DISTRIBUTED BY AEGIS, Your online gateway to a world of people, knowledge, and resources. 714.248.2836 * 8N1/Full Duplex * v.34+ ************************************************************************** AIDS TREATMENT NEWS #233, October 20, 1995 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: Viral Load: New "Strategy" Trial in 15 U.S. Cities Guidelines for Clinical Management Using Plasma HIV RNA Quantitation White House Meeting on AIDS FDA Antiviral Advisory Hearings on Lamivudine (Epivir(TM), 3TC), Saquinavir (Invirase(TM)), Stavudine (Zerit(TM), d4T), November 6-8 International Conference, Vancouver 1996: Arrangements and Deadlines Thalidomide Conflict -- How to Help Internet Newsgroup sci.med.aids -- New Addresses California: Governor Vetoes Cryptosporidium Bill San Francisco Area: Testosterone Replacement Study, Injection vs. Patch Women Prisoners: San Francisco Bay Area Events Office of AIDS Research Announces Advisory Council ***** Viral Load: New "Strategy" Trial in 15 U.S. Cities by John S. James A new kind of trial which focuses on treatment strategy instead of testing individual drugs is now recruiting 1,100 volunteers with CD4 (T-helper) counts of 300 or less, in the following cities: Albuquerque, Atlanta, Baltimore, Camden NJ, Chicago, Denver, Detroit (2 sites), New Orleans, New York City, Newark, Philadelphia, Portland OR, Richmond VA, San Francisco, and Washington DC. The main purpose of this trial is to see if testing for plasma HIV RNA ("viral load") can help doctors make better decisions, leading to provable benefits to patients. To test this, half of the volunteers will be randomly assigned to use viral load in making treatment decisions, and the other half will be assigned not to use viral load. The tests will be free for those assigned to use them. This trial will not tell patients or physicians which treatments to use; that will be decided in the normal course of medical practice. But viral load results will be available to half the patients and physicians to help in making these decisions, and not available to the other half. The trial is expected to run for two to three years. Anyone is eligible to enter this trial if they are at least 13 years old, have HIV, have a CD4 count of no more than 300, and are in reasonably good health and willing to take antiretrovirals if needed. They must be receiving treatment from a physician who is participating in the CPCRA program. This trial imposes no restriction on what drugs the patient may use. This trial is designed and run by the Community Programs for Clinical Research on AIDS (CPCRA), a program of the U.S. National Institute of Allergy and Infectious Diseases (NIAID); the principal investigator is Melanie Thompson, M.D. of the AIDS Research Consortium of Atlanta. Chiron Corporation will donate at least 10,000 bDNA tests for viral load; and SmithKline Beecham, which does medical laboratory testing, will donate the transportation of the samples, a substantial expense since every sample must be shipped in dry ice by overnight express. (The test which will be used is the same one physicians can order, with a cutoff of 10,000 copies of RNA -- not the newer research-only test with a cutoff of about 500 copies.) A fraction of patients assigned to NOT use HIV RNA will have samples drawn anyway for an HIV RNA test, but the results will not be reported to them or their physician until the end of the trial. The purpose of these samples is to help in scientific analysis of the results. Patients who are already using viral load or planning to do so should not enter this study, which is for patients and physicians who have not already decided whether or not to use this test. This trial is named CPCRA 036; its official title is A Randomized Study of the Clinical Effects of Initiating or Changing Antiretroviral Therapy Based on Plasma HIV RNA Quantitation Compared with Initiating or Changing Therapy Based on Current Clinical Practice Alone. For more information about volunteering, call the AIDS Clinical Trials Information Service, 800/TRIALS-A, for the contact telephone number of the CPCRA site in one of the 15 cities listed above. Comment This study will develop important information about how physicians are deciding when to switch antiretroviral therapies -- whether those physicians are using viral load tests or not. Also, if it succeeds in proving that viral load tests can have value, it will help to change everyone's standard of care to make these tests more available, not only for those with money or good insurance, but for all. We do have reservations about being randomized to not use viral load testing to guide therapy. We believe that everyone with HIV should get at least one baseline viral load test -- partly to have it available for comparison with future values, and especially to help decide on how aggressive to be with therapy. If the viral load is high (certainly anything over 100,000 copies is high, and many would aggressively treat values lower than that), the test should be repeated to make sure it was not a temporary high value (which can result from a minor infection, a flu shot or other shot, or from other causes), or due to laboratory error. If the repeat test is also high, we believe that one should use whatever drug combinations, other treatments, or lifestyle changes may be necessary to lower the viral load and keep it down. Many