Insufficient financial support; lack of efficacy for primary endpoint

Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for malaria treatment and prevention, and it also has significant anti-inflammatory effects. No formal study of chloroquine has been performed in people with HIV infection. Chloroquine is used worldwide and is quite inexpensive outside of the United States. If shown to be effective, chloroquine could be a very important tool worldwide in delaying HIV disease progression which would extend the time period without needing anti-retroviral therapy. In countries where anti-retroviral therapy is not available, this could be very helpful.

This is an 8 week trial study requiring 3 study visits. Participants will be ask to take a once a day study medication (chloroquine or placebo) for 8 weeks and have three blood draws for CD4 counts, HIV viral loads, and other research tests. The visits are at study enrollment, 4 weeks, and 8 weeks.

Summary:

A phase I randomized, double-blind, placebo controlled trial to investigate the efficacy of chloroquine to decrease T-cell activation and decrease viral load in early HIV.

Scientific Rationale:

Chloroquine has in vivo direct anti-HIV effects and an anti-inflammatory effect. These properties may be beneficial in reducing viral burden and immune activation therefore delaying HIV disease progression.

Sample Size: 25

Length of Study: 8 weeks, [enrollment + 2 follow up visits].

Intervention:

• Arm 1a: Chloroquine 250mg orally once daily for 8 weeks.
• Arm 1b: Chloroquine 500mg orally once daily for 8 weeks.
• Arm 2: Placebo once daily for 8 weeks.

Measurements:

• Blood draws at weeks: 0, 4, and 8 weeks.
• CD4, viral load measurements will be communicated to the referring provider (with subject consent).

Inclusion Criteria:

• HIV-1 infected adults
• CD4 count > 250 cells/mm3
• Not presently receiving HIV antiretroviral therapy (> 6 months or naïve)
• Viral load > 3000 RNA copies/mL (3.5 log)
• No planned HIV anti-retroviral therapy for 8 weeks

Exclusion Criteria:

• Prior retinal eye disease
• CD4 < 250 cells/µL
• Renal failure
• Active malignancy
• Corticosteroid therapy
• Age < 18 or > 65 years