Minocycline for HIV+ Cognitive Impairment in Uganda

Phase

1/2

Condition

Memory Problems

Mild Cognitive Impairment

Dementia

Treatment

N/A

Clinical Study ID

NCT00855062

Uganda minocycline study

Grant Number: 5 UO1 NS32228

Ages 18-65
All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

HIV infection prior to study entry
Naïve to any antiretroviral regimen and ineligible to receive antiretroviral therapyby cluster of differentiation 4 (CD4) criteria in Uganda
Negative serum or urine pregnancy test for women of childbearing potential
Willingness to use birth control
Age 18-65 years
AIDS Dementia Scale Stage 0.5 OR 1
Impaired cognitive performance as evidenced by an International HIV Dementia Scale (HDS) as defined by the protocol
Ability to sit or stand and swallow intact capsules with an 8-ounce glass of water
Ability and willingness of subject or legal guardian/ representative to give writteninformed consent
Resident within a 20km radius of Kampala city

Exclusion

Exclusion Criteria:

Current cancers other than basal cell carcinoma, in situ carcinoma of the cervix, orKaposi's sarcoma without evidence of visceral involvement or which does not requiresystemic chemotherapy
Severe premorbid psychiatric illness, including schizophrenia and major depressionwhich, in the in investigator's opinion, is likely to interfere with study compliance
Active symptomatic AIDS-defining opportunistic infection within 45 days prior to studyentry
Confounding neurological disorders as defined in the protocol
Central nervous system infections or cancers as defined in the protocol
Systemic lupus
Thyroid disease diagnosed within 24 weeks prior to entry
Breastfeeding
Active drug or alcohol use or dependence that, in the opinion of the investigator,would interfere with adherence to study requirements
Serious illness requiring systemic treatment and/or hospitalization until subjecteither completes therapy or is clinically stable on therapy, in the opinion of theinvestigator
History of allergy/sensitivity to minocycline or other tetracyclines and theirformulations
Any other clinically significant condition or laboratory abnormality that, in theopinion of the investigator, would interfere with the subject's ability to participatein the study. This includes an individual found to have an HIV dementia scale stage 3or 4.
Any esophageal or other condition that would interfere with the swallowing of thestudy medication
Use of excluded drugs as defined by the protocol

Study Design

April 01, 2008

December 31, 2009

Connect with a study center

Infecious Diseas Institute
Kampala,
Uganda
Site Not Available

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