Suspended

Minocycline in the Treatment of HIV-Associated Cognitive Impairment in Uganda

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What is being tested

minocycline

+ minocycline placebo capsule

Drug
Who is being recruted

Blood-Borne Infections+20

+ Urogenital Diseases

+ Genital Diseases

From 18 to 65 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: April 2008
See protocol details

Summary

Principal SponsorJohns Hopkins University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2008

Actual date on which the first participant was enrolled.

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

Official TitleMinocycline in the Treatment of HIV-Associated Cognitive Impairment in Uganda
NCT00855062
Principal SponsorJohns Hopkins University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

73 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeMental DisordersBrain DiseasesCentral Nervous System DiseasesCommunicable DiseasesDementiaImmunologic Deficiency SyndromesImmune System DiseasesInfectionsNervous System DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralAIDS Dementia ComplexHIV InfectionsLentivirus InfectionsNeurocognitive Disorders

Criteria

10 inclusion criteria required to participate
HIV infection prior to study entry
Naïve to any antiretroviral regimen and ineligible to receive antiretroviral therapy by cluster of differentiation 4 (CD4) criteria in Uganda
Negative serum or urine pregnancy test for women of childbearing potential
Willingness to use birth control
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14 exclusion criteria prevent from participating
Current cancers other than basal cell carcinoma, in situ carcinoma of the cervix, or Kaposi's sarcoma without evidence of visceral involvement or which does not require systemic chemotherapy
Severe premorbid psychiatric illness, including schizophrenia and major depression which, in the in investigator's opinion, is likely to interfere with study compliance
Active symptomatic AIDS-defining opportunistic infection within 45 days prior to study entry
Confounding neurological disorders as defined in the protocol
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Minocycline 100 mg orally every 12 hours

Group II

Placebo
Placebo minocycline capsules every 12 hours

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Infecious Diseas Institute

Kampala, UgandaOpen Infecious Diseas Institute in Google Maps
SuspendedOne Study Center