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

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ClinicalTrials.gov Identifier: NCT00308620
Recruitment Status : Terminated (Insufficient financial support; lack of efficacy for primary endpoint)
First Posted : March 29, 2006
Results First Posted : August 17, 2012
Last Update Posted : August 17, 2012
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
HIV Infections Drug: chloroquine phosphate Drug: Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Pilot Study of the Anti-Viral and Anti-Inflammatory Effects of Chloroquine in Early HIV Infection
Study Start Date : March 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Chloroquine
Chloroquine 205mg or 500mg orally once daily (Results pooled)
 Drug: chloroquine phosphate
250mg or 500mg PO (by mouth) QDay
Other Name: Aralen
Placebo Comparator: Placebo
Placebo once daily for 8 weeks
 Drug: Placebo
Placebo once daily for 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. HIV Viral Load Change [ Time Frame: baseline and 8 weeks ]
    HIV-1 viral load change between baseline and 8 weeks


Secondary Outcome Measures :
  1. Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks [ Time Frame: 8 weeks ]
    The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308620


Locations
United States, Minnesota
Minnesota ACTU
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Minnesota Medical Foundation
Investigators
Principal Investigator: David R Boulware, MD, MPH University of Minnesota - Clinical and Translational Science Institute
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
University of Minnesota Clinical Virology Program  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00308620     History of Changes
Other Study ID Numbers: 0510M77007
First Posted: March 29, 2006    Key Record Dates
Results First Posted: August 17, 2012
Last Update Posted: August 17, 2012
Last Verified: May 2012

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
HIV
chloroquine
disease progression
inflammation
treatment naive

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Chloroquine diphosphate
Anti-Inflammatory Agents
Chloroquine
 Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Filaricides
Antinematodal Agents
Anthelmintics