Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00308620
Status:
TERMINATED
Last Update Posted:
2020-06-04
First Post:
2006-03-27
Brief Title:
Investigating the Anti-Human Immunodeficiency Virus HIV Anti-inflammatory Effect of Chloroquine
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
A Randomized Pilot Study of the Anti-Viral and Anti-Inflammatory Effects of Chloroquine in Early HIV Infection
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient financial support lack of efficacy for primary endpoint
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None