Copyright 1992 by John S. James; permission granted for non-commercial use. AIDS TREATMENT NEWS Issue #152, June 5, 1992 phone 800/TREAT-1-2, or 415/255-0588 CONTENTS: [items are separated by "*****" for this display] Gamma Globulin to Prevent Infections? NAC: Is It Absorbed? International Travel with HIV In Memoriam: Scott Slutsky Announcements: Gp160 Vaccine Trial for Asymptomatic HIV-Positive: Baltimore, Nashville, St. Louis MAC (MAI) Treatment Trial at NIH: Sparfloxacin, Azithromycin U. S. Hearing on "Unconventional Medical Practices," June 17 & 18, Bethesda, MD Resources: "Nutrition and HIV" 20-Minute Video AIDS Treatment Politics Newsletter, and Activist Survey ***** Gamma Globulin to Prevent Infections? by John S. James Background: What Is Gamma Globulin? Gamma globulin is the component of human blood which contains antibodies -- certain proteins which are specially made by the body to fight particular infections. A number of gamma globulin preparations are available as prescription drugs; when injected, the antibodies provide temporary protection against certain infections, for up to several weeks. They provide a passive immunity (unlike vaccines, which stimulate the body's own immune system to produce antibodies and/or infection-fighting cells). Unfortunately, the more recently available intravenous gamma globulin preparations are too expensive for widespread use (except for infants and children with HIV, who probably have a greater need for this protection than adults do). But intramuscular gamma globulin, which has been available for decades, costs very little; it is safe, FDA approved, and is routinely used to protect against various infections. It has not been formally tested for persons with HIV, and there might never be such a trial. But the safety and cost "downside" of this treatment -- a sterile preparation made from HIV-negative blood -- is low enough that patients and physicians may want to try it, despite the lack of formal trials. This potential treatment was brought to our attention by Joseph A. Hertell, M. D., an internist in private practice in Atlanta, who was involved in developing intramuscular gamma globulin in the 1950s. We asked several other physicians what they thought about using this treatment for persons with HIV. Our impression is that while few HIV physicians have used it, most do not dismiss the possibility; they recognize that it does have a scientific rationale. (There is more interest among physicians in the much more expensive intravenous gamma globulin, but little use of it for adults because of the cost. Physicians can often get insurance reimbursement, however, by being very familiar with the FDA-approved non-HIV indications for this treatment; patients who are candidates can often be fit into one of those.) We suspect that the low- cost intramuscular gamma globulin may be underused, since there is no commercial incentive for any company to promote it. Dr. Hertell has had little problem getting insurance companies to pay for the intramuscular gamma globulin -- which is not surprising, since this treatment costs very little and might prevent hospitalization or other expensive care. But reimbursement is not critical, since the cost is so low that most patients could pay it themselves if necessary. Interview with Joseph Hertell, M. D. JJ: How did you decide to try gamma globulin? JH: "I was medical director of the American National Red Cross in the early 1950s when we started fractionation of plasma proteins. At that time we brought out gamma globulin, fibrinogen, and the other proteins. My interest was in gamma globulin. We first used it to prevent hepatitis. "I'm a general internist; for a while, we in Atlanta depended on the infectious disease physicians to treat HIV patients. But with the rising number of cases it became impossible for them to carry the load. So I became more involved in taking care of AIDS patients as their counts began to drop. I first tried gamma globulin because I did not see any hazard to the patient; and on the positive side, it has a number of antibodies, and might be of value in preventing infections in immune-deficient persons. "We started using gamma globulin over two years ago. I usually began the treatment when patients' T-helper counts fell below 400. We have followed 14 patients using gamma globulin; only one of them has discontinued the treatment. Of the 14, three started with T-helper counts under 100, two between 100 and 200, three between 200 and 300, five between 300 and 400, and one with over 400. "This treatment does not seem to make much difference in the drop of the T-helper cells. What has impressed me is that none of these people has had any serious AIDS-related illnesses; in fact some of them have been able to resume activities. One with a count of 33 has gone back to work, and one with a count of 52 has taken a long vacation overseas. They're all active, and they have not had the AIDS-related illnesses I see in other patients. "We also start patients on vitamin B-12 injections after they go below 100, because they might not absorb B-12 easily from the gastrointestinal tract. This is based on studies in the very elderly, who have a compromised immune system. "Now I routinely start gamma globulin when patients go below 500 T-helper cells. We give 2 cc of gamma globulin weekly. That seems to be working well. I have not gone to the IV gamma globulin; that is very expensive. We do use it in pediatric HIV cases, especially when they have AIDS-related problems. But for adults it is expensive, and I see no reason for it, since the intramuscular form is rapidly taken up in the blood. "The gamma globulin we use (brand name Gammar) costs about $30 for a multiple-dose vial. The patient buys it; most of the insurance companies will pay for it. The patients bring the vial to us, and we put their name on it. We don't have to charge them for the drug, and we give them the injections once a week. "What I notice is the lack of AIDS-related opportunistic infections. We do use aggressive prophylaxis. We often start Bactrim three times a week when the T-helper count goes below 500; when it drops below 200, we add fluconazole to avoid cryptococcal meningitis, clarithromycin to avoid MAC, and sometimes acyclovir. But the difference seems to be the gamma globulin." JJ: What dose do you use (for adults)? JH: "We give 2 cc of Gammar every week. "I am pleased with the results, and expect to use it increasingly for patients with T-helper counts below 500. We seem to be holding off infections in these patients, by using other peoples' antibodies, from a pool of people. [Blood is pooled from a number of people to make each batch of Gammar; therefore, many different antibodies are likely to be present.] By repeating the treatment weekly, I believe that we are giving immunity to a host of perhaps minor infections, which would not be good for persons with compromised immune systems. While this treatment is not affecting the basic course of the illness, at least these people are able to do activities, to work and take vacations, that otherwise they might not be able to do because of numerous minor infections. The number of patients treated so far is small, but we have seen them in good health month after month." ***** NAC: Is It Absorbed? by John S. James NAC (N-acetylcysteine), a variant of the amino acid cysteine which is found in certain foods, is sold in buyers' clubs and health-food stores and has been used as a possible treatment for HIV infection for over two years; in San Francisco it is one of the most popular products sold at the buyers' club. Despite increasingly impressive laboratory science supporting the rationale of this treatment use, and the record of safety of the drug, NAC has followed the usual pattern in AIDS drug development of several years wasted, for no scientific, medical, or ethical reason, between the time a drug is known to be promising and the time is is tested as a treatment in a scientific trial. A small trial is now ongoing at the U. S. National Institute of Allergy and Infectious Diseases (NIAID), near Washington, D. C. (see AIDS TREATMENT NEWS #138, November 1, 1991), and another trial, a collaborative effort between Stanford and Project Inform, may soon begin. NAC is not easily characterized as either an "antiviral" or as an "immune-based therapy." Instead, it may intervene at various points in the pathogenesis (development) of HIV disease, by restoring normal levels of glutathione -- a substance essential to life which has been found to be abnormally low in T-helper cells and other blood cells in HIV-positive people. Glutathione is composed of three amino acids -- glutamic acid, cysteine, and glycine -- but the limiting factor in determining the body's supply of glutathione is usually cysteine, which is supplied by NAC. (Some health-food stores sell glutathione pills, but most experts believe that taking NAC is a much better way to raise glutathione levels than taking glutathione itself.) NAC is used in mainstream medicine, in very large oral doses, as an antidote for poisoning caused by an overdose of acetaminophen (e.g. Tylenol). This poisoning causes an extremely low level of glutathione in the liver, which can cause death; NAC works by restoring this glutathione level. Another drug, called procysteine, may also be effective in raising glutathione levels; procysteine is now in clinical trials, but is not generally available. Glutathione is important as an antioxidant, helping to protect cells from damage caused by oxidizing agents. Recent laboratory studies have suggested that an antioxidant might also have an antiviral effect. A normal signaling system inside the cell uses low concentrations of the oxidizing agent hydrogen peroxide -- but this same signal was also found to increase the growth of HIV in cells infected with that virus. Abnormally low levels of glutathione might allow the hydrogen peroxide in the cell to increase, causing HIV to grow faster than it otherwise would. [Note: hydrogen peroxide has sometimes been promoted as an "alternative" AIDS treatment; the research described above suggests that it might be harmful. AIDS TREATMENT NEWS published a warning against using hydrogen peroxide as an AIDS treatment (issue #132, August 9, 1991, and issue #134, September 6, 1991).] The only way to know with confidence what role, if any, NAC has in HIV treatment is through clinical trials. But since the necessary trials have not been done, people need to make