CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Chloroquine +1 moredrug
Likely dose
Chloroquine 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00819390
NCT00819390Phase 2Completed
CompareCT.gov

A Phase II, Double Blind, Randomized, Exploratory Study of Chloroquine for Reducing HIV-Associated Immune Activation

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Jan 9, 2009·Updated Oct 13, 2014

In Brief

A Phase 2 clinical trial evaluating Chloroquine and Placebo for HIV Infections. Completed, enrolled 70 participants across 15 sites.

Detailed Summary

HIV is characterized by frequent immune system activation. Early in the course of infection the body establishes an immune activation "set point" related to the amount of HIV in the blood stream. This set point affects the rate of CD4 cell loss. Without CD4 cells, or with very low levels of CD4 cells, the body cannot fight off illness. This is known as immunodeficiency. If left untreated HIV can lead to extreme immunodeficiency and AIDS. Evidence suggests that by decreasing the rate of immune system activation, immune deficiency progression could be prevented. The purpose of this study is to learn how well chloroquine can reduce the level of immune activation and to test the safety and tolerance of chloroquine in people infected with HIV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 9, 2009
Enrollment StartMar 1, 2009
Primary CompletionFeb 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 17.5 years ago

Interventions

Chloroquinedrug

Taken orally, once daily, at a dose of 250 mg for 12 weeks.

Placebodrug

Taken orally, once daily for 12 weeks.