AIDS TREATMENT NEWS #80, June 2, 1989
John S. James

"Monitoring" studies do not give treatment to anyone; they only collect data. Therefore they are much easier to set up and administer than the large-scale, randomized trials favored by large institutions. "Prospective" means that these monitoring studies are designed in advance, allowing clean, uniform data gathering: the same blood tests for every patient, on the same schedule and at the same lab; uniform physical examinations, medical history interviews, and patient diary forms; and an overall study design approved in advance by a scientific committee. If successful, these studies can serve as precedents for rapid, community-controlled research projects to get reliable data for patients and physicians, as soon as new treatments come into use.

The Hypericin Study

We have previously reported on hypericin, an antiretroviral found in St. John's wort, a plant long used in herbal medicine (see AIDS TREATMENT NEWS #63, 74, 75, 77, and 78). While mainstream researchers are synthesizing the chemical, running animal studies, and negotiating for FDA permission to begin "phase I" human trials this year or next, probably hundreds of people are already using herbal extracts. We are hearing anecdotal reports of benefits, but this information is inherently limited because of unknown self-selection biases, and because different blood tests and different labs were used.

The new monitoring study, formally approved May 22 by San Francisco's Community Research Alliance (CRA; for background on this community-based research organization, see AIDS TREATMENT NEWS issue # 70, December 1, 1988), is for people who have not used hypericin in the last six months, but plan to start using a standardized herbal extract. (Standardized extracts are those which have been chemically tested during their manufacture and adjusted to contain a uniform strength of an active ingredient in every batch. Examples of St. John's wort extracts standardized for hypericin content are Yerba Prima tablets, Psychotonin tincture, and Hyperforat tincture.)

The study will last four months. "Baseline" testing (before treatment begins) includes P24 antigen, T-cell subsets, CMI, Beta 2 microglobulin, CBC, ESR, and SMA 25, as well as a physical examination and medical history. Blood tests are given monthly; the last visit includes a second physical exam. A total of five monthly visits is required.

All tests are paid for by the CRA. At this time, the CRA has enough money to enroll 30 patients. More will be enrolled if the money can be raised.

Note: Ten patients per month will be enrolled in this observational study. If you are interested in volunteering, call the Community Research Alliance at 415/626-2145. If more than ten qualify for the study, ten will be chosen by a lottery; those not chosen the first month will be considered again at later months. The first ten may be able to start by late June. However, no starting date can be guaranteed, and there will probably be more volunteers than can be accepted.

It is very important that people who enter this study have not used hypericin in the previous six months. Otherwise, bene- fits may have already occurred before the first physical exam and blood test, and therefore the study would miss them and mislead- ingly underestimate the value of the treatment.

All other treatments (AZT, etc.) are OK, however, either before or during the study. One of the rules of a monitoring study is that it does not ask people to change the treatments they would be using anyway. These must be reported to the researchers, of course.

The Community Research Alliance is also looking for volunteers for office work, etc. If you can help, call the number above.

Ozone Study

Ozone is being studied as an AIDS/HIV treatment in Germany, but aside from a small trial for AIDS-related diarrhea at the Veterans Administration Hospital in San Francisco, there are no government or corporate clinical trials in the United States. Recently, however, a group of ten persons with AIDS or HIV jointly purchased an ozone machine for their own use, and before beginning the treatment they organized their own monitoring study, with the help of research nurse Leland Traiman. Mr. Trai- man runs mainstream AIDS clinical trials professionally, and he volunteered to help coordinate the patients' ozone trial.

This eight-month study includes the same blood tests as the hypericin protocol described above. (These tests are becoming a core subset of uniform blood work and data collection forms, to be used in many prospective monitoring studies.) Laboratory work, medical history, and physical exams were given before treatment started, to obtain baseline values; eight additional appointments were scheduled over the next eight months. The baseline and two other blood drawings have already occurred; the fourth blood draw is scheduled for the end of May.

At this time, the ozone trial is not officially sponsored by any organization; it belongs entirely to the people in the study. When they obtained the ozone machine, the Community Research Alliance was newly organized and not ready to approve and administer a study. But the patients were ready to start, and of course they did not want to wait for a study. So the Healing Alternatives Foundation (the San Francisco buyers' club) donated $2500. for initial blood work; without that support at a critical time, the baseline values could not have been obtained and the study would have been lost. The entire trial will cost about $10,000, almost all of it for lab work, as Mr. Traiman's time is volunteer. Money from an anonymous benefactor, from AIDS TREAT- MENT NEWS, and from Mr. Traiman himself has kept the study going so far.

Recently the Berkeley Gay Men's Health Collective offered to assist, by housing the ozone monitoring project in the Berkeley Free Clinic building.

After seven weeks of ozone treatment, no dramatic changes have been found. At three weeks, lymphocyte counts had improved substantially for many of the patients; other blood work showed no meaningful change. By the seventh week, however, these counts had returned to close to their baseline values. At this time there is no evidence of any benefit, or of any harm, from the ozone treatment.

The lack of early results does not discourage Mr. Traiman. "There are no conclusive results so far; it's too early to tell... I don't believe or disbelieve that ozone is an effective therapy. I've heard some strong positive anecdotal reports, and I want to learn if there is any scientific basis behind them."

A New Model for Community Response?

One of the most successful responses to the AIDS epidemic so far has been the "San Francisco model", close cooperation between public agencies and private, mostly volunteer organizations, in providing prevention education and services to those who are ill. However, this model has traditionally not included any involvement with research.

The ozone and hypericin studies suggest a new, additional model for the years ahead. Small but well-conducted research studies are within the capabilities of grassroots organizations. The key test of the success of these projects is whether they produce information which is credible to front-line AIDS physicians, and useful to patients and physicians alike in making treatment decisions. Community groups responsive first and foremost to patients' interests can move much faster than Federal or corporate bureaucracies ever will; if they can generate solid treatment information, they will make a major contribution to saving lives and improving quality of life.

These small studies which combine the work of professionals, activists, and other volunteers are also relevant to public policy in a time of scarce resources. Monitoring studies cost very little to run. If they produce useful treatment information, they should pay for themselves many times over, by reducing the need for hospitalization and other treatment, by keeping people productively employed instead of ill, and by developing very low cost treatment options (such as hypericin herbal extracts) which other U.S. research institutions seldom or never do.

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