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.