experts do not agree with our view. Some suspect that the CD4 count "mirrors" viral load sufficiently closely that viral load does not add enough new information to be significant. Also, while everyone agrees that people with high viral load do worse on the average than those with low viral load, some experts argue it has not yet been definitively proved that lowering the viral load by drug treatment will improve a patient's prognosis. It is even possible that viral load testing could indirectly result in harm, by prompting many changes of therapy, exposing patients to more different drug toxicities than they would otherwise face. Also, relying on viral load tests before we know exactly what they mean may lead researchers to discard drugs too soon. For example, in some trials of protease inhibitors, viral load greatly declined but then became high again, while CD4 count rises were much longer lasting; no one knows what this means, but it is possible that the drug is providing some benefit even when the viral load test is not showing it. Also, it is not known that viral load in the plasma accurately shows viral activity in all body compartments, for example in the central nervous system; it would be unfortunate to discard a drug that provided a benefit which was not readily seen through this test. The CPCRA viral load study will produce a unique database to answer questions about how well viral load predicts clinical outcome, how it changes with changes in therapy, and how physicians make decisions about antiretroviral treatment. This information will be reviewed monthly as the study proceeds, and will be made available throughout the study to the participating physicians, and through them to the volunteers -- and perhaps even by a World Wide Web page available to everyone. In addition, this study is saving plasma samples from some volunteers for later studies of the effects of drug resistance. Patients and physicians who are already committed to use viral load should not join this study. But those who would not otherwise use viral load can volunteer without reducing the care they receive. And of course if they change their mind later, they can withdraw from the study at any time. ***** Guidelines for Clinical Management Using Plasma HIV RNA Quantitation [Note: The following are the initial guidelines for using viral load, which are being provided to physicians in the CPCRA 036 study described above. These guidelines will be reviewed periodically throughout the study, and will be changed as new information becomes available.] The goal of utilizing plasma HIV RNA quantitation in patient management is to keep viral burden AS LOW AS POSSIBLE FOR AS LONG AS POSSIBLE. At present, there are no clear thresholds for "high" or "low" HIV RNA viral burden. The following points represent the state of the art in this area: * Levels of <10,000 copies (10 Keq/ml) are associated with LOW risk of progression (Mellors J. and others. Quantitation of HIV-1 RNA in plasma predicts outcome after seroconversion. ANNALS OF INTERNAL MEDICINE. 1995; volume 122, pages 573- 579.) * Levels of >100,000 copies (100 Keq/ml) are associated with HIGH risk of progression (Mellors and others, reference cited). * The observed biologic variability of the HIV RNA assays may be as high as threefold. Therefore, a change of more than threefold is considered significant, and a change of less than threefold may be due to assay variability. (Todd J. and others. Quantitation of human immunodeficiency virus plasma RNA by branched DNA and reverse transcription coupled polymerase chain reaction assay methods: A critical evaluation of accuracy and reproducibility. SERODIAG. IMMUNOTHER. INFECT. DIS. 1994; volume 6, number 4, pages 233- 239. * Pachl C. and others. Rapid and precise quantification of HIV-1 RNA in plasma using branched DNA signal amplification assay. JOURNAL OF APPLIED IMMUNE DEFICIENCY SYNDROMES AND HUMAN RETROVIROLOGY 1995; volume 8, pages 445- 454. * D. Chernoff, personal communication, 1995.) * Repeating the assay improves reliability. It is recommended that the assay be repeated, rather than relying on a single value, before the value is used for decisionmaking to initiate or change therapy. (Todd and others, reference cited. * Dewar R.L. and others. Application of branched DNA signal amplification to monitor human immunodeficiency virus type 1 burden in human plasma. JOURNAL OF INFECTIOUS DISEASES 1994; volume 170, pages 1172-1179. * Pachl and others, reference cited.) * Changes in plasma HIV RNA are seen as early as two to four weeks after the initiation of a new therapy with antiviral activity. Obtaining a plasma HIV RNA quantitation at this time may indicate whether the therapy has been effective in acutely decreasing plasma HIV RNA. * Obtaining HIV RNA measurements during any acute intercurrent illness or within four weeks after a patient receives a vaccination (including influenza) may impact on the interpretation of plasma HIV RNA results. ***** White House Meeting on AIDS by John S. James About 130 people will be invited from around the country to a one-day White House Conference on HIV and AIDS on December 6. The invitees will include "people living with HIV and AIDS as well as experts in the areas of research, prevention, care, discrimination, and health and income support." The program is still being put together, but at this time it looks like there will be about ten workshops in the morning, for discussion of particular topics; the people will be invited for a specific workshop. In the afternoon, President Clinton will arrive for a plenary session. In the White House, the Office of National AIDS Policy is now setting up electronic and other channels for people "outside the Beltway" to have input into this process. ONAP is also planning a publication after the conference, to record what happened there, as well as the ideas, information, and experiences forwarded from the public. Comment So far the announced plans are getting diverse responses. People question what can be done with a one-day meeting where many of those coming together are likely to be unknown to each other. Current plans seem to be not to announce the invitees in advance, limiting opportunities for prior organization. On the other hand, we do not rule out the possibility of constructive results. Ideally, Clinton could find a path by which the public could respond to AIDS as a mainstream issue in a way which has not happened before. Our suggestion to Clinton would be for a long-term, high- profile initiative to improve and support medical research overall. This would offer a readily perceived benefit to everybody, since it could save the life of anyone in the United States or elsewhere. At the same time, it builds on U.S. technological and economic strengths, helping to secure our economy and our future. It need not cost much, since big money is already being spent, often ineffectively; this project should focus on low-cost activities such as developing strategic relationships. A number of relevant ideas have already been articulated; the first step of a White House initiative would be for a small, high-level team to borrow from the existing work, and craft several possible options for moving forward. ***** FDA Antiviral Advisory Hearings on Lamivudine (Epivir(TM), 3TC), Saquinavir (Invirase(TM)), Stavudine (Zerit(TM), d4T), November 6-8 The FDA Antiviral Drugs Advisory Committee will hold its most important meeting for a long time on November 6-8 in Silver Spring, Maryland. The FDA usually follows the recommendations of this committee concerning drug approvals. Public testimony will be accepted during a half hour each day. Three different drugs will be considered: * On November 6 the committee will discuss the NDA (New Drug Application, or request for marketing approval) for tablets and oral solution for lamivudine (also called Epivir, or 3TC). The meeting will begin at 8:30 a.m., and be open to the public all day, with public testimony from 11:30 to noon. * On November 7 the committee will consider the NDA for saquinavir (Invirase), a protease inhibitor developed by Hoffmann-La Roche. Invirase is likely to be the first protease inhibitor to be approved. This meeting also will also begin at 8:30 a.m. and be open all day, with public testimony from 11:30 to noon. * On November 8 the committee will look at the results of confirmatory trials of stavudine (Zerit, or d4T). Stavudine has already been approved, but with restricted "labeling," or indications for use. This meeting will be during the morning only, beginning at 8:00 a.m., with public testimony from 10:00 to 10:30. There will be a closed session November 8 in the afternoon to consider proprietary or trade-secret information. Stavudine will NOT be discussed at the closed session; we do not know what drug or drugs will be. All three meetings will be in the Maryland Ballroom of the Quality Hotel, 8727 Coleville Rd., Silver Spring, Maryland (about three blocks from Silver Spring Station, on the Washington Metro "Red Line"). Persons making reservations should mention the FDA meeting, as the hotel has a group rate of $89 per night. Members of the public wishing to speak at any of these three meetings should call Lee Zwanziger or Elizabeth Ortuzar at 301/443-4695, by October 31. You can always find out about upcoming hearings of the Antiviral Drugs Advisory Committee by calling the FDA Committee Management Office hotline, 800/741-8138, or 301/443-0572; the 5-digit code for the Antiviral Drugs Advisory Committee is 12531. This hotline has information even before it is published in the Federal Register. Comment Meetings of the Antiviral Drugs Advisory Committee usually include more detail about the drugs than is presented at professional conferences. And FDA analysts, who have studied the NDAs (New Drug Applications, thousands of pages each, which are not usually released to the public), critique the presentations of the company researchers. Their meetings, therefore, can be the most in-depth source of information available about new drugs. Sometimes one or more community representatives or activists are appointed temporarily, for a single meeting, to FDA advisory committees. We have heard that there is much pressure of people trying to get on for one or the other of these three days. Our understanding of the major issues is as follows: * Lamivudine (Epivir, 3TC). Glaxo-Wellcome is asking the FDA for an indication for AZT plus lamivudine as initial combination treatment for HIV in persons with a CD4 (T-cell) count of zero to 500. This combination has shown good results in viral load and CD4 counts; a longer "confirmatory trial," now going on, is looking for clinical endpoints (death or AIDS progression) in persons with CD4 counts between 50 and 250. Some activists are unhappy that the clinical-endpoint trial does not cover the entire 0-500 CD4 range the company is requesting in the labeling. The problem is that it is hard to measure clinical progression in persons with CD4 counts over 250, since very little clinical progression occurs at high CD4 counts. (Those under 50 were excluded apparently because of an earlier belief, now widely considered to be erroneous, that it is hard to see much effect of drug treatment in those with CD4 counts that low; this may have been true when treatments were less effective than those now being studied.) Our concern is that the AZT plus 3TC combination does appear to be a reasonable treatment possibility for a physician and patient to consider at almost any CD4 count -- and restricting the labeling will create hardship by making it difficult to get the drugs paid for. CD4 boundaries are arbitrary, mostly inherited without much thought from old trials designed years ago. If this combination slows disease progression in those with counts from 50 to 250, there is no reason to believe it will suddenly stop working because the count is 40 or 300 instead. * Saquinavir (Invirase). This drug probably qualifies for accelerated approval, based on surrogate-marker results showing superiority of combinations including saquinavir to standard treatment -- and the existence of large, ongoing clinical-endpoint trials to confirm the surrogate-marker data. But there is concern that the dose which will be recommended -- the standard dose which has been tested in large trials -- is lower than the most effective dose. This could be a problem because too low a dose of a drug can lead to faster development of drug resistance by the target organism. On the other hand, saquinavir seems to cause HIV drug resistance relatively slowly, even at the current dose -- and to cause less cross resistance (resistance to other protease inhibitors, even though the virus has never seen them) than other protease inhibitors do. If this is true -- and we will know better after listening to the experts debate at the meeting -- it would argue for approval. But in either case, unless the danger is very great, we think the drug should be approved, with warnings if necessary. Many people do not have time to wait for the newer formulation of saquinavir which is designed to deliver higher doses, or for new doses, combinations, or treatment strategies to be tested. They should be allowed to make informed treatment decisions now. * Stavudine (Zerit, d4T). Our understanding is that this meeting will focus on whether Bristol-Myers Squibb has met the requirements of confirming the accelerated approval of stavudine. New recommended uses for this drug will be discussed at a later meeting, not at this one. [Stavudine note: Some activists have talked to a number of people who reported sleep disturbances when taking stavudine; usually the problem was solved simply by taking the drug earlier in the evening, not at bedtime. This information does not appear in the official product literature, possibly because less serious side effects are often not reported by clinical-trial volunteers, who may fear losing access to the drug. Stavudine may be taken without regard to meals; the two daily doses should normally be used 12 hours apart.] ***** International Conference, Vancouver 1996: Arrangements, Deadlines by John S. James The XI International Conference on AIDS will take place in Vancouver, British Columbia, July 7-12, 1996. Space is tight and the best time to make arrangements is now -- not only for presenters and organizations, but for anyone attending. Deadlines start as early as February 1. The International Conference on AIDS now occurs once every two years; it was annual until 1994. The theme of the Vancouver conference is, "One World. One Hope" -- with four guiding principles of Excellence, Practicality, Sustainability, and Solidarity. This meeting will introduce a number of innovations: * Program formats. As at previous International Conferences, most of information will be presented as oral abstracts and posters; there are also symposia, daily summaries, and raporteur sessions. The Vancouver conference will also include formal debates, skills-building workshops, and "late breaker" sessions (for new material which could not be submitted by the regular deadline). * Health insurance for attenders, including persons with HIV, is included in the regular conference registration fee. * Three different "pathways" -- Women and HIV, Development and HIV ("individual and societal impact of HIV/AIDS in developing countries and newly independent states"), and Living with HIV -- will be color-coded in the program book. * Blinded review of abstracts. The reviewers who evaluate the abstracts will not know who the authors are. * A World Wide Web site now includes the 40-page "Second Announcement and Call for Abstracts" at: http://unixg.ubc.ca:780/~fortin/Marcel.html (Note: The 'M' must be capitalized.) Also, the conference secretariat now has an email address as well as other contact information (below). Some conference abstracts will be released online at the time of the conference -- but unfortunately not before. Deadlines February 1 is the deadline for: * Receipt of abstracts (except for late-breaker sessions), delivered by mail or courier (not by fax) in