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                    Project Inform Perspective

                    Number 14
                    June 1994
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Project Inform
San, Francisco California


In this issue
AIDS Politics 1994     1 
Perinatal Transmission (AZT and Pregnancy)     4
Health Care Reform     7
D4T -Recommended for Accerated Approval     8
AIDS Cure Act     10
Drug Interactions     12
Compound Q (GLQ 223) -Recent Findings     16
Early Intervention     17
Gene Therapy     18
Cytokines     19
Organizational Update     21

AIDS Research & Politics in 1994 - Are You Better Off Today... ?
==================================================================

Sixteen months into the new Administration in Washington, it is clear 
that the change of political stewardship has not made a major difference 
for people living with AIDS. High hopes that the sympathetic tone of the 
new Administration would translate into better policy, faster research, 
or an improved prevention effort have come crashing back to reality. 
Whether this is due to any fault of the Administration, or just a 
consequence of unrealistic expectations, is open for debate. At the very 
least, there is little evidence that this Administration has made AIDS 
any more of a national priority than the previous one. And, depending on 
how it addresses five key issues facing AIDS research today, it could 
eventually earn the reputation of doing more harm than good. 

The nightly news, and the Presidents attention, is dominated by crime, 
the economy, foreign and military affairs and general health care 
concerns. While the Administration is struggling to convince the public 
that a few more million dollars for CARE and research programs is a big 
step forward, we learn that $750 million in new money has been allocated 
to support US companies manufacturing lightweight color computer 
screens, that billion-dollar military spy satellites are lining up on 
the launch pad, and that the 1995 budget for nuclear weapons development 
exceeds $24 billion. There has been no Bill Clinton "Town Meeting on 
AIDS." The President has appeared twice on MTV, but has yet to take 
questions at an AIDS service organization. Leaders of the automotive 
industry have been escorted into the Oval Office to collaborate with the 
government on making more fuel efficient cars, and Hollywood stars have 
been given phone lines and office space in the White House, but AIDS 
researchers have had no such access and no such invitation. At best, 
AIDS has provided an occasional photo-opportunity for a few people to 
pose with the President.

After collecting big money in the campaign on the promise of important 
things to come in AIDS research, the Administration has since spent an 
inordinate amount of time explaining why Clinton really didnt mean it 
when he called for a "Manhattan Project" on AIDS. 


We do have a new "White House" AIDS policy coordinator, but her first 
several months in office suggest that she has been given little if any 
authority to take action on anything, let alone carry the authority of 
the White House in her job. Similarly, we have a newly appointed 
Assistant Secretary of Health and Human Services (who controls both the 
NIH and the FDA), a new head of the National Institutes of Health, and a 
new director of the Office of AIDS Research - all fine men (yes, once 
again they are all men, white ones at that). New committees, task forces 
and advisory bodies are being formed, taking over where the last bunch 
of committees, task forces and advisory bodies left off. One bright spot 
is a new enthusiasm for strategic planning - largely a response to 
activist pressure and apparently a new idea in medical research - but 
few people engaged in the process have ever seen, let alone studied or 
written a strategic plan before. Some reports from the first budget and 
planning meeting on AIDS research suggest that, because there is still 
no real process for setting priorities, the effort was little more than 
a review of last years expenditures. 

AIDS research is reeling and in serious need of detoxification. Because 
of change in personnel, combined with growing public pressures and 
uncertainties, five key issues are up for grabs. Each represents both an 
opportunity for positive change as well as a risk of making major 
missteps. It is a situation ripe for a five-step program.

Problem 1: The overall AIDS research effort is now being led by people 
who have neither AIDS experience nor expertise in management skills 
required or called for in the Office of AIDS Research reorganization.
Solution Step 1: The Office of AIDS Research should seek the advice of 
proven experts in strategic planning, project management, efficiency and 
quality assurance. As new people have been given responsibilities for 
managing the AIDS research effort, they have been selected on the basis 
of scientific resumes, not their knowledge of AIDS or skills in major 
enterprise management. If they get the proper professional support and 
guidance, they might be effective and bring fresh thinking to the effort 
- hopefully with a minimum of time lost while "getting up to speed." If 
they assume they know how to write and pursue a strategic plan, 
establish balanced, long-range priorities, assure process efficiency and 
quality and effectively oversee the management of research, we are 
headed for trouble. These skills simply are not part of a scientists 
background and are all too often looked down upon as "process skills" by 
"real" scientists. On the contrary, the ability to plan and manage 
effectively in the thicket of AIDS research is fundamental to success.

Problem 2: Key players at the NIH seem convinced that a return to the 
laboratory to pursue "basic research" rather than clinical questions is 
needed. If they are wrong, research and spending priorities could be 
misdirected for years to come. Currently, both clinical research 
programs and drug discovery programs are being targeted for possible 
funding reductions.
Solution Step 2: Make no changes in the balance of priorities until 
scientists, policymakers and advocates agree upon a clear set of terms 
and definitions and an in-depth, independent and honest assessment of 
the real needs of AIDS research takes place. No field is more rife with 
buzzwords and fashion-frenzy than AIDS research. One of the current 
fashions rushing through the NIH is a call for a return to "basic 
research." Wise scientists, bureaucrats and activists nod gravely in 
agreement. But each person in seeming agreement actually has conflicting 
definitions of "basic research" - definitions remarkably consistent with 
each ones own field of interest:
     To the new NIH director and other cell biologists, "basic 
research" means more on fundamental laboratory exploration to tied to 
any specific disease and not geared to development of any particular 
therapy. They argue that this is the font of real innovation. Perhaps 
so, though critics argue this perspective may be motivated more by self 
interest regarding funding streams than by science.

     When virologists applaud "basic research" they envision 
investigation into the molecular biology of HIV (the study of the virus 
itself). This, they feel, is where we will learn to cripple the disease. 
Possibly, but arent these the same people who have told us for years 
that we have learned more about the biology of HIV than any other 
organism in history? How much more do we need to know and where will it 
get us?

     Other scientists argue that "basic research" is the study of the 
immune-pathogenesis of HIV, how the virus interacts with and breaks down 
the immune system. Indeed, this is very important, but its possible 
that the answers will be found most quickly through clinical studies 
involving people, rather than through basic laboratory explorations. The 
opportunity for such clinical studies will be lost if the pendulum 
swings unduly in favor of more laboratory, and less clinical, work. 
Another view is that giving excessive attention to the study of 
pathogenesis might itself be unproductive, since history records that 
most diseases which have been conquered were beaten long before 
scientists fully understood their workings. 

     When some of the community voices call for "basic science," their 
description sounds suspiciously like a demand for more rapid preclinical 
drug development. Important indeed, but definitely not what the others 
are talking about when they use the term.

So far, the call for "basic research" sounds more like confusion than 
consensus. The outcome of the debate will determine the priorities, 
spending, and thus the programs, of the next several years of research. 
No substantive change of direction should be taken, especially in an 
environment of limited resources, without first conducting a critical, 
independent and impartial assessment of the state of knowledge and the 
true needs of AIDS research. If the balance shifts too far in favor of 
"cell biology" benchwork or HIV molecular virology, we will see less 
emphasis on developing and testing new therapies for the next 5 to 10 
years, and consequently fewer new emerging options for people struggling 
against AIDS. This could spell disaster for the generation of people who 
will face the greatest need for therapy in the next five years. People 
with AIDS will be best served by a program which seeks to maintain a 
reasonable balance between bench science, pathogenesis and clinical 
research.

Problem 3: Some voices in and outside of government believe that no 
therapeutic approach currently in development is likely to be a cure for 
AIDS. Thus, they argue for a de-emphasis of drug development in favor of 
developing completely new solutions.
Solution Step 3: Before de-emphasizing therapy development, lets try a 
concentrated effort to speed the development of the most promising drugs 
already in the labs. Recent data from protease inhibitor studies are so 
intriguing that some scientists believe whats needed is an all-out 
engineering effort to maximize the benefits of this new class of drugs, 
along with an accelerated effort to test them in combinations. The 
striking, if time-limited, response seen to one of the protease 
inhibitors may provide the first hint that antiviral research is indeed 
on the right track, a notion many had begun to lose faith in. If so, 
then the greatest benefits in the near term are likely to come from 
developing this model, rather than looking for completely new 
approaches.

Similarly, many avenues of therapy development are floundering not for 
lack of promise, but for lack of sponsorship by government or industry. 
These include products which target cellular, rather than viral 
mechanisms critical to viral replication, integrase inhibitors, LTR 
inhibitors and other approaches targeting the virus in novel ways. 
Moreover, there is a backlog of interesting products in the field of 
immune-based therapies which receive little or no attention or funding. 
There is an unmet need for new forms of collaboration between 
government, industry and academia in developing new avenues of therapy - 
and little evidence that the Administration is moving to meet it.

Problem 4: AIDS research is increasingly characterized by rapid swings 
in belief about clinical trial design, diagnostic markers and drug 
development strategies. The first time a belief or concept fails to 
produce significant results, it falls from fashion, leaving patients, 
physicians and drug developers in a state of confusion. Currently, that 
state of confusion is threatening the hard-won right of people to early 
access to promising new therapies.
Solution Step 4: Understand that uncertainty may remain a hallmark of 
AIDS for many years to come. Adhere to logical, common-sense approaches 
to research, at least until they are proven conclusively wrong - stop 
changing direction with each shift in the scientific breeze. When small 
changes in CD4+ counts in a single study failed to predict the benefit 
of therapy, a lemming-like herd rushed for the cliffs declaring that 
CD4+ counts were meaningless, and that drugs shouldnt be approved 
merely on the basis that they improve CD4+ counts and quality of life. 
In another startling turnaround, mechanisms like parallel track and 
accelerated approval are under attack by voices urging restricted access 
to new therapies and demanding long, survival-based studies before 
further therapies are licensed for sale. While anyone is welcome to 
choose such beliefs to guide his or her own therapy, many people with 
AIDS want the opportunity to access promising experimental therapies 
while theyre still around to try them. If scientists or regulators 
continue to place emphasis on quantifying small differences between 
todays at-best modestly useful drugs, no one will benefit and the costs 
will drive industry away from AIDS drug development. Instead, such drugs 
should simply be available for those who choose to use them, while the 
profits gathered from their sale must be invested in developing a better 
generation of therapies and new diagnostic markers.

Long-term studies which seek to prove survival benefits of mediocre 
drugs have proven all but impossible in the rapidly-changing field of 
AIDS research. People refuse to stay in such studies for more than a 
year or two. Care providers are unwilling to encourage patients to 
remain on a therapy which is failing just to provide data for these 
studies. Ethics demands that people be permitted to switch therapies 
when the existing regimen fails. Long-term studies measuring survival 
will only become practiced when we have a generation of drugs capable of 
producing long-term beneficial activity without major side effects. We 
need no further studies to prove that we are not yet at this point. 

Over time, the restructuring of the Office of AIDS research will almost 
certainly lead to greater focus and less duplication of effort - but 
that change will not be noticed quickly. While the train moves ever so 
slowly forward, we must make sure that people with AIDS continue to have 
the earliest reasonable access to therapies which might help them. The 
fundamental right of freedom of choice, won in hard battles fought in 
the late 1980s, must not be lost in a debate over the conflicting 
results of studies conducted on todays mediocre generation of drugs. No 
bureaucrat, whether inside or outside the community of people with AIDS, 
should be permitted to threaten this right.

Problem 5: AIDS activism is dead, dying or increasingly entwined within 
the bureaucracy. The healthy spirit of criticism which produced so much 
progress in the past has grown quiet as individual activists have passed 
away, become care-givers or burned out. There is a sense of complacency 
driven at least in part by the mistaken assumption that our interests 
are being taken care by the new Administration.
Solution Step 5: Renew the aggressive spirit of AIDS activism which was 
so productive in the past. AIDS research is at a crossroads. A year ago, 
people with AIDS hoped that the start of a new Administration would lead 
to newly invigorated, better-managed and more aggressive programs of 
AIDS research. That moment of opportunity has come and gone with only 
modest changes to show for it. There will be no new major programs or 
initiatives for at least another year. Regardless of its more supportive 
rhetoric, the Clinton Administration should feel no less pressure and 
demand from the streets than the Bush and Reagan Administrations. More, 
not fewer people are dying of AIDS today than at any time in history. 
Will Clinton be content to be remembered as the President on whose watch 
we saw the greatest number of deaths from AIDS? Kind words are not 
enough, nor are modest improvements in funding. To paraphrase a line 
from candidate Clinton, we will never see a cure for AIDS until people 
find the will and the courage to implement change. Change, in this case, 
begins with recognizing that the current effort is still not good 
enough.

