Conditions: HIV-associated Cognitive Impairment HIV Infections
Keywords: Human immunodeficiency virus (HIV) HIV associated cognitive impairment HIV dementia Uganda Acquired immune deficiency syndrome (AIDS) Treatment Naive
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 73
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: Minocycline 100 mg orally every 12 hours arm 2: Placebo minocycline capsules every 12 hours

Interventions: intervention 1: minocycline intervention 2: minocycline placebo capsule
Intervention descriptions: intervention 1: 100 mg capsule every 12 hours by mouth intervention 2: 1 capsule every 12 hours by mouth

Protocol document: