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Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine
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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: Double Blind (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 |
- HIV Viral Load Change [ Time Frame: baseline and 8 weeks ]HIV-1 viral load change between baseline and 8 weeks
- 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 |
| 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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00308620
| United States, Minnesota | |
| Minnesota ACTU | |
| Minneapolis, Minnesota, United States, 55455 | |
| 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 |
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 |
ClinicalTrials.gov processed this record on July 27, 2017