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Sponsors and Collaborators: |
Johns Hopkins University Makerere University |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00855062 |
Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline, an antibiotic, in the treatment of 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 CD4 Count in the 251-350 Range
Primary Outcome Measure:
Secondary Outcome Measures:
Condition | Intervention | Phase |
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HIV-associated Cognitive Impairment HIV Infections |
Drug: minocycline Drug: minocycline placebo capsule |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Minocycline in the Treatment of HIV-Associated Cognitive Impairment in Uganda |
Estimated Enrollment: | 100 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Minocycline 100 mg q12 h: Active Comparator
Active treatment with minocycline
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Drug: minocycline
100 mg capsule q12 hours by mouth
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2: Placebo Comparator
placebo minocycline capsules
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Drug: minocycline placebo capsule
1 capsule q 12 hours by mouth
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Inclusion Criteria
Exclusion Criteria
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
· HIV infection prior to study entry
Exclusion Criteria:
-
Contact: Noeline Nakasujja, MD | (011) 256 41 430 7289 | drnoeline@yahoo.com |
Contact: Elly Katabira, MD | katabira@infocom.co.ug |
Uganda | |
Infecious Diseas Institute | Recruiting |
Kampala, Uganda | |
Principal Investigator: Noeline Nakasuijja, MD |
Principal Investigator: | Ned Sacktor, MD | Johns Hopkins School of Medicine |
Responsible Party: | Johns Hopkins School of Medicine ( Ned Sacktor, MD ) |
Study ID Numbers: | Uganda minocycline study, Grant Number: 5 UO1 NS32228 |
Study First Received: | March 2, 2009 |
Last Updated: | September 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00855062 History of Changes |
Health Authority: | United States: Federal Government; United States: NINDS appointed Data Safety Monitoring Committee for the Neurologic AIDS Research Consortium |
HIV HIV associated cognitive impairment HIV dementia |
Uganda AIDS Treatment Naive |
Anti-Infective Agents Minocycline Sexually Transmitted Diseases, Viral AIDS Dementia Complex Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Cognition Disorders Virus Diseases |
Anti-Bacterial Agents Delirium, Dementia, Amnestic, Cognitive Disorders HIV Infections Mental Disorders Sexually Transmitted Diseases Dementia Retroviridae Infections Delirium |
Anti-Infective Agents Minocycline RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Pharmacologic Actions Cognition Disorders |
Immunologic Deficiency Syndromes Virus Diseases Anti-Bacterial Agents Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |