Clinical Trials

MainTitle

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
University of Minnesota

Collaborator
Minnesota Medical Foundation

Information provided by (Responsible Party)
University of Minnesota
ClinicalTrials.gov Identifier
NCT00308620

First received: March 27, 2006
Last updated: June 2, 2020
Last Verified: June 2020
History of Changes
Purpose

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
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

Further study details as provided by University of Minnesota:

Primary Outcome Measures

  • HIV Viral Load Change [ Time Frame: baseline and 8 weeks ]
    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 ]
    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
Estimated 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

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

    Eligibility

    Ages Eligible for Study: 18 Years to 65 Years  
    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

    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
    Minnesota Medical Foundation

    Investigators

    Principal Investigator: David R Boulware, MD, MPH University of Minnesota
    More Information

    More Information

    Additional Information:

    University of Minnesota Clinical Virology Program

    Responsible Party: University of Minnesota  
    ClinicalTrials.gov Identifier: NCT00308620   History of Changes  
    Other Study ID Numbers: 0510M77007  
    Study First Received: March 27, 2006  
    Last Updated: June 2, 2020  

    Keywords provided by University of Minnesota:

    HIV
    chloroquine
    disease progression
    inflammation
    treatment naive

    Additional relevant MeSH terms:
    Infection
    HIV Infections
    Acquired Immunodeficiency Syndrome
    Chloroquine
    Chloroquine diphosphate

    ClinicalTrials.gov processed this data on July 10, 2020
    This information is provided by ClinicalTrials.gov.