&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& Copyright 1992 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS Issue #153, June 19, 1992 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: [items are separated by "*****" for this display] Tat Drug Development: Current Status Trial to Stop Mother-to-Baby Transmission Set to Begin Alternative and Traditional Medicine at the VIII International Conference on AIDS International Conference Notes: People With AIDS Fight For Life, Amsterdam Finding Hotel Rooms in Amsterdam; Finding Medical Research Announcements: Lymph Node Viral Burden Study Begins: Baltimore, Chicago, Durham, Pittsburg, San Francisco, Stonybrook Free Traditional Chinese Medical Treatment Offered in San Francisco New Organization Advocates for Alternative Treatment Research United For AIDS Action: New Coalition on Presidential Election; Rally July 14 ***** Tat Drug Development: Current Status by John S. James Many AIDS experts agree that one of the most promising treatment research areas at this time is the development of drugs to inhibit the HIV regulatory protein called tat. At least until recently, however, research has moved slowly. This article will outline the current status of development of tat inhibitors, including results of the only human trials at this time, and plans for future trials. Tat inhibitors are promising for several reasons: (1) The tat protein, which is only produced by HIV, greatly increases the replication of HIV. It is essential for its replication; without tat, HIV cannot reproduce. (2) Unlike current anti-HIV drugs, tat inhibitors are likely to be effective in chronically infected cells. All the antiretrovirals in use now only work to prevent infection of new cells; in cells that are already infected, they do nothing. Chronically infected cells, which are not killed by the infection, can continue to produce toxic substances, which may be a major cause of the immune dysregulation found in AIDS. (The approved drug alpha interferon, and "alternative" antioxidant treatments such as NAC, might have some effect on chronically infected cells. But as AIDS treatments, these are limited at best.) Tat inhibitors are likely to be effective in chronically infected as well as other cells. (3) Viral resistance is less likely to occur with tat inhibitors than with the anti-HIV drugs now in use. AIDS TREATMENT NEWS previously reported that no viral resistance to a tat inhibitor was found after a year's laboratory test; by contrast, resistance developed rapidly to other drugs tested (issue #141, December 20, 1991). There is also a theoretical reason to suspect that resistance may be much less of a problem with tat inhibitors than with other anti-HIV drugs in use. Chronically infected cells can continue to produce new viruses, despite the AZT, ddI, or ddC in the body. Those drugs may prevent most of these viruses from infecting new cells. But uninhibited production of new virus is likely to create excellent opportunities for mutations to produce new viral strains which are resistant to AZT or the other drugs. These new strains would have a selective advantage because only they could reproduce if the drug treatment is continued. Therefore, viral resistance to AZT and to other reverse- transcriptase inhibitors is likely to be a problemQthe very problem which destroyed most of the hopes last year for a class of non-nucleoside reverse-transcriptase inhibitors such as Merck's L-661. A tat inhibitor shuts down HIV replication, as well as other HIV activity, in these chronically infected cells. With few new viral particles being produced, there is less chance for resistant mutants to arise. (4) A practical reason for interest in tat inhibitors is that one has already been tested in people (see below), in two small trials with good toxicity and blood-level results so far (no efficacy indicators were measured, so there is still no data on whether this drug will actually work in people). (5) Another practical consideration is that tat inhibitors work against the virus in a completely different way than any other drug now in use. Therefore, the first tat inhibitor which proves useful as a human drug is likely to revolutionize treatment by greatly increasing the number of therapeutic options available. Combination treatments, for example, usually work best when the drugs being combined have different mechanisms of action. (6) The tat inhibitor currently in human studies is taken orally, making it more practical to administer on a long-term basis than drugs which need to be injected. (7) Besides its anti-HIV use, a tat inhibitor might possibly be useful against PML (progressive multifocal leukoencephalopathy). The