AIDS TREATMENT NEWS Issue #237, December 22, 1995 phone 800/TREAT-1-2, or 415/455-0588 CONTENTS: Saquinavir (Invirase): First Protease Inhibitor Approved -- Reimbursement, Info Numbers Abbott Protease Inhibitor Lottery in January, CD4 Under 50 -- Registration Now Abbott Protease Inhibitor: Early Results Reported Major Protease Inhibitor Triple Combination Trial Begins Soon: CD4 Under 200, AZT Experienced, 3TC Naive Wasting Syndrome: Oral Oxandrolone Re-Released in U.S. Lymphoma: MGBG New Studies, Compassionate Use in Earlier Disease Human Retroviruses, Immune-Based, and CPCRA Meetings, Wash. D.C. Late Jan. ACTG Clinical Trial Sites: Seven Cut, Two Added New York: Protease Inhibitor Forum, January Computer Censorship: Effect on AIDS TREATMENT NEWS AIDS TREATMENT NEWS Selected Index, Through December 1995 ***** Saquinavir (Invirase): First Protease Inhibitor Approved -- Reimbursement, Information Hotline Numbers by John S. James Saquinavir (brand name Invirase(TM)), developed by Hoffmann- La Roche, was approved by the FDA on December 6, and is currently available in pharmacies. It is the first of a new class of anti-HIV drugs, called protease inhibitors, to be approved for marketing. AIDS TREATMENT NEWS already covered some technical aspects of this drug in two articles in issue #235, November 17, 1995: "Protease Inhibitors: Drug Resistance and Cross Resistance," and "Grapefruit Juice and Saquinavir." Saquinavir was approved for use in combination with one or more nucleoside analog drugs, but no particular drug was specified. At this time there is no data about combining saquinavir with any nucleoside analog except AZT or ddC. It is likely that physicians will favor AZT for previously- untreated patients, favor ddC for patients already extensively treated with AZT, and also try saquinavir in combination with other antivirals. Saquinavir does not cross the blood-brain barrier. Saquinavir should not be used at the same time as rifampin, which decreases saquinavir blood concentrations by 80% -- and used cautiously if at all with rifabutin, which decreases saquinavir concentrations by 40%. Other potentially important drug interactions are described in the saquinavir package insert (the prescribing information for physicians). The recommended adult dose is three 200-mg capsules taken three times daily, within two hours after a full meal. Lower doses are not recommended, since they have not shown antiviral activity. There is no data on the pharmacokinetics, safety, or efficacy of saquinavir in persons under 16. Price and Reimbursement Help The price of saquinavir to wholesalers is $15.89 per day ($5800 per year); retail prices will be higher because they include the markups of the wholesaler and the pharmacy. Hoffmann-La Roche has suggested that no one will fall through the cracks: "To ensure that every patient in the U.S. who can benefit from Invirase(TM) gets immediate and sustained access to the drug, irrespective of their financial situation, Roche has established the Roche HIV Therapy Assistance Program. This important program will make supplies of Invirase(TM) available to patients who are waiting to be approved for coverage and reimbursement through their existing insurance sources, and to patients who are uninsured and cannot afford to pay for the drug." (Press release, December 7). This assistance program will provide information about coverage for the drug, help callers apply for insurance (including helping with denied or underpaid claims, and with appeals), and screen and enroll eligible patients in the Medical Needs Program for those without insurance or financial means. For more information, patients and health-care providers in the U.S. can call the Roche HIV Therapy Assistance Program, 800/282-7780 (or 202/942-2437), Monday through Friday 9:00 a.m. to 8:00 p.m. Eastern time. Information for physicians about saquinavir and other Roche products is available at 800/526-6367. The number for patients and customers to call is 800/910-4687. Comment The protease inhibitor class of drugs is indeed important; early results suggest that in the right doses and combination regimens, they may work very well. But despite the hype in some media reports, the observed signs of benefit from the low dose of saquinavir now recommended have been modest. T- cell increases and viral load reductions have been more or less comparable to those of AZT. The problem seems to be that saquinavir is now being used at the bottom of its dose- response curve; a new formulation, now being tested by Roche but not yet available, may deliver more effective amounts. Since average blood levels of saquinavir are minimally adequate for antiviral activity, and individuals may vary in how well they absorb the drug, it is possible that the current dose may work well for some people. But we do not know this, as the package insert only gives group averages of CD4 and viral load responses, not information on how these varied among individuals. Also, as our last issue suggested, grapefruit juice may increase blood levels of saquinavir -- although there is no blood-level test available to tell if this is working for you. Patients may want to get a viral load test before starting saquinavir, so that they can later get some estimate of how well the drug is working for them. One overlooked factor that may increase future use of protease inhibitors is that a number of people who have been completely opposed to AZT and other nucleoside analogs do not feel the same way about these new drugs. The objection often was to nucleoside analogs in particular -- not to all high- tech anti-HIV drugs. Today, the great majority of people with HIV, even in the U.S., are not receiving any specific treatment for it; this could change if newer drugs continue to look promising -- provided that ways can be found to pay for them. Concerning the price, no one outside of Roche knows if it is a fair one, as no one knows the development and manufacturing costs of the drug. Manufacturing costs are believed to be substantial; and there is concern that if pharmaceutical companies keep losing money on AIDS, they will not develop important new drugs such as integrase inhibitors. But the increasing total cost of AIDS medications is a major problem, especially as standard of care changes from one drug (AZT) to combinations of two or three. This would still be a major problem even if saquinavir were at half its current price. One possible approach to the cost problem is a strategy of harm reduction -- reducing the harm caused by the high cost. This strategy could start by analyzing how the drugs are actually being paid for, and who is being left out. Roche has come close to saying that no one in the U.S. will be left out (see quote above); we should monitor the Roche HIV Therapy Assistance Program to see how well it accomplishes this stated goal. The next step is to focus on remaining problems, looking at all possible means -- public assistance, private insurance, better targeting and timing of treatments, outcomes research, disease management, price reductions, alternative drugs, etc. -- to make adequate treatment available. ***** Abbott Protease Inhibitor Lottery in January, CD4 Under 50 -- Registration Now Abbott Laboratories will make its protease inhibitor ritonavir (formerly called ABT-538) available to 2,000 people worldwide, in an expanded access program starting in January. Since many more than 2,000 are expected to apply, a lottery will be used to select who gets the drug. This program is limited to persons over the age of 12, with CD4 count under 50. There are additional medical qualifications. Physicians and patients can obtain more information by calling 800/414-AIDS, or by fax at 800/336-2879, or by email at ritonavir@pond.com, or on the World Wide Web at http://www.pond.com/ritonavir. ***** Abbott Protease Inhibitor: Early Results Reported by John S. James Two separate placebo-controlled studies of ritonavir, the Abbott protease inhibitor, were reported December 7 in the NEW ENGLAND JOURNAL OF MEDICINE. Both reported good viral load and CD4 results. A 32-week study in 84 patients in The Netherlands, Spain, and Australia, found the most sustained benefit at the highest dose tested -- 600 mg twice daily. The seven persons who completed the full 32 weeks at this dose had a median CD4 increase of 230 above baseline. The viral load reduction was reported as a mean of 0.81 logs (about a 6.5-fold, or 85%, reduction), but this number is clearly an underestimate; the study used the version of the Chiron branched DNA test which has a lower cutoff at 10,000 copies (4 logs), and since the high-dose group entered the study with a mean log copy number of 4.97, the test used could not possibly have recorded more than about a one-log decrease. A subset of high-dose patients measured with Roche PCR test, which has a much lower cutoff, found almost a 2-log drop in viral load, but complete data are not available. More problematic is the fact that 15 volunteers started the highest dose, and only 7 of them had 32-week measurements reported; a full accounting of the other 8 was not provided. The lower doses tested (300, 400, and 500 mg twice daily) had results at four weeks which were about comparable to the 600 mg dose, but these results were not nearly as well sustained at 32 weeks. The other study, in 62 patients for 12 weeks at five U.S. sites, tested doses of 200 and 300 mg three times daily. The median CD4 increase was 83 at week 12. Viral load decrease of 0.5 logs using the branched DNA test with a 10,000-copy cutoff; when the more sensitive PCR test was used for a subset of patients with values below the cutoff, the 12-week viral load reduction was about 1.1 logs. The main side effects in the European study were nausea, circumoral paresthesia (abnormal sensation around the mouth), and certain blood-chemistry changes; the U.S. study also reported diarrhea, headache, and alterations in taste. These side effects were usually considered minor, and seldom required discontinuation of the drug. ***** Major Protease Inhibitor Triple Combination Trial Begins Soon: CD4 Under 200, AZT Experienced, 3TC Naive by John S. James A major trial in cities throughout the U.S. will compare triple combination therapy with the Merck protease inhibitor (indinavir, brand name Crixivan(TM)) plus AZT plus 3TC (lamivudine, brand name Epivir(TM)), vs. the double combination of AZT plus 3TC. The trial may open in January and will last about one year. Some patients who meet all the major entry conditions -- CD4 count under 200, must have used AZT for at least six months and be able to tolerate the drug, and must NOT have used 3TC, at least not for more than a week -- might look into this trial before starting 3TC (which was recently approved by the FDA for use in combination with AZT). Everyone in the trial will get at least AZT plus 3TC, and some will get the protease inhibitor in addition. The new trial, called ACTG 320, will be run by the ACTG (AIDS Clinical Trials Group), the major Federal clinical trials network, with financial support from Merck. ***** Wasting Syndrome: Oral Oxandrolone Re-Released in U.S. by John S. James Oxandrolone (brand name Oxandrin(R); an earlier name, 'Anavar', is obsolete) is an oral anabolic steroid which is not primarily metabolized in the liver. It became available in the U.S. in December 1995. Anabolic agents work by promoting protein synthesis, and are one approach to the treatment of wasting syndrome, which involves an abnormal loss of protein and lean body mass. Oxandrolone was approved by the FDA more than 30 years ago, specifically for regaining weight lost due to infectious disease, among other uses. This approval -- "as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight" -- is still in force. But despite FDA approval, oxandrolone has long been unavailable in the U.S.; companies chose to drop it instead of meeting the increasing regulatory requirements for anabolic steroids, for a drug which was off-patent and therefore had a low profit margin. Now a small pharmaceutical company, Bio-Technology General Corp. (BTG), has reintroduced oxandrolone for weight gain, and is researching it for four indications for which the drug has orphan-drug status: AIDS wasting, alcoholic hepatitis, Turner's syndrome in girls, and constitutional delay of growth and puberty in boys. A recent double-blind study in 67 patients with AIDS wasting found weight gain with 15 mg/day of oxandrolone for 16 weeks, stable weight with 5 mg, and weight loss with placebo (to be published). Oxandrolone is relatively expensive, with price to wholesalers being $3.75 to $30 per day, depending on dose. This is a fraction of the cost of human growth hormone ($140/day or more to the patient), which is also used to treat this kind of AIDS-related weight loss due to unknown metabolic changes. The FDA approval for weight loss may help with insurance reimbursement. Much less expensive anabolic steroids are also available; some of them may be comparable to oxandrolone, except that they must be injected. (An early study, which measured anabolic activity by changes in nitrogen excretion in human subjects on a constant diet, found that oxandrolone had about six times the anabolic activity of the same amount of testosterone.(1)) The usual adult dose recommended in the package insert is one 2.5 mg tablet two to four times daily; but the instructions also note that doses as low as 2.5 mg per day or as high as 20 mg per day can be used. (Each 2.5 mg tablet costs $3.75 to the wholesalers.) As with other anabolic steroids, the package insert includes many cautions and warnings of possible adverse effects -- too many to summarize here. But a major controlled study used four times the current approved oxandrolone dose in treating severe alcoholic hepatitis, and reported "no complications attributable to its use."(2) Oxandrolone is distributed in the U.S. by Quantum Express; it is a Schedule III controlled substance. Quantum Express can handle assignment of benefits (meaning that it will deal directly with insurance companies); and there is a compassionate-access program for those with no insurance or other way to pay. For more information, health-care professionals should call 800/741-2698. References 1. Fox M, Minot AS, and Liddle GW. Oxandrolone: A Potent Anabolic Steroid of Novel Chemical Composition. JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM. 1962; volume 22, pages 921-924. 