ANNOUNCEMENTS

ddC, one of the important potential anti-HIV treatments, is now in nationwide clinical trials sponsored by Hoffmann-La Roche, Inc. Like ddI, ddC does not cause the hematological toxicity of AZT; but unlike ddI, ddC does not cause pancreatitis. Both ddI and ddC can cause peripheral neuropathy, but the current ddC studies are using very small doses, and serious neuropathy appears to be rare.
ddC is active in very small amounts; the doses currently used are about 100 times less than those of ddI or AZT. As we pointed out earlier (issue #89, October 20, 1989), this low dose contributes to a low manufacturing cost, about five cents a day, making ddC a potential treatment for Third World nations where cost is a critical problem. (Clearly this low price does not include distribution, physician education, etc., or drug development.)
The two major nationwide ddC trials have been filling slowly because they need hundreds of volunteers yet have restrictive entry criteria -- but not because they are unattractive for those who can get in. Below are the most important entry criteria (but not all of them); those who might be eligible can call the numbers below for more information.
The two trials are: (1) protocol N3300 (also called ACTG 114), for patients with AIDS or symptomatic HIV infection who have not had more than 90 days treatment with AZT, and (2) protocol N3492 (ACTG 119), for similar patients who have been treated with AZT for at least a year. In both trials, volunteers are randomly assigned to receive either AZT or ddC -- with a "crossover" provision allowing those who become intolerant to AZT to switch to ddC.
Both trials provide free drug and laboratory tests (except for aerosol pentamidine, which is required but not paid for by Hoffmann-La Roche). Both men and women are eligible, but women of childbearing age must have a negative pregnancy test and must practice adequate birth control during the trial.

Protocol N3300 Criteria and Locations

To enter this trial, patients must be at least 18, have less than or equal to 200 T-helper cells per cubic millimeter and either (1) be within 120 days of their first episode of PCP, or (2) have at least one of the following: unexplained weight loss, oral thrush, unexplained diarrhea over 30 days, or a history of unexplained fever. Hemoglobin must be at least 9.5, granulocytes at least 1,200, platelets at least 100,000, and transaminases within three times the upper range of normal. Patients cannot have KS, most kinds of cancer, severe dementia, or peripheral neuropathy.
Locations for protocol N3300 (cities, listed alphabetically by state) are: California (Harbor City, Los Angeles, Sacramento, San Francisco 3 sites, San Jose), District of Columbia, Florida (Fort Lauderdale, Fort Myers, Miami), Georgia (Atlanta), Illinois (Chicago 2 sites), Massachusetts (Boston), Michigan (Detroit), New Jersey (New Brunswick, Newark), New York (Albany, Brooklyn), North Carolina (Winston-Salem), Ohio (Cleveland), Pennsylvania (Philadelphia), and Texas (Dallas, Galveston, Houston). Protocol N3492 Criteria and Locations
Patients must be at least 13, and have received at least 500 mg of AZT for more than 48 weeks. AZT cannot have been interrupted for more than 30 consecutive days, or for more than 90 days total. When AZT was begun, patients must either have had PCP but no other opportunistic infection, or had less than 200 T-helper cells and at least one of the following symptoms: unexplained weight loss, oral thrush, unexplained diarrhea lasting over 30 days, a history of unexplained fever, hairy leukoplakia, or herpes zoster.
Also, patients must currently have hemoglobin at least 9.5, granulocytes at least 750, platelets at least 75,000, and transaminases within five times the upper range of normal. They cannot have progressive KS, most kinds of cancer, or peripheral neuropathy, or have received prior treatment with ddC.
Locations for this trial are: California (San Francisco 2 sites), District of Columbia, Florida (Miami), Indiana (Indianapolis), Maryland (Baltimore), New Jersey (New Brunswick), Ohio (Cincinnati), Pennsylvania (Philadelphia), and Texas (Dallas).

For more Information

More information about either trial is available through the AIDS Clinical Trials Information Service (run by the U. S. Public Health Service), phone 800-TRIALS-A.

San Francisco: MAI Treatment Study Now Open

San Francisco General Hospital is now recruiting for participants in a study of three combined drugs -- rifampin, ethambutol, and ciprofloxacin -- to treat active infections of Mycobacterium avium intracellulare (MAI), also called M. avium complex (MAC). The protocol designed for the study notes that MAI is the most frequently diagnosed opportunistic infection in people with AIDS, and that in spite of this, very little data exists to advise clinicians treating patients.
This particular trial employs a randomized, crossover/placebo design, meaning that for the first eight weeks, half of the participants will receive the drugs and the other half will receive a placebo. Then for the next eight weeks the two groups will be switched, so by the study's end everyone will have received the drugs. All costs related to the trial will be covered. Interested persons can call David Gary, R. N., at 415/821-5089.

AIDS TREATMENT NEWS PRICE INCREASE JULY 1

by John S. James

On July 1 AIDS TREATMENT NEWS will increase the reduced subscription rate (for persons with AIDS or related conditions who cannot afford the regular rate) from $30 per year to $40. The half-year rate will increase from $16 to $20 All other rates will stay the same. Current subscribers at the reduced rate may voluntarily renew, without waiting for the next billing cycle, at the current rate through July 31.
We have been reluctant to raise the reduced rate, and would like to explain why this increase is necessary.
AIDS TREATMENT NEWS has a staff of six, and no income besides subscriptions and unsolicited gifts; we accept no advertising, and we are not funded by anybody. The $30 reduced rate has not changed significantly since we started the newsletter over three years ago. We calculated that rate to match the incremental costs of sending out each additional copy -- first-class postage, printing, envelope, labor, order processing, billing, and accounting -- with nothing calculated for rent, phone, research expenses, or salaries for anything except subscription fulfillment. In setting the reduced-rate price, our model was that if on our second day of operation we received thousands of subscriptions, every one of them at the low rate, we must be able to fulfill them and not go out of business.
This formula has worked fairly well, but in three and a half years our costs have increased. In addition, we failed to include all of the expenses in computing the incremental cost, especially the costs of answering and returning phone calls, and of providing subscriptions to those who cannot afford the low rate (currently about eight percent of subscribers). Both these expenses increase as circulation grows, and therefore they must be counted as incremental cost if calculations are to accurately reflect the economic viability of the newsletter. Currently 70 percent of our paid subscribers are at the reduced rate. This rate must cover at least the fulfillment costs, especially since research and overhead costs are extra, and we have no other sources of income.
The maximum salary at AIDS TREATMENT NEWS is less than people earn for comparable work at other AIDS organizations, which are notoriously underfunded -- and less than the prevailing San Francisco rates for such jobs as word processing, with no other responsibilities. Recently we obtained employee health insurance, after over three years without. Despite the low pay for this expensive city, we have had little turnover, with most people here for two years or more -- a great benefit to our ability to operate smoothly and keep focused on our central mission. For a time it was appropriate to rely on dedication and emergency commitment. But people cannot be asked to make sacrifices forever; as AIDS work continues, it must eventually become more comparable to similar work elsewhere.
We know that many people cannot afford to subscribe to AIDS TREATMENT NEWS. We believe that the best way to address this problem is to continue to allow free copying by PWA coalitions, buyers' clubs, and other nonprofit groups, as well as offering liberal terms for reprinting articles to publications like San Francisco Bay Times, or Outweek. We will continue to seek new ways to get the information we publish to people who need it. But we have no income besides subscriptions, and must charge enough to cover all costs and continue to operate effectively.
Clarification of Copyright Policy
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STATEMENT OF PURPOSE

AIDS TREATMENT NEWS reports on experimental and complementary treatments, especially those available now. It collects information from medical journals, and from interviews with scientists, physicians, and other health practitioners, and persons with AIDS or ARC.
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.
We also examine the ethical and public-policy issues around AIDS treatment research and treatment access.