Project Inform

Board of Directors
------------------
Tom Beckman, President
Susan Brautovich, Vice President
Rod O'Neal, Treasurer
Tim Wu, Secretary
Martin Delaney
Tom Downing
Marjorie Little
Curtis Ponzi
Joel Thomas
Paul Wisotzky

National Board
-------------
Lynda Dee, Esq.
Adan Rios

Staff
--------
Founding Director - Martin Delaney
Executive Director - Annette Brands

Accounting - Barry Harrison     
Adminstration - Bill Stibich
Advocacy/Publications - Brenda Lein & Ben Cheng
Constituent Services - Sue Bradley
Development - Thomas Teasley & Bill Rosen     
Hotline - Mark Frey
Outreach - David Evans
Program Services - Ben Collins
Public Policy - Anne Donnelly 
Volunteers - Jane Levikow

Volunteer Groups
-------------------------
Hotline Operator
Institutional Review Board
Mailing and Office Assistance
Project Immune Restoration
Project Opportunistic Infections
Writer's Team
Speaker's Bureau
Treatment Action Network

===================================================
Hope for Preventing Mother -to -Child Transmission
===================================================
by Virg Parks

The AIDS Clinical Trials Group (ACTG) recently announced preliminary 
data from ACTG 076, a Phase III randomized, placebo-controlled trial to 
evaluate the effectiveness, safety and tolerance of AZT in pregnant 
women and their infants. Data reveal an impressive reduction in the rate 
of transmission of virus from mother to child. The results of ACTG 076 
may have significant impact on reducing the incidence of pediatric AIDS. 
While there are a number of questions still to be answered, preliminary 
data from this study represent a major victory in the battle against 
AIDS. Additional questions will be answered by further analysis of this 
and other studies in progress. Appropriate responses to public health 
questions concerning testing or treatment of pregnant women will become 
clearer as more detailed and thoughtful analysis takes place with regard 
to these studies.

ACTG 076 began in April 1991 at 59 sites, including 9 in France. The 
study included women with CD4+ cell counts ranging from 200-1800 who had 
not taken antiretrovirals during their current pregnancy, had no 
symptoms of disease and had been pregnant for only 14 to 34 weeks. The 
study population was reflective of the AIDS epidemic in women, with the 
majority of study participants being women of color. Women were given 
500mg AZT or placebo daily from time of enrollment until they went into 
labor, then IV AZT or placebo at a loading dose of 2mg/kg body weight 
and a continuous infusion of 1 ml/kg/hour during labor and delivery. 
Within 24 hours of birth, the infants began oral AZT 2mg/kg 4x daily or 
placebo, which was continued for 6 weeks.

Preliminary Results

As of December 1993, 421 of the targeted 748 infants were born. Of 
those, 364 infants (180 on AZT) had at least one HIV test available and 
could be included in the preliminary analysis. Results of ACTG 076 are 
impressive. Transmission was reduced from 25.5% in the placebo arm to 
8.3% in the AZT arm. In other studies of women in good health with 
excellent prenatal care, transmission rates without therapy have been 
shown to be as low as 11%. In America, however, transmission rates run 
from 20-80%, depending on a variety of factors including the status of a 
womans health during pregnancy, access to prenatal care and various 
immunologic and virologic parameters. Reducing transmission rates to 
8.3% is quite significant. Because of these results, the ACTG decided to 
unblind the study, allowing women to know if they were receiving AZT or 
placebo. It was further decided to close the study to enrollment, and 
offer AZT to all women in the study.

The long-term effects of fetal AZT experience are as yet unknown. With 
the exception of anemia, researchers reported no immediate toxicities or 
side effects in the infants. In all cases, the anemia resolved when AZT 
was discontinued. Some researchers and advocates are concerned over 
potential toxicities of AZT, especially long-term effects, such as 
cancer. In the mean time, we must live with some uncertainties. These 
concerns will be addressed in long-term follow-up and we wont fully 
comprehend the effects of fetal exposure to AZT until the children from 
ACTG 076 become adults.

Seven of the children on AZT and eight children on placebo had birth 
defects which were consistent with those seen in the general population. 
In addition, seven children in each arm died. Most deaths were 
attributed to serious birth defects or rapid progression of HIV. No 
birth defects or deaths in ACTG 076 were attributed to AZT use.

Women reported typical side effects associated with AZT (see Project 
Inform AZT Fact Sheet) and six women, including three on placebo, 
discontinued therapy due to perceived side effects. None of the women 
died during the course of the study.

Follow-Up and Further Analysis

Children will continue to be followed for 18 months, at which time 
confirmatory HIV-testing will be done. Long-term follow-up of children 
will be conducted through ACTG 219, which will continue to evaluate 
children until the age of 21. Women who are considered adolescents (ages 
13-21) will also be followed in ACTG 220. ACTG 220 provides some basic 
gynecological care, including pap smears, and will be revised to 
incorporate concerns regarding initiation of AZT during pregnancy. ACTG 
220 will not follow adult women who enrolled in ACTG 076.

Unanswered Scientific Questions

Studies have suggested that viral load has an impact on perinatal 
transmission (see PI Briefing Paper #13). It is not clear if AZT reduced 
the rate of transmission because it lowered levels of the virus. Without 
this information, its difficult to know if other antiviral therapies 
would have similar effects on perinatal transmission. An analysis of the 
women who transmitted the virus to their children has not yet been 
conducted, which leaves many unanswered questions about possible 
cofactors in transmission, such as CD4+ counts and amount and type of 
virus. With more information, it may be possible to develop guidelines 
regarding AZT in pregnancy, which might better characterize women who 
may best benefit from this intervention. Further analysis of the study 
will be presented later this year, and should help clarify some of these 
issues.

Other Studies

Because ACTG 076 targeted a select group of women, who were healthy with 
high CD4+ cell counts, its unclear if the results of ACTG 076 will 
apply to women with symptoms of HIV-disease, or women who have 
previously been on AZT for an extended period of time. Other studies 
will shed light on this question. ACTG 185 is a study of pregnant women 
with less than 300 CD4+, already taking AZT (or ddI if AZT intolerant), 
who will receive either IVIG or HIVIG during pregnancy and delivery. 
Infants will be infused at birth. IVIG and HIVIG are blood products rich 
in antibodies. HIVIG uses HIV+ donors so that the product will have high 
concentrations of HIV specific antibodies, while IVIG uses HIV- donors. 
High transmission rates have been observed in women with low CD4+ 
counts, and it is hoped that the addition of HIVIG will provide 
antiviral support and prevent transmission. HIVIG is only available 
through small studies, while IVIG is an FDA approved blood product. 
Women will be followed for 26 weeks after they deliver to see if 
temporary administration of HIVIG impacts the course of HIV-disease. At 
this time, continuation of HIVIG postpartum is not planned. Preliminary 
data from this study are not expected before 1996. Phase I studies 
evaluating therapeutic vaccine approaches during pregnancy are also in 
progress.

Regulatory, Access and Policy Concerns

Reduction of perinatal transmission is good news, yet extremely 
complicated issues arise with the results of ACTG 076. AZT is not 
currently approved for use during pregnancy and insurance companies and 
Medicare/Medicaid may not be willing to pay for the drug for this 
indication. To address the needs of pregnant women who are intolerant to 
or have failed AZT, small studies of promising compounds should be 
conducted. Furthermore, observational studies which evaluate the 
differences in women and the outcome of their pregnancy may help 
determine how and when a woman is more likely to transmit the virus to 
her child. Data from these types of observational studies will be useful 
in revising prenatal guidelines. Because the long-term effects of fetal 
exposure to AZT and many other compounds are unknown, a database to 
follow children into adulthood would prove invaluable.

While preliminary results of ACTG 076 do not warrant the need for 
mandatory testing, they do indicate a need for establishing guidelines 
regarding testing of pregnant women and prenatal care of HIV+ women. 
Statements supporting routine testing of pregnant women have been 
released by influential organizations, mandatory testing legislation is 
pending in at least one state, and a policy change by the New Jersey 
Health Department encouraging routine testing is underway. Project 
Inform and other advocacy organizations have received hundreds of calls 
from women and their partners who fear mandatory testing.

Although the words "routine" and "mandatory" have two distinct 
definitions, for many the words are synonymous. Supporters of routine 
testing are concerned that results from ACTG 076 may be ignored by the 
medical community, and that children will continue to be born HIV-
infected despite a promising intervention. Most pregnant women, when 
offered testing for HIV and other disorders, agree to voluntary testing. 
Guidelines which promote routine testing of pregnant women may 
discourage some women from seeking prenatal care out of fear that 
results may be used in a way harmful to herself or her family. Routine, 
unbiased and nonjudgmental HIV counseling accompanied by the offer of an 
HIV test would prove less intimidating. All women, pregnant or not, 
deserve access to voluntary, affordable, anonymous, nonjudgmental and 
culturally appropriate HIV testing.


=================================
Tell others about the PI Hotline!
=================================
Hotline Hours: 
Monday through Saturday
10 am to 4 pm Pacific Time

             1-415-558-9051 (San Francisco)
             1-800-822-7422 (National)

Organizations may request wallet size PI Hotline cards for their 
clients.

Treatment Packet and Updates

New callers to the PI Hotline receive the Treatment Information Packet 
which includes many of the materials listed below. In addition to this 
Introductory Packet, several other Fact Sheets, recent Bulletins, and
handouts on HIV-related issues and treatments are available for free by 
calling the hotline. Some examples:

Drug Interactions
Does HIV = AIDS?
Treatment Strategy
AZT 
Cell Therapy 
ddI
Acyclovir
ddC     
Histoplasmosis
d4T     
Cryptococcal Infections
Hepatitis
Leishmaniasis
Vaccines
Management of Opportunistic Infections

=============
AIDSWATCH '94
=============

The annual battle to ensure that adequate dollars will be available from 
the federal government to fund necessary the National Institutes of 
Healths (NIH) AIDS research effort is underway. This year the President 
has requested a $78 million dollar increase for AIDS research, but once 
again the request falls far below the professional judgment budget, the 
budget which reflects scientific needs, submitted by NIH scientists. 
This year also brings new funding threats as individuals and some of the 
media promote the myths that the epidemic has peaked and that research 
is incapable of producing effective therapies. As the U.S. domestic 
fiscal realities become increasingly difficult, some lobbyists will 
suggest funding their interest at the expense of others. AIDS funding is 
far from invulnerable to this attack.

In this highly charged and complex political reality, given an 
administration that has still not made AIDS a real priority, your voice 
and your advocacy are more important that ever. For the third year in a 
row Project Inform constituents, along with constituents from AIDS 
organizations across the country gathered in Washington, D.C. to bring 
their concerns to elected officials during AIDSWATCH 94. 

The importance of this event cannot be underestimated. Washington needs 
to see and hear the depth of the suffering and the bravery of the 
response to this life-threatening pandemic as funding decisions are 
being made. Each year, people living with AIDS, their friends, families, 
and advocates must counter attempts to minimize HIV/AIDS in the light of 
other problems this country faces. AIDSWATCH participants have been 
effective in bringing a clear, strong message to elected officials that 
HIV and AIDS is a problem confronting all of us. In FY 1994, Ryan White 
moneys in California were increased due to efforts during AIDSWATCH and 
a substantial increase in NIH research dollars was protected by 
AIDSWATCH citizen advocates.

In addition to the critical mission, the experience of AIDSWATCH is 
empowering and exciting. The event opens with a briefing, which includes 
interactive skills building or lobby training sessions, to help 
prepare people for meetings with Congressional representatives or their 
aides. These Congressional visits establish a firm base for an ongoing 
relationship between AIDSWATCH participants and their elected officials. 
Social activities provide a place to meet fellow lobbyists, debrief, 
share experiences and techniques. Through this event, AIDSWATCH 
participants invest themselves in the political process and can make a 
significant difference in the lives of people with HIV.

AIDSWATCH '94 took place on May 22-24. For information on how you can 
join the continuing grass routes campaigns and receive advance notice of 
next years AIDSWATCH event, call Project Inform at (415)558-8669 and 
ask for Dan Perdios or David Lewis. 

Together We Can Have A Voice In Our Future


====================
Resource Notes:
====================

National Trials Hotline. The AIDS Clinical Trials Information Service 
provides information on federally sponsored studies (and many others) 
open to enrollment nationally. Call 1-800-TRIALS-A (1-800-874-2572). 
800-AIDS-012 TTY/TTD serves the deaf and hearing impaired. The service 
also provides free copies of the AMFAR Treatment Directory, which also 
lists studies conducted by private industry.

National AIDS Hotline. The National AIDS Hotline operates 24 hours a day 
and provides referrals to local services throughout the United States, 
and information about a wide variety of non-treatment related topics. 
Call 1-800-342-AIDS (2437). Spanish -speaking operators are available 8 
AM to 2 AM EST at 1-800-344-SIDA (7432). For the deaf and hearing 
impaired, call 10 AM to 10 PM EST at 1-800-AIDS-TTY (243-7889).

WORLD is a newsletter and an organization for, by and about women facing 
HIV disease. WORLD strives to break the isolation of HIV+ women by 
providing a forum for communication and treatment information of 
interest to women. For more information on WORLD call 1-510-658-6930.

======================
Treatment Newsletters:
======================

AIDS Treatment News     1-800-873-2812
Treatment Issues (Gay Men's Health Crisis, New York)     212-337-1950
Test Positive Aware (Chicago)     312-472-6397
BETA (San Francisco AIDS Foundation)     415-863-2437


PI Perspective...

     Distributes information on a limited number of well-qualified 
treatment options; 
     Advises on access to treatment; 
     Encourages personal empowerment through active participation in 
treatment strategies; 
     Increases awareness of the obstacles that impede progress in 
research.
How often does it come out?
     2 times each year, or whenever we can afford it. PI is funded 
primarily by donations.
Do I pay for a subscription?
     It is free. 
What does a donation pay for?
     A toll-free treatment hotline, the journal, outreach on early 
diagnosis and treatment strategies, and efforts to enable sane research 
and treatment access policies.

PI Perspective - not a newsletter... 
but a unique tool for change on behalf of people with HIV.

====================
Health Care Reform
====================

Health Care Reform is one of the most critical issues facing Americans 
today, particularly people living with HIV and other life-threatening 
illnesses. If a cure were discovered tomorrow, nearly 50% of people with 
AIDS in this country might not be able to access it due to inadequate 
health care coverage. Monitoring of the various health care reform bills 
and pressuring Congress with citizen letters, phone calls and meetings 
must be maintained as the debate over reform intensifies. Delivery of 
health care has become a highly profitable industry with many powerful 
and influential players. A health care system that meets the needs of 
people is long overdue and possibly within our grasp, but achieving a 
workable system is unlikely if decisions are left to Congress, the 
Clinton Administration and industry lobbyists. Now is the time for 
concerned individuals to register their needs, comments, questions and 
support for substantive health care reform.

President Clinton has declared health care reform to be his "#1 policy 
priority."  Reform of the health care system is also a high priority for 
many people living with HIV and their advocates. The issue is being 
hotly debated across the country, and with an estimated $1 trillion to 
be spent on health care in 1994, many individuals, businesses and some 
well funded powerful special interest groups have a stake in its 
outcome. The health care industry has poured over $150 million into 
Congressional campaign coffers to influence the outcome of this debate, 
but in the end it is voters - people like you - who will have the final 
word.

While the numbers of insured versus uninsured people living with HIV are 
unknown, the statistics for those living with an AIDS diagnosis are not 
reassuring. Only 29% of people with AIDS have private insurance. Around 
50% of people with AIDS who lack private insurance are covered by 
Medicaid, which is not accepted by many health care providers, or 
Medicare, which does not provide prescription coverage. Many people with 
AIDS have no insurance coverage either because they cannot afford it, 
have been denied coverage because of preexisting conditions or have been 
dumped by a previous insurer as a "bad risk."  Even those with insurance 
often find that their coverage is inadequate. Caps (upper limits on how 
much a company will spend on a given illness or condition) are becoming 
increasingly popular in the insurance business, as are exclusions of 
"off-label" drug use (using a drug developed for another condition to 
treat an HIV-related condition) and expensive procedures. Insurance 
companies, and not doctors or nurses, are increasingly calling the shots 
on what treatments are available and making decisions regarding hospital 
admissions and home care.

"Tony" had a standard private insurance policy. He was allowed to keep 
the policy when he went on disability, but maintaining the paperwork, 
paying deductibles, and communicating with insurance company personnel 
and health care providers became a full time job for his mother, herself 
an insurance agent. During Tonys last hospitalization, his doctor noted 
that Tony was in the terminal stage of AIDS. This determination allowed 
Tonys insurance company, a major national provider, to discontinue 
payment for a number of treatments. Tony was evicted from the hospital 
on insurance company orders, against the wishes of his family, doctors, 
and other providers. Treatments were withheld, and his care during his 
last days was transferred to family and friends as his insurance would 
not pay for 24 hour nursing. While physicians, friends and family are 
often effective advocates for a person unable to advocate for 
themselves, they are not always successful when an insurer refuses to 
make payment.

While some of the proposed health care reform plans seek to address the 
problems faced with insurance reimbursement, there is another issue 
illustrated by Tonys story. The delivery of quality health care is in 
part dependent on hospital and physician standards and ethics. Many 
hospitals as well as private physicians groups will not take patients 
who dont have insurance. Some Health Management Organizations have made 
specialist care difficult to access. Hospital administrations sometimes 
do not allow physicians to give palliative treatments to people in 
terminal stages of disease on insurance company orders. We must continue 
to monitor, question and advocate against this lack of ethics, not only 
on the part of the insurers but also on the part of hospital and HMO 
administrations.

Tonys case is not unique, but it is notable because he had a good 
private insurance policy. His case demonstrates a sad truth about our 
health care system:  for many, it breaks down completely exactly when it 
is most needed. Health care reform is, for many people, literally a life 
and death issue.

While a number of health care reform proposals are on the table, the 
Wellstone/McDermott (Single Payer) and Clinton (Managed Competition) 
plans are the only proposals which come close to addressing the 
important concerns outlined in Figure 1. Other plans insufficiently 
address these bottom line needs. The challenge of health care reform 
will be to keep acceptable plans from being watered down by the 
Congressional committee process and to ensure that critical issues not 
covered in the plans are addressed. It will be essential to maintain 
public interest in what will be a complex and politically charged 
debate.

It is not too late to get involved in the health care reform debate. 
Your participation is vital now to counterbalance the very significant 
influence of powerful business interest groups which are primarily 
interested in protecting profits. We can't allow profit lines to have 
more influence than peoples needs. If a health care bill is not passed 
this year, or if a weak one passes, it will be a long time before we 
have another chance at meaningful reform.

Many issues in health care reform dramatically affect people living with 
HIV/AIDS and their loved ones. More about these issues, such as the 
pitfalls of a managed care (or HMO) program, coverage of undocumented 
persons, and what is to become of the current health care "safety net" 
before and during reform, is available from Project Informs Policy 
Department at 415-558-8669.

===========================================
Guidelines For Evaluating Reform Proposals
===========================================

Figure 1

The following are some guidelines for evaluating reform proposals. Any 
adequate reform proposal should minimally offer:

     Universal coverage for everyone, with reasonable implementation 
dates
     (including the poor, those with pre-existing conditions, and others 
who are "redlined" or systematically excluded from current health plans)
     Employer mandates to pay for employee coverage
     Government guarantees of coverage for low income people
     Portability of coverage (ie. you will not lose coverage by 
changing jobs)
     Proposed individual benefits fully outlined and written into the 
bill itself
     Coverage for long-term care
     Guarantee of affordability
     Choice of physician and specialist care
     Coverage for care expenses related to experimental treatment and 
coverage of "off label" treatments
     Availability of multiple therapy options to treat or prophylax 
against a specific disease
     Option for states to select a single-payer (Canadian-style) system

We do not have the space here to discuss all of the reform plans before 
Congress. More information is available from Project Informs policy 
department

================
WHAT YOU CAN DO?
================
Call your Congressional representatives!
(     Let them know how important health care reform is to you.
(     Ask for their position on health care reform and whether they are 
co-sponsoring or supporting a particular plan.
(     Make sure the plan they support encompasses bottom line needs 
outlined in figure 1.

Look over the existing plans and choose the one that best meets your 
needs. Doing this kind of research might seem daunting, but many 
organizations,such as Project Inform, offer simplified charts for 
purposes of comparison.

Consider the source of information on health care reform. If you are 
watching paid advertising or reading an editorial, look for the fine 
print - who is putting this out and where might they stand to profit? 
Seek out new sources of information.

*     Write your representatives, then write again  (make this a monthly 
exercise) - remind them that you are watching. 1994 is an election year 
and elected officials are paying attention to what their constituents 
want.
*     Mobilize friends and family to write letters and make phone calls. 
Remember: in our system of government, only vast numbers of grass-roots 
actions can counterbalance vast sums of money spent to affect 
legislation. Start a conversation about the importance of health care 
reform whenever the opportunity arises.
(     Contact local non-profit organizations and ask them to be 
proactive in supporting health care reform.
(     Contact local media outlets and give them your story. When talking 
about health care reform, personal stories make the most impact. You do 
not have to become an expert on the issues, you just need to have 
experienced the drawbacks of the current system and be willing to talk 
about your experiences.

Let us know if we can be of assistance.
Write or call Project Inform and ask for David Lewis or Anne Donnelly.


Dont underestimate your own power as an advocate for change!


===========================================
d4T - Recommended for Accelerated Approval
===========================================

d4T, also called stavudine or Zerit, is an antiretroviral drug similar 
to AZT, ddI, and ddC. All these drugs are nucleoside analogues which 
work by inhibiting an enzyme called reverse transcriptase. This enzyme 
is necessary for HIV reproduction. d4T, made by Bristol-Myers Squibb, 
has been studied in humans for five years. To date it has been given to 
almost 11,000 people. Early studies of d4T looked very promising, 
showing CD4+ cell increases sustained for 18 months. These results were 
from studies involving a small number of people. Final data from a 
larger Phase II/III study and the Parallel Track program have yet to be 
released. Preliminary data from the Phase II/III study were presented at 
the Food and Drug Administration (FDA) to the Antiviral Drug Advisory 
Committee on May 20, 1994. As we go to press, the Committee has 
recommended that FDA grant d4T Accelerated Approval.

Preliminary Phase II/III Study Results

While the study was designed to look at clinical endpoints, the effect 
of d4T on disease progression and survival, only preliminary data on 
surrogate markers are currently available. Therefore, the Antiviral Drug 
Advisory Committee is assessing the drugs' toxicity relative to AZT, as 
well as its ability to improve CD4+ counts and decrease levels of virus 
in the blood in people with 50-500 CD4+ cells, with a long history of 
prior AZT therapy. Changes in CD4+ count, p24 antigen, HIV viral titer, 
and weight gain were consistently superior in the d4T-treated group than 
in the group receiving continued AZT treatment.  Data on clinical 
endpoints will not be available until early next year, after the 
completion of the study.

The Phase II/III study enrolled a total of 822 participants. Volunteers 
were randomized to receive either 40 mg. d4T twice a day, or 200 mg. AZT 
three times a day. Preliminary data were presented on 359 people who had 
been on study for at least 4 months. Study participants had a long 
history of prior AZT use. The average volunteer had been on AZT for over 
a year and a half prior to entering the study. The median duration of 
prior AZT use among study participants was 81 weeks in the d4T arm and 
89 weeks in the AZT arm.

The median CD4+ cell count of volunteers entering study was relatively 
equal in both arms of the study, with the group receiving continued AZT 
having a slightly higher counts. Viral activity, measured by p24 
antigen-positive status, was relatively equal between the two groups at 
study entry, with 42% of people on d4T and 40% of people on AZT having 
positive tests. While the AZT-treated arm showed a mean drop in CD4+ 
counts after 2 weeks, the d4T-treated arm showed a mean CD4+ cell 
increase through 20 weeks, after which CD4+ counts began to drop below 
baseline. CD4+ data were available for some volunteers who had been on 
study for 76 weeks. These showed a mean CD4+ decrease of 18 in the d4T 
arm, versus a decrease of 70 in the AZT arm, suggesting that the benefit 
of d4T may diminish over time, but for folks with a prior history of AZT 
therapy, d4T appears to slow the progression of CD4+ decline. Changes in 
p24 antigen showed that the AZT-treated arm had p24 increases throughout 
the study and the d4T-treated arm showed p24 antigen decreases through 
week 20, after which p24 began to rise above baseline levels. At 12 
weeks, HIV viral titers, as measured by viral culture,  had decreased by 
53% in the d4T arm and rose 11% in the AZT arm. An analysis of changes 
in body weight demonstrated that people on d4T showed some weight gain 
compared to the AZT group who showed weight loss. Other analyses 
measuring quality of life and mental performance status showed d4T to be 
superior to continued AZT therapy.

Side Effects and Adverse Events

The most common side effect of d4T is neuropathy (6% in the Phase II/III 
study, 14% in the low-dose arm and 24% in the high-dose arm of the 
Parallel Track program.) The increased risk of side effects in the 
Parallel Track program may be due to the fact that people on Parallel 
Track were generally less healthy than those in the Phase II/III study. 
Pancreatitis, a potential life-threatening condition, was seen in just 
under 1% of study participants, and may not have always been related to 
d4T use. Other side effects reported from the parallel track program 
are: headache (<2%), nausea and vomiting (1.2%), cough and labored 
breathing (0.5%), depression (0.3%), confusion (0.3%), abdominal pain 
(1.2%), and diarrhea (1.5%). Of note, the incidence of side effects 
reported on d4T are much lower than what has been seen with other 
antivirals. The most frequent laboratory abnormalities reported thus far 
are elevated liver enzymes and creatinine phosphokinase (CPK) in 5% of 
patients. (CPK is a muscle enzyme - Myopathy, strenuous exercise and 
heart attack can increase CPK levels.) The phase II/III study reported 
modest elevations of liver enzymes associated with d4T compared to AZT; 
however, severe liver enzyme elevations (>5 times normal) were 
comparable to those seen in people treated with AZT. In the Phase I 
studies, the most common side effects were peripheral neuropathy and 
liver toxicity.

Evidence of insomnia, anxiety, and skin rashes reported by some 
activists and patient advocates have not been confirmed by the study. In 
the Phase II/III study, there were more cases of insomnia reported in 
the AZT-treated arm (23%) than in the d4T-treated arm (15%). Anecdotal 
information from some physicians indicates that adverse events like 
neuro-psychiatric disorders (panic attacks) and neuropathy are causing 
almost 20% of their patients to drop off the Parallel Track program. 
These same symptoms were reported in early studies of AZT, ddI, and ddC. 
Although the company has asked all investigators to be attentive to 
patients complaints and report them in monthly case report forms, a 
study designed to evaluate potential neuro-psychiatric effects of d4T 
may still be warranted.