decisions now on the basis of what information is available -- the laboratory science, and anecdotal reports. What we have heard anecdotally has generally been good, but not dramatic; clearly NAC is only part of the answer, at best, to HIV treatment. T-helper counts seldom show large increases, although NAC might be helping stabilize the counts. People often do report feeling better and having more energy, an effect likely to occur quickly, within several days after starting the treatment. NAC may be especially useful for certain persons with AIDS- related wasting which is not due to obvious problems such as inadequate food intake or gastrointestinal disease. Could NAC improve the functioning of T-helper cells, independently of whether the counts increase? One way to explore this possibility would be to include a delayed hypersensitivity test, such as the Merioux "MULTITEST CMI," in a controlled study of NAC. One laboratory study by researchers at the Linus Pauling Institute has suggested that combining NAC with vitamin C might be beneficial. (Harakeh S and Jariwalla RJ. Comparative study of the anti-HIV activities of ascorbate and thiol-containing reducing agents in chronically HIV-infected cells. American Journal of Clinical Nutrition. 1991; volume 54, pages 1231S- 1235S). This paper noted that a dose of about 12 grams per day of vitamin C, given to healthy adult volunteers, had produced the blood levels used in their laboratory tests. Is NAC Absorbed? An early report from the ongoing NIAID trial of NAC has raised doubts as to whether NAC is absorbed well enough when taken orally to be useful as a treatment. This writer was present when the data was presented at a meeting of the AIDS Clinical Trials Group in April. We believe that most physicians present left that room thinking that orally administered NAC was dead as a potential AIDS/HIV treatment. We, too, would have thought so, if we had not been following this treatment closely. But the report was preliminary; the NIAID research team had been asked to provide the interim results from its work in progress. The researchers conducting the trial do not believe that the drug has been ruled out; they are continuing the study. The data first addressed the question of whether NAC was absorbed when taken orally, by comparing blood levels after oral doses of the drug vs. blood levels after intravenous doses. This is an obvious test to run, and one that the FDA usually requires for a drug intended for oral use. The result was that the intravenous administration led to high concentrations of NAC in the blood, while the oral administration led to almost none. That result would seem fairly conclusive, but NAC experts we talked to explained that there is more to the story. First, that test was not new; NAC has long been used orally in Europe (for treating bronchitis), and similar tests of oral absorption had been done before. And they had found similar results; as with many drugs, only a small part of the NAC taken orally is found in blood tests for NAC. But the tests are limited, because NAC is quickly changed into other compounds by the time it reaches the bloodstream. Testing only for NAC will miss these other chemicals, which still may help to increase the glutathione level in cells; apparently it has not been feasible to test for everything which NAC might become. But in that case, why would much higher levels of NAC be found in the blood when the drug was given by injection? One likely possibility is that intravenous administration could supply NAC faster than the body could transform it (to substances which would not show up on the tests being used). Another reason for being skeptical of the idea that NAC could not work as an oral drug is that it does work as an antidote for acetaminophen overdose -- meaning that it must be absorbed when taken orally, in a form that can raise the glutathione level within liver cells, which NAC must do to treat acetaminophen poisoning, and which is also the effect being sought when NAC is used in HIV treatment. (On the other hand, the case could be made that the liver is unique, because it gets the "first pass" blood circulation from the stomach, and is often exposed to higher levels of oral drugs than is the rest of the body. Yet this may not be relevant in the case of NAC, since the liver in involved with its normal metabolism and supply to other tissues.) Some investigators believe that a better test of NAC is whether it raises the level of glutathione, within T-helper and other white blood cells. This measurement is somewhat difficult, as it requires special equipment and skill. Preliminary results were given at the same meeting which presented the absorption data; in these tests, the laboratory workers who analyzed the data were blinded as to which samples were from persons receiving NAC, and which were from an untreated HIV-negative control. All the samples tested (from volunteers in the small NIAID study mentioned above) showed normal glutathione levels both before treatment with NAC, and after it. This result has been questioned since several published studies have shown that HIV-positive persons have lower than normal levels of glutathione; here, everyone in the trial was HIV-positive, but