A5235 - Trial of Minocycline for HIV-Associated Cognitive Impairment.

Eligible candidates:

• HIV-1 infected individuals between the ages of 18 and 65.
• On current HIV meds for at least 16 weeks, and willing to stay on those same HIV meds for the first 24 weeks of the study.
• Progressive neurocognitive impairment, as evidenced by neuropsycholgical tests given at the screening visit.
• Willing and able to have 2 lumbar punctures or “spinal taps.”
• Additional requirements will be discussed by the study nurse or doctor.

Study Objective:
This is a phase II, randomized, placebo-controlled, double-blind study examining whether minocycline treatment for 24 weeks improves HIV-associated cognitive impairment. It also will examine whether minocycline treatment for 24 and 48 weeks is safe and well-tolerated, and whether it improves functional impairment. Finally, it will examine whether minocycline treatment for 24 weeks decreases levels of several markers of HIV-associated cognitive impairment in the blood and cerebrospinal fluid (CSF).

Study Scheme:
One hundred eligible individuals will receive minocycline or a placebo for 24 weeks. Subjects who are able to remain on study treatment through week 24 will be given the option to enter Step 2 and receive open-label minocycline for 24 weeks.

Study Drugs:

• Minocycline

Study Status: Open to Enrollment.

Study Staff:

• Judith Aberg, MD
• Karen Cavanagh, RN
• Luis Vargas

Study Sponsors:

• AIDS Clinical Trials Group (NIH)

Study Volunteers Receive:

• Cost-free lab work
• Transportation reimbursement