Resistance and drug interactions

Studies looking at resistance have been going on for almost 24 months. 
So far, the company says there is no evidence to suggesting the 
development of d4T resistance. However, in vitro (test tube) studies 
have shown cross-resistance between d4T and ddC. This means that d4T may 
have decreased antiviral benefit for people who have failed ddC. Thus 
far, no drug interaction studies have yet been done with d4T in humans. 
This is problematic as clearly, if d4T is approved, people will be using 
d4T with other drugs including common OI prophylaxis and treatments and 
possibly other antivirals. There are reports that there may be increased 
risk for pancreatitis for people taking d4T with oral ganciclovir or IV 
pentamidine. Test-tube studies combining AZT and d4T resulted in less 
anti-HIV activity, possibly because both drugs compete for the same 
enzyme, thymidine, in order to inhibit reverse transcriptase. Further 
analysis of the phase II/III studies may result in some drug interaction 
data as there are many people with low CD4+ counts in this study who are 
taking several other medications concurrently (especially OI 
prophylaxis).

Whats Next

What will be d4Ts indication (guidelines for how a drug is to be used) 
if it is approved? That decision will be based mainly on the Phase 
II/III study which compared d4T to AZT in people with between 50-500 
CD4+ cells and at least 6 months prior AZT use. The FDA determines the 
indication of a drug based on clinical studies. That being the case, the 
drug may be indicated for people who have failed or are intolerant to 
AZT. When the FDA makes final decisions on the indication for d4T, it 
will probably be three to four months before the drug is available in 
pharmacies. Upon approval, the company will offer parallel track 
volunteers free drug for 1 month. The company has also noted that when 
d4T is approved it will provide drug to those who cannot afford it 
through a patient assistance program. What will it cost? Drug pricing 
takes into account factors such as development costs and the indication. 
If the drug is to be competitive, and is indicated as described above, 
its price may be similar to other HIV drugs like AZT and ddI: $180-$250 
per month.


===========================================
The "AIDS Cure Act" - Science or Politics?
===========================================

In May, H.R. 3310, "The AIDS Cure Act," was introduced in Congress by 
Congressman Jerrold Nadler of New York. Also known as "The Barbara 
McClintock Project," this bill calls for the creation of an expansive 
new program of AIDS research, something of a "Manhattan Project" on 
AIDS. Since many groups, including Project Inform, have been calling for 
a "Second Front" on AIDS - effective reforms and new AIDS research 
initiatives - its important to read the fine print. Not all proposals 
are alike and though well intended, not all are likely to speed the 
search for a cure. Many people have asked whether Project Inform 
supports this particular bill, and some wonder whether it is the same 
thing as the "Second Front" that we have called for and written about in 
previous publications. Project Inform supports the general concept of 
taking bold new initiatives in AIDS Research, and applaud Congressman 
Nadler for sticking his neck out on behalf of people with AIDS. Overall, 
however, Project Inform cannot support this bill in its present form, 
for the reasons described in this article.
First, there are several insightful suggestions in the "AIDS Cure Act" 
which are consistent with views expressed by several groups, including 
Project Inform. These areas of common interest include:
J     Initiation of an intensified program of AIDS research. It is both 
scientifically and politically important in the current climate to make 
a "fresh start" on AIDS, to announce and implement a reinvigorated and 
more aggressive program.
J     A focus on clarifying the pathogenesis of AIDS. While a great deal 
has been learned about HIV, less is known about how it causes damage. 
There are many competing theories of how the virus causes disease, but 
there does not appear to be a clear federal program for prioritizing and 
testing these theories. Until HIV pathogenesis is better understood, the 
element of chance will continue to play an unduly large role in the 
development of new therapies.

J     A call for greater collaboration among scientists. AIDS research 
presently operates on an essentially competitive, rather than 
collaborative model. This model is mostly a reflection of 19th century 
traditions of science. It is not a model designed to produce the fastest 
or best results. The synergistic effects of teamwork, goal orientation, 
strategic planning, efficiency and quality assurance are the hallmarks 
of modern management practices in almost every other field of endeavor, 
but not in federally-funded biomedical research.
J     A call for scientists to work in a more scientifically focused 
environment. Today, it is all too common for AIDS researchers to serve 
many masters competing for their time and attention. Teaching duties, 
writing grants, university faculty responsibilities, consulting 
contracts and professional and political roles all impinge upon the time 
of many researchers, often to the detriment of their focus on AIDS. 
J     A call for a greater emphasis on project management. Much time and 
effort is lost in AIDS research because of the entangling web of 
bureaucratic and regulatory requirements. Giving a management team the 
authority to cut or streamline nonproductive government requirements 
would indeed be helpful.
While these areas of interest make sense to most people, several other 
aspects of the "AIDS Cure Act" are troubling and, we believe, run the 
risk of hindering rather than speeding progress. These areas of concern 
include:
L     The call for a sweeping, new, all encompassing program which will 
run alongside, but not replace, existing programs. By definition, this 
implies a massive duplication of effort. The vast majority of work 
likely to occur under the proposed program is work that is already being 
done, perhaps in a different fashion, under existing programs. Since the 
majority of scientists interested in AIDS are already working in the 
existing system, it is difficult to understand where the personnel for 
the new project would come from. It is unclear how or why Congress could 
be motivated to fund a second massive program while maintaining support 
for duplicative parallel research. Similarly, it is unclear how such 
duplication of effort would demonstrate efficiency in facilitating 
research into new areas.
L     An undue concentration on ideological issues. The "AIDS Cure Act" 
is excessively concerned with the exploration of "alternate" theories of 
the cause of AIDS. While better structures to support the development of 
complementary and alternative approaches to therapy are needed, 
alternative theories of AIDS are quite another matter. At this stage of 
the epidemic, all theories are not equally worthy of support or funding, 
nor should their study be politically mandated. There is sufficient 
opportunity within the existing scientific peer-review process for the 
testing of compelling new pathogenesis theories. Where such approaches 
have failed to achieve respected status, it has almost invariably been 
because they have failed to prove themselves in both human and 
laboratory experience.
L     An insistence upon centralization of decision-making and a primary 
work location. When centralization was demanded in the original 
Manhattan Project, its primary purpose was driven by security needs of 
the top-secret project. There may be benefits of working in close 
physical proximity, but they must be weighed against the enormous costs 
of uprooting hundreds of scientists, their families and their labs, as 
well as the time lost to relocation. While centralized information 
exchange, communications and management make sense, the principal effect 
of centralized labor would be a powerful disincentive for the best 
qualified scientists to participate.
L     An insistence that participating scientists sever all other ties. 
Securing an increased amount of a scientists attention is a good thing, 
as is gaining assurance that conflict of interest will not bias their 
work. But forcing researchers to literally "marry" a project for its 
duration would be counterproductive. Scientists should not be forced to 
pay a large personal and professional price to participate and 
contribute to AIDS research. As conceived, the proposed project would 
expect scientists to abandon professional objectives, such as career-
long university posts. Few are likely to be interested. Similarly, they 
would be asked to sever all industry consulting relationships. In the 
current system, such relationships are key to the flow of technology and 
thinking between government, academia and private industry. There are 
better and less destructive ways of handling concerns about conflict of 
interest.
L     An insistence on majority control of the program by people with 
AIDS and their advocates. It is well-established that scientific 
programs benefit when the voices of people with AIDS and their advocates 
are heard. This is a long way from saying that majority control of 
programs should be left to the lay public, however well-informed the 
public may be. Scientific programs should be primarily directed by 
properly trained scientists, with appropriate input from people living 
with HIV/AIDS and their advocates. Most importantly, the control issue 
should be discussed openly and not determined by language buried in the 
middle of complex legislation. 
L     An emphasis on force rather than incentives. The project talks of 
the use of eminent domain as means of seizing patents and products. An 
approach which favors incentives, rather than force, would be more 
likely to enhance cooperation, while avoiding the inevitable and 
crippling litigation that seizures would invite.
L     A general misunderstanding of how drugs are developed. As 
proposed, the project model seems to place responsibility for drug 
development in the hands of government. Neither government nor academia 
has the capability or resources for doing major drug development work. 
The vast bulk of this work is done in private industry. The implied 
creation of new publicly owned resources and facilities for drug 
development purposes would be an enormous waste of taxpayer money, and 
any effort to seize existing resources would surely result in 
litigation. However, reforms which enable government to quickly fill 
gaps in drug development could well prove beneficial. Instead of 
creating an atmosphere which is hostile to industry, AIDS research would 
be best served if government learned to work more effectively with 
industry, letting each party do what they are best equipped to do. 
Rather than trying to subsume industrys role, government should avoid 
creating obstacles to industry and encourage concentration on AIDS drug 
development.
Whatever Project Informs views, the "AIDS Cure Act" seems unlikely, in 
its present form, to receive the needed support of Congress or the 
scientific community. It seems likely that many individuals and 
organizations signed on to the bill as a statement, in general, in 
support of a reinvigorated new effort or "Second Front" in AIDS 
research. Project Inform also believes in the wisdom of a new approach, 
a "Second Front," but not in all the specific aspects of the "AIDS Cure 
Act." Any new initiative should be considered a pilot program, an effort 
to test new organizational and management approaches before any major 
step is taken to overturn current models. Even though such improved 
management models have worked well in other fields of scientific 
endeavor, they have not previously been employed in a federally-funded 
biomedical research program. Any such new program should focus initially 
on a single aspect of AIDS research, ideally one where there is a crying 
need and opportunity for advances. The "Accelerated AIDS Research 
Initiative," an outgrowth of last years Future Directions in AIDS 
Research meetings, is a draft model for such a project, one which 
provides most of the meaningful benefits, and none of the more 
controversial aspects, of the AIDS Cure Project. Copies of the proposal, 
a summary of which appeared in the most recent Project Inform Briefing 
Paper, are available from Project Inform upon request by calling the 
Project Inform treatment hotline at 800-822-7422, or in San Francisco 
415-558-9051. 


=================
The Basic Message
=================

!     Learn your options and line up your support.
!     Get tested, anonymously.
!     If positive, maximize your health, get a complete physical and 
full immune health workup and get educated! Learn about your options and 
consider antiviral treatment. For women, also get "gyn" and Pap tests 
every six months.
!     Monitor CD4+ cells quarterly, (no matter how high your count), 
charting the trend.
!     If the CD4+ trend is downward or consistently below 500, optimize 
nutrition and consider antivirals  (ideally a combination).     
!     If the CD4+ trend stays below 300, consider preventive treatment 
against PCP (oral drugs if possible). If the count continues to fall 
below 200, reconsider antiviral therapy if not already on and consider 
preventive treatments against other opportunistic infections. Learn 
about drug interactions.
!     If the count stays below 75, intensify monitoring, consider 
preventive action against MAC/MAI and fungal infections.  Learn about 
other preventive therapies.

It's NEVER too EARLY to take CHARGE of YOUR health!!


=================
Drug Interactions
=================

As more drugs are available to treat HIV and prevent or treat 
opportunistic infections, the potential for drug interactions become an 
increasing concern. Developing a health management plan and deciding 
which therapies to incorporate into a comprehensive plan can seem 
daunting. Not only does each particular therapy have potential side 
effects, but how each therapy might augment or diminish the benefit of 
another must be considered when weighing options. Many people are taking 
a wide variety of therapies simultaneously, ranging from experimental 
and approved antivirals and prophylaxis for opportunistic infections to 
complimentary approaches and over-the-counter medications. How  
therapies interact is not always considered, and may play a major role 
in the success of any plan for managing HIV-disease. The following are 
some guidelines to help decrease the likelihood of drug interactions, as 
well as keep health care providers and pharmacist's attention focused 
on monitoring for potential drug interactions:

q     Brown Bag Medicine Check-up - each time you see your health care 
professional, put all your medications, including over-the-counter and 
complimentary products, in a bag and have your health care provider 
conduct a personalized review of your medicine for safety, 
appropriateness, compatibility and instructions for use.
q     Each time you are given a prescription for a new medication ask 
your health care provider and pharmacist if it will work safely with the 
other therapies you are on.
q     Talk to your health care provider about making a medicine check-
up part of your regular visits, and discuss how best to monitor for the 
potential effects of drug interactions. Bring the Project Inform Drug 
Interaction Fact Sheet with you to your appointment.

Drug interactions can take different forms and may occur immediately or 
may take weeks to develop. Potential interactions may prohibit the use 
of two therapies together, while in other instances careful monitoring 
is sufficient to detect emergency problems, which can guide treatment 
decisions to avoid complications. Interactions can occur when one 
therapy affects how another is absorbed, broken down (metabolized), 
distributed or excreted in the system. Interactions can also occur when 
one therapy alters the effect of another. A common form of drug 
interaction can occur when two drugs have similar types of potential 
toxicity. For example, both ddI and ddC can cause peripheral neuropathy, 
a tingling or pain in the legs, hands or feet. Because of the similar 
toxicities of the two drugs, it is not recommended that they are used 
together as this may increase the potential for neuropathy. Similarly, 
AZT and ganciclovir, a treatment for CMV, may both cause bone-marrow 
suppression, which results in neutropenia. With the addition of a third 
drug, G-CSF (also called Neupogen), this drug interaction may be 
managed, however.

