AIDS TREATMENT NEWS Issue #365, May 25, 2001
phone 800-TREAT-1-2, or 215-546-3776

Contents

** Antibodies and HIV: New Evidence. Interview with Ruth
Ruprecht, M.D., Ph.D.
While most antibodies are not effective against HIV, an
immunologist has found some that are. This research might
be very important for vaccine development, for protecting
infants from infection (including from breast milk), and
possibly for developing better treatments for persons
already infected.

** Danger: Counterfeit Neupogen(R) (Filgrastim)
A counterfeit drug with no active ingredient is circulating
in the United States; it could be a serious health risk to
patients. The fake product is easy to recognize, by using
instructions and photos on the company's Web site.

** Danger: Counterfeit Serostim(R) (Human Growth Hormone)
A warning from the company and the FDA about a new
counterfeit human growth hormone -- the second such case
this year.

** June 23: New York March and Rally Before United Nations
AIDS Session
A major rally will take place in New York, just before the
opening of the United Nations General Assembly Special
Session on AIDS (UNGASS). It is seeking funding, debt
cancellation, and political will to make treatments
available to save the lives of persons in developing
countries with HIV.

** United Nations: Civil Society Snubbed at Final
Preparatory Meeting on AIDS
Many of the AIDS organizers, some of whom traveled long
distances at their own expense, found they had little input
into preparations for the United Nations AIDS session in
June.

** Global AIDS: Back to the Past?
We believe the potential availability of affordable
treatment in Africa transformed AIDS from an unsolvable
tragedy to an opportunity to save lives, making
mobilization possible. But in the last few weeks, a push to
avoid funding treatment in order to focus on prevention
weakened the momentum against AIDS as a whole.


***** Antibodies and HIV: New Evidence. Interview with Ruth
Ruprecht, M.D., Ph.D.

By David Scondras, Search For A Cure, and John S. James,
AIDS Treatment News

Background

HIV infection causes the body to produce large amounts of
antibodies -- specialized proteins produced by the immune
system to fight infecting bacteria or other organisms. But
most of the antibodies produced in response to HIV
infection are not effective in stopping the virus -- and
some of them may even increase HIV infection. So in recent
years, many scientists have given up on antibody approaches
to HIV vaccines or treatments. (Instead they are working
with the other major branch of the immune system, cellular
immunity, which now looks very promising for control of
HIV. However, cellular immunity by itself cannot clear most
HIV infections.)

At a recent conference on immune research in HIV, held
April 27-29 at the Institute of Human Virology at the
University of Maryland in Baltimore, Ruth M. Ruprecht,
M.D., Ph.D., an immunologist at the Dana-Farber Cancer
Institute and Professor of Medicine at Harvard Medical
School, presented an update on her team's ongoing work with
HIV antibodies. She agrees with her colleagues that most
antibodies against HIV are not effective. But some are (as
other investigators and Dr. Ruprecht had shown) -- and she
has selected three of them for further research. These
three, injected together, have successfully prevented
infection in monkeys, even when they are given large doses
of HIV-like viruses.

If this approach continues to be successful, it could have
huge implications:

(1) Vaccines could be engineered to cause the body to
produce antibodies already known to work. Such antibody-
inducing vaccines might be effective by themselves -- or
might be combined with approaches that generate cellular
immunity to produce vaccines more effective than either
kind alone. Vaccine development could be greatly
accelerated, because it would be possible to test quickly,
in volunteers, whether or not a candidate vaccine induced
production of the desired antibodies. Problems could be
found and fixed quickly, before the vaccine went into a
large, multi-year trial.

(2) Antibodies might also be able to prevent mother-to-
infant transmission -- without the side effects or
potential toxicities of antiretrovirals, without the risk
of producing drug-resistant virus, and possibly without
requiring the mothers to avoid breast feeding.

(3) It is possible that selected antibodies might help in
the treatment of persons already infected. So far there are
no data, as this has not been tried even in animals.

But many years ago there were experiments with "passive
immunotherapy" for HIV -- collecting serum donated from
persons who were doing well for a long time despite HIV
infection, and transfusing this serum into persons who were
sick. Despite some promising results, this work did not
continue. From the modern perspective, these early attempts
do make some sense -- Dr. Ruprecht explained that a few
patients do produce antibodies that are effective in
stopping HIV. But today we also know that some people are
slow progressors for different reasons, some of which have
nothing to do with antibodies, so there is no reason to
think that transfusing their plasma would be beneficial to
others. Using rationally selected, engineered antibodies
would appear more promising.

Incidentally, passive immunotherapy has long been used to
treat certain other infectious diseases. And recently it
was found effective in animal tests in both preventing and
treating ebola virus infection.(1)

Dr. Ruprecht uses monoclonal antibodies (pure antibodies
produced by genetically modified cells) rather than serum
or immunoglobulins prepared from serum, that deliver a
variable mixture of many different antibodies. So far,
monoclonal antibodies have been much too expensive to use
as treatments. But now it is becoming possible to produce
antibodies in plants, such as tobacco. So price need not be
an obstacle -- if it is found that antibodies could work as
treatment for someone already infected with HIV, which
today is not known.

Note: David Scondras interviewed Dr. Ruprecht on April 28,
and prepared a transcript. Since he then had to leave for
AIDS work in Malawi, John S. James, who was present at the
interview, edited the transcript and wrote the background
section above. Dr. Ruprecht made corrections before the
interview was published.

* * *

Interview with Dr. Ruprecht

SCONDRAS: What is the goal of your work?

RUPRECHT: We want to develop an immunological approach to
prevent mother-to-child transmission of HIV.
Simultaneously, we are also looking for a way to rationally
design an HIV vaccine.

The idea came from how we manage hepatitis B. To prevent
mother-to-child transmission, pregnant women are screened
for the virus. If they are positive, their infants get two
inoculations: the first consists of hepatitis B
immunoglobulins [which contain antibodies against the
hepatitis B virus, providing passive immunity], and the
second is the hepatitis B vaccine.

Used together, the vaccine plus immunoglobulins confer 98%
effective protection to the baby. If you use the
immunoglobulins alone, they are only 70% effective.

Turning to HIV, people who have HIV infection make very
little neutralizing [effective] antibody compared to people
with other viral infections. Instead, with HIV, the body
makes lots of antibodies to parts of the virus that are not
important. This kind of antibody does not stop the virus
from infecting cells and damaging the immune system.
Indeed, it is now known that HIV makes the body produce
antibodies that may even help the virus infect cells.

That was part of the reason I decided to stay away from
polyclonal sera [such as antibody preparations made from
the blood of persons whose HIV was progressing slowly]. You
cannot do a rational analysis of the specific antibodies.

SCONDRAS: Hasn't this approach of looking at antibodies
been tried before?

RUPRECHT: Every once in a while, a patient develops
relatively high titers of neutralizing antibodies [meaning
that they produce antibodies that effectively block HIV].
It is also known that monoclonal antibodies can be made
from these people. But in scientific research, the pendulum
had swung away from antibodies.

SCONDRAS: How did you think that antibodies could play an
important role anyway?

RUPRECHT: I knew that antibodies help prevent hepatitis B
virus infection. I also knew that the hepatitis B virus has
some similarities to HIV. So I decided to focus on finding
potent antibodies from HIV-infected people. Other
investigators have succeeded in engineering cultured cells
to produce just a single antibody, called monoclonal
antibody. My colleagues kept isolating B cells [the cells
in the blood that produce antibodies], and kept screening
until they found cells that produced antibodies that
successfully neutralized HIV. Then we could learn to mass
produce the monoclonal antibodies. Today this is possible;
in fact, tobacco plants can be engineered to produce these
antibodies.

The Animal Tests

RUPRECHT: We decided to combine antibodies that worked
against HIV, in the hope that a cocktail of antibodies
would be more effective than one antibody alone. We looked
for overall potency of triple combinations, picked a
combination that stopped HIV in the test tube, and then
tested if that combination would stop a virus similar to
HIV that can grow in animals.

The three antibodies that we picked are human monoclonal
antibodies, targeting conserved epitopes of the envelope of
HIV. [The "envelope" is the outside part of the virus, that
antibodies can get to. "Epitopes" are particular shapes of
parts of HIV; antibodies target foreign substances by being
shaped just right to fit them. "Conserved" epitopes means
ones that do not change much from one strain of HIV to
another (probably because when they do change as a result
of mutations, the virus is not able to survive).]

This kind of therapy that uses antibodies is called
"passive immunotherapy." It is important for babies, in
particular, because it may be able to protect babies from
getting HIV from their mothers, and also protect them from
getting HIV from breast milk from the infected mother.
Antibodies stay in the blood for a fairly long time [so it
might be possible to protect babies with only a few
injections, instead of shots or pills every day].

SCONDRAS: Is there any connection between this and
developing a vaccine to protect people from HIV?

RUPRECHT: Yes. We have antibodies now that are completely
characterized [meaning that we know to what part of HIV
they bind]. If these antibodies can provide complete
protection from HIV transmission, then a vaccine that
elicits these antibodies should be protective.

SCONDRAS: Is it possible that these antibodies could be a
therapy for people who have HIV?

RUPRECHT: We just do not know yet -- no experiments have
been conducted to test this approach.

SCONDRAS: Why do you think you may have found the right
antibodies?

RUPRECHT: We have data showing that these three antibodies
can completely protect against SHIV challenge in adult
rhesus monkeys. [SHIV is a virus which combines parts of
SIV, which infects monkeys, and parts of human HIV.] We
have also shown that newborn monkeys could be protected
completely with the triple combination of antibodies
against mucosal SHIV infection. Then we tried a much more
aggressive SHIV strain, and it was stopped in some newborn
animals. We purposely infected these monkeys with much,
much more virus than is usually transmitted from mothers to
babies, and the antibodies worked well.

One other point: The antibodies we have identified are of
the IgG subtype, not IgA, the typical mucosal antibodies.
This implies that you do not need mucosal immunity to HIV
to protect people from HIV.

SCONDRAS: Dr. RUPRECHT: How did you get started in AIDS
research ?

RUPRECHT: I was about to start a thesis in physical
chemistry in Switzerland, my native country, but my real
love was molecular biology. When I was in the U.S. as a
summer intern in chemistry, I discovered that the U.S.
graduate-school system would allow me to make this change
of fields, unlike my school in Europe. So I decided on the
spur of the moment to stay in the US, and went to Columbia
University. I worked on cancer-causing retroviruses and
studied the mechanism of reverse transcriptase.

After getting my Ph.D., I attended a two-year medical
school at the University of Miami, and then completed my
residency in internal medicine at UCLA. I was there when
the first HIV patients came to the hospital. I started a
fellowship, moved back to New York City, then got an
academic position in 1984 at the Dana-Farber Cancer
Institute, and have worked in AIDS research ever since.

References

(1) M. Gupta, S. Mahanty, M. Bray, R. Ahmed and P.E.
Rollin. Passive transfer of antibodies protects
immunocompetent and immunodeficient mice against lethal
Ebola virus infection without complete inhibition of viral
replication. Journal of Virology. May 2001; volume 75,
pages 4649-4654.


*****Danger: Counterfeit Neupogen(R) (Filgrastim)

On May 10 Amgen Inc. warned medical professionals that
counterfeit vials labeled as Neupogen (filgrastim) have
been found in the United States (but not in other countries
at that time). These vials contain a clear liquid, but no
active ingredient -- a fraud that could be life-threatening
to patients.

The Amgen Web site has detailed instructions for
distinguishing the counterfeit product, which is easy to
do, because there are differences in the lot number,
packaging, and labeling. For example, lot number P000948 is
counterfeit; while lot number P000890 with one expiration
date is counterfeit, but the same lot number with another
expiration date is probably authentic. Since other fake
labels may be printed, check the Amgen Web site,
http://www.amgen.com

(Try clicking Corporate Center, then Amgen News -- check
the May 10 or 11 press release, which has photos showing
the differences, and see if there are any later press
releases.)


***** Danger: Counterfeit Serostim(R) (Human Growth
Hormone)

On May 17 Serono, Inc. and the U.S. FDA warned that new
counterfeit drug labeled Serostim had been found. There had
been a warning of a previous case of counterfeit Serostim
in January of this year. From the press release:

"Serono, Inc. and the U.S. Food and Drug Administration
(FDA) are informing distributors, pharmacies, physicians
and patients of the existence of a new counterfeit lot of
Serono's Serostim(R) 6 mg [somatropin (rDNA origin) for
injection]. The counterfeit material, which is made to
resemble Serostim(R), bears lot number MNH605A. Any product
labeled as Serostim(R) and carrying this lot number should
be considered to be counterfeit.

"Patients in possession of the counterfeit lot should
return it immediately to their pharmacy for a replacement.
Patients seeking additional information may also call
Serono's product information line at 1-888-275-7376.

"Serono is sending a 'Notification of Counterfeit Product'
letter to wholesale distributors, pharmacies, physicians
and AIDS service organizations to alert them. The
counterfeit material was neither manufactured nor
distributed by Serono and is definitely not Serostim(R).
Therefore, it cannot be assumed that the counterfeit
product is either safe or effective.

"Serono is cooperating fully with the FDA in its effort to
stop the distribution of the counterfeit product and to
prosecute those responsible for it.

"Serostim(R) (SEHR'-uh-stihm) is approved in the U.S. for
the treatment of AIDS wasting."


***** June 23: New York March and Rally Before United
Nations AIDS Session

Dozens of organizations have called for a march and rally
in New York on June 23, just before the United Nations
General Assembly Special Session on AIDS (UNGASS). Some
international delegates and organizers who have traveled to
New York for the United Nations session are planning to
join the march.

Sponsors include the African Services Committee, Bailey
House, Global AIDS Alliance (GAA), Health GAP Coalition,
and ACT UP New York -- in cooperation with NAPWA South
Africa, and the Treatment Action Campaign (TAC) in South
Africa. Endorsers include many other AIDS, international,
and social-justice organizations. [Note: This is not to be
confused with the June 3 march on the 20th year since the
discovery of AIDS, which takes place in Washington.]

This event is the same day as the NYC Dyke March, and one
day before New York's Lesbian/Gay Pride parade.

For more information, see
http://www.stopglobalaidsnow.org

***** United Nations: Civil Society Snubbed at Final
Preparatory Meetings on AIDS

by John S. James

On June 25 - June 27 the United Nations will hold an
historic special session on AIDS, often called UNGASS
(United Nations General Assembly Special Session). Two
preparatory sessions were scheduled to allow official
delegates and civil society to interact; the last one was
May 21-25. The United Nations also set up an email
discussion list, Break the Silence, for organizations and
individuals throughout the world to have their voices heard
during the preparation for the Special Session. (At the
June 25-27 official meeting it will be too late for
significant changes and initiatives, as most of the outcome
will have been set up in advance.)

The preparation process uses the well-known "single text"
method of negotiation. A document is drafted, put out for
comment, and then changed periodically in the attempt to
reach agreement. The second version of this document (May
28, 2001) is now being circulated; it is on the UNAIDS Web
site, at http://unaids.org

The email discussion list is working well. Readers may want
to subscribe by sending email to:
join-break-the-silence@...

The first session set up for meetings between official
United Nations delegates and civil society also went very
well, although perhaps by accident. Due to glitches in the
agenda, there were entirely unexpected opportunities for
official delegates and civil society members to meet and
discuss AIDS.

The May 21-25 preparatory session was different. According
to a May 24 press release by 12 organizations from the
U.S., Canada, Venezuela, Ukraine, Brazil, UK, India, and
Norway:

"Many NGOs [non-governmental organizations, usually called
nonprofits in the U.S.] traveled to New York from around
the world, responding to the invitation of the President of
the General Assembly, but found themselves unable to
participate meaningfully or share their expertise with
delegates, contrary to the General Assembly's own
resolution which called for involvement of civil society in
the development of a Declaration of Commitment to be signed
by all 189 UN member states in June. While a handful of
countries strongly supported civil society's contributions,
two brief "dialogue" sessions - scheduled during the lunch
and evening hours - went unattended by the majority of
countries. Anand Grover from the Lawyers Collective
HIV/AIDS Unit, Mumbai, India, said 'I am very disappointed
at the absence of the delegates from countries who are most
affected, their short attention span, and the lack of
meaningful government participation.'

