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
  Purpose

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 Intervention Phase
HIV Infections
Drug: chloroquine phosphate
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 13
Study Start Date: March 2006
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

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).
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00308620     History of Changes
Other Study ID Numbers: 0510M77007
Study First Received: March 27, 2006
Results First Received: September 26, 2011
Last Updated: July 9, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
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
Chloroquine diphosphate
Anti-Inflammatory Agents
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014