AIDS TREATMENT NEWS No. 066 - October 7, 1988
John S. James

By integrating scientific trials with normal medical prac- tice, community-based trials allow credible testing of treatment options with far less administrative delay than usually involved, and at far less cost; often the main expense is laboratory tests which the patients should be receiving anyway. These trials differ from everyday medical practice in being designed in advance by a research professional, and being approved by scientific and by ethical review boards. Criteria for patient selection and for evaluating the success of the therapy are as rigorous as in any other trials. And patient compliance can be better in community-based than in other trials, because of the closer physician-patient relationship, and because community-based trials often test treatments which are already available, meaning that no one is forced into the studies to get treatment, so there is no incentive to cheat; volunteers come forward only for altruistic reasons. The greatly reduced cost of community-based trials encourages research by pharmaceutical companies, and also allows testing of medically attractive treatment options which lack commercial or scientific glamor, and thus would not be studied otherwise.

Community-based trials are most suitable for testing poten- tial therapies which already have known safety records in human use -- including most of the treatments which have developed a grassroots following among patients or scientists without commercial prompting. Drugs which are unusually dangerous, difficult to use, or untried in humans usually need to be studied in major medical centers, not through private physicians' offices in community trials.

Grassroots Treatment List; What the Community Wants to Test

Most treatments already being studied in community-based trials are products being developed by pharmaceutical companies. The immediate reason for this focus is of course financial; it has been hard to fund trials of substances which are medically promising -- or used by thousands of people -- but which are unpatentable or otherwise lack commercial potential. Certainly the commercial treatments must be studied; "second generation" HIV drugs can be the most promising possibilities. But we also need trials of the "grassroots" treatments which the public is using, for at least two reasons: (1) to give patients objective assessments of risks and benefits of different options, and (2) because treatments attractive enough to have developed a following among patients, physicians, or scientists, with little commercial or organized promotion, may well have objective benefits which academic research and medicine should consider.

While community-based trials clearly should study both the industrial and grassroots treatment possibilities, in our list below we focused on those with a popular interest or following (some also have commercial sponsors). We chose this focus for the practical reason that AIDS Treatment News has better information about treatments with grassroots support, which usually come to our attention, than about treatments being developed by pharmaceutical companies, which are often kept secret.

We selected the treatments listed below because there is public interest in them, they have some medical or scientific rationale, and they appear suitable for community-based research. This list is not nearly complete, and we welcome suggestions for additions.

Readers should note that the rationales we present below are necessarily sketchy; we could not research every treatment thoroughly by press time. We published this list to emphasize the wide range of treatment possibilities suitable for testing in community-based research.

Potential Treatment List (Alphabetical)

**Acidophilus.

Acidophilus preparations, available in health-food stores, contain live beneficial bacteria, intended to help crowd out harmful micro-organisms in the gastrointestinal tract. (For more background information, see AIDS Treatment News # 32, May 22, 1987.)

A community-based study of acidophilus could begin by asking clinicians experienced with it to specify (a) how to select the patients believed most likely to benefit, and (b) what benefits should occur, and when.

While community-based trials would seldom use a placebo, a randomized double-blind placebo trial might be appropriate in this case because:

* The placebo would be strictly voluntary, as anyone who wanted could obtain acidophilus outside the study. The only rea- son for volunteering would be to contribute to the advancement of knowledge, not to obtain treatment.

* Benefits of acidophilus (if any) are likely to be noticed very rapidly. The placebo phase of the trial would probably need to last for only a few days.

* Evaluating the success of this treatment might necessarily be subjective, through patients' reports that they were feeling better. Lack of laboratory measurements of success increases the danger of a false positive outcome of the trial due to "placebo effect", making a double-blind design more necessary.

Incidentally, it should be easy to make a placebo which looks and tastes like acidophilus, simply by heat treating the capsules or otherwise making sure the organisms were dead.

** AL 721 or substitutes.

The Community Research Initiative in New York is already conducting a community-based trial of egg-lecithin lipids. The study is fully enrolled, and preliminary results should be available in a few weeks.

** Aloe vera.

Aloe vera preparations are used for medicinal purposes in many cultures. For AIDS/HIV, the most systematic studies are being done by advocates of carrisyn, a chemical found in aloe vera and now being moved through the FDA approval process by Carrington Laboratories in Dallas, Texas.

Carrisyn may take months before showing improvement (usually measured in T-cell numbers). It would be difficult to ask patients to stay off other treatments during this time. Therefore the study could be designed not as a test of carrisyn (or other aloe preparation) by itself, but rather of whatever combination therapy patients are most likely to want to try anyway. Such patient-led design should make it easier to recruit patients, reduce any incentive to cheat, and also take advantage of any practical knowledge in the community of patients and front-line physicians on how best to use carrisyn (or other aloe preparations).

