Minocycline for HIV+ Cognitive Impairment in Uganda

NCT ID: NCT00855062

Last Updated: 2011-02-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-12-31

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

Conditions

HIV-associated Cognitive Impairment; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Minocycline

Minocycline 100 mg orally every 12 hours

Group Type: ACTIVE_COMPARATOR

minocycline

Intervention Type: DRUG

100 mg capsule every 12 hours by mouth

Placebo

Placebo minocycline capsules every 12 hours

Group Type: PLACEBO_COMPARATOR

minocycline placebo capsule

Intervention Type: DRUG

1 capsule every 12 hours by mouth

Interventions

minocycline

100 mg capsule every 12 hours by mouth

Intervention Type: DRUG

minocycline placebo capsule

1 capsule every 12 hours by mouth

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• 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 written informed consent
• Resident within a 20km radius of Kampala city

Exclusion Criteria

• 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
• 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 subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator
• History of allergy/sensitivity to minocycline or other tetracyclines and their formulations
• Any other clinically significant condition or laboratory abnormality that, in the opinion of the investigator, would interfere with the subject's ability to participate in the study. This includes an individual found to have an HIV dementia scale stage 3 or 4.
• Any esophageal or other condition that would interfere with the swallowing of the study medication
• Use of excluded drugs as defined by the protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Makerere University

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Johns Hopkins School of Medicine

Principal Investigators

Ned Sacktor, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Infecious Diseas Institute

Kampala, , Uganda

Countries

Uganda

Other Identifiers

Grant Number: 5 UO1 NS32228

Identifier Type: -

Identifier Source: secondary_id

Uganda minocycline study

Identifier Type: -

Identifier Source: org_study_id