AIDS Treatment News
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Nelfinavir Protease Inhibitor
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A new trial of nelfinavir -- VIRACEPTTM-- the experimental
protease inhibitor being developed by Agouron
Pharmaceuticals, Inc., is now recruiting 200 volunteers with
CD4 count under 100 (measured any time in the last 90 days),
who are already taking nucleoside analog drugs (AZT, ddI,
ddC, d4T, or 3TC). This trial is being conducted in eight
U.S. cities: Berkeley, Chicago, Dallas, Fort Lauderdale, Los
Angeles, New York City (2 sites), San Francisco, and St.
Paul. All of the volunteers will receive the same dose of nelfinavir, 750 mg three times a day. Half of them will be randomly assigned to stay on the nucleoside analogs they are currently using; the other half will be assigned to switch to different nucleoside analogs. For more information, including the specific sites and contact numbers, call 800/501-2474, then dial 1 for a recorded message.
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Five-Drug or Six-Drug
by John S. James
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A small clinical trial and observational study in San
Francisco (1) reported very good HIV suppression with
regimens of as many as six antiretrovirals. We asked Steven
F. Scheibel, M.D., one of the physicians who conducted these
studies, for more recent information than is available in the
published Vancouver conference abstract. ATN: We understand that you tried the same five-drug combination in two different groups of patients. First, could you describe the study with patients who were recently infected? Dr. Scheibel: We treated six patients who were recently HIV-1 infected (within the past 6 months), with a low-dose combination of AZT, ddI, ddC, and interferon-alpha. Most of these patients were also receiving full dose 3TC. For this small group of recent seroconverters, there was a mean 4.5 log decrease in plasma HIV-1 RNA at an average followup of six months. All these patients attained undetectable HIV RNA as measured by the Roche Ultradirect Monitor assay, which has a limit of detection of 10 copies/ml of plasma. ATN: But wouldn't recently infected patients be expected to have a viral load decline anyway, even without treatment? Dr. Scheibel: Even though there may be a drop in plasma HIV RNA in untreated recent seroconverters, there is still a measurable HIV RNA level. Overall, in the absence of treatment, one would expect to find a one to two log reduction in viral load [in patients like those who were treated]. Our results suggest that most recent seroconverters can reach undetectable viral load with this treatment -- accompanied by preservation or restoration of CD4 cells. And this was accomplished without using a protease inhibitor, reserving that class of drugs for later use if needed. ATN: What other results did you find? Dr. Scheibel: We did a lymph-node biopsy on one patient, at week 78, and found a normal architecture, with no evidence of HIV by in situ hybridization. ATN: What about persons who have been infected for longer? Dr. Scheibel: We also conducted extended observation of 15 patients with prolonged HIV infection. They were on the above regimen, and most were also taking one of the approved protease inhibitors. They had a mean drop in HIV RNA of 3.5 log. Many of these patients had undetectable HIV RNA levels when tested with the Roche Ultradirect Monitor assay. ATN? What research should be done next? What are your future plans? Dr. Scheibel: Once the plasma HIV RNA level is consistently negative, quantify the HIV proviral DNA load, and note changes in proviral DNA with combination antiretroviral therapies. The proviral DNA load is a measure of the reservoir cells which must be eliminated prior to stopping combination antiretroviral therapy.
References1. Saget BM, Elbeik T, Guthries J, Drews B, and Scheibel S. Dramatic suppression of HIV-I plasma RNA using a combination of zidovudine, didanosine, zalcitabine, Epivir, and interferon-alpha in subjects with recent HIV-I infection. XI International Conference on AIDS, Vancouver, July 7-12 [abstract # We.B.533].
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1592 -- New Experimental Antiretroviralby John S. James |
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An experimental drug code-named 1592U89 (or 1592 for short)
is a new kind of nucleoside analog which appears to have a
much stronger anti-HIV effect than AZT, ddI, or other
approved nucleoside analogs. It is now in phase I/II human
testing, with one trial giving the drug to about 80 patients.
Volunteers have had average viral load reductions of about 95
to 99 percent (approximately 1.5 to 2.2 logs), and average
CD4 count increases of 79 to 127, at four weeks of treatment
with this drug alone, and this improvement was sustained for
the remaining eight weeks of the study. The drug has a short
but acceptable half life in the blood (1 to 1.3 hours in
early human tests; a shorter half life usually means more
frequent doses are needed, but the results above were
obtained with no more than three times daily dosing), and a
fairly good ability to cross the blood-brain barrier. The patients in this trial had CD4 counts of 200-500, and less than 12 weeks of prior use of AZT. 1592 is being developed by Glaxo Wellcome. There is growing interest in the possibility of compassionate-use access to this drug for patients who have failed other treatment options.
ReferencesSaag M, Lancaster D, Sonnerborg A, and others.Preliminary data on the safety and antiviral effect of 1592U89, alone and in combination with zidovudine (ZVD) in HIV-infected patients with CD4+ counts 200-500/mm3. XI International Conference on AIDS, Vancouver, July 7-12 [abstract # Th.B.294]. McDowell JA, Symonds WT, LaFon SW. Single-dose and steady- state pharmacokinetics of escalating regimens of 1592U89 with and without zidovudine. XI International Conference on AIDS, Vancouver, July 7-12 [abstract # Mo.B.1140].
Note to Readers
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Medical Marijuana: California Updateby John S. James |
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As we reported in our last issue, on August 4 the Cannabis
Buyers' Club in San Francisco was raided by the office of
California Attorney General Dan Lungren, who acted without
informing San Francisco police and city officials. The club
is still closed, depriving thousands of people with AIDS,
cancer, and other major illnesses of safe access to medical
marijuana. Some have collected their documentation and
applied again at much smaller buyers' clubs in Oakland and
Santa Cruz; many others have had to buy marijuana on the
streets, at considerable risk for persons who are unfamiliar
with the street dealer scene and also are seriously ill. Many
of their stories have been told in the major news media. We have seldom seen an issue which left people more angry and upset. There is near-universal revulsion toward the politically ambitious state attorney general and the other California officials who are widely seen to have acted for political purposes in depriving many people with major illnesses of a treatment vitally important to them. There is widespread agreement that the important issues now are 1 access to marijuana for those with urgent medical need, 2 return of the confidential medical records of almost 12,000 people, which were seized August 4, and 3 passage of California Proposition 215 in the November election, to make it clear that doctors and patients who use marijuana for legitimate medical purposes are not criminals under California law. Since the raid, at least two major medical organizations -- the San Francisco Medical Society, and the California Academy of Family Physicians -- have publicly supported Proposition 215. No major medical organization has opposed it. On August 9 the Cannabis Buyers' Club answered charges against it. For example, on the allegation that they sold to teenagers, CBC said that the teenager was given the marijuana by his mother, an undercover narcotics officer who bought it at the club. On the allegation that there were sales to non- medical users, the CBC admitted that some had slipped through with fraudulent documentation, and that the CBC needs to tighten its procedures. On August 15 the San Francisco city government rejected a proposal to declare a state of medical emergency in order to allow the CBC to operate. AIDS prevention groups were concerned that this declaration might cause needle exchange in San Francisco to be shut down, since it now operates under a similar declaration of medical emergency, despite opposition from Lungren. Persons with a documented medical need for medical marijuana may still be able to get it through other cannabis buyers' clubs; see our list of California organizations, below. Also, note the list of organizations working for passage of Proposition 215.
CommentOpponents of Proposition 215 argue that medical marijuana is being used as a wedge issue to legalize drugs. (Incidentally, a similar argument is used against needle exchange.) This is hard to understand, since morphine and other drugs are widely used medically, without that causing any push toward their legalization for non-medical purposes. The public can easily separate the issues of urgent medical need vs. recreational use.There is also widespread misunderstanding of the role of Marinol(R) (dronabinol), a legal prescription drug which contains THC, a major active ingredient of marijuana; opponents of medical marijuana say patients should use Marinol instead. But anyone who knows the people affected realizes that because individual patients are different, some can use marijuana but not Marinol (and others can use Marinol but not marijuana). The appropriate medical care is to have both available, so that individuals can use whichever works best for them. (Marinol is believed to be about three times as expensive as marijuana to use; we could not confirm this figure as marijuana prices and potencies vary greatly.) Meanwhile, the Federal government continues to block medical research into medical use of marijuana, almost certainly for political reasons. And under President Bush, the Federal government closed its emergency medical access program which had been running well until then; President Clinton, who "did not inhale"and does not want the marijuana issue used against him again, has been unwilling to reconsider the Federal hostility toward medical access, despite overwhelming public support for it. On August 15 Clinton's new drug czar, retired Army general Barry McCaffrey, attacked Proposition 215 in a press conference on Haight Street in San Francisco, saying "There is not a shred of scientific evidence that shows that smoked marijuana is useful or needed," according to the SAN FRANCISCO CHRONICLE, August 16. While that statement is easy to refute, the main issue is that information is indeed lacking because the U.S. has prohibited medical research on how to use marijuana as medicine. While preparing this article we checked the literature on adverse effects of marijuana. Much of what we found is scientifically ludicrous. This literature is filled with reports of a handful of people (sometimes only one) who had smoked marijuana and were diagnosed with some illness -- with the implication that marijuana was a likely cause. Since millions of people receive medical care for serious illnesses, and many of them smoke marijuana, there must be hundreds of thousands in both categories by chance alone; finding a handful of examples proves nothing. What this literature does show is the desperate grasp for something, anything, that can be used as scientific cover for political efforts to keep the drug wars going. The real fear may be that medical marijuana could indeed be a wedge issue -- not to legalize drugs, but to allow rational discussion of the overall costs and benefits of the current "war on drugs" approach to policy, and creative consideration of new options. The medical issue could open doors to re- thinking which otherwise are closed, since it is almost impossible to demonize sick people who use an illegal drug for urgent medical reasons, and much easier to demonize other users. But any change threatens powerful interests, since the war on drugs has become an economic base for major industries, including law enforcement, unprecedented prison operation and construction, and a whole cluster of supporting economic activity -- as well as a funding stream for many government bodies through seized property, and a benefit to politicians and the press, who can use police stories to distract and entertain the public. In addition, the multi-billion dollar illegal drug industry absolutely depends on prohibition, as it could not exist otherwise; and this industry has influence even though it is illegal. All this could be threatened by a re-thinking of drug policy free of the overlay of demonization. The focus could then be on the costs we all pay in the misdirection of resources and the degradation of our quality of life. What shapes certain kinds of institutional madness is empire building -- the normal tendency for institutions (both public and private, legal and illegal) to expand their role, influence, power, and prestige. What drives this process is the natural desire of individuals to get ahead, to become more important in their jobs. Growth is not wrong, but without effective public scrutiny, institutions can become self-perpetuating -- expanding without regard to any public purpose, and becoming parasitic, wasteful, and cruel. All eligible Californians have a vital interest in registering and voting in this election -- whatever they might think of certain candidates on the ballot. Proposition 215 might open doors to new thinking beyond drug policy, on the larger issues of dysfunctional institutions and their tragic consequences for national and personal life.
Cannabis Buyers' Clubs in California:Oakland CBCNote: San Francisco's Cannabis Buyers' Club can be reached through Californians for Compassionate Use (see contact information below). Due to an injunction against it, the CBC is not distributing medical marijuana at this time, but is focusing instead on passage of Proposition 215.
