A Pilot Study of the Effect of Minocycline on Cerebrospinal Fluid HIV-1 Infection

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be an uncontrolled, open-labelled pilot study exploring whether minocycline has a measurable and selective effect on HIV infection of the central nervous system.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Minocycline

Criteria

Inclusion Criteria:

1. HIV infection with plasma and CSF HIV RNA concentrations (using Roche Amplicor assay) > 1,000 copies/ mL (available after baseline LP).

2. Off antiretroviral therapy (ART) for > 6 weeks before the study and no plans to begin treatment for the study duration. (The decision of whether or not a subject takes antiretroviral therapy will be made by the subject in consultation with his/her primary care provider prior to screening for this study.)

3. Predicted adherence to the medication.

4. Capable of providing informed consent.

5. > 18 years old

6. CD4 cell counts >150 cells/μL (though likely most, if not all, will be >250 cells/μL).

7. When available, subjects will be screened for stability of blood CD4 and HIV RNA levels.

Exclusion Criteria:

1. Taking a tetracycline within 6 months or history of adverse reaction to minocycline or another tetracycline.

2. Enhanced risk from lumbar puncture, including documented or suspected cerebral mass lesion predisposing to brain herniation or bleeding diathesis.

3. Pregnancy or expectation of pregnancy during the study.

4. Active opportunistic infection or active neurological disease that might confound evaluation.

5. ADC Stage > 1.

6. Hemoglobin < 10 Gms/dL.

7. BUN or creatine above the normal limits.

8. Taking other drugs known to reduce the metabolism of minocycline and thus increase the probability of toxicity.