Vancouver, by 1700 hours; * Early registration ($975 Canadian -- which is about $750 U.S., as of October 20). After the deadline, the price goes up; * Full refund for registration cancellation (less $60 fee); * Scholarship applications. (The government of Canada has funded 1,000 scholarships; more will be offered if funding can be found.) May 1 is the deadline for: * Standard registration; * Registration cancellation with 50% refund; * Hotel accommodations. Early registration is strongly advised. Because of limited hotel space, it is possible that some registrants may be housed in Whistler, two to three hours away. Most hotel space is reserved for the conference or for other groups, and persons cannot make hotel reservations through the conference without registering first. There is a student discount, which is basically the same as the regular fee, except that it includes accommodations. Media registration is without charge. It requires a photocopy of official press credentials, or a letter from a media organization verifying one's assignment. Freelance journalists must submit three bylined articles; newsletter writers and editors must submit three issues with bylined articles or credit in the masthead. Media may then request hotel accommodations through the conference (which was not allowed in some prior conferences). A Community Liaison Committee provides advice regarding community participation and program needs of the community, and it coordinates with groups representing people with AIDS, and with AIDS service organizations, throughout the world. The U.S. representative on this committee is Eric Sawyer, 212/864-5672; or you can call Andrew Johnson in the Community Liaison office at the Conference (see contact information below). Eric stresses that (for any organization that want to hold a session or otherwise influence the conference) the time to get involved is now; decisions about the conference program will be made starting in November, as abstracts are submitted. There will not be enough space for all organizations likely to request a meeting room. Note that satellite symposia -- sponsored both by nonprofit organizations (often called "private volunteer organizations," or "non-government organizations," in different countries), and by companies -- will be scheduled for July 6 and July 7, and for July 12; they can also be scheduled in the evenings on the days of the conference itself, which may be especially suitable for nonprofits. Check-in for the conference is July 6, 12:00 - 18:00, July 7 08:00 -18:00, and July 8-11 07:00 - 16:00. The conference opening ceremony begins at 16:30 on July 7, and the closing ceremony begins at 18:30 hours on July 11. Note: $30. of the regular registration fee can be directed by the registrant to either a 1996 membership in the International AIDS Society, a donation to the Global Network of People Living with AIDS (GNP+), or a donation to the International Council of AIDS Service Organizations (ICASO). The registration form can also be used to make an additional contribution to the scholarship fund. For more information on registration, travel and hotel arrangements, submission of abstracts, the scholarship program, etc., and for copies of the forms required, contact the XI International Conference on AIDS, Conference Secretariat, PO Box 48740, 595 Burrard St., Vancouver, BC Canada V7X 1T8. Phone: 800/780-AIDS (Canada or U.S.), 604/878-9995 (worldwide), fax 604/668-3242, email aids96@hivnet.ubc.ca. Or use the World Wide Web address above; but note that the Web site does NOT include the registration, accommodation, and other forms. ***** Thalidomide Conflict -- How to Help On October 16 the PWA Health Group, the largest buyers' club in New York and the activist group most expert on issues around thalidomide, protested tentative plans to make patients pay to participate in a randomized clinical trial, when they needed compassionate access to thalidomide to treat wasting syndrome. The issues around thalidomide are critically important, rapidly changing, and complex; we could not prepare a full report in time for this issue, but will try to do so in the future. For more information now, including suggestions for how you might help, call or fax the PWA Health Group, 212/255-0520, fax 212/255-2080. ***** Internet Newsgroup sci.med.aids -- New Addresses The Internet "newsgroup" called sci.med.aids, probably the most widely distributed AIDS information on the Internet, is now moving and has new email addresses. sci.med.aids is an electronic mailing list which allows you to post information which is then distributed around the world, and likely to reach over 70,000 people. This is a "moderated" newsgroup, meaning that submissions are not sent out until they are approved (by at least two of the five moderators of sci.med.aids). Most people use sci.med.aids only or mainly to obtain information, not to send it out. But in case you also want to submit material to the thousands of subscribers, we have summarized some of the rules: To be accepted, submissions must be relevant; sci.med.aids covers topics of interest to people with HIV, their caregivers, service providers, educators, researchers, health officials, and the general public. Unconventional medical or research claims must be accompanied by references to major newspapers or magazines, or to major scientific journals. Opinion/analysis