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AIDS Treatment Data Network
(ATDN) Vitamin E Drug

April 1, 1995
Treatment Review #18; April 1995

The Dana Farber Institute has been sponsoring an information gathering study about HIV-related dementia. They have now added a vitamin E-like compound, OPC-14117. This drug may protect nerve cells from damage due to HIV infection. Two of the sites conducting this study will add this drug to see if it treats changes in thinking associated with HIV infection. To participate, you must be HIV+, 18 years or older, and experiencing problems with short term memory, concentration, and feeling slowed down. If you're taking antiretrovirals, you must be on an unchanged dose for 6 weeks or more. You cannot have a seizure disorder, opportunistic infection of the central nervous system, serious liver or kidney dysfunction, Kaposi's sarcoma requiring systemic chemotherapy, or take more than 2 drinks of alcohol per day. You cannot be getting chemotherapy for any malignancy. Participants will be divided into two groups. One group will take the study drug. The other group will take a placebo. For the first 12 weeks neither the participant nor the doctor will know which treatment is being given. After that, open-label drug will be provided for 12 weeks. Seventeen clinic visits are required during the 24 weeks of the study. A stipend is provided for the first visit, and to cover transportation costs for following visits. Clinic visits will include tests for neurological, neuropsychological, medical and functional status.