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AIDS TREATMENT NEWS
Needs Your Support
by John S. James
Since we started publishing more than 10 years ago, AIDS
TREATMENT NEWS has been supported by subscriptions. In the
last year, tight finances have forced us to miss conferences,
delay equipment upgrades, and spend time and attention on
business that we would rather devote to our mission. Our
current staff is half the size it was at its peak. We are
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Total expenses for AIDS Treatment News are $265,000 per year,
which includes large fixed costs for rapid printing and
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Our basic subscription income pays 85% of the total, and has
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We have not increased the $100 per year subscription price
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We are now working with the nonprofit AIDS Treatment News
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Clinical Trials and Viral Load:
Statement for FDA
Community Meeting May 16
by John S. James
Introduction
We wrote the following statement to suggest issues for
discussion at the FDA community forum on May 16, concerning
using viral load instead of "clinical endpoints" in certain
trials of anti-HIV drugs (see announcement in AIDS TREATMENT
NEWS #270). This introductory section provides background for
readers who are not familiar with current debates and issues
in clinical trial design.
In the early years of the epidemic, due to historical
accident, clinical trials of AIDS drugs developed from the
model of cancer trials. The traditional "gold standard" in
cancer trials was five-year survival. Since five-year trials
would clearly slow drug approval, there have been years of
debate about whether substitute ("surrogate") cancer
measures, such as tumor size, were an acceptable substitute
for survival for drug approval.
In AIDS, the cancer standard of survival was quickly relaxed
a little, and the traditional gold standard for AIDS drugs
became improved survival or reduction of major disease
progression (usually taken as the development of a new AIDS-
defining opportunistic condition) for some unspecified period
of time. These are the "clinical endpoint" trials referred to
in the article below. In a clinical-endpoint trial, a new
drug must prove that it is at least as good as some standard
treatment in reducing death or major disease progression in
some group of patients.
The first problem with clinical endpoint trials is that they
commonly require over a thousand volunteers and take well
over a year of actual time on treatment (plus more years to
plan, set up, and recruit) to get statistical proof. And more
recently, especially within the last year, a new problem has
arisen. The importance of lowering viral load (especially to
levels so low that it is undetectable) has become widely
accepted. Since viral-load trials can be run much more
rapidly than clinical-endpoint trials (and can usually get
statistical proof with about a tenth as many volunteers as
required for clinical-endpoint trials), it can quickly be
learned that some of the treatment arms in clinical-endpoint
trials are inferior to others in lowering viral load. It is
now widely considered unethical to ask volunteers to stay on
these virologically inferior treatments for years (see
discussions in SCIENCE, April 25).
For many years there has been debate on whether anti-HIV
drugs must go through clinical endpoint trials in order to be
approved, or whether improvement in "surrogate markers"
(especially viral load) would be enough. Several years ago
the FDA started a system called "accelerated approval," which
allows a drug to be approved based on surrogate markers
(without having to wait years for clinical endpoint trials),
provided that clinical endpoint trials are run later (to
confirm that the surrogate-marker benefit translated into a
real clinical benefit for patients). Today these confirmatory
trials are creating intolerable problems, mainly because it
is no longer considered ethical to keep patients on
virologically inferior treatments, now that the importance of
viral load has become much more accepted than it used to be.
During the last year and a half, the viral load measurement
which has become widely regarded as most important is the
proportion of volunteers whose viral replication can be
essentially shut off (as shown by undetectable viral load in
the blood plasma) for as long as possible. Other
measurements, like the group average fall of viral load, are
not considered as relevant. Our article below explores the
surprisingly strong advantages of using the ability to
maintain undetectable viral load as the primary way to judge
an antiretroviral drug regimen in confirmatory trials.
Statement to May 16 FDA Community Meeting:
Clinical Trials and Viral Load: Complete Viral Suppression As
Primary Endpoint for Confirmatory Trials
The ethical, practical, and scientific problems with the
current regulatory requirements for confirmatory trials of
antiretrovirals are well known. The biggest problem concerns
trials with suboptimal treatment arms. These often try to
show clinical-endpoint superiority of a regimen containing
the drug being tested, compared to some other regimen which
the trial designers or sponsors thought they could get away
with -- but which must prove inferior through death or major
illness for the trial to be a success. The need now is to
articulate consensus and/or develop regulations to encourage
workable trials which are ethical in the context of modern
medical knowledge, yet provide the answers physicians need
and can use.
It is now becoming widely accepted that instead of clinical
endpoints, some degree of viral load suppression, for some
period of time, should be required for final approval.
(Formulating this agreement and providing specifics is the
apparent mission of the mid-July meeting of the Antiviral
Drug Products Advisory Committee.) Since the time required
for showing durable viral suppression is likely to be a year
or more, approval should not be delayed until completion of
these trials. Therefore, the current system of accelerated
approval, which has been successful, should be kept in place.
Complete HIV Suppression, and Trial Design: A Fortunate
Synergy
Today it is widely agreed that antiretroviral therapy should
aim for complete suppression of HIV replication (to
undetectable levels of plasma viremia), sustained for as long
as possible. Far from making it impossible to test new drugs,
as some have feared, this modern view makes possible a new
generation of very attractive confirmatory trials. The key is
to use loss of complete viral suppression as the primary
endpoint to define failure of the assigned treatment regimen
for that individual -- that is, as long as a treatment
completely suppresses the virus, it is regarded as
successful, but when complete suppression stops, it is
counted as having failed. In that case, the individual is
immediately unblinded and offered new treatment options
(which should usually include new randomizations, for further
research). Drug failure due to toxicity or intolerance of the
regimen would also lead to unblinding and new treatment
options.
Especially near the beginning of treatment, and later as
required, frequent viral load testing would be used to detect
failing regimens quickly, and volunteers would be offered
other options without delay.
"Treatment failure" would not be declared from a single viral
load result, if only because of the possibility of testing
errors. Exact criteria for virological failure -- either loss
of complete suppression after it had been achieved, or
inability to achieve it in the first place -- would be
defined in the protocol.
Some advantages of this approach:
* Each trial volunteer always receives virologically optimal
treatment (or is given the option of trying another therapy).
No one need stay in any arm unless the therapy is suppressing
viral replication to the greatest extent that can be
measured. This attractiveness to patients and treating
physicians should greatly help in recruiting.
* These randomized controlled trials would provide the data
which is widely regarded today as most central: How well does
a regimen prevent drug failure (due either to viral
breakthrough, or to drug toxicities) in the patient
population being tested?
* Failure of complete viral suppression is already in common
use in drug trials, and is well regarded as a virological
measure. (It has not yet been used as the primary endpoint
for confirmatory trials, because the FDA has required
clinical endpoints so far.)
* This trial design avoids most of the need to hide
information. Volunteers are of course given their viral load
results immediately (since the viral load must remain
undetectable, or the volunteer will be unblinded and offered
different treatment).
* There is much less need than with previous trials to
conceal overall results as they develop, in order to avoid
biasing the trial. This is because, regardless of the overall
statistics of drug failure, each volunteer is either on a
treatment which, virologically at least, is working perfectly
for them (as far as can be measured), or is already changing
to a different treatment. Participants are unlikely to
abandon a (blinded or unblinded) regimen which works this
well for them, in favor of a treatment which may not work,
based on statistical results from other people.
* Long-term data on treatment success or failure are
critically needed -- and this kind of trial can obtain such
data much more easily than conventional designs. Trials could
regularly be planned to run for five years or more. This is
because participants are not kept on a treatment which is not
working for them. Instead, their failure and abandonment of
the treatment provide the data for measuring the
effectiveness of the antiviral regimen. Therefore, the only
volunteers who will be kept on a regimen for years are those
for whom it is working very well. They will be unlikely to
want to change.
Also encouraging long-term continuation of randomized
controlled testing is the fact that results can be reported
as they develop, with little fear of subsequent bias. There
is no need to close the trial or risk its future integrity so
that results can be published for general use.
For the same reasons, approval and marketing of the drugs
should have little effect on these trials -- further
encouraging the generation of long-term data from randomized
treatment, regardless of when accelerated approval and final
approval occur. The key difference from most current trial
designs is that the only people on the long-term treatments
are those who are doing very well, who therefore have no
incentive to leave the study -- while those who left after
treatment failure are not dropouts responsible for missing
data, but instead reached a primary endpoint exactly as
planned in the protocol.
And sponsors will be happy to pay for long-term followup for
as many volunteers as possible, because that will mean that
their drug is successful. The more people who stay on the
treatment long term, the more valuable the drug is. This
creates a strong economic incentive to collect long-term
data.
* This kind of trial might reduce the bias which now occurs
because volunteers who are more ill are less likely to report
for study visits. Those who are doing poorly would probably
already be recorded as treatment failures, so any
appointments they miss will not affect the primary endpoint
of the trial.
Followup after treatment failure -- even after leaving the
protocol -- is also important. Especially those who have left
the protocol need reimbursement for their time and expenses
in study visits, since the drugs no longer serve as
incentive. It is a great mistake to just drop people after
they leave a protocol -- yet that is commonly what happens.
* Because virologic treatment failure (loss of complete
suppression) is likely to occur much more rapidly than
clinical endpoints -- with today's treatments at least --
these trials should require far fewer volunteers than
clinical-endpoint confirmatory trials.
* When treatments improve enough that failure (either from
viral breakthrough or drug toxicity) becomes rare, then these
trials will keep more of their participants on their original
randomized arms for a long time -- effectively becoming
CLINICAL ENDPOINT trials, with increasing power as more
volunteers remain on their assigned treatment for longer.
This provides an ethical way to look for any unexpected
disease progression in spite of complete viral suppression.
In the most likely case -- that no such disconnect is found
-- nothing is lost, since all of the volunteers will have
received optimal treatment, all groups will have done well
clinically, and the trial will have provided valuable
assurances about the drugs.
Regulatory Oversight Needed
Several areas will need continuing FDA and public attention
to ensure that confirmatory trials with virological endpoints
best serve the public interest:
* What happens after treatment failure? Are volunteers just
dropped because the sponsoring company has no further
interest in them? Those who have participated in a trial
should have assistance in finding a treatment strategy which
works for them -- especially since the public could benefit
greatly by knowledge obtained in this process.
The medical community needs to know what options are useful
after certain drugs have failed -- both to treat those
individuals successfully, and to learn how initial choice of
therapy may limit future choices. In some trials, subsequent
randomization options after failure of the initial
antiretroviral regimen will be appropriate for obtaining this
information. For various reasons, including the fact that
drugs from different manufacturers are likely to be involved,
a private sponsor may not want to do this research. It should
be public policy to ensure that such studies are done as part
of a drug's approval.
* At the very least, long-term observational followup should
be part of most if not all antiretroviral trials. Safety and
quality of life information is needed for all who are
randomized to a treatment, even after they discontinue it.
* Antiretroviral drug development must include testing in
advanced or heavily pretreated patients. Any new
antiretroviral will be widely used by them. It is
unconscionable to collect no data and test the drugs only
where they are likely to look best.
* Physicians and patients need other data from the approval
process -- data often neglected today. Small, rapid
pharmacokinetic trials should be required, to establish:
- Doses for infants and children;
- Possible dose adjustments for sex, race, or body weight;
- More interaction data with other medications which patients
being treated with the drug being tested are likely to use --
including illegal or recreational drugs -- when there is any
reason to suspect an interaction;
- Per-patient variation in blood levels due to individual
differences in absorption or metabolism -- and the effect of
such variation on treatment failure.
Ending the previous generation of clinical-endpoint
confirmatory trials will save enormous resources which are
now mostly wasted. The FDA, supported by professional
consensus, should require pharmaceutical companies to use
some of the resulting savings to provide a rational package
of information to the patients and physicians who will rely
on their products.
1592: Small Distribution
Programs Begin June, July
On April 29 Glaxo Wellcome announced that it will begin three
small compassionate-use programs for access to 1592, an
experimental antiretroviral. A pediatric program is planned
to start in June, and dementia and adult programs in July.
1592 is a nucleoside analog -- a drug in the same class as
AZT -- but it appears to give much better viral suppression
than AZT. Also, its resistance profile is different. About
250 people have been treated with 1592 so far. About 20
additional trials are planned, involving more than 2,000
people.
The three programs and their entry criteria are:
* Pediatric program (ages 90 days through 12 years): To
enter, patients must have a viral load greater than 100,000
copies/ml, CD4 percent less than 15, and have failed at least
one nucleoside analog drug (e.g. AZT, ddI).
* AIDS dementia complex (ages 18 through 65): Patients must
have severe dementia (MSK grades 3-4) diagnosed by a
neurologist. They must have had prior treatment with AZT
(which is known to be effective in treating AIDS dementia in
some cases).
* Other adults: Patients must have viral load greater than
50,000 copies, CD4 count under 100, and they must have
previously failed at least two nucleoside analog drugs and
one protease inhibitor.
The pediatric and dementia programs will have a central
registration procedure; physicians will call to register
patients. The other adult program will be conducted at
centers in North America, countries in Europe which are
currently running trials of 1592, and Australia. The list of
centers is not yet final.
2,500 slots will be available in all three programs together
worldwide.
Comment
There is widespread concern that 2,500 slots will be
entirely inadequate -- that the adult program especially
could fill up in days. In that case the drug will be
available to those with connections and luck -- those whose
physicians can have someone stand by the phone or fax to get
them in line first.
There is also concern that the development of this drug has
proceeded too slowly (see "Why Isn't Glaxo's New AIDS Drug
Ready Yet" in THE WALL STREET JOURNAL , November 12, 1996,
page B1). Current plans are to apply for FDA approval well
into 1998. Glaxo hopes to have a larger expanded access
program starting in early 1998.
The company has given two reasons for the small size of the
current program: some supply limits due to unexpected
difficulties in scaling up the production process to make
large batches, and concern about distributing a drug very
widely when it has been tested on few people so far.
1592 is expected to be most useful to people who have limited
treatment options and need to find a combination which works
for them to suppress HIV replication.
Indinavir (Crixivan(R)) Becoming
Available at Many Pharmacies
On May 14 Merck & Co. announced that its protease inhibitor
indinavir will soon be available at 27,000 pharmacies. Until
now the drug has been sold primarily through one source,
Stadtlanders Pharmacy; this system was used so that patients
could be counted, to make sure that supplies of the drug
would not run out -- which would have forced interruption of
therapy and increased the risk of viral resistance.
According to Merck, all pharmacies and clinics are eligible
to participate in the new system, but they must register for
it, and report the number of patients using the drug.
Patients may continue getting their Crixivan from
Stadtlanders, as before. Or they may get a new prescription
from their physician and fill it at another pharmacy.
Patients can call 1-888-CRIXIVAN to find a participating
pharmacy near them, or to ask other questions about the
program.
AIDS Internet:
Treatment Information Online
Introduction to a Series
by Tadd Tobias and John S. James
The Internet's World Wide Web provides more choice of current
AIDS treatment information than you can find in any other
way. Almost all of it is free; and you can get to it any
time, from any place with a telephone and computer (or from
some public libraries, if you do not have a computer). Unlike
sending away for information, you see what you request almost
immediately; so if it is not what you want, you can keep
looking and follow dozens of leads in one session. And the
World Wide Web is so easy to use -- once the equipment and
software have been set up -- that you can learn it almost
immediately, with no need for training or documentation.
On the other hand, there is a glut of information on the
Internet, and quality and credibility vary greatly. The World
Wide Web can be pictured as about one million(1) bulletin
boards connected throughout the world. Almost anyone who
wants to post almost anything can find a place to do so --
and then it is immediately available to millions of people
from anywhere in the world, if they are interested in the
information, and know or can find out where to look for it.
On the whole, quality is higher than one might expect --
probably because truly anonymous posting is difficult and
unrewarding, and those who place their work in a public forum
want it to look good. (But those with an axe to grind are
often inclined to do so in public. For example, few if any
sites misspell the names of AIDS drugs -- but some do advise
rejecting medical care for AIDS and relying on clean living
alone, or on someone's favorite remedy.)
We are organizing this article series around different kinds
of AIDS information which readers might seek on the World
Wide Web, or elsewhere on the Internet; most articles will
focus on one or more major sites, and list others as well.
For example, the article below looks at AIDS news, focusing
on the AEGIS site. For beginners not already using the World
Wide Web, we will publish hints on getting started later.
References
1. Internet Archive in San Francisco is saving a copy of most
of the contents of the World Wide Web, for use by future
historians and scholars. It has found about one million
different Web sites, and an estimated 80 million separate Web
pages as of January 1997. For more information, see "Crawling
Towards Eternity" by Mike Burner, WEB TECHNIQUES May 1997,
pages 37-40. Or see "Preserving the Internet" by Brewster
Kahle (the founder of Internet Archive), SCIENTIFIC AMERICAN
March 1997, pages 82-83.
AIDS News on the World Wide Web:
AEGIS (http://www.aegis.com) and Others
by Tadd Tobias and John S. James
The well-known AEGIS site (AIDS Education Global Information
System), with over 350,000 documents online dealing with
AIDS/HIV, is probably the most comprehensive single Web site
for AIDS news and general information. Major strengths are
(1) mainstream news reports, both current and archival; (2)
the AEGIS library, with current and back issues of community
newsletters and fact sheets, and government documents and
databases; and (3) a clean user interface, and rapid,
flexible search engine to find the information you want.
AEGIS also allows you to do free AIDSLINE searches (which are
available through other Web sites as well), and has a well-
organized collection of links to other sites.
AEGIS has been given permission to reproduce many (not all)
of the AIDS stories from major media, including THE
WASHINGTON POST, THE WALL STREET JOURNAL, LOS ANGELES TIMES,
CHICAGO TRIBUNE, SAN FRANCISCO CHRONICLE, SAN FRANCISCO
EXAMINER, REUTERS, ASSOCIATED PRESS, BUSINESS WIRE, and AIDS
WEEKLY PLUS. It also includes the AIDS DAILY SUMMARY from the
U.S. Centers for Disease Control, which summarizes major news
stories each weekday and makes the abstracts available for
noncommercial use. The result is a huge, free, searchable
clipping service of U.S. and some international media on all
aspects of AIDS; you can have the stories delivered to you by
email (which we will discuss in a separate article), or
search on the AEGIS Web site for stories containing any words
you specify.
While major newspapers and wire services seldom have
information detailed or accurate enough to be useful in
medical care, they do tell you that something has happened --
usually the publication of a journal article or conference
presentation, or a statement by a major company or recognized
expert. The stories probably include the names of potential
treatments and/or the people involved -- a starting point for
conversation with your physician, or for other research. When
you hear part of a story on television or in a rumor, you can
usually use AEGIS to find a longer press report; try to
remember one or more names or key words to search for. But
usually the date of the broadcast will be enough to locate
more information on AEGIS about a national news story.
Treatment Newsletters on AEGIS
AEGIS has current and back issues of about 30 AIDS
newsletters and other publications. You can search through
all of these publications together, or any single one alone,
for articles containing any words you specify. Usually AEGIS
has all the issues of every newsletter, from #1 up to and
including the current issue.
Newsletters on AEGIS include:
* AIDS INFORMATION NEWSLETTER (from the U.S. Veterans
Administration)
* AIDS Treatment News
* AIDS TREATMENT UPDATE (published in the UK)
* AIDS WEEKLY PLUS (which has extensive coverage of
scientific conferences and publications on AIDS treatments
and scientific advances)
* BETA (BULLETIN OF EXPERIMENTAL TREATMENTS FOR AIDS, from
the San Francisco AIDS Foundation)
* JOURNAL OF THE INTERNATIONAL ASSOCIATION OF PHYSICIANS IN
AIDS CARE
* NOTES FROM THE UNDERGROUND (from PWA Health Group, New
York's oldest buyers' club)
* TAGLINE (from the Treatment Action Group)
* TREATMENT ISSUES (from GMHC in New York)
* TREATMENT REVIEW(from the AIDS Treatment and Data Network)
* TREATMENT UPDATE (from CATIE in Canada)
* WOMEN ALIVE
There are also many newsletters, fact sheets, and
publications from the U.S. Centers for Disease Control and
other government agencies.
