Subject: AIDS Treatment News #160 Date: Oct 02 1992 (757 lines) &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 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 #160, October 2, 1992 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: [items are separated by "*****" for this display] International Conference and Clinical Practice: Interview with Kenneth Mayer, M. D. ddI: FDA Approves Additional Indication Rifabutin: FDA Advisory Committee Recommends Approval for MAC Prophylaxis 566C80 (Atovaquone): FDA Advisory Committee Recommends Approval for Pneumocystis Treatment Warning: "Poppers" Return, More Evidence of Harm Political Funeral in Washington D. C. October 11; Date, Time, and Route Changed ACTG Meeting Starts Election Day; Remember Absentee Ballot What to Ask of Clinton: Call for Information ***** International Conference and Clinical Practice: Interview with Kenneth Mayer, M. D. by John S. James Kenneth H. Mayer, M. D., an infectious disease specialist, is the director of the Brown University AIDS program, and research director at the Fenway Community Health Center in Boston. We asked Dr. Mayer to outline some of the clinical "bottom lines" of the Eighth International Conference on AIDS (in Amsterdam, July 1992), information that can help physicians today in treating persons with HIV. [To make this interview easier for non-physicians, AIDS Treatment News added explanatory notes in brackets.] JJ: Looking back after two months, what do you see as the most important information from the International Conference for physicians treating HIV disease today? KM: "What the general media didn't report about Amsterdam is that certain clinical questions are closer to being resolved, but there are still many questions related to standards of care. Two major pragmatic issues are: combination antiretrovirals, given the drugs that are currently approved; and when to prophylax specific opportunistic infections. "Much of how you change your practice is nuance. I function as a specialist, I am not doing primary care; I generally see patients in consultation and advise their primary care doctors. I try to individualize recommendations for each person; some patients want to be on as few drugs as possible, and others want to pursue all possible leads, depending on how symptomatic the persons are and their perception of where they are with their infection. You have to respect these choices and work with people on each issue. Much of the data that informs clinical practice is fragmentary and evolving, often more slowly than we would like." JJ: What is most important now in anti-HIV treatments? KM: "One change will be parallel-track access for stavudine, or d4T. [This program will be for persons without approved treatment options; for more information about d4T, see AIDS Treatment News #159, September 18, 1992]. Several of us at Brown did a phase I trial, and were impressed early on that while the neuropathy could be problematic, we could cut back on doses and at times restart people after we had to stop. Eventually, we are all looking forward to new kinds of drugs, such as protease and tat inhibitors, but we can't bank on them yet, given the paucity of human trial data. With later- phase studies of d4T looking good, we will have another option for now. The long-term T-helper data that Lisa Dunkle, M. D., presented on this drug looks promising for many individuals. We hope this will be a nucleoside analog that is not associated with pancreatitis and may have better efficacy than others. It may be one of the more important nucleoside analogs by itself." KM: "Then we have the concern raised by the presentation of David Cooper, M. D., on treating people with much higher T- helper counts than when we are accustomed to begin therapy. Should we start nucleoside analogs even before the T-helper count drops to 500? Because there weren't many deaths or disease progressions in that study, what he reported was time to drop of T-helper count. Those with T-helper counts over 500 who were randomized to AZT did have a delay in their T- helper drop. "This one study does not make me start putting everybody with T-helper counts over 500 on AZT. But we should be open to the possibility that in the future, standard of care might be single-drug treatment initially [at any T-helper count], then starting to add drugs as the counts decline. But that is a leap of faith. Some people have already made that leap; I am not there. But it is hard to reject drug intervention out of hand. If a patient came to me and wanted to start AZT at a higher T- helper count, at least we have this promising data, but concerns about resistance, cost, possible chronic toxicities, and whether it really gives any clinical benefit in the long term, have to be considered as well. "Regarding combinations, multi-arm studies are now ongoing; we are waiting for results of ACTG 155 and ACTG 175 [clinical trials conducted by the AIDS Clinical Trials Group of the U. S. National Institute of Allergy and Infectious Diseases] to get a better feel for how and when to start combining. Robert Yarchoan, M. D., presented data comparing combination treatment with AZT