2. Mendenhall GL, Moritz TE, Roselle GA and others. A study of oral nutritional support with oxandrolone in malnourished patients with alcoholic hepatitis: Results of a Department of Veterans Affairs cooperative study. HEPATOLOGY 1993; volume 17, number 4, pages 564-576. ***** Lymphoma: MGBG New Studies, Compassionate Use in Earlier Disease by Mark Mascolini Results of two early trials of mitoguazone (MGBG) for advanced cases of AIDS lymphoma have encouraged investigators to study the drug in people with newly diagnosed lymphoma, and especially in those with lymphoma of the central nervous system. Susan Smith, a representative of MGBG's developer (ILEX, San Antonio, Texas, 210-667-8000), said the company could help pay expenses for people who qualify for the current trials but cannot afford to travel to one of 29 trial centers. People with AIDS lymphoma who do not qualify for the trials may be able to get MGBG on a compassionate use basis. ILEX hopes to submit the drug for FDA approval in mid-1996. The two completed studies, headed by Alexandra M. Levine, M.D., of the University of Southern California in Los Angeles, found that more than 1 in 5 people who had failed therapy with one or more lymphoma treatments responded to MGBG. Another 1 in 5 had stable disease after MGBG treatment. Although that response rate is not high, the 56 people in the two studies had advanced disease. Complete responses to MGBG lasted for about 6.6 months. Dr. Levine, who presented her results on December 5 at the annual meeting of the American Society of Hematology in Seattle, said she and other investigators suspect that MGBG will be more effective in people with newly diagnosed AIDS lymphoma, especially if it is combined with other antilymphoma drugs. MGBG had been studied earlier for non-AIDS lymphoma but had too many side effects. Dr. Levine and her co-investigators seem to have overcome that problem by lowering the dose to 600 mg/m(2) given intravenously over 30 minutes once a week for 2 weeks, then every 2 weeks. With that regimen, MGBG has only relatively mild adverse effects on the production of blood cells. That would be an important advantage for people with AIDS lymphoma, because many antilymphoma drugs, as well as drugs such as AZT, can hurt the production of new blood cells. ***** Human Retroviruses, Immune-Based, and CPCRA Meetings, Washington D.C. Late January The Third Conference on Retroviruses and Opportunistic Infections, which may be the second most important AIDS meeting of 1996 (after the International Conference in Vancouver in July) will be held at the Sheraton Washington Hotel in Washington, D.C., January 28-February 1; preregistration deadline is December 29, later registration is on site if space is available. For nonmembers of the Infectious Diseases Society of Americas (IDSA), the sponsoring organization this year, the conference registration fee is $425, for IDSA members, $375. The conference rate for the hotel is $118 for a single or double, $138 for a triple or quadruple room. For more information, call the IDSA, 703/299-0200, fax 703/299-0204. Registrants for this meeting should also know about the Third HIV Immune-Based Therapies Workshop, which will be held in the same hotel on January 26-28; registration is $160 for non-members of the Clinical Immunology Society. For registration information, call SLACK Incorporated, 609/848- 1000 ext. 208, or fax to 609-251-0278. Also in the same hotel, the 19th meeting of the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) will be held on January 18 and 19. No fee is required to register for this conference. For more information, call Social & Scientific Systems, 301/986-4870, ext. 342. ***** ACTG Clinical Trial Sites: Seven Cut, Two Added Since its founding in 1987, the AIDS Clinical Trials Group (ACTG) has been the largest network of research centers studying AIDS treatments in people; it is operated by the National Institute of Allergy and Infectious Diseases, the primary agency of the National Institutes of Health (NIH) sponsoring AIDS research. Over 40,000 adults and children have participated in ACTG clinical trials through university- based medical centers across the country. As a result of a recent "recompetition" for funding, clinical trials at seven of the 35 current sites will be phased out over the next year, and two new sites will be added to the surviving sites. NIH will continue to fund clinical trials at defunded sites only if they require the data which those patients would provide; otherwise, patients will be referred to other clinical research centers. More drastic ACTG cuts were first discussed, including elimination of major research sites at Harvard and New York University, although it has been denied that plans were changed in order to save these sites. There is concern that other AIDS research may be cut to pay for centers which were saved. The NIH refuses to speculate whether the budget for the ACTG, or the entire NIH clinical research budget, will likely increase or decrease until Congress and the Administration agree on their total budget, which at press time has again been stalled in partisan negotiations. The seven existing sites which will be phased out over the next year are: Connecticut: Yale University District of Columbia: Georgetown University New York: Albany Medical College New York: Albert Einstein College of Medicine New York: Columbia Presbyterian Medical Center New York: SUNY/Brooklyn Tennessee: Meharry Medical College (Nashville) ***** New