articles are acceptable, but they should not include personal attacks, and should not invoke religion. Submissions must not violate copyright laws. And to avoid inefficiency, they should not include more than 20 percent text from a previous article; instead, it is usually better to tersely summarize the article to which you are responding, in square brackets. Before replying in anger, it is best to wait a day and see what other reactions have been posted. And a great many submissions are rejected just because they would be more appropriately sent to an individual who posted a previous message, or to the moderators of sci.med.aids, instead of going out to 70,000 people. Before submitting articles, one should read sci.med.aids and become familiar with the kinds of material distributed there. Despite such policies, readers should beware. There is no way to screen out all erroneous or dangerous treatment suggestions, and many messages on this system are from people with an axe to grind. How to Use sci.med.aids * Most people read sci.med.aids as a "newsgroup," which is made available by their Internet service provider. If your Internet service provides the sci.med.aids newsgroup feed, the messages will be saved, usually for several months or more, and you can read them whenever you want. It is preferable to receive sci.med.aids this way, as a newsgroup, if that option is available to you. * If your service provider does not receive sci.med.aids, you might ask them to carry it. Or you could subscribe on your own; then you can get sci.med.aids sent to you by email, whether or not your service provider carries it. * If you need to subscribe to sci.med.aids, send email with "subscribe aids" (without the quotes) in the body of your email message to: majordomo@wubios.wustl.edu (Note that the character before the '.edu' is the letter 'l', not the number '1'.) The "subject:" field in your message can be left blank. * If you need to subscribe but would prefer to get all the postings in a 24-hour period sent to you as a single message instead of being sent as separate messages, then send "subscribe aids-digest" in the body of your email to the above email address. * Note: Previous users, who were already receiving sci.med.aids either through the newsgroup or by email, do not need to subscribe again. They have been switched to the new system automatically. * If you want to submit your own message to the newsgroup, send your message -- exactly as you want it to appear -- to aids@wubios.wustl.edu DO NOT include comments to the moderators in your message. (Note: This address -- or any other that includes wubios.wustl.edu -- applies to old users and new users alike.) * To ask questions to the moderators, send them to aids- request@wubios.wustl.edu * If you have software to access the World Wide Web, you can get the most recent FAQ (frequently asked questions) list for sci.med.aids (and for HIV and AIDS) from http://family.hampshire.edu/aidsfaq/aidsfaq.html ***** California: Governor Vetoes Cryptosporidium Bill by John S. James On October 12 California Governor Pete Wilson vetoed legislation that would have allowed bottled water or home- filtration systems as a Medi-Cal (Medicaid) benefit to those most in need of safe water. Wilson also vetoed a bill to allow persons with AIDS, cancer, and other major diseases to use medical marijuana, and another bill to allow compassionate release of prisoners with terminal illness so they could die at home. On the other hand, he signed a bill strongly supported by the AIDS community to include HIV education in prenatal care. The bottled/filtered water bill would have only applied to persons with immune deficiency who could not safely boil their own water, and had no one else to boil it for them -- and it would only have applied when the county health department had made a recommendation that tap water be boiled. The bill was narrowed to this extent to satisfy legislators who otherwise would not have voted for it. The total cost, though hard to estimate, would clearly have been minimal -- in part because health departments and water districts are notoriously reluctant to declare boil-water advisories. Why would Wilson veto this bill, which would cost so little and address the greatest need in an area of serious and growing concern in many parts of California? Wilson said he did because, "If a Medi-Cal beneficiary is incapable of boiling water or cannot obtain boiled water from a family member or friend, then the beneficiary is eligible to receive attendant services through the Medi-Cal program," and the attendant can boil water for them. In fact, attendant service is not available for many people. The real reason seems to be that Wilson plans to cut Medi-Cal benefits, and safe water would have been an increase, although a small one. Until more people use the vote to insist on better quality public officials, the value of human life will remain small when government decisions are made. ***** San Francisco Area: Testosterone Replacement Study, Injection vs. Patch by John S. James Several dozen clinics and physicians' practices in the San Francisco area are now enrolling volunteers in a study of testosterone replacement for men who have abnormally low testosterone levels. This study will compare testosterone injections every two weeks with replacement by a patch which is worn daily on the