plus ddI, vs. alternating treatment with those drugs [the combination seemed to work better]. I don't think it puts the nail in the coffin on alternating these drugs, but it makes me feel more comfortable combining them. "I still recommend monotherapy on AZT if people do not want to participate in trials and are asymptomatic and have T-helper counts less than 500. If the T-helper count does not stay stable over the next few months, I have a lower and lower threshold for adding another nucleoside analog. Depending on where their T- helper count is at that time and their clinical status, there are a number of people I put on ddC per indication, but there are times when peoples' counts have dropped rapidly and I put them on AZT plus ddI, now that this combination is prescribable. Their rate of change, their clinical history, makes me decide to use one drug or the other." JJ: Do you usually prefer ddC or ddI for combination with AZT? KM: "I feel frustrated that there is not enough data yet to make the decision. If there is any concern with the pancreas, the data would push me toward ddC. On the other hand, if there's a fairly rapid drop in T-helper counts, I have extrapolated from the data to add ddI instead of ddC at times, since ddI is looking so promising as monotherapy. There isn't enough data because there have not been adequate studies. When ACTG and CPCRA [the Community Program for Clinical Research on AIDS, which conducts community-based trials sponsored by the U. S. National Institute of Allergy and Infectious Diseases] results are available, I will feel more strongly about using one or the other. JJ: What about adding acyclovir to HIV treatment? That seems to be continually controversial. KM: "The acyclovir issue is a tricky one. The study which got so much press at first in the Times of London [in December 1991] and was reported by Mike Youle, M. D., at the International Conference found a survival benefit but not a decrease in CMV retinitis. The question is what is the acyclovir doing? Perhaps it is stopping subclinical reactivation of members of the herpesvirus family, and therefore reducing transactivation of HIV. [See "Activation of Human Immunodeficiency Virus by Herpes Simplex Virus," The Journal of Infectious Diseases, September 1992, pages 494-499.] It is also possible that subclinical CMV disease may cause organ dysfunction or susceptibility to other opportunistic infections; maybe we are not detecting it because we are using such an advanced endpoint, CMV retinitis. There have been studies with different doses of acyclovir that have not shown clear-cut benefit; here we see survival benefit. The drug continues to impress me; aside from the cost, it is well tolerated, and I have not seen it impede peoples' care. There is the issue of how many pills people are willing to take, but now that there is an 800-mg acyclovir pill, this is less of a problem, taking three or four or even five of those pills a day. "One question that remains is whether the new acyclovir prodrug can have a role in CMV prophylaxis; it is going into a trial in the ACTG. [A prodrug is a pharmaceutical that turns into an effective drug inside the body. The advantage of the acyclovir prodrug, BW 256U87, is that it allows larger doses to be given orally than would be possible with acyclovir itself. Acyclovir may have a very small anti-CMV effect.] "We still don't understand the biology [of acyclovir's benefit with HIV disease], but if something nontoxic has survival benefit I am happy to use it, but not entirely clear when to. If somebody's T-helper count is down and they have been on maximal antiretroviral therapy, or if acyclovir is something the patient requests, I increasingly add it in to the regimen. But it is hard to base a standard of care on one study with a survival benefit but not a clear-cut mechanism. There is biological plausibility, and we want to maximize quality of life, and how well people do over the long haul." JJ: What are the most important conference results on opportunistic infections? KM: "Some of the most useful information at the International Conference was on macrolide antibiotics and MAC. Also, Lowell Young, M. D., and colleagues had a paper in The Lancet [November 2, 1991] on azithromycin and MAC. R. E. Chaisson, M. D., and colleagues had particularly interesting data on clarithromycin at 500, 1000, and 2000 mg twice a day. The decrease in MAC bacteremia [in the blood] was impressive, and it happened quickly. The sobering data is that resistance did develop fairly quickly, so I do not think that single-drug therapy with either of the newer macrolides [clarithromycin or azithromycin] is a good idea. It is certainly important to treat this infection; data from Stephen Nightingale, M. D., showed that there are very many MAC cases. People with low T-helper counts are living longer, and therefore this disease is a major source of illness and death. Aggressive treatment with macrolides is clearly indicated. The question is, is it macrolide plus one drug? Chaisson said ethambutol; many of us would also use other oral agents. One thing the macrolides have done is to make it less likely for