Organizations Working for Proposition 215Californians for Medical Rights (CMR) Notes(1) The above list only includes organizations actively working for passage of Proposition 215 -- not the much larger list of endorsers
(2) The major organization opposed to Proposition 215 is
Citizens for a Drug Free California,
(3) Our lists above include organizations working on medical
marijuana; many others focus on drug policy concerns. For
example, see the excellent newsletter of California NORML
(National Organization to Reform Marijuana Laws), available
from :
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Calendar of AIDS
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There is no complete list of AIDS research/treatment
conferences; here are some which have come to our attention.
Let us know of any others which should be listed; we will
publish updates occasionally.
This calendar includes: scientific or clinical conferences which are open to the public and are likely to release new information relevant to AIDS/HIV treatment; meetings on related topics, such as viral hepatitis, complementary AIDS/HIV treatments, or managed care; and some exceptional meetings for educating the public on AIDS treatment and research. We are compiling a separate list of vaccine meetings. This calendar focuses on September through December 1996, but includes some meetings after 1996 which came to our attention. We have verified the following information in August 1996,
unless otherwise stated; we have not verified all email
addresses. Meeting times often change after announcements
have been published, so check with the contact person or
organization before making travel plans. September 1996Mechanisms of AIDS PathogenesisSeptember 5-6 Rockville, Maryland. Contact: Opendra Sharma Division of AIDS, NIAID 301/496-8378. Project Inform Town Meeting
Project Inform Town Meeting The 7th European Conference for Nurses in AIDS Care ICAAC (Relatively little new AIDS information is expected this year; AIDS TREATMENT NEWS is not going to ICAAC this time. We do suggest following AIDS reports from the meeting through the free conference calls organized by BETA, a treatment newsletter of the San Francisco AIDS Foundation, on September 16 and 17 -- see listings below. ICAAC focuses on new antibiotics, and is most likely to be strong on AIDS in odd-numbered years when the International Conference on AIDS does not occur. Note: We have been told that this year, photography will be allowed in the poster exhibits, although the printed program may say otherwise -- but no photography, and probably no tape recording either, will be allowed in oral sessions. Check with ASM if necessary.) Conference call: (Note: These free conference calls are presented by BETA, the quarterly AIDS treatment magazine published by the San Francisco AIDS Foundation; during each call you can listen to and ask questions of a panel of experts. To join either or both calls, you must register in advance at the contact number above, which can be done 24 hours a day; one may want to register for both calls, as ICAAC will be ongoing, so different information will be presented. Both the September 16 and September 17 calls will be 4:00 p.m. Pacific Time, 5:00 p.m. Mountain, 6:00 p.m. Central, and 7:00 p.m. Eastern. If you miss the calls, there might be facilities for listening to them later; call the registration number above to find out. You can still hear recordings of similar calls which took place during the Vancouver conference. This program supported by an educational grant from Hoffmann-La Roche.) First Annual Disease Management Conference (Comment: "Disease management" is today's buzzword for an approach to fixing some of the problems of managed care. We know little about this particular conference, except that it has been extensively publicized. It is not specifically focused on AIDS; we included it for readers who may want to look into the disease-management movement.) Conference call: First National Harm Reduction Conference (Note: The concept of harm reduction focuses on strategies, such as needle exchange programs, to diminish the adverse consequences of drug use and other life-threatening activities.) Infectious Diseases Society of America (IDSA) These contact numbers are for travel, etc. arrangements; IDSA itself can be reached at 703/299-0200. (In this meeting, several hundred doctors gather in an auditorium to listen all day to lectures on infectious diseases, including AIDS, from leading experts. Few AIDS activists attend. This year the dates are coordinated