HIV Infections Clinical Trial
Official title:
A Randomized, Pilot Study of the Anti-Viral and Anti-Inflammatory Effects of Chloroquine in Early HIV Infection
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.
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).
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