Minocycline for HIV+ Cognitive Impairment in Uganda
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV-associated Cognitive Impairment; HIV Infections
Intervention: minocycline (Drug); minocycline placebo capsule (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): Ned Sacktor, MD, Principal Investigator, Affiliation: Johns Hopkins School of Medicine
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 Details
Official title: Minocycline in the Treatment of HIV-Associated Cognitive Impairment in Uganda
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
Primary outcome: 24-week Change of Uganda Neuropsychological Test Battery Summary Measure (U NP Sum)
Secondary outcome: 24-week Change of Memorial Sloan Kettering (MSK) HIV Dementia Stage24-week Change of Karnofsky Performance Score Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms. Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms 24-week Change of CD4 Cell Counts 48-week Change of CD4 Cell Counts 24-week Change of Instrumental Activities of Daily Living 24-week Change of HIV RNA Plasma Viral Loads (Log10 Transformed) 24-week Change of Center for Epidemiologic Studies Depression (CES-D) Score
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Infecious Diseas Institute, Kampala, Uganda
Additional Information
Starting date: April 2008
Last updated: January 28, 2011
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