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Page 12 AIDS FOCUS Experimental AIDS Drugs: Should You Take Them and When? Part 2 of a 2-part series In Part 1 of this series (see Southern Voice, Vd. I, No. 9), Terry Francis discussed the pros and cons of taking experimental AIDS drugs and the need for HIV positive persons to stay current on the different approaches to treatment. In Part 2 of "Experimental AIDS Drugs", Francis continues his analysis ofdextran sulfate and other drugs currently available in this country. Southern Voice neither advocates nor endorses these drugs. Dextran Sulfate A promising drug that was given "high priority" status by the National Institutes of Health (NIH) last year, Dextran sulfate should finally enter clinical trials in San Francisco later this summer, but possibly only with persons who arc asymptomatic. Research has been delayed due to bureaucratic problems. Currently charges of ineptness and mismanagement are flying at the NIH and National Institute of Allergy and Infectious Diseases(NIAID) over the handling of Dextran sulfate. Early reports indicate strong antiviral effects in vitro, and trials overseas suggest Dextran sulfate might work best in combination with other drugs. Dr. Donald Abrams of San Francisco General Hospital has satisfactorily completed a Phase I toxicity trial. In April a House subcommittee on human resources held hearings to uncover reasons for the delay of testing "high-priority" drugs such as Dextran sulfate. Dr. Anthony Fauci, director of NIAID, testified that lack of staff was responsible for delays in beginning research. Dr. Thomas Merigan who heads an AIDS Clinical Trial Unit at Stanford University asserted that delays were "NIH asserts that it is not seeking to prevent sale of Dextran Sulfate to Americans in Japan or prevent them from inporting it into the U.S." caused by problems ascertaining drug levels in the bloodstream and choosing proper dosage. But a trip before the House subcommittee apparently helped to make blood measurements behave, because San Francisco General's Phase n trial was soon given the go-ahead. This is another instance in which NIH and NIAID appear to not be living up to their promise of keeping the public informed on exactly why certain delays are taking place. Dextran sulfate has been in use in Japan for at least 20 years and is available there over-the- counter. Americans may legally import a small amount into this country for personal use. NIH asserts that it is not seeking to prevent sale of Dextran sulfate to Americans in Japan or prevent them from importing it into the U.S. "Living With AIDS," which normally appears on the AIDS Focus Page, will continue in future issues. Submissions to "Living With AIDS" are welcome from PWAs, PWARCs, health professionals and others affected by the AIDS crisis. Submissions should be no more than 400 words in length, and typed or legibly printed. Mail submissions to: Southern Voice P.O. Box 54719 Atlanta, GA 30308 Dextran sulfate seems to work as an antiviral by inhibiting replication of HIV and somehow blocking the formation of syncytia (clumps of white blood cells that form when an infected T- cell bonds to other T-cclls, perhaps killing large numbers of uninfected cells). Some researchers believe that the formation of syncytia may play an important role in HIV’s ability to impair the immune system. When used alone, Dextran sulfate appears to be only modestly effective. Many researchers believe the drug's worth lies in its synergy with other antivirals. Los Angeles physician Dr. Michael Scolaro has been following 30 patients using Dextran sulfate. Nearly half have been taking the drag for two months in combination with various other substances such as AZT, AL 721 and acyclovir. Dr. Scolaro reports that about 60% of those using Dextran sulfate for at least two months have shown improvements in lab values, including T- cell counts. He cautions that the drug at this stage appears less effective for persons whose counts have fallen below 100. Readers should be advised, however, that Dr. Scolaro's is not a formalized test with controls. It is difficult to draw meaningful conclusions from his optimistic results. "Workalikes" of Dextran sulfate are becoming available in Canada and Mexico, the latter of which should not be used. Persons interested in learning more about Dextran sulfate may write to Project Inform and the Gay Men's Health Crisis. At doses taken for HTV, the drug is said to be non toxic. San Francisco General has submitted a protocol to study the drug in combination with AZT, though approval has not been given. Some persons in New York and San Francisco are already combining the drugs. Ampligen Hopes are riding high on this drug (currently undergoing trials in Atlanta) as both an antiviral and immune booster. It appears so far to have little or no side effects. In the Atlanta study, principal investigator Dr. James Braude has reported that he is seeing many patients improve but not along a dramatic 50-50 split (the ARC study is placebo controlled). A very preliminary view of T-cell data on 32 patients after 5 months shows that 12 are higher than baseline and 20 lower, of which 4 are only slightly lower. T-cell increases have not been impressive. Investigator David R. Strayer of Hahnemann University has drawn conclusions from data collected from persons taking