clinicians to use amikacin or other injectable aminoglycosides. "You can easily give a four-drug regimen with azithromycin or clarithromycin, ethambutol, ciprofloxacin, and then either rifampin or clofazimine. One of the issues on which drugs to use is whether to hold some in reserve because of the emergence of multidrug resistant MAC; that will be a hard one to sort out. There is also the issue of cross-resistance when people are at risk of getting tuberculosis; there is concern about using any rifamycin in that situation. "Concerning MAC prophylaxis [as opposed to treatment], one of the concerns of the FDA and its advisory committee has been that rifabutin might increase the probability of developing rifampin-resistant TB. The data is not at all clear; it is a theoretical concern." [Note: the Antiviral Drug Products Advisory Committee recommended approval of rifabutin for MAC prophylaxis on September 24, 1992, the day before this interview was conducted; the FDA will almost certainly approve the drug.] JJ: What is your practice now when somebody needs to start clarithromycin or azithromycin for MAC? What other drugs do you use? KM: "I would always add ethambutol and ciprofloxacin; when it was hard to get clofazimine I was adding rifampin, now I am adding clofazimine. At least those four. With five or more drugs, it gets onerous in cost and toxicity. Many physicians feel three would be enough; I would be happy to cut back. Studies of optimum combinations are underway. The other things you have to consider are which other drugs the patient has used or is currently using. "One important value of the data from Adria Laboratories [which conducted trials on rifabutin for MAC prophylaxis] is the good epidemiological information, showing, for example, at which T-helper counts people are likely to get MAC bacteremia. Very few above 100 developed it. But people with T-helper counts below 100 were also likely to be on multiple other medications, or to have other complications. If somebody has abnormal liver- function tests, for example, I certainly will not give them rifampin. And I do not think it would be wise to give full-dose ethambutol to somebody who had CMV retinitis, because the drug can cause ocular toxicity; even though it is a different kind of toxicity [than the damage CMV retinitis causes], one would not want to take any chance of impairing somebody's vision. You balance the regimen according to these kinds of considerations." JJ: What about rifabutin, which will probably be approved for prophylaxis soon? KM: "I put a couple people on the treatment IND [for early access to rifabutin before its marketing approval] in the past, and will use the drug when it is approved. I have been concerned that some physicians, even without a positive blood culture for MAC, have put people on clarithromycin or azithromycin because of the low T-helper count and the ease of writing a prescription. These are broad-spectrum and very useful drugs, but resistance can develop rapidly. "In the rifabutin trials, for ethical reasons, people were not kept on placebo after they developed MAC bacteremia. Because they were offered rifabutin and could also use other drugs, these trials would not show differences in survival. And unless you have autopsies, you may not be able to prove that MAC was the cause of death. But MAC bacteremia often indicates that people are severely ill, so I do not feel that I would be treating a laboratory value [meaning that people should start treatment for MAC (with more than one drug) if a positive blood culture is found, even if there are no MAC symptoms yet]. "The idea of MAC prophylaxis is that you would like to start early [before a positive blood culture]. In my mind, early enough is when the T-helper count is close to 100. I tend not to put many people on rifabutin with T-helper counts between 150 and 200. Again it would depend on the individual case, e.g. the presence of otherwise unexplained constitutional symptoms or laboratory abnormalities [which might justify rifabutin prophylaxis at higher T-helper counts]." JJ: What about other opportunistic infections? KM: "One concern is the intestinal parasites. There was data at the International Conference about better diagnostic techniques for microsporidiosis. One question is how much of the AIDS-related intestinal disease may be caused by undiagnosed infectious agents. "For cryptosporidiosis, there was some promising data on albendazole. And for patients with higher T-helper counts, many have had good experience with paromomycin [Humatin, a readily available prescription drug]. But not everybody responds to this drug; we clearly need better ones. Macrolides may be helpful here. "On toxoplasmosis, there was data suggesting that sulfonamide drugs used for pneumocystis prophylaxis or for other purposes seemed to have some protective effect against toxo. A European study looked at dapsone plus weekly pyrimethamine, an interesting approach. The pyrimethamine issue is still confusing, because there are people who are sulfonamide or sulfone intolerant and cannot be desensitized, so we want to know how effective pyrimethamine could be alone or in combination. There was a CPCRA study which suggested that pyrimethamine for toxo prophylaxis could be detrimental, but the mechanism was not clear. Perhaps use of folinic acid (leucovorin) might be helpful there. We need more information on toxoplasmosis prophylaxis; trials are looking at it both in the U. S. and in Europe. "The big issue in opportunistic infections is that we need large-scale multi-site trials of multiple OI prophylaxis regimens. Which ones give the broadest spectrum of prevention with the best tolerance, also considering drug interactions, and real-world issues of ease of administration and cost? "The other group of infections that need much more study are fungi. At what T-helper count should one consider fluconazole prophylaxis? Should the recommendation be gender-specific? "We are studying fluconazole prophylaxis of mucosal fungal infections in HIV-infected women. The CPCRA network is also doing a study; they are looking at a once-weekly dose, and we are trying smaller doses three times a week, 50 mg Monday, Wednesday, and Friday. It might be that antifungal prophylaxis should begin when T-helper counts are low, but the optimal starting point is unclear. This issue needs to be sorted out. Also, when should fluconazole be used to prevent cryptococcal disease -- or other disseminated mycoses?" JJ: Such as histoplasmosis, in some areas? In San Francisco we seldom see it. KM: "We rarely see cases in Boston, but in the South, and parts of the Midwest, it is a big problem. And in Arizona and some parts of California, coccidioidomycosis [valley fever] is a big issue as well." JJ: What else from the international conference comes to mind? KM: "The therapeutic vaccine data looked promising to me, as an adjunctive therapy in keeping peoples' T-helper counts higher. There were several good presentations. The followup [on people using some of the vaccines] is getting to be long enough that I am looking forward to expanded-access trials. We are very eager to participate in community-based therapeutic vaccine studies, based on the Amsterdam data. "The other treatment I thought was very promising -- I have prescribed it occasionally on an individual basis -- is pentoxifylline. Bruce Dezube, M. D., and colleagues did show reduction in viral load. That was impressive. I think quality of life measurements are important. We want people to feel better, even if we are only palliating them, as long as we are not causing any detriment immunologically. That pentoxifylline made a difference in HIV replication was important; I am looking forward to seeing more intensive studies and a better definition of the population where it will be beneficial. [For more information on pentoxifylline and the report at the conference, see AIDS Treatment News #156, August 7, 1992, pages 4-5.] "I think ICAAC will be a good conference for information on followup to Amsterdam." [For information on ICAAC, the Interscience Conference on Antimicrobial Agents and Chemotherapy, which will be held October 11-14 in Anaheim, California, see AIDS Treatment News #159, September 18, 1992]. "Progress has been incremental -- slower than we would like, but there were more practical developments at the conference than were generally reported. Hopefully a new U. S. administration will be able to mobilize the resources and cooperation needed for a more efficient process to get treatments from the lab to the patient." ***** ddI: FDA Approves Additional Indication On September 28 the U. S. Food and Drug Administration officially approved an additional indication (use) for ddI -- for treatment of patients who had already received prolonged prior treatment with AZT. Previously, ddI had only been officially approved for persons who could not tolerate AZT or had significantly worsened while using it. While the new approval does not give physicians any power which they did not already have, it will in practice encourage wider use of ddI. [Physicians can prescribe an approved drug for other than its approved indications, but many are reluctant to do so. Also, some third-party payers refuse to reimburse for expensive drugs which are used "off label" (for conditions other than the FDA- approved indications) -- despite the fact that FDA indications were never intended to be used in this way, since the standard of care in medicine often includes unlabeled use of approved drugs, especially for serious diseases such as cancer and AIDS.] The new ddI approval is based on results of a major study by the AIDS Clinical Trials Group of the U. S. National Institute of Allergy and Infectious Diseases (James O. Kahn, Stephen W. Lagakos, Douglas D. Richman and other, "A Controlled Trial Comparing Continued Zidovudine with Didanosine in Human Immunodeficiency Virus Infection," New England Journal of Medicine, August 27, 1992, pages 581-587.) This study enrolled 913 volunteers who had successfully tolerated AZT for at least 16 weeks; they were randomly assigned to either continue AZT, switch to low-dose ddI, or switch to high-dose ddI. The low-dose ddI group did best, with significantly fewer deaths and AIDS-defining events than the group assigned to AZT. The researchers were surprized that it did not matter how long the patients had been on AZT before switching. Another major study (ACTG 116A) has compared first-line use of ddI vs AZT, but the results are not known yet. They are expected later this year. ***** Rifabutin: FDA Advisory Committee Recommends for MAC Prophylaxis On September 24 the FDA's Antiviral Drug Products Advisory Committee recommended the approval of rifabutin (brand name Mycobutin) for prevention of MAC. Two studies conducted by the drug's sponsor, Adria Laboratories, found that volunteers with T-helper counts less than or equal to 200 developed MAC bacteremia (shown by positive blood cultures) about half as often in the group given rifabutin, compared to the group given a placebo. The FDA is not required to follow the recommendations of its advisory committees, but it almost always does so. Official approval of rifabutin is expected in the coming weeks or months. For more information about rifabutin, see the interview with Kenneth Mayer, M. D., in this issue. ***** 566C80 (Atovaquone): FDA Advisory Committee Recommends Approval for Pneumocystis Treatment On September 24 the FDA Antiviral Drug Products Advisory Committee also recommended approval of 566C80 (also called atovaquone), a drug developed by Burroughs Wellcome Company, for treating pneumocystis. The committee recommended that the drug be used as second-line treatment, if trimethoprim/sulfamethoxazole (TMP/SMX, commonly known as Septra, or Bactrim) could not be tolerated or failed to work. Trials had shown that TMP/SMX was more likely than 566C80 to be effective against pneumocystis, but also more likely to be discontinued because of side effects. The importance of 566C80 is to offer another pneumocystis treatment option for those times when it is needed. 566C80 might also be useful in treating toxoplasmosis. FDA approval of 566C80 is expected in the next several weeks or months. Meanwhile, a Burroughs Wellcome "treatment IND" program which started in November 1991 will continue to be available for those who need the drug now; there is also a similar "compassionate release" system for use outside North America. More than 800 patients have been treated in these programs. To enroll a patient in the treatment IND, physicians can call 800/755-2020, 7 days a week 24 hours a day. ****** Warning: "Poppers" Return, More Evidence of Harm by John S. James "Poppers" are nitrite inhalants which have been used in the gay community as a sexual aid. Following research reports that these chemicals might be contributing to immune problems in AIDS or to the development of Kaposi's sarcoma, they were banned in the United States in 1988. But now they are coming back, being sold allegedly for such purposes as removing fingernail polish, in sex clubs, bars, through the mail, and by advertisements in gay publications. One concern is that promoters of new preparations, in an effort to get around the law, could replace banned chemicals with substitute ones, with completely unknown effects when deliberately inhaled; one unlucky choice of ingredient could cause widespread damage. Efforts are under way to analyze inhalants now being sold to determine what they contain. [The 1988 law, section 8 of the Consumer Product Safety Act, banned the manufacture for sale, distribution in commerce, or importation of various forms of "butyl nitrite." Manufacturers then substituted isopropyl nitrite, and in 1990 Congress amended the law to also ban "volatile alkyl nitrites that can be used for inhaling or otherwise introducing volatile alkyl nitrites into the human body for euphoric or physical effects." We do not know if the current products have substituted other chemicals in order to evade this language.] In most of the world poppers are not illegal or regulated, and they have remained in widespread use in some countries. According to Hank Wilson, a well-known AIDS activist with ACT UP/Golden Gate who fought poppers years ago and recently brought the current resurgence to our attention, one problem in alerting the gay community to the dangers is that some gay newspapers are reluctant to report negative news about poppers because they carry advertisements for these preparations. As a result, young people now entering the gay community often do not know that there ever was a health issue or controversy about the use of these drugs. (A San Francisco law requiring a warning sign where poppers are sold took effect in January 1984. But today the traffic is underground, so this warning law isn't working.) The issue of poppers in the gay community first surfaced in 1981, and some observers suspected that poppers themselves might cause AIDS. Later, those theories were largely dismissed, but confusion occurred because some people thought the issue was finished. The remaining concerns are that poppers might be a cofactor in the development of AIDS, or could lead to relapse to unsafe sex, or make HIV infection more likely by causing changes in blood vessels(1), or possibly cause poisoning if unknown chemicals are substituted in an effort to evade the law. And some of the chemicals are known to degrade over time, so there could be