York: Protease Inhibitor Forum, January 6 Representatives of the major companies with anti-HIV protease inhibitors in human use will discuss their results and plans at a free educational forum, Saturday January 6, 1:00 p.m. to 4:30 p.m., at New York University Medical Center, Farkas Auditorium, East 31st Street and 1st Avenue (entrance on 1st Avenue). There will also be a talk on using immune-based therapies with protease inhibitors, and time for questions from a community panel, and from the audience. This event is organized by treatment activist Jules Levin. Seating is limited; for reservations, call 212/229-9102. ***** Computer Censorship: Effect on AIDS TREATMENT NEWS by John S. James As we go to press, Congress is about to pass legislation which supposedly targets computer pornography, but which will in fact restrict all two-way public discussion by computer, on all topics, even those completely unrelated to sex. AIDS TREATMENT NEWS is developing a World Wide Web site, to serve as a directory and annotated guide to AIDS treatment information on the Internet. The flexibility and usefulness of our site will be seriously reduced. The legislation, an amendment to major legislation on telecommunications deregulation, will basically make it a felony to electronically transmit "indecent" material to anyone under 18, or to a computer where someone under 18 could receive it; computer services may be liable for what others place on their systems. The word "indecent" has not been defined by Congress or the courts, so basically it means whatever a prosecutor and jury anywhere in the U.S. want it to mean; convictions can be reversed on appeal, but that usually takes years and thousands of dollars. ("Obscene" IS legally defined, and publication is already forbidden in electronic or any media; and parents can already block other objectionable material with software which is now available for this purpose, or by subscribing to special Internet services for children.) Well-publicized compromise legislation, reluctantly accepted by some civil libertarians, was first accepted by a Congressional committee, then rejected by a critical 17 to 16 vote on December 6, due to pressure from the Christian Coalition and other right-wing groups; there is almost no chance for a compromise at this time. A White House veto of the telecommunications bill, which also has other serious problems because it would allow further centralization of control of the entire telecommunications industry, is possible but uncertain. If Clinton does not veto the bill, court challenges are already being prepared by the American Civil Liberties Union and others, but it could take many years to reach a final court decision. (Until recently people had not realized there was a problem, because earlier this year the House had voted 420-4 for an alternative approach, favored by civil libertarians, of encouraging private computer services to control objectionable material by removing legal obstacles to their doing so.) If the current legislation becomes law, it is likely to be enforced selectively but aggressively, as right-wing groups are expected to use it to generate complaints and prosecutions in conservative regions, against persons throughout the country. This may be a new strategy for their movement: developing a grassroots taste for blood which can massively target individuals for prison. Nothing published in AIDS TREATMENT NEWS is likely to be illegal under the new law (unlike safe-sex information, which probably will be prosecuted). But the law will still affect us directly: * Our World Wide Web site will be responsible for anything which others place on our system. It will be a serious risk to allow the public to post messages, unless we completely read everything in advance. Otherwise, a few fanatics anywhere in the world could shut us down, by posting well- crafted messages and arranging for complaints in conservative regions of the U.S., with hand-picked prosecutors and judges. Even a small organization can easily get thousands of visits to its World Wide Web site per month. We do not have the resources to censor everything users might contribute. No software can screen out messages which might be prosecuted under the "indecency" legal standard. We cannot read everything immediately, and even if we could, we would need to know the thinking of all Federal prosecutors throughout the country, while an enemy would only need to know one. Our choice will be to ban public discussion or risk prosecution. If we cannot sponsor a public forum for discussion of AIDS treatments (or of any other subject), much of the potential usefulness of our system will be lost. In today's moderated newsgroups, every contribution is checked by moderators before being made available to the public. But usually a glance is enough to show if a submission is relevant or not. When online felonies become easy to commit and hard to defend against, thorough reading and checking will be