"Yesterday the United States went so far as to ask all NGO
representatives to leave the room, including those with
ECOSOC accreditation who are normally entitled to observe
country delegation negotiations. Since the US made a formal
complaint, the Chair was forced to take the action,
although he was perfectly willing to have the NGOs stay in
room. 'This is a very bad precedent for the future and
makes NGOs worry as to what will happen at the General
Assembly itself,' said Carol Lubin, one of those who was
ejected."

The NGOs called on the United Nations to encourage member
nations to include civil society and especially people with
HIV or AIDS in their delegations, encourage member states
to attend sessions they set up for dialog with civil
society, and otherwise ensure that civil society can
participate meaningfully in the process of developing
worldwide programs for controlling AIDS.

There is particular concern that some countries want to
roll back human rights in general, and some do not want to
acknowledge or even name vulnerable groups (such as men who
have sex with men, injecting drug users, transgenered
individuals, and sex workers) because of prevailing
attitudes.

Comment

The fundamental problem, we suspect, is that any successful
global AIDS program is likely to threaten powerful
interests: big pharmaceutical companies (fearful about
patent rights), some conservative religions (threatened by
sex), and even part of "AIDS Inc." (concerned that momentum
for other AIDS programs might damage theirs). We suspect
that political problems like these are what has kept the
world from dealing successfully with AIDS so far. It will
be hard to negotiate among all the special interests that
hold some degree of veto power over global progress against
disease.


***** Global AIDS: Back to the Past? Comment by John S.
James

Summary: The new affordability of treatment in poor
countries made possible the unprecedented high-level
mobilization against global AIDS earlier this year, by
transforming AIDS in poor regions from an unsolvable
tragedy to a moral issue and chance to save lives. But then
a backlash turned funders against treatment -- transforming
AIDS again, from a chance to save lives to a chance to sit
by and watch tens of millions die. As a result, AIDS lost
some political support and momentum -- not only for
treatment, but for prevention as well. If treatment is a
key to mobilization, we need to recognize that.

* * *

Just weeks ago, governments of rich and poor countries
alike seemed more likely than ever before to mobilize
serious commitment to controlling the global AIDS epidemic.
There was growing consensus that 7 to 10 billion dollars
per year -- the amount proposed by United Nations Secretary
General Kofi Annan, about 1% of world military spending --
would be enough to greatly reduce the spread of AIDS, treat
many of those who are ill, do operational research to make
sure the programs are effective, speed the development of
vaccines and new treatments, and greatly reduce the burden
of tuberculosis, malaria, and other infectious diseases.

But suddenly rich-country governments in the U.S. and
Europe pulled back. The U.S. contributed $200,000,000 to
the United Nations fund -- about 2% of the need, about a
tenth of what would have been regarded as serious. European
governments so far have not contributed anything. And in
the recently concluded World Health Assembly, the U.S. and
European governments actively blocked proposals to help
poor countries buy low-cost medicines -- on behalf of the
proprietary pharmaceutical industry, which seems to fear
that any plan to make patented medicines permanently
affordable in poor areas would threaten its patents or
ability to charge high prices in the U.S. and other rich
countries.

What happened?

We suspect that one key cause of the loss of momentum on
global AIDS is something that has not been discussed or
recognized even by the participants.

For years it was an article of faith that public money for
AIDS control in poor countries should go to prevention,
never to treatment. Few said otherwise, because at $10,000
per year for drugs alone (or even $2000), HIV treatment was
not going to become widely available in poor areas no
matter what anyone said or did.

Some prevention advocates have long feared that treatment
would out-compete prevention politically (probably because
it saves the lives of identifiable people, unlike
prevention), resulting in resources being misdirected to
treatment of the terminally ill instead of to stopping the
epidemic. But in fact, treatment gives people reason to be
tested, reason to mobilize to save their own lives or their
family members or friends, reason to become involved in
comprehensive AIDS-control programs. It also motivates the
fight against AIDS stigma, by transforming it from
something unpleasant but only rarely life-threatening, to a
direct threat to the lives of specific people. Some
professionals have missed the fact that treatment access is
a strategic cause to improve prevention and reduce the
spread of HIV, as well as a humanitarian cause to save
lives because it is the right thing to do.