nobody's glutathione level was low. If it was simply a case of the NAC not working, one would have expected the glutathione levels to be low both before and after treatment. (And if the levels were normal to begin with, NAC would not have been expected to raise them; glutathione levels are regulated by the body, so NAC probably could not increase the amount of glutathione if it already was normal.) These measurements of intracellular glutathione levels are fairly difficult; in the NIAID trial, the fresh blood samples had to be shipped 2,500 miles to a laboratory which had the necessary equipment. Confirmatory tests, including some at a different laboratory, are now in progress. Early results of the NIAID trial had previously been examined at an invitation-only meeting of NAC and glutathione experts in February 1992. We were not at that meeting, but have heard that these issues were raised. In the ACTG meeting in April, however, there was little time on the agenda for NAC, only a few minutes -- just enough to present the data itself, but not enough to consider different interpretations, or address the questions which had been raised. Although the NIAID trial was not designed to test the efficacy of NAC, it did measure T-helper counts, and indicators of viral burden (both acid-dissociated p24, and plasma viremia). None of the study volunteers showed improvement in any of these measures. Because of the possible importance of NAC and of the approach to therapy which it represents -- because of the great need for safe and affordable treatments, and for treatments which may reduce HIV activity in chronically infected cells, which AZT, ddI, and ddC do not do -- we believe that it would be a mistake to abandon oral NAC based on doubts raised by the early data from an unfinished study. The critical question remains the same as it has been for the last several years: Can NAC help in the treatment of AIDS or HIV? The answer remains unknown. Project Inform Will Assist New Study The NIAID trial mentioned above was designed primarily to test safety and absorption of different doses of NAC. Another study, cosponsored by Project Inform, has been developed to examine earlier reports that NAC can raise glutathione levels in T-helper cells and other white blood cells. This study was designed in a team effort including: Stanley Derezinski, M. D., of the AIDS Community Research Program in Redwood City, California; Leonard Herzenberg and Leonore Herzenberg, both Ph.D. and both members of the genetics department at Stanford University, and their associates; and staff of Project Inform. The Herzenbergs have been the driving force in bringing this potential treatment to the attention of the U. S. scientific and medical community. This study, now seeking the required approvals, will monitor glutathione levels while patients use 600 mg twice per day of a NAC formulation which is widely used in Europe. There will be 30 subjects in this trial, ten in each of three groups. One group will be persons with T-helper counts over 200, and a second will be those with under 200; both of these groups will start using NAC immediately. The third group will have five persons with T- helper counts over 200 and the other five with under 200; it will delay starting NAC for seven weeks, to serve as a control group during this time. Volunteers will be assigned at random to the immediate or delayed treatment groups. Glutathione levels in blood cells will be measured twice before treatment begins, and four times afterwards. Also, if funding permits, viral load measures, including acid-soluble p24 and DNA/RNA PCR, will be done before treatment, and on days 14 and 42 after treatment begins. No placebo will be used, but the researchers will be blinded when they measure the blood samples -- they will not know which are from persons taking NAC and which are not. This trial has not started yet. When approvals are received, Project Inform will handle all of the recruiting. For More Information * AIDS TREATMENT NEWS has published background articles on NAC. The major ones are in issues #88 (October 6, 1989), #92 (December 1, 1989), and #121 (February 15, 1991). * A two-page fact sheet on NAC is available from the PWA Health Group, the buyers' club in New York, 212/255-0520. It examines the difference between brands, possible problems if NAC is mixed with certain antibiotics, and the preliminary results of the NIAID study described above. * Dozens of technical articles have been published. A handful of the most important recent ones are listed below. They include bibliographies of other articles, for those who want to study this subject in more depth. Selected Bibliography Staal FJT, Ela SW, Roederer M, Anderson MT, Herzenberg LA, and Herzenberg LA. Glutathione deficiency and human immunodeficiency virus infection. THE LANCET. April 11, 1992; volume 339, pages 909-912. Roederer M, Ela SW, Staal FJT, Herzenberg LA, and Herzenberg LA. N-Acetylcysteine: A New Approach to Anti-HIV Therapy. AIDS RESEARCH AND HUMAN RETROVIRUSES. 1992; volume 8, number 2, pages 209-217. Staal FJT, Roederer M, Israelski DM, and others. Intracellular glutathione levels in T-cell subsets decrease in HIV-infected individuals. AIDS RESEARCH AND HUMAN RETROVIRUSES. 