reason for this is that the tat protein might increase the replication of the JC virus, which is suspected to cause PML. Tat-Inhibitor Development The technology which made tat inhibitors possibleQa fairly simple assay which could be used to screen thousands of drugs or other chemicals for anti-tat activityQwas developed independently by a number of pharmaceutical companies. We have heard that several companies have now found or synthesized anti-tat substances for possible development as drugs. But pharmaceutical companies are traditionally secretive about pre-clinical drug development, and the only company which we know for sure is developing a tat drug is Hoffmann-La Roche, which has completed two small human trials at Johns Hopkins University. We will discuss this drug below. But note that what is important is this class of treatments, not necessarily any one particular drug. Different tat inhibitors can be entirely unrelated to each otherQtoxicity, bioavailability, dosage and scheduling, chemical structure, etc. may have nothing in common. What is important is the technology for finding these drugs. It is likely that anyone with appropriate laboratory facilities could search for new anti-tat drugs. What might make the most sense would be to test thousands of existing drugs, natural products, and other chemicals already in human use, to see if there is a tat inhibitor which is already available, which might then be used almost immediately, after minimal human testing. This is unlikely to be done, however, because pharmaceutical companies are unlikely to test other companies' drugs; and academic, government, and community- based groups have not stepped forward. Hoffmann-La Roche RO-24-7429 The first tat inhibitor in human testing happens to be a benzodiazepineQa member of a class of chemicals which includes certain tranquilizers, including Valium. (Valium and other tranquilizers were tested and found not to have anti- tat activity.) The reason a benzodiazepine was found first is that Hoffmann-La Roche, which developed one of the first assays for tat inhibitors, applied that technology to substances available in the Roche "library" of chemicalsQmany of them leftovers from the development of Valium. The first tat inhibitor, RO-5-3335, was found to be too toxic in animal tests, due to kidney toxicity; therefore a variant of it, code-named RO- 24-7429, is now being developed. The first human study tested two doses in a handful of HIV- positive volunteers. Only a single dose was given to any one patient in this study, in order to measure levels of the drug in the blood. The purpose was to design a regimen to achieve a target blood level of one micromolar, which was found to inhibit HIV at least 90 percent in laboratory tests. (What matters is the level of the drug inside the cells, rather than in the blood; however, the researchers had no way to measure the level in cells.) The target level was easily reached and maintained for at least four hours with an oral dose of 200 mg. No serious toxicity was found. The second study was placebo controlled, with one third of the volunteers getting a placebo. The drug was given every six hours for five and a half days. With a total dose of 200 mg per day (divided into the four smaller daily doses), the blood concentration was maintained above the 1 micromolar target in most of the six patients. With a dose of 600 mg per day, most of the six volunteers were ten times the target level or more (this is the "trough" level, the lowest drug level reached between doses). There were no side effects that were different in those receiving the drug than in those receiving the placebo. RO-24-7429 was found to have complex pharmacokinetics (the body's absorption, distribution, etc. of drugs). For example, the trough level gradually increased over time, which was not expected. And increasing the dose does not increase the blood level proportionately, but more than that. These findings complicate the dosing of the drug, and also raise questions about long-term effects. The most notable side effect of the drug is that it turns the urine bright yellow. Chemists have discovered what causes this coloring. In the bloodstream, three different chemicals are found after someone has taken RO-24-7429: the drug itself, and two metabolites (one of which, found in only small amounts, happens to be RO-5-3335). In the urine, there are three different substances; these are hydroxylated derivatives of the substances in the blood. Apparently it is these derivatives which give the urine its color. In animals, high doses of the drug cause kidney toxicity. No one knows if this will be a problem in humans at doses which might be used therapeutically. Kidney function will be carefully monitored in these studies In the first trials there was controversy over exclusion of women of childbearing potential. Future studies will probably allow women providing they are not pregnant or breast feeding, and will not become pregnant in the study. (For an example of the problems resulting from the earlier study, see "He for God Only: Why Sexism in Clinical Trials Is Killing Women," by Teresa McGovern, QW, May 31, 1992, pages 44-49. QW, formerly named NYQ, is a new lesbian and gay magazine published in New York.) Future Trial Plans Hoffmann-La Roche recently held a meeting of a newly-formed community advisory board, and outlined plans for future trials. The next trial of RO-24-7429, a pharmacokinetic study on safety and tolerance of the drug for 14 days, will be done at Johns Hopkins; it has currently been submitted to the IRB (institutional review board) for approval. It could be recruiting in about a month. Because of the buildup of this drug in the body, researchers want to study it over a longer period than tested before, in order to accurately administer it to humans. While primarily a pharmacokinetic study, this trial will measure at least one indicator of viral activity. Volunteers will need an acid-dissociated p24 of over 70 in order to enter; the reason for this requirement is so that the study can test whether the drug has anti-HIV activity in people. The following trial, which will be called ACTG 213, is planned for four ACTG (AIDS Clinical Trials Group) sites: Johns Hopkins, University of California San Diego, Case Western, and Harvard. These sites were selected for their virology capabilities. This study will test the drug at an earlier stage of HIV infection, with T-cell counts under 500. Fortunately this trial will not necessarily be delayed until the new Johns Hopkins trial is completed; these trials, and also the ones below, can overlap. This trial might be delayed, however, by the need to test a new tablet form the drug to make sure it is properly absorbed. All the previous trials have used RO-24-7429 formulated as an oral solution, but oral solution is not a commercially viable way to deliver a drug. The new Johns Hopkins trial will also use this solution, but then no more of it will be made; the drug will be supplied as tablets instead. With the complex planning required, no one knows whether the tablet or the protocol will be ready first. Still, current plans call for much faster development of this drug than is normally practiced, with faster analysis, overlapping of trials, and pushing for rapid IRB approvals. Meanwhile, or slightly later, Hoffmann-La Roche plans a separate trial for persons with more clinically advanced disease. It will be conducted outside the ACTG. It will not begin until about a month or more of data from the above trials is analyzed, because of concern about potential kidney toxicity. It, also, will use the drug in the tablet form. Later, a large combination trial will test RO-24-7429 with AZT, probably within the ACTG. First, there will be a pharmacokinetic study at Johns Hopkins to make sure there is no problem in how the drugs interact. This sequence of trialsQearly disease, later disease, and combinationQis modeled on the Hoffmann-La Roche trials, in Europe, of the company's proteinase inhibitor (another class of anti-HIV drugs). The community representatives at the Roche advisory-board meeting were relieved that plans were to stagger the trials, instead of waiting for each to finish before starting the next. But no time line for these studies was given; also, there were no protocols at the meeting for specific comments, although there are plans to let the board members comment on the protocols later. The main dissatisfaction of the advisory board was the lack of a plan for a trial of RO-24-7429 for Kaposi's sarcoma. Apparently Roche had plans for a seminar to look at this possibility, instead of for a trial, which is what the community wants, of course. No final decision has yet been made. Comment and Suggestion The plans outlined above suggest that RO-24-7429 could move more rapidly than other drugs in the past. It is notable that a number of trials have been thought throughQincluding coordination between ACTG and non-ACTG trials. We do have one suggestion, which might save much time in drug development, as well as saving money for both Roche and the government. There is an alternative design sometimes called the "N of one" trial, in which a drug's effects are studied intensively in one patient, instead of by statistical analysis of a large group receiving a standardized protocol. The N of one design allows more flexibility in early