The issue of drug interaction is becoming of increasing concern as 
prevention of multiple opportunistic infections (OI), by taking a number 
of different drugs, is being proposed or is already considered standard 
practice by many physicians. Multiple OI prevention brings the issue of 
drug interactions to a critical head. It is possible that drug 
interactions may cause more harm than good in some multiple OI 
prevention regimens. For example, one drug could reduce blood levels of 
another drug, which may lead to the development of drug resistant 
organisms or result in the drug having no prophylactic value. In other 
words, drug interactions could result in the development of a disease 
which is not responsive to standard treatment. It is also possible that 
the added toxicity of taking numerous therapies outweigh their potential 
benefit for preventing disease. For these reasons, health care providers 
and people living with HIV/AIDS should carefully choose OI prevention 
regimens, monitor for drug interactions and other side effects and make 
informed decisions about combination therapies and OI prevention 
approaches.

Unfortunately, most drug interaction studies are done with only two 
drugs and most people with HIV take many more than that. As a result, 
very little is known about how all the commonly used drugs may interact 
with each other. For this reason, ACTG (AIDS Clinical Trials Group) and 
CPCRA (Community Programs for Clinical Research on AIDS) are proposing 
to conduct multiple opportunistic pathogens prophylaxis studies (MOPPS), 
to determine the benefits of preventing all the major opportunistic 
infections versus the potential toxicities and drug interactions of 
these commonly used therapies (fluconazole, rifabutin, clarithromycin, 
azithromycin, TMP/SMX, dapsone, oral ganciclovir, and valacyclovir).

In the meantime, it is important to discuss potential drug interactions 
with a health care provider and a pharmacist. Before starting a new 
therapy, be it approved, experimental or complimentary, factor in the 
potential for drug interactions and possible side effects. Not everyone 
experiences side effects of drugs and many problems of drug interactions 
may be managed by careful monitoring and adjusting dose or discontinuing 
therapy as needed.

A more comprehensive Drug Interaction Fact Sheet is available by calling 
the Project Inform Treatment Hotline.

=====================================
How To Use the Drug Interaction Chart
=====================================
To use the drug interaction chart, identify the name of a therapy in a 
gray bar. The drugs listed below the gray bar are therapies which may 
potentially interact with the drug in the gray bar. For example, 
identify the gray bar for ddI. Scan the list of compounds and substances 
listed below ddI. You will note that if you take ddI with food or right 
after youve eaten, the food will decrease the absorption of ddIand this 
will result in decreased blood levels of ddI. Therefor, its not wise to 
take ddI with food as you may be under-dosing.

=========================================
Antivirals - Potential Drug Interactions
=========================================

Acyclovir (Zovirax)      plus
------------------------------
AZT      Increase antiviral activity in test tubes
Interferon-alfa     Increase antiviral activity in test tubes
Probenecid     May increase acyclovir levels and decrease acyclovir 
               clearance
     
AZT (Retrovir) plus     
------------------------------
Acyclovir     Increase antiviral activity in test tubes
Amphotericin B     May increase risk of bone marrow toxicity
Antineoplastics     May increase risk of bone marrow toxicity
Clarithromycin     May decrease AZT levels
Dapsone     May increase risk of bone marrow toxicity
ddC     Increase antiviral activity in test tubes
ddI     Increase antiviral activity in test tubes
Delavirdine     Increase antiviral activity in test tubes
d4T     May decrease antiviral activity
Flucytosine     May increase risk of bone marrow toxicity
Food in stomach     May decrease AZT levels
Foscarnet     Increase antiviral activity in test tubes. May increase 
              risk of anemia
Interferon-alfa     Increase antiviral activity in test tubes and risk 
          of bone marrow toxicity
Ganciclovir     May increase risk of neutropenia 
Methadone     May decrease AZT metabolism and increase AZT levels
Pentamidine     May increase risk of bone marrow toxicity
Pentoxifylline     May increase risk of bone marrow toxicity
Probenecid     May increase AZT levels and decrease AZT clearance
Protease inhibitors     Increase antiviral activity in test tubes
Pyrimethamine +     May increase AZT levels and increase bone  
sulfadiazine     marrow toxicity
Ribavirin     Decrease antiviral activity in test tubes
Rifabutin     May decrease AZT levels
Rifampin     May decrease AZT levels
3TC     Increase antiviral activity in test tubes
TMP/SMX     May increase risk of anemia, neutropenia. May increase AZT 
            levels and decrease AZT clearance (high dose TMP/SMX)
     
ddC (Hivid) plus     
------------------------------
Aminoglycosides      May increase ddC levels and increase risk of 
neuropathy
Amphotericin B     May increase ddC levels and increase risk of 
                   neuropathy
Antineoplastics     May increase risk of neuropathy
AZT      Increase antiviral activity in test tubes. May increase risk of 
         pancreatitis
Chloramphenicol     May increase risk of neuropathy
Cisplatin     May increase risk of neuropathy
Dapsone     May increase risk of neuropathy
ddI     Should not be used in combination
Disulfiram (Antabuse)     May increase risk of neuropathy
Food in stomach     May decrease ddC levels
Foscarnet     May increase ddC levels and increase risk of neuropathy
Ethionamide     May increase risk of peripheral neuropathy
Hydralazine     May increase risk of neuropathy
Iodoquinol     May increase risk of neuropathy
Isoniazid     May increase risk of neuropathy
Metronidazole     May increase risk of neuropathy
Pentamidine (IV)     May increase risk of neuropathy and pancreatitis
Phenytoin     May increase risk of neuropathy
Ribavirin     May increase risk of neuropathy
     
ddI (Videx) plus     
------------------------------
Antineoplastics     May increase risk of neuropathy
AZT     Increase antiviral activity in test tubes
Cimetidine     Needs to be taken two hours apart
Dapsone     Needs to be taken two hours apart otherwise dapsone has no 
            activity
ddC     Should not be used in combination
Delavirdine     Needs to be taken an hour apart otherwise decrease in 
delavirdine levels. Increase antiviral activity in test tubes
d4T     Increase antiviral activity in test tubes
Food in stomach     May decrease ddI levels
Ganciclovir     Oral ganciclovir increases ddI levels by up to 70% and 
ddI decreases oral ganciclovir levels by up to 20%. May increase risk of 
pancreatitis
Ketoconazole     Do not take within two hours of ddI otherwise 
ketoconazole has no activity
Pentamidine (IV)     May increase risk of pancreatitis
Quinolones     Do not take within two hours of ddI otherwise quinolone 
               has no activity
Ranitidine     Needs to be taken two hours apart
Ribavirin     Increase antiviral activity in test tubes
     
Delavirdine (U-90152) plus
Antacids     Needs to be taken an hour apart or decrease in delavirdine 
             levels
Astemizole (Hismanal)     May increase astemizole levels
AZT     Increase antiviral activity in test tubes
Barbiturates     May decrease delavirdine levels
Carbamazepine     May decrease delavirdine levels
Cimetidine     May decrease delavirdine levels
Clarithromycin     May increase delavirdine levels
Cyclosporine     May increase cyclosporine levels
Dapsone     May increase dapsone levels
ddI     Needs to be taken an hour apart or decrease in delavirdine 
        levels. Increase antiviral activity in test tubes
Digitalis     May increase digitalis levels
Diltiazem (Cardizem)     May increase diltiazem levels
Erythromycin     May increase delavirdine levels
Estradiol     May increase estradiol levels
Hydrocortisone     May increase hydrocortisone levels
Itraconazole     May increase itraconazole and delavirdine levels
Ketoconazole     May increase ketoconazole and delavirdine levels
Lidocaine     May increase lidocaine levels
Loratidine     May increase loratidine levels
Lovastatin     May increase lovastatin levels
Midazolam     May increase midazolam levels
Nifedipine     May increase nifedipine levels
Phenytoin     May decrease delavirdine levels
Prednisone     May increase prednisone and delavirdine levels
Prednisolone     May increase delavirdine levels
Progesterone     May increase progesterone levels
Quinidine     May increase quinidine levels
Ranitidine     May decrease delavirdine levels
Rifampin     Should be taken together otherwise delavirdine levels 
             significantly decreased in blood
Rifabutin     Decreases delavirdine levels
Terfenadine (Seldane)     May increase terfenidine levels
Testosterone     May increase testosterone levels
Triazolam     May increase triazolam levels
Warfarin     May increase warfarin levels

d4T (Zerit) plus    
------------------------------ 
AZT     Decrease antiviral activity in test tubes
ddI     Increase antiviral activity in test tubes
Ganciclovir     May increase risk of pancreatitis
Pentamidine (IV)     May increase risk of pancreatitis
     
Nevirapine plus
------------------------------
Amoxicillin     May increase risk of Stevens-Johnson syndrome
Astemizole (Hismanal)     May increase astemizole levels
AZT     Increase antiviral activity in test tubes
Cimetidine     May decrease nevirapine levels
Clarithromycin     May increase nevirapine levels. May increase risk of 
liver toxicity
Dapsone     May increase dapsone levels
ddI     Increase antiviral activity in test tubes
Erythromycin     May increase nevirapine levels. May increase risk of  
                 liver toxicity
Itraconazole     May increase itraconazole levels
Ketoconazole     May increase ketoconazole levels
Phenytoin     May decrease nevirapine levels
Prednisone     May increase nevirapine levels
Ranitidine     May decrease nevirapine levels
Rifampin     May decrease nevirapine levels
Rifabutin     May decrease nevirapine levels
Terfenadine (Seldane)     May increase terfenadine levels
Ticarcillin     May increase risk of Stevens-Johnson syndrome
Warfarin     May increase warfarin levels
     
Protease inhibitors plus
------------------------------
Cimetidine     May increase protease inhibitor levels
Fluconazole     May increase protease inhibitor levels
Ketoconazole     May increase protease inhibitor levels
Itraconazole     May increase protease inhibitor levels
Rifabutin     May decrease protease inhibitor levels
Rifampin     May decrease protease inhibitor levels

=======================================
Common OI - Potential Drug Interactions
=======================================

Atovaquone (Mepron) plus     
------------------------------
Acetominophen     May decrease atovaquone levels
Acyclovir     May decrease atovaquone levels
AZT     May increase atovaquone levels
Benzodiazepines     May decrease atovaquone levels
Cephalosporins     May decrease atovaquone levels
Fluconazole     May increase atovaquone levels
Fatty foods     Increase atovaquone levels
Laxatives     May decrease atovaquone levels
Prednisone     May increase atovaquone levels
Rifampin     May decrease rifampin levels
     
Azithromycin (Zithromax) plus     
------------------------------
Antacids     Needs to be taken two hours apart or reduced azithromycin 
levels
Cyclosporine     May increase cyclosporine levels
Food in stomach     May decrease azithromycin levels (only azithromycin 
capsules)
Phenytoin     May increase phenytoin levels
Rifabutin     May increase rifabutin levels
     
Ciprofloxacin (Cipro) plus     
------------------------------
Antacids     Needs to be taken two hours apart otherwise decrease in 
             ciprofloxacin levels
Caffeine     May increase caffeine levels
Cyclosporine     May increase risk of elevated serum creatinine
ddI     Needs to be taken two hours apart otherwise may decrease 
        ciprofloxacin levels
Food in stomach     Decreases ciprofloxacin levels
Iron supplements     Needs to be taken two hours apart otherwise may 
                     decrease ciprofloxacin levels
Probenecid     Increases ciprofloxacin levels
Sucralfate     Needs to be taken two hours apart otherwise may decrease 
               ciprofloxacin levels
Theophylline     May increase theophylline levels
Warfarin     May increase warfarin levels
Zinc containing       Taken two hours apart otherwise may multivitamins    

                      decrease  ciprofloxacin levels
     
Clarithromycin (Biaxin) plus     
------------------------------
Anticoagulants     May increase anticoagulants effect
Astemizole (Hismanal)     Should not be taken together, may increase 
                          risk of cardiovascular toxicity
AZT     May decrease AZT levels
Carbamazepine     Increases carbamazepine levels
Cyclosporine     May increase cyclosporine levels
Digoxin     May increase digoxin levels
Phenytoin     May increase phenytoin levels
Rifabutin     May increase rifabutin levels by up to 80% and decrease 
              clarithromycin levels by up to 50%. May increase risk of 
              painful eye inflammation, arthritis, joint pain, 
              tenderness or pain in muscles. 
Terfenadine (Seldane)     Should not be taken together, may increase 
                          risk of cardiovascualr toxicity
Theophylline     Increases theophylline levels
Triazolam     May increase triazolam levels