1992; volume 8, number 2, pages 305-311. Kalebic T, Kinter A, Poli G, Anderson ME, Meister A, and Fauci AS. Suppression of human immunodeficiency virus expression in chronically infected monocytic cells by glutathione, glutathione ester, and N-acetylcysteine. PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, USA. February 1991; volume 88, pages 986-990. ***** International Travel with HIV by Dave Gilden Note: Dave Gilden has covered AIDS for gay publications for two years. This is his first article in AIDS TREATMENT NEWS. Because of the upcoming VIII International Conference on AIDS (July 19-24 in Amsterdam), we asked him to research what people with AIDS or HIV should know -- about food safety, medical care, vaccinations, and crossing borders -- on international travel in general. Unfortunately, there is no comprehensive source of such information; what we did find is in the article below. JSJ Going to a foreign country, especially the large majority of nations where English is not dominant, can invert one's world. Nothing is easy, and even mundane chores like shopping for food or getting the laundry done suddenly require learning a whole new set of steps. The strain of daily life in a new country can be stressful. Many people get ill while traveling, especially since they are meeting new gastrointestinal and other microbes for which their immune systems are unprepared. What is true of many people is even more true of people with HIV, but this does not mean they cannot travel. "People with HIV who are reasonably smart about it can do anything everyone else can. They just have to be more compulsive about the normal precautions," said noted AIDS specialist Marcus Conant, M. D. . Medical Precautions To get a sense of the reasonable precautions to take while traveling in unfamiliar lands, AIDS TREATMENT NEWS talked with Susan Jacobson, M. D., an infectious disease physician by training, who runs a travel medicine clinic and also sees patients at the East Bay AIDS Center in Berkeley, California. Dr. Jacobson noted the dearth of information any physician has about the issues of traveling with HIV. Nobody is correlating individuals' experience. There are nevertheless many obvious considerations. Unlike some other physicians, Dr. Jacobson feels that no area of the world is a no-no for people with HIV. "There are just places to be a little more careful and a little less adventuresome." Certain parts of Africa and Asia, where medical care is poor, might be avoided depending on how isolated you will be -- and how much money you have. The key is to go with more drugs and be extra careful about sanitation. Travelers' diarrhea is perhaps the biggest threat around the world for everybody, striking as many as half of all visitors in certain countries. Of course, it threatens those with HIV worst of all. Fortunately, Septra/Bactrim (cotrimoxazole), which many already are taking to prevent pneumocystis, is a cheap and excellent preventive for gastrointestinal infections. Two tablets of Pepto-Bismol four times a day also helps, but the "gold standard" is the costly antibiotic ciprofloxacin (500 mg per day).The same agents are also good for treating diarrhea once it occurs. Usually, however, prophylaxis for diarrhea is not recommended unless you are very immunosuppressed. A wide range of microbes, including E. coli, shigella and salmonella bacteria plus amoebas and such exotics diseases as cholera and typhoid fever, can cause diarrhea. The safest way to avoid them is to look after your food and water: "Boil it, cook it, peel it or forget it is the rule to follow," says Dr. Jacobson. (This is also important in Europe, where undercooked meat is a major source of toxoplasmosis in people with AIDS.) Two diseases that cause not only diarrhea but much worse effects are typhoid fever and cholera. Vaccines exist for them, but the cholera one is not very effective and the killed typhoid vaccine has many side effects. Assiduous attention to sanitation, including proper cooking and safe drinking water, should help to prevent these diseases in places where they are common. There is a live typhoid vaccine that is usually safer than the killed one, but vaccines containing live, attenuated strains of bacteria and viruses are dangerous for people with HIV. Their immune systems may not be strong enough to resist even these weakened microbes. Generally recommended killed vaccines include tetanus/diphtheria and polio boosters; measles and hepatitis B (if susceptible); and pneumococcus and hemophilus influenza type B for all HIV-positive persons. Gamma globulin shots to ward off hepatitis A for up to four months is also a good idea when traveling to poor countries where the disease is widespread. Vaccines have been controversial because it is feared that stimulating people's immune system might increase the rate of HIV reproduction. This has not turned out to be a major concern given the small amounts of material used in vaccines. Dr. Jacobson noted that studies of immune system function after vaccination have not found any decline. Of greater concern is that the effectiveness of vaccines goes down along with the T- helper count. Vaccines are not very useful in people diagnosed with AIDS. Getting Emergency Care HIV