Always note the DATE of newsletter articles. We often hear
from someone who has read a years-old article as if it were
current.
AEGIS -- Other Strengths
* Religious links. AEGIS, started by Sister Mary Elizabeth of
the Sisters of St. Elizabeth of Hungary, has a strong
collection of links to Web sites of AIDS religious
organizations, including Christian, Jewish, Islamic,
Buddhist, and interfaith organizations.
* International involvement. AEGIS currently has links to Web
sites in Australia, Canada, France, Israel, Malaysia, South
Africa, and the United Kingdom. Also, some of its services
are available through FidoNet, which connects computer
bulletin boards in many parts of the world which do not have
regular access to the Internet.
* AEGIS also has links to Web sites of over 20 scientific and
medical journals, over 15 U.S. government agencies, and about
15 pharmaceutical companies. There are also links to general
health resource Web sites, and separate categories for sites
on tuberculosis, and on sexually transmitted diseases.
AEGIS Search Example: Sinusitis
To illustrate searching on AEGIS, we picked sinusitis as a
sample topic. From the home page, click "Search" (either the
"Search" button, or the underlined word "Search" -- both are
exactly the same, which can be confusing at first).
We selected All (meaning to search all databases on AEGIS),
entered "sinusitis" as our only search word, and started the
search. Within 15 seconds the system found 233 documents
which used the word "sinusitis" at least once, and returned
titles of the first 10 of them (and a link to get to the next
10 titles, etc., if you want to see them). The system tries
to list the most relevant documents first; however, this may
or may not be what you want. The "search engine" used by
AEGIS allows you to display the found documents in either of
two ways: full text with the searched words highlighted, or
excerpts from the text showing where the searched words
appear. (In the case of medical-journal articles, the "full
text" is usually only the abstract, as the full article is
unlikely to be available online at all. For the AIDS
newsletters and wire service stories, the entire article is
usually on AEGIS.)
We looked at some of the 233 titles and documents, and most
are indeed relevant, with medical information from around the
world about AIDS-related sinusitis and its treatment. Do note
the dates; while most of the articles we saw were 1997 or
1996, the first one listed was from 1992.
AEGIS allows a search to be limited to a particular day (for
example, a search for "970512" [without the quote marks] will
get all articles dated May 12, 1997; this can be used to find
very recent documents, such as today's entries, or
yesterday's, for example to follow up on a television or
radio report). A search can also be limited to a month (for
example, "sinusitis and 9701*" will find the sinusitis
articles dated January 1997). However, limiting a search to a
year (97*) does not work at this time; the system returns no
documents, with a message saying that the search would be too
expensive to complete.
Other AIDS News Sites
Here are news highlights from several other sites, which we
listed in alphabetical order. These sites have much more than
the news described here, and we will return to them in future
articles.
We have not included news from AIDS conferences, nor
newsgroups, nor Web search engines, as we will cover them
separately.
ACT UP/Golden Gate
(http://www.actupgg.org)
Two news collections on this site are particularly useful.
Most of the AIDS treatment articles written by the ACT
UP/Golden Gate Writers' Pool, and published weekly in the BAY
AREA REPORTER from 1995 through the present, are available.
Also, the news releases (1996 and 1997) provide a history of
the work of this leading treatment activist organization.
This site, written primarily for physicians, includes: news
briefings, current and archived, including REUTERS reports,
the AIDS DAILY SUMMARY, and a link to SCIENCE NOW; special
reports, in-depth articles from major professional sources;
and Journal Scan -- postings of abstracts from major journals
and related commentaries, sometimes with links to the full-
text articles (which often require registration, however, and
may not be free).
Critical Path AIDS Project
(http://www.critpath.org/bulletin.html)
Includes treatment and research news, and Federal, state, and
local policy issues.
New York Academy of Medicine
(http://www.aidsnyc.org)
This site is host to many AIDS organizations in New York. A
"What's New" link tells what has been posted recently on all
of the sites, and the date of each posting. You get the
benefit of over 20 different AIDS organizations bringing to
the public what they feel is important. Also, upcoming AIDS
forum announcements (generally for the New York City area)
are posted.
Project Inform
(http://www.projinf.org)
Includes treatment and policy news, action alerts, and press
releases.
Help Wanted: Project Inform
Seeks Hotline Manager
Project Inform is hiring a manager for its AIDS treatment
hotline. A resume and letter of interest should be sent by
May 30 to HM Search, 1965 Market Street #220, San Francisco,
CA 94103.
A detailed job description is available on the Project Inform
web site, http://www.projinf.org If you do not have access
to the Web, call the Project Inform office at 415/558-8669 to
obtain a copy.
California: ADAP Program Adds
Cidofovir, Nevirapine, and Nelfinavir
Three drugs were recently added to the California ADAP (AIDS
Drug Assistance Program) formulary. ADAP pays for certain
medications for persons meeting income requirements. Although
largely funded by Title II of the Federal Ryan White CARE
Act, the program varies tremendously among different states
-- and recently some states have denied drug access because
ADAP financing has not kept up with the increasing interest
in AIDS/HIV treatment.
Cidofovir (Vistide(R)) and nevirapine (Viramune(R)) were
added to the California ADAP formulary on April 24, and
nelfinavir (VIRACEPT(R)) was added May 12.
The current California ADAP drug list (generic names, not
brand names) is: acyclovir, aerosolized pentamidine, alpha
interferon, amphotericin B, atovaquone, azithromycin,
bleomycin sulfate, cidofovir, clarithromycin, clindamycin,
clofazimine, clotrimazole, cyclophosphamide, dapsone,
dexamethasone, didanosine, doxorubicin, dronabinol, epoetin
alfa, ethambutol, filgrastim, fluconazole, flucytosine,
foscarnet, ganciclovir, indinavir, itraconazole,
ketoconazole, lamivudine, leucovorin calcium, megestrol
acetate, methotrexate, nelfinavir, nevirapine, nystatin,
paromomycin, prednisone, pyrimethamine, rifabutin, ritonavir,
saquinavir, stavudine, sulfadiazine, trimethoprim,
trimethoprim/sulfamethoxazole, trimetrexate glucuronate,
vinblastine sulfate, vincristine sulfate, zalcitabine, and
zidovudine (AZT).
California: Seventh Annual
AIDS Lobby Day, June 2
On Monday June 2 hundreds of persons from around California
will meet in Sacramento to speak with their representatives
or staffs about AIDS funding and other AIDS legislation in
the state. AIDS Lobby Day is sponsored by the AIDS Budget
Coalition, which includes half a dozen major AIDS service
organizations.
For more information you can call the San Francisco AIDS
Foundation (415/487-3080); or call AIDS Project Los Angeles
(213/993-1365). Early registration is important so that
appointments can be made with your representatives. AIDS
Project Los Angeles is organizing a bus and hotel package for
the trip, which will cost about $38. per person.
San Francisco: Lark Lands, Other
Experts to Speak on Nutrition,
Lean Body Mass, and Wasting, June 14
Healing Alternatives Foundation will sponsor a free public
seminar on nutritional health and prevention of wasting, on
Saturday afternoon June 14, 1:00 p.m. - 6:00 p.m., at the
Metropolitan Community Church, 150 Eureka St. (between 18th
and 19th Streets) in San Francisco. Scheduled speakers are:
* Carl Grunfeld, M.D., Ph.D., an expert on AIDS-related
wasting, who will speak on metabolic dysfunction and wasting
syndrome;
* Lark Lands, Ph.D., on using nutrients "to eliminate
symptoms, reduce drug side effects, lessen infection risk,
improve drug effectiveness, slow disease progression, and
prevent internal damage and wasting"; and
* Michael Mooney from PoWeR (Program for Wellness
Restoration) who will focus on anabolic steroids and exercise
for restoring lean body mass in HIV.
Nutritional counseling and BIA testing (bioelectric impedance
analysis, to assess lean body mass) will be available without
charge.
For more information, call or come by the Healing
Alternatives Foundation, phone 415/626-4053, 1748 Market St.
Suite 205, San Francisco; hours are Tuesday through Friday
12-6, and Saturday 12-5.
Copyright 1997 by John S. James. Permission granted for
noncommercial reproduction, provided that our address
and phone number are included if more than short
quotations are used.
