A5235

A Phase II, Randomized, Placebo-Controlled, Double-Blind Study of Minocycline in the Treatment of HIV-Associated Cognitive Impairment

Purpose of this Study: This study is being done to see if taking minocycline improves mental function and is safe for patients infected with HIV.

Requirements to Enter Study:

Receipt of a stable antiretroviral regimen for at least 16 consecutive weeks prior to entry and no plan to change therapy between screening and week 24.
Cognitive impairment as evidenced by neuropsychological tests administered at screening and centrally reviewed by the protocol-designated certified neuropsychologist.
Progressive neurocognitive decline determined by the objective (preferable) or subjective requirements stated in the protocol.
Ability to sit or stand for at least two hours and swallow medications with an 8-ounce glass of water.
Patient willingness to have multiple lumbar punctures as per protocol schedule.

Treatment:

Step 1: Double-Blind: Day 0 through week 24.

Arm 1: Minocycline 100 mg, orally every 12 hours.
Arm 2: Matching placebo, orally every 12 hours.

Step 2: Open-Label: Week 25 through 48

Subjects who complete the 24-week double-blind phase (Step 1) will be offered the option to enter Step 2 and participate in the open-label minocycline phase for an additional 24 weeks. The open-label participation is optional.

Minocycline 100 mg, orally every 12 hours.

Duration of Study: Step 1: Double-blind: 24 weeks Step 2: Open-label (optional): an additional 24 weeks.

For more information contact:

Study Contacts
Joseph Quinn, RN (215) 349-8092