necessary. * The central power of the World Wide Web is that each Web site can link to others anywhere in the world. Users "click" on a link -- usually a highlighted word or phrase -- and access the remote site just as if the information were on the local computer. The new law may make us responsible for anything appearing on any site we link to, or anything placed on those sites in the future. This will be especially problematic with foreign sites, since they will not be subject to U.S. censorship, and may include material in languages we cannot monitor. Could we avoid criminal liability by not providing foreign links, but giving the addresses in text, which users could type in on their own? No one knows. * We would normally purchase computer time for our information service, instead of obtaining our own computer and connecting it to the Internet. But computer service companies will be cautious in interpreting the new law. Recently, for example, America Online deleted user profiles containing the word "breast" -- then apologized and restored the profiles, after protests from breast-cancer activists. To avoid living with ever-changing rules and restrictions, with having to repeatedly change our material or see it deleted, we will need our own computer and high-speed communication line -- an unwanted trouble and expense. * What about restricting our service to persons over 18, so that we could then allow open public discussion of AIDS treatment information? Aside from the ethical problems with such restriction, it would be unworkable for practical reasons. A separate Internet for adults only -- not for sex, but for free discussion of any topic -- would require some central organization to police the restriction. Either a government agency or a private organization would be problematic. Either one could and probably would impose other restrictions as well. But without a central policing system, each online service's adult audience will be separate and proprietary. AIDS TREATMENT NEWS and other independents will be locked out of all those audiences, unless we can run separate information systems on some of them and accept whatever terms and conditions -- including exclusivity, and content restrictions -- the owners may choose to impose. Today the Internet is a worldwide commons, the town square of the global village; it is without central control, open to all, allowing anyone to provide information as well as receive it. The new censorship law will make this open commons unworkable, by limiting all communication to that suitable for children -- ultimately replacing the open forum with a closed, adults-only, proprietary commons. Eventually a single mega-corporation may be able to banish from the general meeting place any message, any topic, or any person, for almost any reason, with no appeal. * AIDS TREATMENT NEWS expects to have to compete with subsidized sites which will provide treatment information, but mainly exist to push company products or political views. We can compete -- but only if people are allowed to choose what they want to read. The current Internet protects competition by offering universal access. If public discussion is forced into closed adult audiences, we will likely be excluded in favor of promotional systems which have the money to buy exclusive access. * The audience for online communication may be reduced. Will people feel comfortable using a medium for ordinary conversations with friends, when felonies are only a few keystrokes away -- when every word, written in whatever heat of the moment, becomes immortal and may be selected, now or for years into the future, by a prosecutor anywhere in the country to bring criminal charges? Will parents be reluctant to let their children use computer communication, for fear that an angry or careless child could bring legal problems on the family? Industry has gone to great lengths to establish computers as friendly, creative, educational, and fun -- but other images are not far in the background. If computers become seen as Big Brother, a mechanical boss or cop monitoring you, or overcontrolled and uninteresting, people will use them only when required. Computer communication could go out of style even for entertainment and shopping, costing the U.S. a valuable area of industrial leadership. These are just some of the ways that our newsletter -- like everyone else who uses computer communication -- will be affected by the new legislation, even though our material is innocuous. Open public discussion by computer on any topic will be strongly discouraged, except within proprietary, adult-only audiences. Most people are not paying attention to this issue, because the media has presented it as a question of pornography; those not involved in pornography think it will not affect them. They are mistaken. What You Can Do Now During the holiday Congressional recess, call both your Senators, and your Representative (at their local offices in your city or state, not the Washington