This is a randomized double blind placebo controlled trial of oral memantine taken concurrently with an antiretroviral regimen in subjects with ADC Stage 1, 2, or 3. The purpose of this study is to determine the safety and effectiveness of memantine, a drug that has been used for several years in Germany for the treatment of neurological disorders, but has not been approved in the U.S. for any disease state. This study af ADC in subjects taking antiretroviral therapy will evaluate memantine to see if it improves the effects of ADC. The primary objective is to assess the possible efficacy of oral memantine in ameliorating AIDS Dementia Complex. Secondary Objectives: 1) To assess the possible efficacy of oral memantine in ameliorating painful peripheral neuropathy in subjects concurrently treated with antiretroviral regimen. 2) to correlate dosing levels of memantine with observed toxicities and clinical outcomes. 3) to determine the effect of mamantine on cerebrospinal surrogate markers and viral load.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000750-27S1
Application #
6291019
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
27
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Type
DUNS #
005436803
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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