These arguments had no consequences until recently, when
generic pharmaceutical manufacturers started offering some
modern combination antiretrovirals at under $500 per year.
At this price widespread treatment in Africa became
thinkable for the first time.

We believe this new possibility of treatment in poor
regions fundamentally transformed world thinking about
AIDS. Before, most of the public in the U.S., and probably
other rich countries as well, basically saw the global
epidemic as an unsolvable tragedy (or as a bottomless
resource pit) in Africa. Tens of millions of people already
infected were doomed, and nothing could be done to change
that, nothing anyone did could make any meaningful
difference.

But with drugs less than $500 per year, the perception of
global AIDS changed from a hopeless cause to a moral issue
and chance to save lives. Now people could get involved.
The result was the first-ever move toward serious
government commitment to control the epidemic, and other
major infectious diseases -- not just through treatment,
but through prevention, research, treatment, whatever was
needed.

The "Harvard plan" -- a widely discussed analysis of how to
provide treatment in developing countries, released in
early April -- also helped to show it was doable, and at a
cost amounting to "small change" in the global economy.

But then a backlash occurred. Some prevention experts
became alarmed and upset by the new momentum behind
treatment. As one "international health official who asked
not to be identified" told The Washington Post:

"It's so politically incorrect to say, but we may have to
sit by and just see these millions of [already infected]
people die," he said, acknowledging that this was an option
that would be considered unacceptable in the developed
world. "Very few public health professionals are willing to
take on the wrath of AIDS activists by saying that. But a
whole lot of them talk about this in private." (Global AIDS
Strategy May Prove Elusive: More Funds Available, but
Consensus Lacking, Washington Post, April 23, 2001, page
A01).

We do not know to what extent anyone went to the major
funders -- the handful of key staff people involved in AIDS
funding in the U.S. and European governments, and major
foundations -- and soured them on treatment. AIDS activists
were surprised to find unexpected lack of support in
Congressional offices, and to hear international-
development experts new to AIDS saying the fight was to
save future generations. One Congressional bill earmarked
10% or less for treatment, vs. 70% for prevention. Overall,
there was a sudden surge in official sentiment for
abandoning those in poor countries who are already infected
-- and the millions more who will become infected there.

One might think that pharmaceutical companies would lobby
for global treatment, providing balance. If anything, the
opposite was true. Widespread treatment in poor countries
might threaten their patents and high prices in rich
countries -- the cash cow that supports the entire
industry.

Potential donor governments seem to have responded mainly
not by shifting future money from treatment to prevention,
but by losing interest in AIDS. Why?

We believe that what happened is that with treatment
marginalized, AIDS was transformed again -- from a moral
issue and chance to save lives, to a chance to sit by and
let tens of millions of people die. Government officials
and their staffs are people, too; and when this happened,
they lost enthusiasm for the whole project of controlling
global AIDS. Other world issues are always available.

Many have said (correctly, we believe) that without hope of
treatment, prevention will not work well. What has been
overlooked is that without hope of treatment in poor
countries, it becomes very difficult to mobilize against
global AIDS in rich countries. The triple track of
advocating funding for research, prevention, and treatment
-- long successful for U.S. domestic AIDS programs --
should be considered for international funding advocacy as
well.

As one activist put it, treatment is easier to sell than
condoms. Of course the point is not to substitute treatment
for prevention, but to facilitate widespread mobilization
to do whatever is necessary to stop the epidemic.

We suspect that hope of treatment was the key that
transformed the meaning of the global epidemic, and made
possible the beginnings of the unprecedented mobilization
earlier this year. When this hope was removed, the movement
stalled. Rich-country governments, which had never made a
commitment to a properly funded campaign against global
AIDS and other infectious diseases, reverted to business as
usual.

This is only a theory -- that the possibility of treatment
in developing countries was central to the rise and then a
sudden fall in high-level interest in global AIDS. Many
theories are wrong. We urge those involved to consider this
one, and see if it holds true.

If hope of treatment is key to effective political
mobilization against the global epidemic -- critical to
involving people in rich countries even though they are not
directly affected (as they already have access), as well as
people in poor ones who are directly affected -- we need to
recognize that fact and design comprehensive research,
prevention, and treatment programs that do not abandon
those already infected.


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