scrotum; some volunteers will receive a placebo for the first 12 of the 24 weeks of the trial. (Both treatment options are already approved, and can be prescribed by any physician.) All study-required treatments and tests in the study will be free, except for an initial test for either free or total testosterone level. Low testosterone in men can cause fatigue, loss of energy, reduced sense of well being, reduced sexual drive, and possibly loss of muscle and lean body mass; this deficiency (whether or not HIV-related) has long been treated by testosterone injections. The patch may be a better replacement option, however, as the testosterone is delivered daily, like natural testosterone, not every two weeks as with the injections. Testosterone replacement should not be used in men with known or suspected prostate or breast cancer. The new study, called Testosterone Replacement in HIV-Related Hypogonadism, is being run by the Community Consortium, an organization of physicians in San Francisco Bay Area. It will randomly assign people to receive either the injections (intra-muscular testosterone enanthate, 200 mg every two weeks) or the patch (Testoderm(TM) by ALZA, worn on the scrotum, which must be shaved). In each of these two groups, two thirds of the volunteers will receive active drug throughout the 24 weeks of the study; the other 1/3 will receive a placebo for 12 weeks, then switch to active drug. Everyone will have lean body mass measured by DEXA scans (dual energy x-ray absorptiometry), and by BIA (bioelectrical impedance analysis), performed at the General Clinical Research Center (GCRC) of San Francisco General Hospital. Other measurements include weight, serum testosterone levels, CD4 and CD8 counts, viral load, changes in quality of life questionnaires, and self-reported compliance with the study regimens. This study is open to men over 17 years old, with either serum or free testosterone level below normal. For men over 40, the PSA (prostate-specific antigen, an indication of possible prostate cancer) must be no greater than 4.0. To avoid biasing the study, volunteers cannot have been hospitalized within the last month; and they must not have had a severe illness resulting in loss of more than 10 percent of body weight within six weeks, nor changed their antiretroviral treatment within 30 days. In order to enter this study, you must be seen for your routine care by a physician at a participating site. You can find out if your clinic or physician is participating by calling the Community Consortium, 415/502-0658. Note: A separate multi-center trial of the Testoderm patch is now being planned. Comment Anyone considering testosterone replacement should know that there is now a new testosterone patch which does not need to be worn on the scrotum, but can be worn on the abdomen, back, thighs, or upper arms. This is the Androderm(TM) Testosterone Transdermal System, which was approved by the FDA on October 2, 1995. It is marketed by SmithKline Beecham, and should be in the pharmacies soon. Its main disadvantage is that it often causes skin irritation at the application site. Another testosterone replacement system is a jell which has been approved in France for ten years; it is not currently available in the U.S., but will soon by tested here by UNIMED, Inc. The jell is applied to the forearm, and delivers a daily dose of testosterone in about 45 seconds. ***** Women Prisoners: San Francisco Bay Area Events November 4 (Saturday): An organizing meeting for a December 11 demonstration (see below) will take place from 3-5 p.m. at Catholic Charities, 433 Jefferson St., Oakland. For more information, call the California Coalition for Women Prisoners, 415/255-8350, or 510/834-5657 ext. 3150. November 10 (Friday): "Sparks Fly VI", 6th annual poetry, songs, and video, on the International Day of Solidarity with Women Political Prisoners. 7:30 p.m., Women's Building, 3543 18th Street, San Francisco, donation $7 to $25. For more information call 415/995-4735. December 11 (Monday): Demonstration on International Human Rights Day "to tell the California Department of Corrections that women prisoners need basic medical care, and to shut down the high security control units." The demonstration will be at the California Department of Corrections Region 2 Headquarters, 1145 Market St. (between 7th and 8th), San Francisco. It is sponsored by the California Coalition for Women Prisoners, and the Prisoners' Justice Action Network; for more information, call 510/255-7036 ext. 4, or 510/845- 8813. ***** Office of AIDS Research Announces Advisory Council On October 16, another government committee on AIDS was announced. The Office of AIDS Research Advisory Council "will provide expert advice to the Secretary the Assistant Secretary for Health, the director of the NIH, and the Director of the OAR on the planning, coordination, and evaluation of AIDS and AIDS-related research conducted or supported by the agencies of NIH." The press release listed 15 members and nine non-voting ex- officio members. ***** 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 fax: 415/255-4659 Internet: aidsnews@aidsnews.org Editor and Publisher: John S. James Reader Services and Business: Richard Copeland Thom Fontaine Denny Smith Tadd Tobias 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. 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