Dapsone plus     
------------------------------
AZT     May increase risk of bone marrow toxicity
Clofazimine     May decrease effectiveness of clofazimine
ddC     May increase risk of neuropathy
ddI     Needs to be taken two hours apart otherwise dapsone has no 
        activity
Probenecid     May increase dapsone levels and decrease dapsone 
               clearance
Pyrimethamine     May increase risk of hematological reactions
Rifampin     May need to take higher doses of dapsone because it is more 
             rapidly excreted
Trimethoprim     May increase both trimethoprim and dapsone levels
     
Fluconazole (Diflucan) plus     
------------------------------
Astemizole (Hismanal)     Should not be taken together, may increase 
                          risk of cardiovascular toxicity
Cimetidine     May decrease fluconazole levels
Cyclosporine     May increase cyclosporine levels
Hydrochlorothiazide     May increase fluconazole levels
Oral contraceptives     May decrease effectiveness of oral 
contraceptives
Phenytoin     Increases phenytoin levels
Ranitidine     May decrease fluconazole levels
Rifabutin     May increase rifabutin levels by up to 80% in blood
Rifampin     Decreases fluconazole levels
Sulfonylurea oral     Increase risk of low blood sugar levels 
                      hypoglycemic drugs 
Terfenidine (Seldane)     Should not be taken together, may increase 
                          risk of cardiovascular toxicity
Warfarin     Increases prothrombin time
     
Ketoconazole (Nizoral) plus     
------------------------------
Alcohol     May increase risk of nausea, vomiting, hypotension
Antacids     Take two hours apart otherwise may decrease ketoconazole 
             levels
Astemizole (Hismanal)     Should not be taken together, increases risk 
                          of cardiovascular toxicity
Cimetidine     Take two hours apart otherwise may decrease  ketoconazole 
               levels
Cyclosporine     May increase cyclosporine levels
ddI     Take two hours apart otherwise may decrease  ketoconazole levels
Isoniazid     Should not be taken together, may significantly decrease 
              ketoconazole levels
Phenytoin     May alter both drug levels
Prednisolone     May increase prednisolone levels
Ranitidine     Take two hours apart otherwise may decrease  ketoconazole 
               levels
Rifampin     Decreases ketoconazole levels
Sulfonylurea oral     Increase risk of low blood sugar levels 
hypoglycemic drugs 
Terfenadine (Seldane)     Should not be taken together, increases risk 
                          of cardiovascualr toxicity
Testosterone     May decrease testosterone levels
Warfarin     May increase prothrombin time

Pentamidine (Pentam) plus     
------------------------------
Antineoplastics     May increase risk of bone marrow toxicity
AZT     May increase risk of bone marrow toxicity
ddI     May increase risk of pancreatitis
Foscarnet     May increase risk of severe low levels of calcium and 
              kidney toxicity
Interferon-alfa     May increase risk of bone marrow toxicity
     
Rifabutin (Mycobutin) plus     
------------------------------
Analgesics     May decrease effectiveness of analgesics
Anticoagulants     May decrease effectiveness of anticoagulants
AZT     Decreases AZT levels
Barbiturates     May decrease effectiveness of barbiturates
Clarithromycin     May increase rifabutin levels by up to 80% and 
                   decrease clarithromycin levels by up to 50%. Increase 
                   risk of painful eye inflammation, arthritis, joint 
                   pain, tenderness or pain in muscles
Corticosteroids     May decrease corticosteroid levels
Cyclosporine     May decrease cyclosporine levels
Dapsone     May decrease dapsone levels
Diazepam     May decrease effectiveness of diazepam
Disopyramide     May decrease effectiveness of disopyramide
Estrogen     May decrease effectiveness of estrogen
Fluconazole     May increase rifabutin levels by up to 80%. Increase 
                risk of painful eye inflammation, arthritis, joint pain, 
                tenderness or pain in muscles
Ketoconazole     May decrease ketoconazole levels
Itraconazole     May decrease itraconazole levels
Methadone     May reduce activity of methadone
Mexilitine     May decrease effectiveness of mexilitine
Oral contraceptives     May decrease effectiveness of oral 
                        contraceptives
Progesterone     May decrease effectiveness of progesterone
Quinidine     May decrease quinidine levels
Sulfonylureas      (oral low blood sugar levels drugs)May decreas  
                   sulfonylurea levels
Theophylline     May decrease theophylline levels
Verapamil     May decrease effectiveness of verapamil
     
TMP/SMX (Bactrim, Septra) plus     
------------------------------
Antineoplastics     May increase risk of anemia, neutropenia
AZT     May increase risk of anemia, neutropenia. May increase AZT 
        levels and decrease AZT clearance
Diuretics     May increase risk of thrombocytopenia
Phenytoin     May increase phenytoin levels
Pyrimethamine     May increase risk of anemia
Theophylline     May increase theophylline levels
Warfarin     May increase prothrombin time



===============
New News on Q
===============
by Mark Frey and Rick Flynn

The names Compound Q, trichosanthin, and GLQ223 are often used 
interchangeably to describe the natural and synthetic form of a plant 
protein extract from the root of the Chinese cucumber called 
Trichosanthes kirilowii. In China, it has been used for many years to 
induce abortion and to treat some forms of cancer. It is currently being 
studied as a potential treatment for HIV. Laboratory studies have shown 
Compound Q to selectively kill HIV-infected macrophages and CD4+ cells. 
GLQ223 is manufactured by Genelabs and is available through clinical 
trials. Trichosanthin, imported into the US by Buyers Clubs, is used in 
some doctors offices and  in "guerrilla clinics."

Preliminary data from a Phase II/III study of GLQ223 were presented in 
October 1993. The study was designed to gather preliminary information 
on the use of GLQ223 in people with AIDS and ARC who had been on long-
term prior AZT therapy, and to evaluate clinical, immunologic and 
virologic parameters. The study compared GLQ223 to GLQ223 + AZT to AZT 
alone in 148 volunteers. GLQ223 was given every 3 weeks at doses of 36, 
50, and 100 micrograms/kilogram (mcg/kg) of body weight, escalating 
every other dose, followed by 10 doses of 150 mcg/kg, for a total of 16 
doses. The drug was administered intravenously over a three hour period. 
AZT dosage was the standard 500 mg/day.

Study endpoints were:
1.     Time to treatment failure, defined as:
     w     25% decrease in CD4+ cells sustained over 6 weeks
     w     new opportunistic illness
     w     death
2.     Five-fold reduction in blood levels of HIV RNA (viral load) as 
       measured by QC-PCR
     (QC-PCR is a highly sensitive blood test designed to accurately 
     measure and quantify levels of virus in the blood.)

Based on these criteria, there were no significant differences among the 
three study arms. Five people in the AZT arm had clinical progression, 
five confirmed and one suspected clinical progression in the combination 
arm and one confirmed and two supected in the GLQ223 arm. Time to 
treatment failure was about equal among the three groups. Subsequent 
analysis has shown that disease progression in the AZT arm occured 
during the course of study, while all cases of progression in both 
GLQ223 arms occured during follow-up, after volunteers had gone off 
study drug. Interestingly, QC-PCR (viral load) proved to be a good 
predictor of disease progression. Virtually all cases of treatment 
failure in the GLQ223 arm of the study, as measured by CD4+ decline, 
were related to the use of steroids as a pretreatment to GLQ223 therapy. 
According to the company, early analyses of the data suggest that people 
in the GLQ223 arms of the study developed fewer opportunistic illnesses 
after cessation of treatment. Confirmation of this awaits further data 
analysis.

The most common side effects of GLQ223 were acute allergic reactions, a 
flu-like syndrome and elevated muscle and liver enzymes. The severity of 
allergic reactions was reduced with changes in dose regimen. At the 
beginning of the study, participants receiving GLQ223 were given the 
drug every 3 weeks. Due to a large number of study drop-outs because of 
side-effects (especially in the form of allergic reactions), the 
protocol was amended to administer drug once a week for the first four 
weeks, then continue subsequent infusions every three weeks. Apparently 
this change helped volunteers tolerate GLQ223 much better.

The company is committed to continue research on GLQ223, feeling initial 
data warrants further investigation.

Compound Q:  Most of the information about Chinese Trichosanthin remains 
in the anecdotal experiences of people who have used the drug on the 
underground. Anecdotal reports cover the entire spectrum from desired to 
undesired results. Some people report improvement in CD4+ counts, while 
others who tried the drug are no longer alive. In as much as reports are 
quite varied, its only safe to say that the drug certainly warrants 
continued study.

In the meantime, Compound Q is legally available, with a few essential 
restrictions. The underground practice of administering Compound Q is a 
2 to 3 hour infusion every 3 to 6 weeks. People normally start out with 
an infusion of 35/mcg/kg and gradually increase the dose in subsequent 
infusions until they reach a 100-150 mcg/kg dose. Longer infusions and 
higher doses have been tried by a few people, however it is yet unclear 
what the optimum dose and schedule are. Infusion costs can vary from $40 
to $80 on the underground, where the drug is given by skilled nurses 
equipped with the proper medications to control adverse reactions, to 
$100-$250 in more formal settings with doctors supervision. Compound Q 
is sold in vials costing 8 to 10 dollars each. Low starting doses are 2 
to 3 vials per infusion and higher doses require 10 to 20 vials. 
Compound Q is not inexpensive, and people considering therapy with 
Compound Q, as with any approved or experimental therapy, should talk to 
people who have tried Q, discuss the issue with their health care 
provider, learn about the drug and its potential side effects and make 
an informed decision.

The most dangerous complication seen with the drug is anaphylactic shock 
- a sudden, severe life-threatening allergic reaction. Between 10 and 20 
percent of people may experience this reaction during one of their first 
6 infusions. Because of this, it is critical that skilled medical 
professionals be on hand when this drug is administered. In 1989, when 
the drug was used predominantly on people with very low (<100) CD4+ cell 
counts, there were a few deaths possibly related to Compound Q. It is 
still unclear if these deaths were Q-related, as the deaths occurred 
after the drug had cleared the system. Nonetheless, people with fewer 
than 50 CD4+ cells are discouraged from using Compound Q as confounding 
factors may lead to complications.

Common reaction to the drug is a flu-like symptom and water retention 
starting 12 to 36 hours after infusion and lasting 2 to 3 days. It is 
noted on the underground that these effects tend to diminish with 
subsequent infusions. Because of the potential for painful side effects 
many people pre-treat prior to infusions with an anti-inflammatory like 
ibuprofen or Tylenol, and an antihistamine like Benadryl and, perhaps, a 
steroid like prednisone or decadron. These pre-medications are given to 
help ameliorate side effects. Some of these pre-treatment drugs may 
negatively impact the immune system. People considering therapy should 
discuss this with their health care provider

Due to the potential for life threatening reactions, underground sources 
will only release Compound Q through a prescribing physician or skilled 
medical professional. Some of the doctors experienced with administering 
the drug are willing to guide other physicians. People interested in 
trying Q should put their physician in contact with doctors experienced 
with Compound Q. For more information, contact the Project Inform 
Hotline.


==========================
Early Intervention - 1994
==========================

Beginning with the 1993 International AIDS Conference in Berlin, many 
people and their physicians became confused about the value of early 
intervention against HIV disease. Most of the confusion stemmed from 
conflicting reports about the effectiveness of long-term use of AZT in 
healthy people with CD4+ counts below 500. While there are continuing 
debates about the validity and implication of recent studies, there is 
no reason for this debate to cause confusion over the value of early 
intervention. Early intervention has never meant just using a drug once 
CD4+ cell counts fall below some predetermined level. Thus, the value of 
early intervention does not hinge upon the long-term success or failure 
of any individual drug. Instead, the concept has always referred to a 
broad spectrum approach of personal responses to HIV infection, an 
approach which was as valid and helpful in 1984 as it is today. What has 
perhaps fallen since Berlin, and rightly so, is the notion that there is 
some simplistic "cookbook" medicine solution to dealing with HIV 
disease. There will be no "cookbook" solutions until a cure is found. 
For now, response to HIV disease must always combine a variety of 
behavioral and medical approaches.

The Early Intervention Model

The Project Inform early intervention model, published in various forms 
since 1987 is a true expression of a holistic approach to health. Some 
aspects are meant to apply beginning the first day a person learns he or 
she is HIV positive. Other aspects, such as an antiviral or 
opportunistic infection strategy, come into play at various stages of 
disease progression.

General Health Maintenance
o     Diet, nutrition, exercise
o     Sleep habits, a reasonable workload
o     Reduced alcohol and recreational drugs
o     Health promoting behaviors

Studies in recent years have emphasized the importance of nutrition and 
exercise as key steps in HIV disease. Alcohol and drug abuse at the very 
least have severe indirect affects because they counteract all the other 
steps in the model. 