with ICAAC, so it is possible to go to both meetings with the same trip to New Orleans; but next year for the first time the organizations will meet separately, with IDSA holding its 1997 meeting in San Francisco.) Managing Risk and Integrating Care for HIV/AIDS in a Managed Care Environment Comprehensive Nursing Management of HIV Disease AIDS Research Advisory Committee AIDS Medicine: An Intensive Course V International Symposium on Viral Hepatitis October 1996[Note: Dozens of AIDS events will take place in Washington D.C. in early to mid October, at around the dates of the NAMES Project Quilt display, October 11-13 at The National Mall (contact: The NAMES Project AIDS Memorial Quilt, 202/296-2637, fax 202/296-4121, email info@aidsquilt.org, website http://www.aidsquilt.org for more information or to volunteer). Since many thousands of people will be visiting the Quilt and related gatherings (just assisting the Quilt display will require over 12,000 volunteers), hotel rooms in Washington are already scarce. 2nd International Conference on Health and Human Rights National AIDS Treatment Advocates Forum (Note: Dates are coordinated with the Sixth Annual National Skills Building Conference, below.) Managing Risk and Integrating Care for HIV/AIDS in a Managed Care Environment New Insights in HIV Infection and Disease Sixth Annual National Skills Building Conference This conference is sponsored by three organizations, the AIDS National Interfaith Network, 202/546- 0807; National Association of People with AIDS, 202/898-0414; and National Minority AIDS Council, 202/483-6622. It has reserved a block of rooms at the conference hotel, The Washington Hilton and Towers; reservations must be made by September 20 to obtain the conference rate. However, at press time, the nights of October 11 & 12 have been sold out at the Hilton and Towers; rooms are still available at the overflow hotels: Capitol Hilton, 202/393-1000, and the Radisson Barcelo Hotel Washington, 202/293-3100. Identify yourself as a conference participant to get the conference rate. AIDS, Medicine, & Miracles This one-day meeting, "What Holds Promise," is being held in conjunction with the National Skills Building Conference. Scheduled speakers include Charles Steinberg, M.D., Richard Elion, M.D., and Lark Lands, Ph.D. 48th Annual Meeting of the National Hemophilia Foundation Community Programs for Clinical Research on AIDS (CPCRA) November 1996Quality of Care 11th Annual Symposium 3rd International Congress on Drug Therapy in HIV Infection Protease Inhibitors: New Therapeutics and Approaches (This meeting is not AIDS-specific, but includes HIV protease inhibitors among drugs for other viral infections, and for non-infectious diseases.) AIDS, Medicine, & Miracles This holistic retreat includes three one-day institutes -- one in Spanish, one for women with HIV, and one for caregivers and service organizations. Annual Meeting of the American Public Health Association The theme for this year is Empowering the Disadvantaged: Social Justice in Public Health. HIV Surrogate Markers: Virological and Immunological
Indicators Novel HIV Therapeutic Strategies December 1996Clinical Care of the AIDS Patient AIDS Clinical Trials Group (ACTG) 19974th Conference on Retroviruses and Opportunistic Infections Until There Is a Cure (Not a research meeting, but a well-regarded conference on complementary and mainstream treatment options.) AIDS Research Advisory Committee Community Programs for Clinical Research on AIDS (CPCRA) 9th National AIDS Update AIDS Pathogenesis Community Programs for Clinical Research on AIDS (CPCRA) 11th Annual AIDS Update for Primary Care Bio'97 International Biotechnology Meeting & Exhibition (Biotechnology business focus; sponsored by BIO, the Biotechnology Industry Organization, "the world's largest trade organization to serve and represent the biotechnology industry." Program and registration material not available until January 1997.) Fourth International Symposium on Clinical Immunology AIDS Clinical Trials Group (ACTG) Community Programs for Clinical Research on AIDS (CPCRA) AIDS Clinical Trials Group (ACTG) 199812th World AIDS ConferenceJune 28 - July 3, 1998 Geneva. Scholarship deadline February 1, 1988. Contact: Congress Secretariat 12th World AIDS Conference c/o Congrex (Sweden) AB P.O. Box 5619 S-114 86 Stockholm, Sweden. Phone +46 8 612 69 00 fax +46 8 612 62 92 email aids98@congrex.se website http://www.aids98.ch .
4th International Congress on Drug Therapy in HIV Infection |
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