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

Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: chloroquine phosphate (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Terminated

Sponsored by: University of Minnesota - Clinical and Translational Science Institute

Official(s) and/or principal investigator(s):
David R Boulware, MD, MPH, Principal Investigator, Affiliation: University of Minnesota - Clinical and Translational Science Institute


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: HIV Viral Load Change

Secondary outcome: Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks

Detailed description: 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.


- Blood draws at weeks: 0, 4, and 8 weeks.

- CD4, viral load measurements will be communicated to the referring provider (with

subject consent).


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

Minnesota ACTU, Minneapolis, Minnesota 55455, United States
Additional Information

University of Minnesota Clinical Virology Program

Starting date: March 2006
Last updated: July 9, 2012

Page last updated: August 20, 2015

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