testing of how to use the drug in practice, since it does not require the imposition of a rigid protocol in order to try to make different patients comparable. Instead, the best medical and scientific judgment of leading clinical researchers can be applied to modify the trial as it proceeds. Because AIDS is a public health emergency, several N of 1 trials should be started simultaneously; they could be run by the same researchers. This would differ from a standard statistical trial with an N of several (too small to get useful statistics if there is much variability in what is being measured) in that each course of treatment could proceed individually, depending on the best interests of the patient as well as the interests of scientific discovery. Clinical information, not statistics, would be the goal. There would be no shortage of volunteers, and such a trial would pose no greater risk to them than the volunteers will be exposed to anyway in the standard trials being planned. And consider some possible outcomes. If most of the patients in the N of 1 trials had to stop the drug due to toxicity, without showing signs of antiviral activity, then it would be clear that the drug should be abandoned and another one (for example, another tat inhibitor) tried in its place; months or years and millions of dollars would have been saved. On the other hand, if the drug looked good, then efforts to test it would be redoubled. The FDA would still require standard statistical trials; but if a treatment were promising enough, it might qualify for accelerated approval quickly, with most of the large trials conducted post- marketing. Then the treatment would be available to the physicians and patients who clearly needed it, much sooner than under the current system. And at the very least, the design of the standard trials could be improved, based on the knowledge and experience gained from using the drug to treat people, under the most rigorous scientific management and observation available anywhere. ***** Trial to Stop Mother-to-Baby Transmission Set to Begin By Nancy Solomon A clinical trial to test whether HIV Hyperimmune Globulin (HIVIG) Q a blood product containing antibodies to HIV Q can prevent transmission from pregnant women to their babies is expected to begin this summer now that Abbott Laboratories has agreed to provide the HIVIG product. The study by the AIDS Clinical Trials Group, named ACTG 185, had been delayed from its April start by Abbott, which refused to sign a contract that would hold the pharmaceutical company liable for any health problems that may arise in the patients or their babies or for cost overruns. Abbott agreed last week to sign the contract under pressure from ACT UP and the U. S. National Institutes of Health (NIH), but may not be able to deliver the product until the price goes up 15 percent in October. "The negotiations dragged on for a fairly long period of time until we found another source of product," said Elaine Sloand, M. D., special assistant to the director of the National Heart, Lung and Blood Institute. "I can't say what it was exactly, but they were getting a lot of pressure from ACT UP. '' The phase III trial is designed to enroll 400 HIV-positive pregnant women at 12 sites that have yet to be announced. All the women will be given AZT while half receive HIVIG and the other half receive Intravenous Immune Globulin (IVIG). IVIG is a blood product similar to HIVIG but without any HIV antibodies. To be eligible for the study, the women must have a CD4 T- cell count of less than 500 or had an AIDS-defining illness that would have previously initiated AZT therapy. As of March, the number of cases of women with AIDS had grown to 22,607, according to the Centers for Disease Control. Some 20 to 30 percent of pregnant women with HIV pass on the virus to their babies, the CDC says. But activists say the CDC undercounts women, that the numbers are more likely to approach 40,000, and that transmission from mother to baby occurs less than 20 percent of the time. Because researchers suspect that HIV may be transmitted from mother to baby during labor, the women will receive a "loading dose" of the combination therapy by infusion while giving birth. The final phase of the study provides the babies with AZT/HIVIG or AZT/IVIG beginning shortly after birth and continuing for six weeks. Abbott produces HIVIG by concentrating several liters of blood plasma taken from asymptomatic people with HIV. The blood donors are selected because they have shown a strong immune response to HIV, meaning they are unusually healthy and have a high amount of antibodies. When the concentrated plasma is injected into patients, it is expected