Minocycline for HIV+ Cognitive Impairment in Uganda
Status:
Terminated
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline,
an antibiotic, in the treatment of Human immunodeficiency virus (HIV)-associated cognitive
impairment in Uganda.
Study Design: Treatment, 24-week Randomized, Placebo-Controlled, Double-Blind Phase with
Optional 24-week Open Label Phase for Subjects with a cluster of differentiation 4 (CD4)
Count in the 251-350 Range
- Arm 1: Minocycline 100 mg orally every 12 hours (50 subjects)
- Arm 2: Matching placebo orally every 12 hours (50 subjects)
Primary Objective:
ยท To examine whether minocycline treatment will improve cognitive performance after 24 weeks
compared to baseline
Secondary Objectives:
- To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in
individuals with HIV-associated cognitive impairment
- To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in
individuals with HIV-associated cognitive impairment
- To examine whether minocycline treatment for 24 weeks improves functional impairment