and AIDS are not that great a problem when traveling because the illnesses related to them often (but by no means always) develop slowly so that there is plenty of time to go home or at least find appropriate care. The most frequent emergency facing travelers with HIV involves automobile accidents, just as with everyone else. If you need to see a doctor outside the U. S., try to find out where the U. S. consulate staff or the local expatriate community goes. That is a useful source of safe, expert medical assistance. U. S. consulates and other agencies do provide lists of physicians, but their reliability is questionable. When AIDS TREATMENT NEWS enquired at the State Department about its lists, we were told that the Department cannot recommend specific doctors. The lists that consulates maintain merely record all those doctors who expressed an interest in treating Americans. American consular officials also can help you contact friends or family back home for money to pay the doctor. They can even loan you money in case of dire need. (But note that they then stamp your passport that you owe the government money. This makes the document unusable except for the return trip until you repay the loan.) The financial entanglements of emergency foreign care are fearsome. According to John Schmidt, a partner in a gay- oriented insurance agency, "There's not a person I know who will cover [HIV-related] conditions" when traveling. AIDS and HIV fall under the "pre-existing conditions" exclusion clause of all types of traveler's insurance (including that for canceled tickets). If you already have health insurance that covers you in your trip's destination, you are lucky. Know the Country To get around the State Department's lackadaisical services, John Slama of Winship Travel, which counts many HIV-positive people among its clients, recommends: "Educate yourself about the countries you're going to. Find out about the AIDS situation there and about repression of local gays. It's good to develop contacts among the residents so that you can obtain reliable doctors and lawyers." One good place to start accumulating this information is in the Spartacus Guide for Gay Men (Bruno Gmnder Publications, U. S. office: 100 E. Biddle St., Baltimore, MD 21202; telephone: 410/727-5677), which is sold in gay bookstores and lists legal conditions along with health and service organizations by country. Slama, like Dr. Jacobson, notes that there is a need for someone to collect and disseminate individuals' actual experience. Theory counts for little in travel, where one's good times can be wrecked by the whim of some immigration or other official. Even coming back to the United States can be problematic for people packing a load of strange medicines, and HIV-positive resident aliens take a special risk. Still, international borders here and elsewhere have not proved a consistent hassle. So, have fun this summer. Just keep in mind the limits of your body, try to bone up on local conditions before you leave home, and you should be all right. Note: For additional food-safety information, whether for traveling or otherwise, obtain the brochure "Eating Defensively: Food Safety Advice for Persons with AIDS," by the U. S. Food and Drug Administration. It includes a short section on international travel. You can obtain a free copy from the CDC National AIDS Clearinghouse, 800/458-5231, Monday through Friday 9 a.m. through 7 p. m. Eastern time. ***** In Memoriam: Scott Slutsky by Bill Snow and Michael Becker Scott Slutsky, one of the most dedicated and effective AIDS activists, died in New York on May 28. Scott, a long-time, active member of ACT UP/New York, was particularly good at working with difficult drug companies and sticking with unglamorous issues until they were resolved. He contributed to forcing the approval of fluconazole for fungal infections, and to getting Abbott Laboratories to provide expanded access to clarithromycin, making that drug available for thousands of people as well as gathering data leading toward approval. Scott also worked on making rifabutin available as prophylaxis for MAC. Scott was one of the founders of the Countdown Eighteen Months project to develop treatments and prophylaxis for the five most common opportunistic infections, of a working group on non- nucleoside antivirals in ACT UP/New York's Treatment and Data Committee, and of the new treatment activist group TAG. Scott will be greatly missed. We hope others will pick up his work. ***** Announcements ** Gp160 Vaccine Trial for Asymptomatic HIV-Positive: Baltimore, Nashville, St. Louis A one-year phase I trial, sponsored by the U. S. National Institute of Allergy and Infectious Diseases, will test a therapeutic vaccine manufactured by Immuno AG, a company headquartered in Vienna, Austria. Volunteers must be asymptomatic, ages 16-60, with a T-helper count greater than 600. At least 40 percent of the volunteers accepted will be women. The vaccine is a genetically engineered (recombinant) gp160 (a protein of the AIDS virus). This vaccine differs from others in that it is produced in a mammalian cell line, instead of insect or other cells; therefore the protein better matches the shape of the gp160 made by native HIV. The same vaccine is already being studied in HIV-negative volunteers. A related vaccine has succeeded in protecting chimpanzees against HIV infection; it also induced a strong immune response in two chimpanzees who had previously been infected. Note: the requirement of a T-helper count above 600 does not mean that the vaccine will only work for persons in that range. This requirement probably reflects the ethical problem of running such a trial in volunteers with T-helper counts under 500, since AZT would be indicated for some of them, and such treatment, if allowed, would complicate the trial. For information on how to volunteer, please contact one of the following: Bill Wilson, Johns Hopkins University Center for Immunization Research, Baltimore, 301/955-4345. Lois Wagner, Vanderbilt University, Nashville, 615/343-2437. Carol Berry, St. Louis University School of Medicine, St. Louis, 314/577-8648 (women and hemophiliacs only). Michael Klebert, Washington University School of Medicine, St. Louis, 314/454-0058 (may be already filled for men). ** MAC (MAI) Treatment Trial at NIH: Sparfloxacin, Azithromycin Persons with MAC bacteremia but who are in a relatively stable condition and are able to travel to the U. S. National Institutes of Health, near Washington, D. C., may be eligible for a trial which will randomly assign sparfloxacin, azithromycin, or the combination of these drugs for MAC treatment. All volunteers receive treatment (there is no placebo), and all medication is taken orally. Study visits will be weekly for one month, every two weeks for the next eight weeks, and then monthly. Volunteers will be followed as long as possible. Those who fail any treatment arm may receive a four-drug combination consisting of sparfloxacin, azithromycin, clofazimine, and ethambutol. Part of the purpose of the study is to test this regimen. For more information, contact either Martha Larson, R. N., 800/772-5464 x311, or Barbara Baird, R. N., same phone number x420. ** U. S. Hearing on "Unconventional Medical Practices," June 17 and 18, Bethesda, Maryland The Office of the Associate Director for Science Policy and Legislation, at the U. S. National Institutes of Health, will hold a public meeting on unconventional medical practices, from 9 a.m. until 5 p. m., in conference room 10, building 31C, sixth floor, on the NIH campus, 9000 Rockville Pike, Bethesda, Maryland. "The purpose of this meeting is to convene a working group on unconventional medical practices and to receive public testimony from individuals and organizations interested in the subject of research and validation of unconventional or alternative medical practices." The entire meeting is open to the public; attendance may be limited by space available. The first day will be panel discussions, and planning for a larger meeting in the Fall. Public comment is scheduled for the second day. Persons wishing to make a presentation should contact the office below by June 8, and include a one-page summary of their presentation. Written requests to participate should be sent to: Stephen C. Groft, Pharm. D., Office of Science Policy and Legislation, National Institutes of Health, 9000 Rockville Pike, Building 1, Room 218, Bethesda, MD 20892. For more information, call 301/402-2466. ***** Resources ** "Nutrition and HIV" 20-Minute Video A 20-minute videotape on maintaining proper nutrition, overcoming eating obstacles, and safe food handling presents information from Larry Waites, M. D., M. P. H., who has a large HIV practice in San Francisco, and from Laurie Mello, a clinical nutritionist who specializes in nutrition for immune-compromised persons. Despite an introduction consisting of an "FBI warning" about unauthorized commercial duplication, various disclaimers, and sudden music, the material presented is well organized. It is divided into four sections: nutrition, weight loss, and the immune system; overcoming poor nutrition, caused, for example, by nausea, diarrhea, and loss of appetite; defensive eating (food safety); and total parenteral nutrition (TPN). The last section says little about TPN, beyond explaining what it is. This tape, priced at $19.95, is the first in a LIFETAPES series, which is produced by a not-for-profit venture of North South Films and Clinical Homecare. For information on how to order, call 415/281-8375. ** AIDS Treatment Politics Newsletter, and Activist Survey A newsletter from the Human Rights Campaign Fund, a gay and AIDS lobbying group in Washington, D. C., has started to fill a serious gap in information about what is going on within the Federal government concerning the funding, management, and politics of AIDS treatment and research. The founder and editor of AIDS Treatment Politics is Terry Beswick, who recently moved to HRCF from Project Inform. The current ten- page issue (#5, May/June 1992) includes an additional four- page supplement of treatment activists' comments on AIDS research, in response to an earlier survey by HRCF. Issue #5 includes information on Congressional testimony by Secretary of Health and Human Services Louis Sullivan (notable for its failure to mention AIDS), Assistant Secretary James O. Mason (which didn't occur at all because not enough committee members planned to attend), and Anthony Fauci ("Director of the NIAID (since November 1984), NIH Associate Director for AIDS Research, Director of the NIH Office of AIDS Research, Chief of the Laboratory of Immunoregulation, as well as Chief of the Immunopathogenesis Section within the Laboratory of Immunoregulation. In addition, Dr. Fauci serves as Executive Secretary of the NIH AIDS Program Advisory Committee and Chair of the National Advisory Allergy and Infectious Diseases Council.") Other articles reviewed a meeting of APAC (AIDS Program Advisory Committee), not to be confused with ARAC (AIDS Research Advisory Committee), which was reviewed in AIDS Treatment Politics issue #4. Another article reviewed the CDAC (Combined Division Advisory Committee), which includes members from ARAC and from NAAIDC (National Advisory Allergy and Infectious Diseases Council). The CDAC meeting, which Beswick described as the most interesting advisory committee he has attended, included some remarkable discussion by top scientists about what is needed and not being done in the management of Federal AIDS research: "What made the meeting interesting was a discussion of what was not being done. Dr. Maurice Hilleman, a senior, highly respected researcher with the Merck Institute for Therapeutic Research, elevated the level of discussion by raising a little hell. What follows is a loose paraphrase of his remarks from my notes: 'The failing of the science of AIDS is pathogenesis. If I were doling out this money, I'd be doling it out for pathogenesis... "'What is the shortage? It isn't scientists, investment capacity, dollars...What about the organization? I've been around even before polio. Research in the U. S. and around the world is investigator-initiated. But this is directed at basic knowledge and publication. But what does it take to do target development research? You need a critical mass of people sticking together, working together. Working together with the requisite discipline. Dedicated facilities. Sole intent. A benign dictator...Ideally you'd like to have a Manhattan Project. The single room concept: One big warehouse, one boss. But I don't think this is going to happen. "'Yet if you could get a group together every month or two and present results...Stand together, and determine what remains to be done. Use a collective committee structure -- not an advisory committee -- with a mechanism supported by contract. The way we did it (with polio), we had a contract officer sitting at the table with us, and the dollars went out immediately. The six months wait is a waste of time. These grant reviews -- sure death...But these models have worked in the past. That sort of thing is going to have to be created, hopefully by the Public Health Service...Form a collective group, get a benign leader -- just do it...' "After this little lecture, discussion relapsed to what was meant by 'coordination' and whether there was enough money to undertake such a different approach. Hilleman explained that he was talking about coordinating basic research and that there was "probably too much money and too little thinking... Maybe what we need is guts in government. At some point we need government to tell government what to do. Piddling is getting us nowhere.'" [AIDS Treatment Politics #5, pages 6-7] Other news concerned positive statements on AIDS by Presidential candidate Bill Clinton, and Derek Hodel's move from New York's PWA Health Group to Washington, D. C., to do treatment advocacy for the AIDS Action Council, starting in July. A number of upcoming meetings on vaccines, TB, and other topics were listed. There was also a report of Project Inform's immune restoration conference in Washington (see AIDS TREATMENT NEWS #151, May 15, 1992). Activist Survey The four-page supplement to AIDS Treatment Politics #5 published the responses to a survey sent out in a previous issue -- responses from "treatment activists on both coasts, a congressional aide, a treatment newsletter editor, a few directors of community-based treatment organizations, and a prisoner with AIDS. " It would be hard to summarize the responses, which were published in full and anonymously. The questions they address concern the major obstacles or problems with current research efforts, problems in the efforts of AIDS treatment activists, what could be done to improve research efforts, and specific steps that might strengthen the activist movement. The many well-considered viewpoints expressed will help stimulate ideas and discussion. To obtain a copy of the newsletter and the survey results, send a self-addressed stamped envelope (with three ounces postage) to: AIDS Treatment Politics, Human Rights Campaign Fund, 1012 14th Street, N. W., Suite 607, Washington, D. C. 20005. To subscribe, send a postcard with your name and address. AIDS Treatment Politics is free, although donations to HRCF are appreciated. ***** 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: John S. James Michelle Roland Denny Smith Reader Services, Business, and Marketing: Thom Fontaine Jason Heyman 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. Posted to sci.med.aids by: -- ----------------------------------------------------------------------- Jack Hamilton jfh@netcom.com P. O. Box 281107 SF, CA 94128-1107