** Amino acids.

A number of people are using lysine, readily available in health-food stores, as an antiviral for herpes and/or HIV. Some are convinced that at least two other amino acids should be avoided -- not supplemented or used in large amounts -- as they are believed to encourage the growth of viruses. We have heard of this use of lysine from at least three well-informed sources; however one nutritionist who is familiar with the literature on amino acids had never heard of using them in antiviral treatment.

The scientific review committee would need to research whether there is credible justification for this therapy, and if so, what patients should be selected and what measurable end- points used to look for beneficial results.

** Antabuse.

Thousands of people are using this prescription drug as a substitute for imuthiol (DTC), an immune modulator developed in France but not easily available in the United States. Much of the antabuse taken becomes imuthiol in the body.

The Community Research Initiative in New York is now con- ducting a monitoring study of antabuse.

** Anti-inflammatory therapy.

Various published and unpublished information suggests that certain anti-inflammatory drugs such as indocin or even aspirin may be helpful to some patients. Others might not be helped or might be harmed by the drugs.

By reviewing the literature and interviewing clinicians, some of whom have been using this treatment for years, the scien- tific committee could determine which patients are likely to benefit, what measurable results could be expected, how long it should take to see them, and what is known about risks of long- term use of the drugs by persons with AIDS or ARC (less relevant to the safety of this short-term study than to the usefulness of a positive result).

If benefits could be expected very quickly (perhaps within days) it might be feasible to use a placebo and double-blind design for only the first week or two of the test, after which everyone would go on the drug. Only volunteers would risk the placebo; the rest would start open label immediately. This protocol not only eliminates the unethical extortion of withholding treatment to force participation in a placebo study, it also removes any incentive to cheat. Only those who volunteer to help research may get the placebo -- and only for a short time.

** AZT for cryptosporidiosis.

At the June Stockholm conference, six researchers at a Paris hospital presented results from 16 patients (poster #3672). Marked improvement was found in 14 of the 16 in the first month; diarrhea disappeared in 10 of the 15 patients who were treated for at least three month. Half and full doses of AZT seemed to work equally well. Unfortunately this poster session received less attention than it deserved, because it was not indexed under cryptosporidium in the abstract book.

Other scattered reports have suggested such an effect -- not as surprising as it may seem, since AZT is an antibiotic as well as an antiviral, effective against a number of micro-organisms including at least one intestinal parasite, giardia. An anti- cryptosporidiosis effect of AZT may explain why this disease has been less common than had been feared.

It might be hard to find patients for the trial, as most of those ill enough to have cryptosporidiosis would already be using AZT, unless they could not tolerate it.

** BHT.

This food preservative is very effective against most lipid-coated viruses in the test tube, and has prevented viral infections in animals. One published human trial found it effective for treating herpes. One laboratory test found particular activity against CMV. (See AIDS Treatment News #10, August 15, 1986).

For several years hundreds of people have been using large doses of BHT, about one gram a day, to help control herpes. Few have tried it for AIDS-related conditions. Laboratory results with HIV are mixed, with NIH finding no efficacy.

In recent months public interest has greatly increased, perhaps due to widespread publicity about encouraging laboratory results mentioned by RC Aloia and others in the February 1988 Proceedings of the National Academy of Sciences USA (pages 900- 904). This public interest in a readily available chemical makes it even more important to have a trial with medical monitoring to learn more about safety as well as efficacy of this potential treatment.

Other Possibilities

We had not written annotations for the following by press time. These and others may appear in future issues.

** Bile salts. ** Chinese medicine. ** Chlorophyll. ** Coenzyme Q. ** Dapsone. ** DDI. ** Deficiency testing and supplementation. ** Dextran sulfate. ** DHEA. ** DNCB. ** Fatty acids. ** Ganoderma. ** Garlic. ** Germanium. ** Ginseng. ** Homeopathy. ** Hydrogen peroxide (or chlorine dioxide). ** Imuthiol (DTC) from France. ** Iscador. ** Japanese herbs (over 100 paid for by national health system). ** Lentinan. ** Macrobiotic diet (investigate status of earlier study). ** Milk antibodies (or colostrum, or veterinary antibodies from whey).

** Naltrexone. ** Nutrition improvement. ** Ozone. ** Peptide T. ** Plasmapheresis (and related, eg Prosorba column, packed washed red cells). ** Polio killed-virus vaccine. ** Propolis. ** Selenium. ** Typhoid immunization. ** Vitamins: A, C, E, others. ** Zinc.

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