Supportive Therapy
o     Psychological, emotional, spiritual 
o     Stress management
o     Empowerment, activism
o     Balancing medicines (e.g. anti-oxidants)
o     Philosophy of health / wellness

No one is prepared through learning or experience to cope with a plague. 
No one is inherently equipped to casually accept a diagnosis of a life-
threatening illness or to see that illness devastate our communities. We 
all need help. Some find that help in the form of psychological, 
emotional, or spiritual support. Most seek help in learning how to 
better manage the stress that is so much a part of HIV disease. Many 
find great strength and support through the empowerment of taking 
control of their own health and in taking action against the failure of 
government and institutions to effectively address the issue of AIDS. 
Such activism can take many forms, such as demonstrations in the street, 
volunteering at AIDS service organizations, or writing a check to 
support groups who take action. Even medicine has its "supportive" 
approaches, such as the use of anti-oxidant supplements and vitamins to 
help counteract some of the cellular damage done in HIV disease. 
Finally, many people find great comfort in exploring philosophies of 
medicine, such as Traditional Chinese Medicine or ayurvedic healing, or 
scientism. Such approaches give people a meaningful way of understanding 
what health is. Ideally, they complement,  rather than conflict with 
each other. Each has something to offer and there is no one single right 
path for everyone. The greatest benefits come from choosing ones own 
personal pathway, while respecting the pathways of others.

Antiviral Strategy
o     The virus is active and replicating
o     Viral load increases as disease progresses and has consequences
o     The challenge: when , what, how

The rationale for using antiviral medications is as clear or clearer 
today than it has ever been. But making decisions about what to use and 
when to begin are sometimes difficult. For a few years, the official 
government recommendation suggested that the choice could be made solely 
on the basis of a CD4+ count under 500. While the interpretation of 
early intervention studies such as the Concorde and ACTG 019 remain 
debatable, most scientists are in agreement that simply putting everyone 
with fewer than 500 CD4+ cells on a single drug, for an indefinite 
period of time, is not a rational approach. People with such counts 
differ widely in their needs and status, as well as in their response to 
therapy. For some, a CD4+ count of 500 is maintained for many years. For 
them, the argument for intervening with a drug might be modest or weak, 
since disease progression is less rapid. For others, a count of 500 is a 
brief stopping point between 600 and 400 or 300. For them, the argument 
for intervention might be much stronger based on the evidence of 
decline. In this sense, the t-cell trajectory (stability, improvement or 
decline) is more meaningful than a simple cell count. 

Other factors which might influence the decisions about when of whether 
to use of antiviral medications include mild clinical decline, such as 
unexplained weight loss or minor symptoms. For some people, 
understanding ones own general experiences with drug therapy is 
important. If you generally tolerate drugs well or poorly, this might 
predict your response to antiviral medications as well, at least on a 
psychological basis. Personal philosophy likewise plays a role, as some 
people prefer to confront disease as early as possible, while others 
might prefer to wait. Project Informs philosophy is not so much to 
recommend any particular drug or starting time, but to encourage people 
to become educated about the choices, the issues, and the risks and 
benefits. This applies to decisions about when to begin using such 
drugs, when to switch, when to combine drugs, and perhaps when to give 
the body a rest. 

Decisions about the use of antivirals will become easier over time as 
better and less toxic drugs become available, and as better diagnostic 
markers of disease progression are available to guide one's choices.

Opportunistic Infection Strategy
o     Compensate for failing immune response
o     Goal: maximum prophylaxis with minimum number of drugs
o     Ultimately limited by drug interaction, tolerance, and resistance

This part of the model only affects people who have suffered a 
significant degree of disease progression. The first risk of major 
opportunistic illness occurs, on average, when CD4+ counts fall below 
200 (though there is some modest risk for people with minor symptoms and 
counts below 300). While it is critical to take action to prevent 
infections in this stage of progression, there are real limits to our 
ability to do so. The best approach is one which employs the fewest 
drugs to prevent the largest number of infections. See the Project 
Inform Guide to Opportunistic Infections for more information.

Immune System Strategy
o     Logical approach, building on the apparent temporary success of 
      the immune system in combating HIV
o     Goal is to support or strengthen immunity rather than fight the 
      virus directly 
o     But much easier said than done

Ideally, HIV disease would be completely controlled through the immune 
system. Unfortunately, we know that the immune response eventually fails 
in most people, so we know there are limits. Many approaches have been 
proposed for utilizing the immune system itself to combat HIV, ranging 
from therapeutic vaccines and cytokine therapy to magic immune-boosting 
potions in a bottle. One thing we know for sure is that the immune 
system is far more complex than anyone had imagined, so simplistic 
solutions, while common, are almost always misleading. While research 
pursues the best ways to strengthen or rebalance the immune response, 
everyone has the power to make the best of their immune response through 
simple interventions with nutritional support, exercise, and the 
avoidance of immune-damaging chemicals, such as alcohol and recreational 
drugs. 

Summary
Early intervention is as alive and important today as it ever was. If 
anything has changed, it is the over-simplistic notion which some gave 
used to narrowly define early intervention as the use of a single drug. 
While drugs may indeed play a role in early intervention, they are only 
likely to help when used as part of a comprehensive life-enhancing 
strategy, one which understands that the body is more than the sum of 
its parts. 


Early Intervention Model 
o  General Health Maintenance
o  Supportive Therapies
o  Antiviral Strategies
o  OI Strategies
o  Immune Strategies


=============
Gene Therapy
=============

The field of gene therapy has progressed rapidly over the past three 
years. The first human gene therapy protocol was started in May 1989 and 
now several dozen protocols are in human studies for a variety of 
diseases, including HIV. Gene therapy, sometimes referred to recombinant 
DNA technology, is a broad term referring to the use of genetic 
materials. As this technology moves into clinical trials, it is 
important to understand the goals of each approach and how they differ. 

Gene therapy may be used to alter immune system cells to make them 
resistant to HIV-infection and perhaps be useful for immune 
reconstitution. Other gene therapy approaches are antiviral approaches, 
which disable the virus during its life cycle in order to inhibit viral 
replication. Gene therapy can be used as a vehicle to deliver drugs, 
such as interleukin-2, a chemical which has shown encouraging results in 
studies being conducted through the National Institutes of Health. Gene 
therapy approaches may also prove useful in preventing or treating 
opportunistic infections associated with HIV. While gene therapy 
research is still in its infancy, this technology is quickly moving 
toward the clinic, with eight human studies in HIV currently being 
developed, four of which are already underway.

Immunogenetics

Immunogenetics is an effort to insert or modify genes in an effort to 
stimulate natural immune defenses. Viagene is testing an approach which 
delivers a new gene to cells which causes them to produce proteins 
similar to HIV itself, making them act like a vaccine in hopes of 
strengthening immune response against HIV. Preliminary results 
demonstrate the therapy to be safe, and further studies are enrolling 
volunteers in both Northern and Southern California. Perhaps the most 
important aspect of the Viagene study is that it is testing a method 
which directly delivers the new gene into body cells and tissue. Most 
other gene therapy experiments use indirect, or vector-based approaches 
to delivery, which is more complex.

Immune Reconstitution

A very small pilot study is about to begin at the Howard Hughes Medical 
Center, University of Michigan, wherein cells are manipulated outside 
the body with REVM10, a gene which may render them resistant to HIV-
infection. If successful, this approach opens new doors to immune 
reconstitution. The initial study will look at cells drawn from the 
peripheral blood, to examine the effect of genetic manipulation on cell 
function and the ability of the cells to express the gene. While the 
preliminary study will probably not result in clinical benefit, it is 
ground-breaking work and will lead to valuable insights into direction 
for this approach to therapy for HIV-disease. Eventually this research 
will lead to inserting this gene into a cell which is typically found in 
the bone marrow, called a stem cell. Stem cells are the mother of all 
cells and can literally mature and differentiate into all of the cells 
of the immune system. By inserting a gene which renders a cell resistant 
to HIV-infection into a stem cell, it may be possible to repopulate the 
immune system with an entire repertoire of cells which cannot be 
infected by the virus. Stem cells are an attractive target for gene 
therapy as they may provide the key to true immune reconstitution. 
Systemix, of Palo Alto, California, is developing stem cell technology 
as well as conducting research into gene constructs which may be useful 
in HIV-disease.

Drug Delivery

A unique approach to gene therapy, which combines cell therapy with 
immunogenetics, is being developed at the University of Washington, in 
Seattle. Phil Greenberg is developing a method to genetically alter 
cells to produce interleukin-2 (IL-2). IL-2, also known as T-Cell Growth 
Factor, is an important naturally occurring chemical, which is necessary 
for T-cell differentiation and development. Preliminary studies of IL-2 
in HIV-disease are encouraging and suggest that as we better learn how 
to use the drug, it may become an important part of the armature to 
fight HIV. By combining cell therapy with genetic manipulation, Dr. 
Greenberg hopes to boost HIV immune response as well as repair some of 
the immune dysfunction.

Dr. Greenberg is looking at manipulating CD8+ cells, which are believed 
to be very important in controlling HIV. Preliminary studies involve 
inserting a ganciclovir-sensitive gene, often referred to as a 'suicide 
gene'. If CD8+ cells, expanded or manipulated outside the body, produced 
a potent antiviral response when reinfused, the amount of inflammation 
created by this response could prove dangerous, possibly causing 
pneumonia or serious swelling of the brain. By inserting a ganciclovir-
sensitive gene into these cells, it is possible to administer 
ganciclovir to destroy the cells if they create too potent of an immune 
response. A study of the safety and effectiveness of ganciclovir-
sensitive gene insertion has enrolled its first patient in Seattle. 
Because CD8+ cells rely on the presence of IL-2, which is deficient in 
HIV-disease, the possibility of delivering a gene which will make these 
cells produce IL-2 is attractive. Dr. Greenberg has been working on 
developing IL-2 receptors which could help cells produce this chemical 
despite whatever immune dysfunction, caused by HIV, is creating an IL-2 
deficiency. 

Antiviral Approaches

Technologies which are related to gene therapy include antisense and 
ribozyme technologies. Both antisense and ribozymes target specific 
viral RNA sequences. However, antisense is being developed as a drug 
whereas ribozymes require a gene transfer approach. They also attack 
the viral RNA sequences differently. Antisense drugs bind to the viral 
RNA whereas ribozymes chop up the viral RNA.
Antisense technology involves arranging short strands of genetic 
material that are targeted to bind to specific viral RNA sequences. When 
HIV incorporates into the machinery of a cell, it does so by binding its 
RNA with the immune cells DNA, in a fashion that can be likened to a 
zipper. When the teeth of the zipper come together and close, the viral 
RNA being one set of teeth, and the cells DNA being another, the virus 
is initiating the process of transforming the cell into a factory for 
new virus. Antisense acts like a piece of gum in that zipper. By binding 
to one side of the teeth, when the zipper comes to close, the 
antisense has gummed up the binding area and the virus cannot attach, 
thereby disabling its activity. The first antisense for HIV, being 
developed by Hybridon, went into humans in Europe last year. Human 
studies of the Hybridon antisense, called GEM 91, began in spring at 
University of Alabama, Birmingham. This strategy hold potential for 
controlling many viral diseases, including those associated with HIV-
disease. ISIS Pharmaceuticals recently announced that it is about to 
begin a Phase I/II study of an antisense for CMV. Unfortunately this 
entire field of research has been slowed down due to restrictions placed 
on its development by NIH patenting and licensing agreements. 

Ribozymes, which are sometimes referred to as molecular scissors, cut 
viral RNA strands at selected sites. Ribozymes seek out viral particles 
and chop them up into bits, hopefully rendering them non-infectious and 
incapable of replicating. One of the problems with ribozymes is that 
they lose their specificity in chopping up the RNA. In test tube 
studies, ribozymes can get sloppy and chop up unspecified RNA, which 
could result in toxicities and may be dangerous. There are different 
kinds of ribozymes, the two most common forms being hammerhead and 
hairpin ribozymes. The names simply refer to the similarity of the 
structure of these ribozymes to a hammerhead shark and a hairpin. The 
first human trial of a ribozyme was approved last year, and will be a 
trial of a hairpin ribozyme, which was developed by Flossie Wong-Staal 
at the University of California, San Diego. Problems with manufacturing 
have delayed this study, which is now expected to begin sometime this 
year in Southern California.

Conclusion

Recombinant DNA technology, or gene therapy, holds great potential as 
therapy for HIV-disease. The field of recombinant DNA technology is 
still in its infancy, however, and there are many unanswered questions 
about its usefulness. Finding a gene construct which efficiently 
inhibits HIV replication or protects a cell from HIV infection is only 
half the battle. Getting that gene into human cells, either by injecting 
the genetic material directly or by packaging the gene in a virus and 
delivering it to the cells by injection, or infecting cells outside the 
body, is another challenge to optimizing gene therapy approaches. A 
number of non-viral delivery mechanisms are being explored in an attempt 
to decrease the risk of causing harm in delivering the genes to the 
appropriate cells in the body. How genetically manipulating cells will 
affect cell function is a concern which only further human 
experimentation will clarify. There are many unknowns and uncertainties. 
Despite these uncertainties, success with gene therapy for other 
diseases provides reason for cautious optimism.


==========================
|       In Memory         |
==========================

We dedicate this issue to:

Bill Bailey          Jim Bohl
Bill Bradley         Michael Callen
Nicholas Carter      James Casey
Jesse Dobson         Tom Docter
Morgan Fine          Randy Galloway
Don Hall             Steve Hall
Ken Hill             William Hoekstra
Paul Kostrewski      Leon McCusick
Patrick McGuire      Will McKee
Kent Newby           Norm ONeil
John Payne           Andy Pearson
Aberham M. Pierce    Don Sango
Steve Sem            Kevin Sharber
Randy Shilts         Larry Silva
Greg Slagg           Paul Trupin
Larry Waites         Andrew Zysman

and all the others for whom the system didn't move fast enough or try 
hard enough.

