Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: Minnesota Medical Foundation
• Treatments: Anti-Inflammatory Agents; Chloroquine; Chloroquine diphosphate

Criteria

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