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

HIV Infections Clinical Trial

Official title:

A Randomized, Pilot Study of the Anti-Viral and Anti-Inflammatory Effects of Chloroquine in Early HIV Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00308620
• Other study ID #: 0510M77007
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: March 2006
• Est. completion date: June 2009

Study information

• Verified date: June 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Drug:
• chloroquine phosphate
250mg or 500mg PO (by mouth) QDay
• Placebo
Placebo once daily for 8 weeks

Locations

Country	Name	City	State
United States	Minnesota ACTU	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Minnesota Medical Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1128/JVI.01466-10. Epub 2010 Sep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV Viral Load Change	HIV-1 viral load change between baseline and 8 weeks	baseline and 8 weeks
Secondary	Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks	The Change in the percentages of CD38+ HLA-DR+ CD8 and CD4 memory T cells from baseline to 8 weeks.	8 weeks

External Links

•   University of Minnesota Clinical Virology Program