harmful byproducts as well. Some researchers also suspect that the body may metabolize the nitrites to nitrosamines, which are strongly carcinogenic(1). Because of the high profit margin -- it costs about 25 cents for the chemical which sells for about $10 retail -- this issue is expected to remain with us for some time. Recent Studies of Popper Use Poppers have not been conclusively proven to be harmful; absolute proof would require a large clinical trial with people randomly assigned to take a placebo or each of the various chemicals in use, clearly an ethical impossibility. One recent study(2), however, gave repeated doses of amyl nitrite to volunteers and found suppression of immune functions, especially of natural killer cells, following moderate inhalation. The number of these cells did not decrease, but their activity decreased about 30 percent, and remained low until several days after the use of the drug was stopped. (The volunteers were HIV-negative men who had used poppers previously. The researchers' institutional review board would not allow the test to be repeated on HIV-positive volunteers, because of the risk of harm their health.) An epidemiological study in Vancouver published in May 1992(3) followed a cohort of 353 gay men and found that those who used nitrite inhalants were 2.3 times more likely to develop Kaposi's sarcoma than those who did not. Because such an association could be caused by factors other than the chemical effect of the nitrites (for example, those who used poppers might also have had more unsafe sexual contacts), the data was statistically adjusted for known HIV risk factors. Poppers use was still associated with increased risk of KS. However, an English study of 65 gay men(4) failed to find an association between poppers use and KS. An epidemiological study in Boston(1) found that poppers use increased the risk of HIV infection, especially during unsafe sex. And the same Vancouver research group mentioned above reported, at the 1991 International Conference on AIDS in Florence, that gay men who practiced unsafe sex were more likely to use poppers than those who did not(5). Two 1990 articles from the U. S. National Institute of Drug Abuse(6,7) called nitrite inhalants a leading candidate as a cofactor for the development of KS in persons with AIDS, and urged physicians to encourage patients to avoid their use. However, a report from the San Francisco City Clinic Cohort Study(8) did not find differences in nitrite use among AIDS patients with KS vs those who did not have KS. A study of gay men in the Paris area found that poppers use was associated with increased risk of being HIV positive, even after the data was adjusted for known risk factors(9). In an animal study, mice exposed to isobutyl nitrite 45 minutes a day for 14 days showed several kinds of immune suppression(10). This list is far from complete; there are many other medical-journal articles on poppers, most of them reporting evidence of health risks. We only included the ones which were published in 1990 or later, and which seemed most important. Therefore our list entirely omits the earlier medical-journal warnings about poppers which led to the law against them in the United States. Comment We may never have final answers to the questions about health hazards of poppers; some of the articles cited here did not find evidence of harm. But the weight of the evidence strongly suggests that poppers are certainly not safe and probably do cause damage to health, especially to persons with HIV. Since these drugs are coming back into use despite the U. S. law against them, people will have to make their own decisions. It is important that the available information be widely circulated in the gay community and among other users of such inhalants. Note: Anyone who wants to work on the poppers issue can call Hank Wilson at 415/441-4188, or write to him at 55 Mason Street, San Francisco, California 94102. References (1) Seage GR 3rd, Mayer KH, Horsburgh CR Jr, Holmberg SD, Moon MW, and Lamb GA. The relation between nitrite inhalants, unprotected receptive anal intercourse, and the risk of human immunodeficiency virus infection. American Journal of Epidemiology. January 1, 1992: volume 135, number 1, pages 1- 11. (2) Dax EM, Adler WH, Nagels JE, Lange WR, and Jaffe JH. Amyl nitrite alters human in vitro immune function. Immunopharmacology and Immunotoxicology. 1991: volume 13, number 4, pages 577-587. (3) Archibald CP, Schechter MT, Le TN, Craib KJ, Montaner JS, and O'Shaughnessy MV. Evidence for a sexually transmitted cofactor for AIDS-related Kaposi's sarcoma in a cohort of homosexual men. Epidemiology. May 1992: volume 3, number 3, pages 203-209. (4) Beral V, Bull D, Darby S, and others. Risk of Kaposi's sarcoma and sexual practices associated with faecal contact in homosexual or bisexual men with AIDS. Lancet. March 14, 1992: volume 339, pages 632-635. (5) Willoughby BC, Schechter MT, Craib KJ, and others. Characteristics of risk takers among seronegative men in a gay cohort. VII International Conference on AIDS, Florence, June 16-21, 1991 [abstract # W. C. 3003]. (6) Haverkos HW. The search for cofactors in AIDS, including an analysis of the association of nitrite inhalant abuse and Kaposi's sarcoma. Progress in Clinical and Biological Research. 1990: volume 325, pages 93-102. (7) Haverkos HW. Nitrite inhalant abuse and AIDS-related Kaposi's sarcoma. Journal of Acquired Immune Deficiency Syndromes. 1990: volume 3, supplement 1, pages S47-S50. (8) Lifson AR, Darrow WW, Hessol NA, and others. Kaposi's sarcoma among homosexual and bisexual men enrolled in the San Francisco City Clinic Cohort Study. Journal of Acquired Immune Deficiency Syndromes. 1990: volume 3, supplement 1, pages S32- S37. (9) Messiah A, Bucquet D, Mettetal JF, and Rouzioux C. Sexual practices associated with increased risk of HIV infection: the danger of self-defined safer-sex? VI International Conference on AIDS, San Francisco June 20-23, 1990 [abstract # S. C. 686]. (10) Soderberg LSF and Barnett JB. Exposure to inhaled isobutyl nitrite reduces T cell blastogenesis and antibody responsiveness. Fundamental and Applied Toxicology. 1991: volume 17, pages 821- 824. ***** Political Funeral in Washington D. C. October 11; Date, Time, Route Changed The political funeral in Washington D. C. (announced in AIDS Treatment News #158) has been moved up one day, to Sunday, October 11 (which is the last day of the display of the Names Project AIDS Memorial Quilt on the Washington Monument grounds). The new plan is to meet at the steps of the Capitol building at 1:00 p. m., and march from there to the White House. Bring ashes of someone who has died, or a picture, or an obituary. For more information, call Shane in New York, 212/866-7967, or call David in San Francisco, 415/252-7401. ***** ACTG Meeting Election Day; Remember Absentee Ballot On November 3-6, in Washington, D. C., several hundred AIDS researchers and assistants, and some AIDS activists, will attend the thrice-yearly meeting of the AIDS Clinical Trials Group of the U. S. National Institute of Allergy and Infectious Diseases. Since many of those attending will be traveling to the meeting and unable to reach their polling place on November 3, they will need to apply for an absentee ballot before the deadline to avoid missing the national election. (In California your application for an absentee ballot must reach the elections official by 5:00 p. m. on October 27; the deadline and rules may vary in other states.) For information call your registrar of voters, or a local political organization. Anyone who may be unable to get to the polling place due to illness or for any other reason should also consider absentee voting. ***** What to Ask of Clinton: Call for Information by John S. James If Clinton wins the presidential election on November 3, his transition team will have two months to prepare for the change of administrations. It will be a time of frantic political activities, mostly behind the scenes, as thousands of different interests try to influence planning and policy decisions and the appointment of hundreds of top officials throughout the Federal government. This transition work will mostly wait until after November 3, since until then the candidates will be preoccupied with the election. How well the AIDS community does in relating, for the first time, to a White House which is potentially responsive instead of fundamentally hostile, will depend greatly on how well this community knows what it wants to ask for -- and when and how to best ask for it. Government cannot come up with successful policies by itself; instead, its success will depend on relating with the people and organizations who have been working with the issues for years. But the AIDS community has never known a responsive White House, and has much to learn about its end of the relationship. There is no time to waste. To promote early discussion and planning, AIDS Treatment News will be covering the issues around a potential transition to a Clinton administration. If you have government or political experience or have thought much about this matter, you can help us by sharing your knowledge and ideas. What would we want from the White House? Do we want an "AIDS czar," or would it be better to focus on getting good people throughout the government? Who should (or should not) be appointed or re-appointed to the health-related offices that Clinton's team will fill? What kind of system do we want for providing access to health care? What should we ask for during the transition, and during the first hundred days of a new Administration? How could a president signal that it is time to change the widespread denial, hostility, and indifference toward AIDS in government, in the corporate world, and elsewhere in the national life? And is there any danger that the Democrats might backtrack on one thing Bush has done well -- supporting faster FDA action on treatments for life-threatening conditions? Send information and comments on these and other White House issues to: attn: Transition, AIDS Treatment News, P. O. Box 411256, San Francisco, CA 94114. [Obsolete subscription information has been removed. See the latest issues for up-to-date information. -- sysop] &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display