Clinical trial NCT00308620: Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine
Official title: A Randomized, Pilot Study of the Anti-Viral and Anti-Inflammatory Effects of Chloroquine in Early HIV Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: HIV Infections
Keywords: HIV
chloroquine
disease progression
inflammation
treatment naive
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Minnesota Medical Foundation
First posted: 2006-03-29
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: HIV Viral Load Change
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Change in Immune Activation Assessed by Flow Cytometry Analysis From Baseline to 8 Weeks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minnesota ACTU
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: David R Boulware, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 15.