to boost the immune response against HIV. The plasma is screened for HIV, meaning that it is safe and unable to infect healthy cells, according to the research protocol. Studies at the New York Blood Center with chimpanzees showed that purified doses of HIVIG taken from asymptomatic people with HIV may prevent the animals from getting the infection. People with HIV apparently do not produce enough antibodies to kill the virus in their own bodies. Laboratory studies of HIVIG suggest that combination therapy with AZT may be better than either treatment alone. Dr. Diane Wara of the Department of Pediatrics at the University of California in San Francisco and a team investigator for the study says the possibility of blocking transmission to the baby is very promising. "It's a great study Q it's win-win, everybody gets treated and everybody wins," Dr. Wara said. The study will also collect data to answer biological questions about how the immune system works during pregnancy and how HIV is transmitted from mother to baby. "So little is known about mothers and babies," Dr. Wara said. "Why do some transmit and others don't? This study will allow us to look at that." Abbott had originally agreed to sell HIVIG to the ACTG study for $1.2 million over the course of the entire study, but held up signing the contract until the NIH agreed to give the company a cost increase of 15 percent beginning the next fiscal year, which begins in October. But Abbott has now told the researchers that they cannot provide HIVIG until October. Fortunately, the NIH already has enough product to begin studying 50 mothers. "I thought we'd have product available in August," said Dr. Lynn Mofenson, medical officer for the study for the National Institute of Child Health and Human Development. "But we have enough for 50 women and I don't think we'll have 50 enrolled before October." An initial phase of the trial is expected to begin enrolling women in July at test sites at Baylor University in Houston, the University of Texas in Houston, Mt. Sinai Medical Center in New York City, the University of Rochester (Rochester, New York), and the University of California in San Francisco. The full-blown study is expected to get under way in September at additional sites, including sites in Albany, New York, Duke University in Durham, North Carolina, the Medical University of South Carolina in Charleston, San Juan City Hospital in Puerto Rico, the University of California in San Diego, and Westchester Hospital in New York. Five undisclosed sites are still pending approval. ***** Alternative and Traditional Medicine at the VIII International Conference on AIDS By Jason Heyman The VIII International Conference on AIDS, entitled "A World United Against AIDS," will take place from July 19 through 24 in Amsterdam. For the first time, alternative and traditional medicines will be officially included in the research meetings. "Traditional" medicines are treatments not historically part of the Western medical system, including Chinese, African, Native American, and Ayurvedic. "Alternative" treatments are loosely defined as non- pharmaceutical treatments that have not had the benefit of clinical trials, but are in use by people with AIDS; these include herbal and naturopathic treatments, vitamins, and non-invasive procedures such as massage. Four official meetings on alternative and traditional medicine will be conducted as round table sessions, which do not include any formal presentations of abstracts, but consist instead of discussions among knowledgeable individuals in the field. These sessions will cover: "Diet and Micronutrient Supplementation;" "Choosing Therapies for Individual Treatment Strategies;" "Mixing Therapeutic Approaches;" and "Stress, Stress Reduction and Coping." We talked with some researchers who will be presenting papers on alternative and traditional therapies this summer and are looking forward to their presentations. New research into specific alternative treatments such as bitter melon, Iscador (mistletoe extract), acupuncture, and vitamin C will be presented. There are also research projects in Africa that are studying the role of traditional African medicine in the treatment of HIV disease, and cooperative efforts between traditional and Western doctors in developing countries. Most of these papers will be presented in the form of poster exhibits. The results will be included in our coverage of the conference in future issues. Minicourse on Alternative, Traditional and Complementary Medicine On three evenings during the conference a "minicourse" will be held on "Alternative, Traditional and Complementary Treatments"; this minicourse is being organized by AIDS