*billion* dollars from Medicaid over the next 10 years, mainly
to finance tax cuts for the richest Americans (the war on Iraq
and its followup had not yet been accounted for, and could
result in further massive cuts). The Senate voted for no
Medicaid cuts, and possibly an increase in some funding. Now a
House/Senate conference committee will decide between the two
budget plans, probably but not necessarily coming to some
compromise between them. Medicaid pays for much of the HIV
treatment in this country, in addition to other programs
including long-term care for the elderly.

Meanwhile, the Bush Administration has proposed what has been
estimated at a $600 billion tax cut -- when many states already
face their worst financial crisis in decades. The Bush proposal
for Medicaid is not known in detail, but it appears that states
that agree to give up entitlement to Federal matching funds for
Medicaid will be able to split two large block grants, one for
long-term care and one for all other care. But the grants would
have to be budget neutral -- and to meet this requirement,
states could cut prescription drug coverage, home health
services, primary care case management, physical therapy, dental
care, and other services. (For more information, including a
list of who is most likely to lose benefits, see the
Pennsylvania Health Law Project:
http://www.phlp.org/Bushproposal.htm )

For More Information on Medicaid and HIV

For background on Medicaid policy, see the Kaiser Family
Foundation, http://www.kff.org -- especially the section "Kaiser
Commission on Medicaid and the Uninsured."

For state profiles on HIV and Medicaid, see http://www.hivma.org
(published by the Infectious Diseases Society of America),
especially http://www.hivma.org/HIV/CEN/ToC.htm Most but not
all states have a profile available on this site.

How You Can Help

- Join the Medicaid Defense Group, "an ad-hoc coalition of
HIV/AIDS advocates fighting to preserve, improve, and expand
Medicaid." To join, email Lei Chou at theaccessproject@....

- Join Project Inform's Treatment Action Network. For more
information contact Ryan Clary, tan@....


***** Africa Activism: Money for AIDS Not for War; South Africa
Antiretrovirals

(1) Africa Action: Money for AIDS, Not for War

Africa Action, based in Washington D.C., is seeking
organizational endorsements for its call to give priority to the
global AIDS epidemic, which will kill 3,000,000 people in the
coming year. From the statement:

"AIDS is an urgent wake-up call to a deeper crisis in the state
of the world. The huge global inequalities that fuel this
pandemic are de-stabilizing and they are deadly. Only racism has
allowed the loss of so many lives to AIDS. Fighting a war
against AIDS is the most important positive step toward building
a stable future for everyone."

The full statement and endorsement information are at:
http://php.africaaction.org/action/moneyaids.php

(2) South Africa: Activists Call for Global Support in Campaign
for Antiretrovirals

The Treatment Action Campaign (TAC) and hundreds of AIDS
activists in South Africa have called for international support
for a new civil disobedience campaign to get their government to
provide antiretroviral treatment for HIV, which is killing 600
people a day in that country. The government does not want to
offer treatment because of the cost. Antiretrovirals on the
private market are completely out of reach of the great majority
of citizens. As a result, the average life expectancy of black
South Africans in Cape Town is expected to be reduced to 40
years.

TAC has prepared documents charging the Minister of Health and
Minister of Finance with homicide, and asked the police to
arrest the ministers. In Durban, police used water cannons and
other violence to disperse a protest, sending several TAC
members to the hospital. In other cities protests occurred
without incident.

"We cannot wait any longer for a visible and dynamic response
from the government, business and international community. We do
not need any more reports to tell us what we already know --
HIV/AIDS is killing 600 people a day in this country and ruining
lives and hopes. But with will and commitment this does not have
to happen. With leadership from business and government,
together with labour and communities, it is still possible to
save lives and restore hope."

International supporters can fax or phone the South African
embassy or consulate. Also, international demonstrations in
support may take place April 24 and/or April 27. For background,
see the TAC site, http://www.tac.org.za/ For U.S. specifics,
see the Health Gap site, http://www.healthgap.org/


***** PRISON HEALTH NEWS First Issue Available

A newsletter for prisoners, family members, and medical staff,
focusing on HIV, hepatitis, and other major illnesses in prison,
is available without charge. The first issue looks at taking
care of one's health, getting necessary medical services both in
prison and after release, the different stages of HIV infection,
and hepatitis C. It also has organizations to write for help.

Future plans include articles on nutrition, exercise, specific
drug treatments, how to advocate for yourself, HIV and hepatitis
C co-infection, depression, and getting assistance with housing,
medical care, drug treatment, finding work, and other needs when
you get out.

This newsletter was first intended as a prison edition of AIDS
TREATMENT NEWS. But it became a separate publication not limited
to AIDS. It is published by Philadelphia FIGHT, a nonprofit
service organization that provides healthcare, education, and
other services to people with HIV in Philadelphia. It has been
funded by an unrestricted educational grant from Ortho Biotech,
and is seeking additional funding.

To subscribe to PRISON HEALTH NEWS, send a request to: Laura
McTighe, Philadelphia FIGHT, 1233 Locust St., 5th floor,
Philadelphia PA 19107.

***** AIDS TREATMENT NEWS

Published twice monthly

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Editor and Publisher: John S. James
Reader Services: Allison Dinsmore


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