Minocycline for HIV+ Cognitive Impairment in Uganda

Status Terminated

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Cognition Disorders
HIV Infections
HIV-associated Cognitive Impairment

Clinical Trial Details

NCT number	NCT00855062
Study type	Interventional
Source	Johns Hopkins University
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	April 2008
Completion date	December 2009

View Details

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