TREATMENT NEWS and the Center for Natural and Traditional Medicine. The first evening will address the general usage of these treatments around the world with Olayiwola Akerlele, M. D., Programme on Traditional Medicines, World Health Organization; David Baker, R. N., M. S. N., San Francisco; Tanne de Goei, ACT UP/Amsterdam; Kaiya Montaocean, Ph.D., Center for Natural and Traditional Medicine, Washington, D. C. ; John Rwomushana, Ph.D., Uganda AIDS Commission, Uganda; and Nelson Solano, Grupo pela Vidda, Sao Paulo. The second evening will address research into alternative and traditional medicines. Specific ways of conducting clinical trials of these treatments will be discussed, as well as barriers to further research. Scheduled speakers include Cal Cohen, M. D., Community Research Initiative, Boston; Jon Greenberg, Treatment Alternatives, New York; Raxit Jariwalla, Ph.D., Linus Pauling Institute, Palo Alto, California; E. Lugakingira, Traditional Medicines Unit, Tanzania; Leanna Standish, N. D., Ph.D., Bastyr College, Seattle; Hans-Dieter Wolfstadter, Klinik fur Naturheil-kunde, Berlin; and Qingcai Zhang, M. D., O. M. D., Sino Med Institute, New York. The final evening will focus on creating networks among communities using alternative treatments to disseminate information, and facilitating communication between researchers and individuals with common interests in this area. Scheduled speakers will include Imani Harrington, Baker New Place Services, San Francisco; Stephan Korsia, AIDS Project Los Angeles; Howard Moffet, M. S., L. Ac., American College of Traditional Chinese Medicine, San Francisco; Leo Ortega, M. D., Mayatech Corporation, Venezuela; Elliott Rivera, New York Department of Health, New York; John Rutayuga, M. D., Ukimwe Orphan's Assistance, Tanzania; H. J. Shroff, M. D., Bombay; and Charles Williams, Chief of Staff for U. S. Congressman Jim McDermott (D-Washington). Comment The effort to include alternative treatments in the conference was organized by the Center for Natural and Traditional Medicine, Washington D. C., the ACT UP/San Francisco Treatment Committee, Treatment Alternatives/New York, the ACT UP/New York Alternative and Holistic Treatment Committee, and ACT UP/Amsterdam. Originally, the coalition wanted to create what would be known as the "Fifth Track", an entire section of the conference that would focus on alternative treatments, but the conference organizers would not agree to this. What has been accomplished, however, is the inclusion of alternative and traditional medicines in a track that already exists, Track B (Clinical Science). Discussion of different approaches to the treatment of HIV and AIDS should be an integral part of a global research meeting, instead of something that has to be fought for. The gains made this year are significant, but they do not do justice to the basic issue of studying alternative treatments. These are potential treatments which do not have the financial backing of pharmaceutical companies to move them through the prohibitively expensive journey of drug development. Their inclusion in the conference also came under attack from influential researchers who for a variety of reasons do not want to see them developed. This year's conference sets a precedent in terms of acknowledging the wide range of treatments which are in use around the world. Unfortunately, each year a completely new staff organizes the conference and there is no way to ensure that alternative and traditional medicine will be included in the future. We can only hope that the organizers of next year's conference in Berlin understand the importance and global implications of including all the different treatment approaches that are in use, and that they will make every effort to do so. ***** International Conference: ** PWAHA Fight for Life, Amsterdam The People With AIDS Health Alliance Fight for Life is a private medical clinicQsufficiently unusual under Holland's national healthcare system to have attracted international attention in Europe. This clinic, which is loosely affiliated with Fight for Life, the AIDS service organization in Oakland Park, Florida, specializes in AIDS/HIV treatments, including experimental therapies. For example, it helped many people in Europe and the U. S. obtain ddC when that drug was not available through standard channels. Currently there are three clinic physicians: Joseph (Jeff) Graafmans, M. D., Rolf Eussen, M. D., and Henk Maarten Laane, M. D., Ph.D. Because of the U. S immigration policy on HIV infected people, the clinic receives many questions on how to obtain medications, especially AZT, when traveling in the U. S. If U. S. physicians could help solve this problem, please call the clinic, or come by if you attend the International Conference on AIDS in July. Fight for Life is also one option for obtaining HIV-related medical care if that is necessary in Amsterdam. For more information, contact Fight for Life, Postbus 15552, 1001 NB Amsterdam. Phone (20) 627-5093, fax (20) 626-4522. If you are in the area, the clinic is located at Vijzelstraat 77 I, 1017 HG Amsterdam. ** Finding Hotel Rooms in Amsterdam; Finding Medical Research Two travel agencies we checked had no hotel rooms available in Amsterdam during the International Conference on AIDS; they have been sold out for weeks. But last week we reserved a room easily, through the Netherlands Reservations Centre, phone 070- 320-2500. Neither travel agent gave us that number, despite thousands of dollars of business we had done with each. We got the number from ACT UP. We find this case a metaphor for AIDS research. Travel agents are not agents of the traveler, who does not pay them; rather, they are independent salespersons for airlines, hotels, and other businesses. If they were truly the traveler's agent, serving the traveler's interests, they would do things differently -- for example, by telling their clients how to find a room even when they would not get a cut. Similarly, medical research is not the agency of the people who hope to benefit, but of the businesses, governments, and other institutions which pay for it. If medical research truly served the interests of its ostensible clients, many things would be done differently. There isn't time now to reform the whole system. But meanwhile, we have ACT UP, Project Inform, community-based research, buyers' clubs, and other activist groups, which give voice and weight to the public interest when the real decisions are made. ***** Announcements: ** Lymph-Node Viral Burden Study Begins: Batimore, Chicago, Durham, Pittsburg, San Francisco, Stonybrook Leading AIDS researchers suspect that an important obstacle to measuring how well antivirals work is that HIV infection may be primarily in the lymph tissue, but measurements of viral levels are usually done on blood. Lymph-tissue testing may be more accurate; but this measurement is more difficult, since it requires a lymph-node biopsy. A new trial will will see how viral burden in lymph tissue changes in response to treatment by AZT, ddI, and the combination of those drugs; viral measurements (by quantitative viral culture and quantitative PCR) will also be correlated with changes in T- helper counts. The hope is to learn more about the pathogenesis of AIDS, and to learn how well T-helper counts correlate with effects of antiretroviral drugs on viral levels. This information will help in the design of future trials. [Note: Volunteers not currently on AZT when they enter this trial will be randomized to receive either AZT, ddI, or placebo for the eight weeks of treatment. Those on AZT will continue on AZT, and in addition will receive either ddI or placebo.] This study is sponsored by DATRI (Division of AIDS Treatment Research Initiative), a new program by the U. S. National Institute of Allergy and Infectious Diseases to run very rapid trials which are important for improving our scientific understanding of AIDS. The study will open will open at several sites; some of them are recruiting now. Approximately eight volunteers will be enrolled at each locationQa total of 32 in the entire study. Persons who have never used AZT or other antiretrovirals must have T-helper counts over 350; those on a stable AZT regimen must have over 250. A total of seven visits will be required, during a nine-week period; two of these visits will include a lymph-node biopsy, surgery which is usually performed under light general anesthesia (it may also be done with local anesthesia). Volunteers who complete the study will be reimbursed $500. For information about the study, or to volunteer at one of the San Francisco sites, call Jay Lalezari, M. D., Mt. Zion Hospital, 415/476- 6356. The trial will be conducted at one or more sites in or near Balitmore, Chicago, Durham, Pittsburg, San Francisco, and Stonybrook, New York. For contact persons and phone numbers at each location, call the AIDS Clinical Trials Information Service, 800/TRIALS-A. ** Free Traditional Chinese Medical Treatment Offered in San Francisco Two clinics in San Francisco are offering free acupuncture and Chinese herbal medicine with federal funding under the Ryan White CARE Act. The Immune Enhancement Program and The American College of Traditional Chinese Medicine are each offering treatment to fifty low- income, HIV-positive, symptomatic individuals. The treatment program begins on July 1, 1992, and includes