SAN FRANCISCO: LENTINAN STUDY RECRUITING

Persons who are HIV positive, have T-cell counts between 200 and 500, and are not using other antiviral or immune modulator treatments, are needed for a three-month study of lentinan at the AIDS Clinic at San Francisco General Hospital. To be eligible, volunteers can be either asymptomatic or mildly to moderately ill, but cannot have AIDS.

Lentinan, an extract of the shiitake mushroom which is given intravenously in 10-minute infusions once per week, has been used in Japan to treat thousands of cancer patients, with very little toxicity. It has immune potentiating effects, and may also be antiviral against HIV. The San Francisco study will look for both effects by blood tests. (For earlier
background on lentinan, see AIDS TREATMENT NEWS issue #19, December 5, 1986.)

Persons entering the trial will be randomly assigned to one of four groups: 2 mg per week, 5 mg, 10 mg, or placebo. There is one chance in four of getting the latter. However, the placebo is given for only eight weeks (followed by four weeks off treatment, to see what happens when the lentinan is stopped); and the study will be ended early if any dose is found to be clearly effective. And if the lentinan proves effective, all volunteers who complete the study will
probably have access to it "open label" (without placebo) without charge; however, this access is not guaranteed.

Aerosol pentamidine and some other treatments are OK during the trial. AZT is probably not.

The study is being conducted by Donald Abrams, M.D., Eric Goosby, M.D., and Roberta Wong, Pharm. D. Financing is from Ajinomoto Co., Inc., Yokohama, Japan, through Lenti-Chemico Pharmaceutical Laboratory, Inc., Teaneck, New Jersey.

Forty patients are being recruited (10 for each arm of the study). If you meet the qualifications above and are willing to volunteer, call Vince De Genova at San Francisco General Hospital, 821-5089.

Comment

This study is important for the community. Lentinan might be an effective therapy for delaying or preventing the development of AIDS in persons at early stages of illness. A trial should have been done four years ago, but there was no money then for a U.S. trial, and there were not enough patients in Japan.

Dr. Abrams originally designed the San Francisco study without a placebo. The FDA asked that the placebo arm be added, because if the drug does seem to work it will never again be possible to test it against a placebo, and researchers will be less confident that improvement seen in trials is really due to the drug.

We believe that the placebo is justified in this case. The randomized treatment lasts only eight weeks; the trial is designed to look for blood changes, not serious illness or death. Ten people (not hundreds) will get the placebo. And if the study shows that the drug does work, it will have more credibility and more quickly become available to thousands of people.

This study design is workable and can answer important questions about the drug. We hope that people will volunteer in order to help the AIDS community, despite the personal sacrifice of giving up other treatments temporarily.