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GAY PEOPLE'S CHRONICLE OCTOBER 28, 1994

THE COLUMBUS EAGLE

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HEALTH WATCH

An explanation of AIDS Clinical Trials Units

by John Carey, M.D.

Early on in the HIV/AIDS epidemic it became clear that the medical establishment needed new therapies and new treatments to help the people infected with this virus live productive, full lives. One of the aspects of the HIV epidemic that is invisible in the Cleveland area is how much is being done locally to combat the epidemic.

Case Western Reserve University's Department of Medicine receives over $5 million per year in federal funding for AIDS research. Some of the researchers are interested in the treatment of HIV and opportunistic infections; some are investigating what makes HIV tick; some are interested in how the body defends itself against disease; and some are working on the best ways to tell people about HIV and prevent its spread.

In this and future columns I will describe the people working in AIDS research in the Cleveland area, the clinical and basic science problems they are working on, and what this means to you.

The CWRU AIDS Clinical Trials Unit is the first major AIDS-related research project in Cleveland funded by the National Institutes of Health. This unit is housed at University Hospitals of Cleveland and has subunits at Cleveland Metro General Hospital and the Medical College of Ohio in Toledo. The purpose of this unit is to conduct clinical trials for HIV and complicating conditions.

Clinical trials are the process that is used to find out if a new treatment is helpful in treating a disease. Clinical trials are the only way to find out if a given treatment is going to help people. There are many different styles of clinical trials. Some types of clinical trials are used if a drug or treatment is just recently discovered, and others are used if a lot is already known about a drug.

These trials are driven by patients' and doctors' needs. For example, Pneumocystis carinii pneumonia is a big problem for people who have AIDS. It is the most frequent reason for being admitted to the hospital for people who are not aware of their HIV status. Fortunately, we can prevent PCP in most people who are at risk. The drug that most doctors prefer for prevention of PCP is trimethoprim/

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sulfamethoxazole, marketed under the names of Bactrim or Septra. If people are able to take this drug, then the likelihood that they will develop PCP is low, about 5 people in 100 when followed for a year. Trimethoprim/sulfamethoxazole also helps to prevent toxoplasmosis. Unfortunately, many people are very allergic to trimethoprim/sulfamethoxazole, so doctors have to look at alternative treatments for these people. The currently available treatments for sulfa-allergic people include a drug called dapsone or a form of pentamidine delivered by a breathing treatment called an aerosol.

Dapsone is relatively cheap, costing approximately $20 per month. It comes in the form of a pill that must be taken daily. People who can take dapsone also have a low rate of PCP. About 8 people in 100 on the drug will develop PCP when they are followed for a year. Dapsone also helps to prevent toxoplasmosis.

Some HIV positive people cannot take dapsone and these people are usually prescribed aerosolized pentamidine. Aerosolized pentamidine needs to be given just once a month but it is expensive, about $200 per month. People on aerosolized pentamidine have a higher rate of PCP. About 18 people per 100 followed for a year will develop PCP. Aerosolized pentamidine also makes people cough and there is a concern that this can spread tuberculosis among people who are HIV positive.

Recently, the FDA has approved a new drug for the treatment of PCP. This drug is called atovaquone, and it comes in pill form. Atovaquone is expensive. A course of treatment with this drug for PCP would cost $600. This drug, however, seems to have relatively few side effects and may also prevent toxoplasmosis. So the question for patients and their doctors now is, "What treatment is better now for people who cannot take trimethoprim/ sulfamethoxazole, dapsone or atovaquone?" Well, a clinical trial has been designed to answer this question.

The trial, called ACTG 277 (AIDS Clinical Trials Group 277), will compare dapsone to atovaquone for people who are unable to take trimethoprim/sulfamethoxazole. People will be followed for the occurrence of either PCP or toxoplasmosis. The medications will be provided free of charge. For more information, call Margaret Cuttler at 216844-8175.

John Carey has cared for people with AIDS since 1983. He is the medical director of the Special Immunology Unit at University Hospitals of Cleveland, an outpatient unit for people with HIV/AIDS.

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