offices), and urge them to vote against the telecommunications bill, because of the computer-censorship provisions. And get others to call. (The Congressional recess should start in late December -- the exact date is uncertain due to the budget battle -- and end January 22.) Every member of Congress will vote again on this bill; it does not matter what committees they are on. Background: As we go to press (December 19), the bill is in Conference Committee, to reconcile Senate and House versions; any compromise there on the censorship issue is now unlikely. The Senate and the House both must vote on the final version of the bill, probably in January or February, with no amendments allowed. The bill has other serious problems as well, and could be defeated in one of those votes. If not, we will need to mobilize calls to the White House to urge Clinton to veto it. No matter what happens, this is a long-term issue which will come back again and again. The current legislation would impede all public discussion on the Internet, on any subject from AIDS treatment to politics to art to religion; it would be especially disastrous for AIDS prevention information, which usually could be prosecuted. We must inform the public about the importance of this issue, and help organize the support for free speech. For More Information Because the status of legislation can change daily, the most current information is on the Internet. Dozens of organizations are opposing the computer censorship legislation; good starting points are the Electronic Frontiers Foundation (http://www.eff.org), the American Civil Liberties Union (ftp://ftp.aclu.org/aclu/), WIRED magazine (http://www.hotwired.com/special/indecent/), or Voters Telecommunications Watch (http://www.vtw.org/). Also, subscribe to the alerts of the Voters Telecommunications Watch. Send a message to listproc@vtw.org, with the following in the message body: subscribe vtw- announce FIRSTNAME LASTNAME (with your name in place of the capitalized words). If you only have email, send a message to vtw@vtw.org for more information. If you do not have a computer, you can call the American Civil Liberties Union, 212/944-9800, ext. 414. That is the press office, which can provide further referrals. [Freelance writer Bruce Mirken helped with research for this article.] ***** AIDS TREATMENT NEWS Selected Index Through December 1995, Issue #237 3TC (lamivudine) 212,220,222,226,227,228,233,236 3TC / AZT 212,216,226,227,228,236 1592U89 223 ABT-538 (Abbott's Protease) 223,231,235,237 ACT UP 146,147,165,213 ACTG 237 activism 130,147,151,164,188,212,213,237 acupuncture 130,157,230 acyclovir (Zovirax) 143,165,168,190,198 AEGIS (computer) 191,212 AG 1343 (Agouron Protease) 222,231,235 AIDS Drug Interaction Guide 208,234 AIDS Information Obstacles 230 AIDS Patents 210,216 AIDS-Related Research Meetings 214,218,222,229 amphotericin B/liposomal Am B 41,58,117 anabolic steroids 166,187,237 animal cell transplantation 226 Antabuse (disulfiram) 29,70,132,223 arthritis 218 aspirin 109,118,183 ateviridine 183 ATIS (info service) 210 atovaquone (566C80) 123,129,133,139,160,164 AzdU (azidouridine,CS-87) 72 azithromycin (Zithromax) 124,132,133,136,139,152, AZT (zidovudine,Retrovir) 207,211,212,217,231,232 AZT/Perinatal Transmission 194,207 Azulfidine (Sulfasalazine) 218 Bactrim (co-trimoxazole,TMP-SMX) - see Desensitization bDNA test 228,237 beta carotene 134,158,213 biaxin (see clarithromycin) 190 Bioelectrical Impedance Analysis 225 bitter melon 155,157 breast cancer 145,213 buyer's clubs 143,144,145,167,176,188,195,213 cancer 122,126,135,139,162,174,213 candidiasis (thrush) 37,96,133 capsaicin (Axsain,Zostrix) 121 CD4 percent vs CD4 count 228 cell transfer 207 censorship 227, 237 children/infants 90,114,120,123,124,130,174,210,217,236 Chinese medicine 61,68,71,75,93,107,126,153,158,224,230 clarithromycin 109,113,124,129,137,139,190 clinical trials 216,217,218,228,233,235,237 CMV 167,168,171,179,189,190,227,234 CMVIg 168 codon 215 196 combination therapies 219,226,227,228,229,230,231,232,237 community research 65,66,83,85,105,143,229 compound Q (trichosanthin) 82,88,99,104,119,155 computerized information 114,116,124,154,165,191,212,237 Concorde Study 173,177 Congress 211,221,237 Crixivan (MK-639) 219,220,221,225,226,227 cross resistance/3TC 236 cross resistance/protease inhibit. 235 cryptosporidiosis 133,139,206,227,234 cryptosporidium/water 227,233 curcumin 174,176,177,198 cyclosporin 223 d4T (stavudine) 185,198,200,201,203,222,233 daunorubicin (DaunoXome) 117,122,174 ddC (HIVID) 150,154,155,166,167 ddC/AZT 115,132,145,150,154,167,201 ddI 150,160,166,167,185 ddI/ d4T 185 ddI/AZT 167,168 dementia 97,101,156,171 desensitizaton 147,161,180 diarrhea 133,141,224 Dilantin 203 disability regulations 144 DNCB 14,116,157,182 DOXIL/DOX-SL 184,195,208,213,215,217 Drug Policy Reform 231 e-mail 172 Early rapid testing/ new treatments 220,221,223 elections 211 exercise therapy 157 Exon Amendment 227,237 FDA 195,205,206,207,208,215,220,228,233 FDA Reform: New Senate Bill 235 FDA workshop / Clinical trials 228 foscarnet (Foscavir) 71,83,94,108,110,129,133,136,138,168,213,215,223 ganciclovir (DHPG,Cytovene) 124,129,133,138,167,168,227 ganciclovir eye implants 167 garlic/cryptosporidiosis 206 Genentech 213 Glaxo 212,220 Global AIDS Action Network 187,191 glutathione 88,92,93,119,121,152,157,187 glycyrrhizin 17,103,115,181 GM-CSF 87,93,94,105,108,110,122,167 gp120 (vaccine) 130,149,174 gp160 (vaccine) 130,152,174,183,185 grapefruit juice/Saquinavir 235 HandsNet 212 HBY 097 232 health care politics 179,192,203 health insurance 230 HER/2-nev. 213 herpes/shingles 80,83,94,100,115,133,138,143,146,149 HIV Drug Book (Project Inform) 234 HIV Lipopeptide vaccine 228 HIV RNA 194,204,206,209,210,211,228,233 HPMPC 76,96,149,190,223 human growth hormone 187,205,209,213,226,227,228,234 hydroxyurea 178,211,230 hypericin 117,125,138,141,146,155,167,168 hyperimmune milk (colostrum) 49,95,107 ICAAC - 1995 231,232 ICC trials 219,220,222,223 IL-2 122,186,218 immigration politics 125,128,129,134,150,170,177 Immune Enhancement Program 230 immune globulin (IVIG) 119,120,124,129,148,152,154,168 immune restoration 151,169,200,218 Immune-based therapy 190 international travel 128,152 Internet Newsgroup 233 Invirase (saquinavir) 201. 226. 231,233,235,237 Kansui plant 223 Kaposi's sarcoma (KS) 162,195,196,197,213,215,217,234 Kassebaum Bill 235 ketotifen 158,226 L- carnitine 183 liposomes 109,117,122 lipsomal daunorubicin 168 long-term survival 175,178,216 LTR inhibitors 174,190,192,195,196 lymphoma 93,110,136,140,224,237 marijuana 131,133,139,141,148,156,232 Marinol 131,133,141,148 maternal transmission / HIV 194,207,209 Med Express 227 Medicaid (Medi-Cal in CA) 231 Megace (megestrol acetate) 76,77,133,150,183,226 mexiletine 121 MGBG 237 micronutrients 214 microsporidiosis 129,133,139 MK-639 (Merck Protease,Crixivan) 219,220,221,225,226,227,235,237 NAC 88,119,121,138,141,152,157,184,226 "naive' T-Cells 222 naltrexone 16,52,119 National AIDS Information Project 220 National Task Force 188,193 nerve growth factor 221 neuropathy 121,130,156,221 nevirapine 170,211 niacin 214 NIH / Clinical Research 234 NIM 811 223 NNRT (non-nucleaside RT inhibitors) 223 nonsteroidal anti-inflammatories 109 nutrition 152,158,163,181,204,205,208,214 on-line computer systems 154,165,191,212 oral ganciclovir 214,234 oxandrolone 237 oysters / FDA warning 229 ozone 80 pain medication 154 passive immunotherapy 67,92,148,149,151,158,165,209 pathogenesis 147,156,206 patient / doctor relations 100,111 patient drug assistance program 186,192,195 Peptide T 84,119,126,178,201,234 phenytoin 203 photodermatitis 197 physician interviews 119,124,126,132,135,142,143,149,160,166,171,175,176,179, 184,186,189,192,200,217,219,226,227,228 PMEA 156,223,226,236 PMPA 236 PML 79,88,100,115,129,153,156,201,220 political funerals 157,160,178,213 poppers 160,187 pregnancy 90,112,153,154,194,207 prescription drug assistance 186,192,195 Primary HIV infection 191 prisons 106,125,126,130,149,151,161,183 protease inhibitors / combinations 231,235,237 protease inhibitors 117,156,184,190,191,193,194,198,199,201,209,210,219,220,221, 222,223,225,226,227,228,229,230,231,232,235,237 protease inhibitors/cross resistance 232,235 recombinant human growth hormone - see Human growth hormone research meetings 222 research priorities & policy 77,78,104,105,110,112,124,126,127,136,140,142,145,146,150, 151,152,155,156,157,158,167,168,173,191,199,200,201,203, 205,206,207,208,214,215,228, resource list 143,144,145,167,170 ritonavir (Abbott protease inhibitor) 223,231,237 Saccharomyces boulardii 224 saquinavir (Invirase) 201,226,231,233,235,237 sci.med.aids 233 Search for a Cure (Boston) 235 Septra (co-trimoxazole,TMP-SMX) - see Bactrim sinusitis 225 small rapid trials 215,218,221 snake bush 182 Social Security guidelines 144 sulfasalazine 218 surrogate markers 119,144,204,209,228 symptom-reduction trials 229,231 syphilis 124 taxol 188 tecogalan (SP-PG) 195 testosterone 226,233,237 thalidomide 133,179,221,226,230,233,234 thymomodulin 202,203 thymopentin (TP5) 123,149,168,202 thymosin (thymic hormone) 151 thymosin alpha 1 194 topotecan 174,178,197,220 travel 152 treatment access 83,84,85,115,116,118,119 treatment strategy 83,100,111,119,124,224 trental 133,145,156,158,185 U.S./China AIDS Research 235 Valacyclovir 217 Vancouver Conference 1996 233,235 Viatication 173,193,218 viracept (AG 1343) 222,231 viral load 209,211,215,221,225,228,233 vitamin A 134,158,185,214 vitamin B 134,152,158,214 vitamin B-12 158,171,214 vitamin C 111,152,157,158,214 vitamin D3 analogs 122 warts 112,118 wasting/weight loss 7187,205,213,221,226,234,237 water / CDC Guidelines 227 women 115,118,130,153,154,194,207,214 World Bank / AIDS Prevention 225 yohimbine 158,159,166 Zerit (d4t) 198,200,201,203,233 zinc 134,158,214 ***** 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. 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 1995 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.