Their memory lives on in the work that remains.


==========
Cytokines
==========


The immune system is an intricate network of cells, which communicate 
through a chemical network called cytokines. Cytokines are messengers, 
or communicators, produced by immune system cells, and are the general 
mediators of immune response. Unfortunately, cytokine function is very 
complicated. When properly functioning, the immune system maintains a 
delicate balance, where extremely small concentrations of combinations 
of cytokines are produced by cells in order to turn on immune responses, 
turn off immune responses or promote the development, maturation or 
function of certain cell populations. Some combinations of cytokines 
determine the maturation of cells, while other combinations determine 
cell's function. It appears that some cytokines have biphasic natures - 
at low concentrations they produce one immune response, while at high 
concentrations they produce another. 

There are no simple solutions, no "T-cells in a jar," no simple pathways 
to "boost the immune system." On the contrary, the immune dysfunction in 
HIV-disease is often contradictory, with some aspects of the immune 
system suppressed while others are over-active.

Interleukin-2

IL-2, originally called T-Cell Growth Factor, has been studied in both 
HIV and cancer for a number of years. Toxicities associated with IL-2 
include fevers, swollen lymph nodes, flu-like symptoms and increased 
levels of gamma interferon. Because IL-2 promotes T-cell activation, and 
HIV can only infect active T-cells, IL-2 also increases viral 
replication and therefore should be administered with an antiviral. IL-2 
has been researched extensively in HIV since the early '80s. One of the 
earlier studies of IL-2 in HIV demonstrated that after administration of 
IL-2, CD4+ cell counts rose dramatically, sometimes hundreds of cells, 
then fell dramatically though slightly above what they had been prior to 
therapy. More recent study of IL-2 at the National Institutes of Health 
(NIH), in people with greater than 200 CD4+ cells, demonstrated 
substantial and sustained CD4+ cell increases in some study 
participants. The difference between the earlier study and the more 
recent study at the NIH was the dose and schedule of IL-2 
administration. Because cells mature and develop in cycles, when IL-2 
occurs naturally in the body it might be produced in varying amounts 
according to some type of natural pattern. Therefore, changing frequency 
of administering synthetic IL-2 may result in dramatic differences in 
the outcome of clinical studies. Similarly, in the body, IL-2 is 
produced in extremely small concentrations at specific locations, by 
specific cells. Dumping large amounts of IL-2 into a vein may be an 
extremely crude way to deliver the drug. Changing the dose may also 
alter the effect, both in toxicity as well as impact on CD4+ count. A 
number of trials are enrolling across the country, evaluating different 
doses and administration schedules. Gene therapy approaches to 
delivering IL-2 are being explored but are not yet in human studies in 
HIV. It may be possible to insert an IL-2 gene into cells so that the 
cells themselves are induced to produce IL-2. This may help toward 
optimizing the delivery and dose of this cytokine.

IL-2 is currently FDA approved for use in certain cancers and some 
physicians are using the drug in their practice. Because it is not 
approved for HIV, it may be difficult to get insurance companies to pay 
for it. IL-2 is also available through a number of studies across the 
country.

Interleukin-12

IL-12, also called Natural Killer Cell Growth Factor, is a cytokine 
primarily produced by cells called monocytes. IL-12 is has been shown to 
be important in promoting T-helper type 1 (TH1) immune responses (See 
February 1993 PI Perspective). TH1 cells are responsible for inducing 
cell-mediated immune responses, while TH2 cells are responsible for 
inducing antibody responses. IL-12 appears to promote TH1 responses 
while suppressing TH2 responses. As science seeks to understand HIV-
disease and the natural immune response, cellular immune responses are 
increasingly being viewed as critical toward controlling HIV replication 
and disease progression. Monocytes and macrophages are a primary 
reservoir of HIV. IL-12 production might be disrupted because of a 
general dysfunction in immune response caused by HIV infection of these 
cell lines. Research into IL-12 is provocative not only because it holds 
the possibility of bolstering cellular responses against the virus, but 
also because it may correct a general immune dysfunction caused by the 
virus. Preliminary studies of IL-12 in animals have been reviewed by the 
FDA and a small phase I clinical trial is about to start at San 
Francisco General Hospital. While the drug has not been tested in 
humans, animal studies suggest there may be some neurotoxicities 
associated with IL-12. These were more pronounced in female primates, 
possibly suggesting a hormonal interaction. Women will not be excluded 
from early Phase I studies of IL-12, and doses studied in the trial are 
well below those at which they would expect side effects. Potential 
neurotoxic effects of the drug will be monitored carefully in the study.

Cytokine Inhibitors

While some cytokines may promote or restore immunity, some can 
accelerate HIV replication and are associated with disease progression. 
Cytokines associated with inflammation, such as IL-1, IL-6 and TNF-
alpha, have been associated with increased viral replication, wasting 
syndrome and progression of Kaposis Sarcoma. A number of strategies to 
inhibit these cytokines are currently in clinical trials. Thalidomide, 
once a controversial drug which causes severe birth defects if taken 
during the first trimester of pregnancy, is a selective and potent 
inhibitor of TNF-alpha. Test tube studies suggest that thalidomide has 
anti-HIV activity and its inhibitory effect on TNF-alpha may prove 
useful in managing wasting syndrome. There have been anecdotal reports 
of success in using thalidomide to treat HIV-related aphthous ulcers. 
Two studies are currently underway to evaluate the benefit of 
thalidomide in HIV-disease. One study is examining the antiviral and 
anti-TNF activity of thalidomide, while the other is examining the use 
of thalidomide in the treatment of aphthous ulcers. Pentoxifylline, also 
called Trental, is an approved drug for use in people with clotting 
disorders and is thought to inhibit IL-1, IL-6 and TNF-alpha. A number 
of studies evaluating pentoxifylline in HIV-disease are being reviewed 
by the manufacturer to determine if results are significant enough to 
warrant further study. This information should be available shortly.

In the mean time, pentoxifylline is an approved drug which can be 
obtained "off label." Similarly, an antioxidant called NAC may be useful 
in reducing TNF-alpha levels.  NAC can be obtained through many Buyer's 
Clubs and health food stores.

As knowledge of cytokines and their functions increases, there has been 
a growing interest in the potential to augment or suppress cytokine 
production in order to control HIV-disease. The danger in manipulating 
cytokine response rests in our limited knowledge of the immune system 
and the pathogenesis of HIV. Because the immune system maintains a 
delicate balance that is not wholly understood, it is unclear if 
administering a cytokine which appears to be deficient in HIV-disease 
will restore an immune response, or further aggravate immune 
dysfunction. Understanding the best use of cytokines as therapy in terms 
of both frequency and dose, may be an arduous process of trial and 
error. An early dose escalating study of gamma-interferon was stopped 
because it appeared to increase HIV-replication. Subsequent study of 
gamma-interferon suggests that this cytokine has a biphasic nature. At 
high doses gamma-interferon increases HIV-replication, while at low 
doses it appears to inhibit HIV replication. While cytokines as therapy 
hold great potential in the battle against human disease, there are 
still many uncertainties which demand caution when manipulating immune 
responses. Further clinical studies will help clarify how best to use 
these drugs which may be powerful weapons in the fight against AIDS.


======================
Organizational Update
======================

1994 presents many challenges to the new Administrations response to 
AIDS. As the Clinton Administration has thus far failed the community in 
making AIDS a national priority, we must work ever harder to ward off 
the institutionalization of AIDS research and AIDS bureaucracy. As an 
organization, Project Inform is ready to rise to the challenge of the 
second decade of this epidemic. Over the past year we have shored up our 
organizational structure, expanded our national Town Meeting program, 
increased utilization of our toll-free treatment hotline, doubled our 
information production and intensified advocacy efforts toward 
accelerating the pace of discovery in AIDS and furthering the 
development of new therapies. Your ongoing support of Project Informs 
activities has been critical as we strive to increase our delivery of 
treatment information and enhance our advocacy efforts.

Administration: 

To complete the reorganization which began last year, Project Inform has 
hired Annette Brands, MFCC, in the role of Executive Director, reporting 
to Martin Delaney, Founding Director. Ms. Brands brings extensive 
organizational and fiscal management experience from her previous role 
as Associate Director of Conard House, Inc., a non-profit community 
mental health agency in San Francisco. Her extensive work with the 
community of people living with HIV, both through private practice as 
well as community mental health programs, complements and enriches the 
mission of Project Inform. From her extensive resume in the field of 
mental health, Ms. Brands brings team management and long-range planning 
skills essential to strengthening the infrastructure of Project Inform, 
enabling the expansion of programs and services. The Board of Directors 
and Staff welcome Ms. Brands to Project Inform.

Development: 

Project Inform recently hired Thomas Teasley as Development Director. 
Mr. Teasley comes to Project Inform from Children Now, a California-
based national advocacy organization on childrens issues. For the past 
five years, he has served as a member of the Board of Directors of Face 
to Face, Sonoma County AIDS Network. Mr. Teasley brings an impressive 15 
years of professional fundraising experience to Project Inform, where he 
will be developing and implementing long-range development plans.

Information and Advocacy: 

To strengthen our Information and Advocacy Department efforts, Project 
Inform has hired Ben Cheng, who comes to us from Boston where he had 
extensive treatment advocacy experience through his work with ACT 
UP/Boston and the AIDS resource library. Mr. Cheng has been a community 
representative to the federal governments drug development efforts on 
opportunistic infections, and has been appointed to the Primary 
Infection Committee of the AIDS Clinical Trials Group (ACTG), which 
focuses on antiviral therapy. Moreover, Mr. Cheng has recently been 
appointed to the Dept. of Health and Human Services new Task Force on 
AIDS Drug Development, which will advise the federal government on 
reforms toward accelerating the pace of research. Mr. Cheng brings a 
great wealth of expertise and knowledge in the area of opportunistic 
infections and antivirals to the Information Department in his role as 
Information and Advocacy 
Associate. His efforts complement the work of Brenda Lein, Director of 
the Information and Advocacy Department and Martin Delaney, Founding 
Director of Project Inform.

Policy: 

In addition to Project Informs advocacy efforts with the National 
Institutes of Health, Food and Drug Administration, academia and 
industry, we have increased our involvement in legislation which impacts 
the community. We have built up our lobbying efforts and are currently 
in the process of strengthening the Treatment Action Network (TAN) which 
is one of the largest national grass-roots AIDS lobbying teams, 
comprised of Project Inform constituents. A recent grant from 
Mobilization Against AIDS will enable us to hire a TAN coordinator and 
further develop this network to respond to critical issues on AIDS. 
Continuing efforts on the Second Front initiative, an intensified AIDS 
research effort with greater coordination and flexibility, has resulted 
in several policy recommendations. In addition to these efforts, Project 
Inform is playing an active role in assessing various health care reform 
proposals and working diligently to see a plan enacted which meets the 
needs of people living with HIV and AIDS.

Outreach: 

In an effort to get Project Informs treatment information to more 
people, we have tripled our outreach activities, conducting Town 
Meetings throughout the country in both the major epicenters of the 
epidemic as well as secondary cities which are often times out of the 
AIDS information loop. In order to inform folks of our free services and 
rise to the challenge of information needs, David Evans has moved from 
the Development Department to a new position of Outreach Coordinator. 
David brings strong organizational skills to the Outreach Department and 
has been networking with organizations around the country to broaden 
Project Informs information delivery, providing a critically needed 
link to AIDS information to many people.

Volunteers: 

Jane Levikow, who comes to Project Inform from Health Access, a 
coalition of organizations working on health care policy and reform in 
California, has been hired to coordinate volunteer activities. Ms. 
Levikow brings both the personal and professional skills necessary to 
coordinate the activities of the over 175 volunteers, who are the heart 
and soul of the organization. As Project Inform is volunteer-driven, Ms. 
Levikows role is key to all aspects of the organization. She replaces 
Ben Collins, who has been promoted to Program Services Director, which 
oversees Project Informs hotline, outreach and volunteer programs.

All this recent programmatic development at Project Inform has enabled 
us to better meet the goals of Project Inform, in both providing for the 
treatment information needs of the community, as well as standing firm 
as an articulate critic and a voice for change in the way AIDS research 
is conducted. Together, with your ongoing support, we will fight for the 
changes necessary to end the AIDS epidemic.


===========================
     Project  Inform 
  SF Town Meeting Schedule
===========================

(X = no meeting)

Introd.     Updates
Meetings    Meetings
4     May       25
1     June      29
6     July      27
3     August    31
7     September 28
5     October   26
2     November  30
7     December  X

For more info call 800-822-7422
or 415-558-9051


Copyright San Francisco Project Inform, 1994

Project Inform
1965 Market St., Suite 220, 
San Francisco, CA 94103, 
Offices 415-558-8669
Fax, 415-558-0684
Hotline Number 800-822-7422 or 415-558-9051
Hotline hours: Mon - Sat, 10am - 4pm Pacific standard time.

<<< END OF FACT SHEET >>>