weekly acupuncture and Chinese herbal medications provided at no cost to the participants. The College of Traditional Chinese Medicine has received more than fifty applications but is still accepting names for its waiting list. The Immune Enhancement Program still has many openings available. For more information contact the Immune Enhancement Program, 3450 Sixteenth St., San Francisco, CA 94114, 415/252-8711 or 415/252- 8710 (fax)Qor the American College of Traditional Chinese Medicine, 455 Arkansas St., San Francisco, CA 94107, 415/282-7600 or 415/282-0856 (fax). ** New Organization Advocates for Alternative Treatment Research "Treatment Alternatives" is a group of people with AIDS or HIV, scientists, and AIDS activists, who are promoting controlled clinical trials of commonly used "alternative" and non- pharmaceutically based AIDS treatments. They agree that only well designed and conducted research can lead to the reliable information which people with AIDS need to make informed treatment choices. Treatment Alternatives develops concept sheets (the outlines of clinical trials) for a number of treatments it believes should be studiedQfor example, vitamin C, and glycyrrhizin (licorice root extract). These concept sheets are then presented to research organizationsQa potentially effective strategy, since such organizations have often complained about the lack of coherent, well-developed ideas of what to study. Treatment Alternatives needs donations and volunteers, especially those with expertise in treatments and trials. For more information call Jon Greenberg, at 212/673-0491. ** United for AIDS Action: New Coalition on Presidential Election; Rally June 14 A new coalition of over 200 organizations is effectively bringing AIDS issues to the U. S. presidential election campaign. Governor Clinton met with UAA, at his request, endorsed the organization's program, and agreed to make a major speech on AIDS. UAA has called for a Unity Rally in New York's Times Square on July 14, to coincide with the Democratic National Convention; it is also organizing a Mother's March at the Republican National Convention in Houston this August, and a national drive to register voters concerned about AIDS. Members of UAA include the International Ladies Garment Workers Union, the Latino Commission on AIDS, AIDS Project Los Angeles, Gay Mens' Health Crisis, San Francisco AIDS Foundation, Whitman-Walker Clinic, AIDS Action Council, several ACT UP groups, Project Inform, and AIDS TREATMENT NEWS. UAA's five-point program calls for Presidential leadership, a single-payer universal health care plan, intensive research to develop a cure and a vaccine, AIDS prevention education that works, and protection against HIV discrimination. For more information, call United for AIDS Action, 212/337- 1227, or write to: UAA, 175 5th Ave., Suite 2179, New York, NY 10010. ***** AIDS TREATMENT NEWS Published twice monthly Subscription and Editorial Office: P. O. Box 411256 San Francisco, CA 94141 800/TREAT-1-2 toll-free U. S. and Canada 415/255-0588 regular office number 415/255-4659 fax Editor and Publisher: John S. James Medical Reporters: Jason Heyman John S. James Nancy Solomon Reader Services, Business, and Marketing: David Keith Thom Fontaine Jason Heyman Nancy Solomon Laura Thomas Tadd Tobias Rae Trewartha Statement of Purpose: AIDS TREATMENT NEWS reports on experimental and standard treatments, especially those available now. We interview physicians, scientists, other health professionals, and persons with AIDS or HIV; we also collect information from meetings and conferences, medical journals, and computer databases. Long-term survivors have usually tried many different treatments, and found combinations which work for them. AIDS Treatment News does not recommend particular therapies, but seeks to increase the options available. Subscription Information: Call 800/TREAT-1-2 Businesses, Institutions, Professionals: $230/year. Nonprofit organizations: $115/year. Individuals: $100/year, or $60 for six months. Special discount for persons with financial difficulties: $45/year, or $24 for six months. If you cannot afford a subscription, please write or call. Outside North, Central, or South America, add air mail postage: $20/year, $10 for six months. Back issues available. Fax subscriptions, bulk rates, and multiple subscriptions are available; contact our office for details. Please send U. S. funds: personal check or bank draft, international postal money order, or travelers checks. VISA, Mastercard, and purchase orders also accepted. ISSN # 1052-4207 Copyright 1992 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used. &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&