Minocycline for HIV+ Cognitive Impairment in Uganda

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: · 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

Timeline

Start

2008-04

Primary completion

2009-12

Completion

2009-12

Drugs

Indications