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

Phase 2

Terminated

• Conditions: HIV Infections
• Interventions: Drug: Placebo; Drug: chloroquine phosphate

• Registration Number: NCT00308620
• Lead Sponsor: University of Minnesota

Brief 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.

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.

Measurements:

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

* CD4, viral load measurements will be communicated to the referring provider (with subject consent).

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-27
• Study First Submitted QC: 2006-03-27
• Study First Posted: 2006-03-29
• Primary Completion: 2008-12
• Study Completion: 2009-06
• Results First Submitted: 2011-09-26
• Results First Submitted QC: 2012-07-09
• Results First Posted: 2012-08-17
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo once daily for 8 weeks
Chloroquine	chloroquine phosphate	Chloroquine 205mg or 500mg orally once daily (Results pooled)

Primary Outcome Measures

Name	Time	Method
HIV Viral Load Change	baseline and 8 weeks	HIV-1 viral load change between baseline and 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks	8 weeks	The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks.

Trial Locations

Locations (1)

Minnesota ACTU; 🇺🇸 Minneapolis, Minnesota, United States