Ampligen over a longer period of time. He believes that Ampligen can stabilize persons with ARC and over time stabilize or gradually (if slightly) increase the number of T-cells. He has observed mean T-cell increases of 4% at 4 months; 8% at 8 months; and 17% at 12 months. Ampligen is available in drug trials. Scandalously, Ampligen is not currently under study in combination with AZT. A study published as early as April 18,1987 in Lancet predicted that AZT plus Ampligen would reduce the dose of AZT required for therapeutic effect (i.e„ synergy), thus lessing exposure to AZT- associated toxicity. The article went on, "Moreover, since Ampligen has demonstrated immunomodulatory activities clinically as well as antiviral properties (both possibly mediated through similar mechanisms), its use together with AZT may have pronounced beneficial effects on the course of AIDS beyond that which can be estimated in vitro." I repeat; It is scandalous, and no reasonable excuse has been offered, that tests are not currently underway to determine the efficacy of these drugs in combination. Imuthiol (Antabuse) Promising in early French studies, with reports of persons experiencing significantly fewer opportunistic infections. Reportedly doctors in Paris and Lyons will give persons a six-month supply of Imuthiol for free in exchange for mailing them lab results performed in the U.S. (Contact Gay Men's Health Crisis for updates on this). Antabuse Antabuse, a prescription drug related to Imuthiol, might offer the same benefits. The hope "It is scandalous,... that tests are not currently underway to determine the efficacy of these drugs (AZT and Ampligen) in combination." is that Antabuse will speed and protect the maturation process of T-cells. There have been no controlled studies of Antabuse, but informal conversations with doctors suggest that after a minimum of four months of therapy some persons report rises in T-cell counts. A common dosage is 500 mg. every two weeks. Antabuse is apparently most beneficial to persons who are less sick. At the Atlanta HTV symposium it was reported that one physician saw 40% of 39 patients on Antabuse have a 30% increase in their T-cells after a slow response over several months. However, this once again was not a controlled study. Persons on Antabuse cannot drink alcohol and should monitor their body's exposure to products containing alcohol, such as shampoos, moisturizers, cotton swabs used to wipe skin for blood samples, foods, etc. Persons on Antabuse also should have their liver enzymes monitored at least every three months. Naltrexone A possible immune booster with no known side- effects, and available on prescription. Information on this drug is sketchy, but it is informally said to possibly reduce the frequency and severity of opportunistic infections. A study involving Naltrexone is in the works for Atlanta (more about this in the future). It does not appear to promote viral replication of HIV, and is believed by some to be an acceptable therapy for persons at early stages of exposure. Tests to determine interferon levels in the blood reveal whether or not Naltrexone is working. Alpha interferon There has been some success using this drug with persons who have Kaposi sarcoma. Early tests indicate that 20-40% of patients respond to alpha-interferon (side-effects include flu-like symptoms which sometimes disappear after a few weeks). Clinical trials are underway. In vitro the drug appears synergistic with AZT. Persons interested in acquiring alpha interferon should have their physician contact NIH. Aerosol pentamidine This drug is being routinely administered as a prophylaxis to persons who have already had PCP and persons whose T-cclls liave fallen below 250. Its success rate in preventing first and second episodes of PCP Is being viewed as one of the major advances in treating AIDS-related infections. At the Atlanta HIV symposium it was suggested that Aerosol Pentamidine be used in the following manner: persons should use a nebulizer (preferably not hand-held) that creates as fine a mist as possible. Persons should inhale the drug while reclining, but not lying flat, so that it will have a better chance of reaching all parts of the lungs. Information on these and other drugs arc now available from numerous sources, including the Gay Men's Health Crisis, Department of Medical Information, Box 274,143 West 24th Street, New York City, NY 1001 Land Project Inform, 25 Taylor Street, Room 618, San Francisco, CA 94102. The toll-free national phone number is (800) 822-7422. - Terry Francis A thoughtful article titled "Whether to Take Experimental Drugs: Counseling Issues," has been published in FOCUS-A Guide to AIDS Research (a publication of The AIDS Health Project, University of California San Francisco and the Department of Public Hedth). Southern Voice is offering a limited number cf reprints of this article to persons sending in a self-addressed stamped envelope to PO Box54719, Atlanta, Georgia 30308. The article can be viewed as a primer to persons interested in discussing experimenld drugs with their physicians. As dways, no one should ever take any drug without first consulting and being monitored by their physician. Franklin Abbott, L.C.S.W. Jane DeMore, R.N., M.N., C.S. Martha Lou Brock, L.C.S.W. Elaine Mueller, R.N., Ms.T. 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