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

Official Title: “A Randomized, Pilot Study of the Anti-Viral and Anti-Inflammatory Effects of Chloroquine in Early HIV Infection”

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 1: 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).

Intervention(s) in this Clinical Trial

• Drug: chloroquine phosphate
  • 500mg PO (by mouth) QDay
• Drug: Placebo
  • Placebo once daily for 8 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Chloroquine 500mg orally once daily
• Placebo Comparator: 2
  • Placebo once daily for 8 weeks

Primary Measures

• HIV Viral Load change
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Decrease in immune activation assessed by FACS analysis
  • Time Frame: 8 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Minnesota - Clinical and Translational Science Institute Other

Overall Clinical Trial Officials and Contacts

Winston Cavert, MD Principal Investigator University of Minnesota - Clinical and Translational Science Institute  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00308620

Study ID Number: 0510M77007

ClinicalTrials.gov Identifier: NCT00308620

Health Authority: United States: Institutional Review Board

Minnesota AIDS Clinical Trials Unit