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

This study has been terminated.
(Insufficient financial support; lack of efficacy for primary endpoint)
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00308620
First received: March 27, 2006
Last updated: July 9, 2012
Last verified: May 2012

March 27, 2006
July 9, 2012
March 2006
December 2008   (final data collection date for primary outcome measure)
HIV Viral Load Change [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
HIV-1 viral load change between baseline and 8 weeks
HIV Viral Load change
Complete list of historical versions of study NCT00308620 on ClinicalTrials.gov Archive Site
Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks.
Change in cellular activation assessed by FACS analysis
Not Provided
Not Provided
 
Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine
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 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).
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Drug: chloroquine phosphate
    250mg or 500mg PO (by mouth) QDay
    Other Name: Aralen
  • Drug: Placebo
    Placebo once daily for 8 weeks
    Other Name: Placebo
  • Experimental: Chloroquine
    Chloroquine 205mg or 500mg orally once daily (Results pooled)
    Intervention: Drug: chloroquine phosphate
  • Placebo Comparator: Placebo
    Placebo once daily for 8 weeks
    Intervention: Drug: Placebo
Murray SM, Down CM, Boulware DR, Stauffer WM, Cavert WP, Schacker TW, Brenchley JM, Douek DC. Reduction of immune activation with chloroquine therapy during chronic HIV infection. J Virol. 2010 Nov;84(22):12082-6. Epub 2010 Sep 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
June 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00308620
0510M77007
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Minnesota Medical Foundation
Principal Investigator: David R Boulware, MD, MPH University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP