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NCT00819390 · ClinicalTrials.gov registry record · Phase 2
Chloroquine for Reducing Immune Activation in HIV- Infected Individuals
A Phase 2 study of HIV Infections, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 15
- Study locations
NCT00819390: Completed Phase 2 study of HIV Infections, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT00819390 is a Phase 2 study of HIV Infections that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 70 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (84% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00819390, a Phase 2 study of HIV Infections, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 15
- Study locations
Study 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.
Primary Outcome
The baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Chloroquine
Study Locations (15)
Ohio
- Univ. of Cincinnati CRS (2401) - Cincinnati
- Case CRS (2501) - Cleveland
- MetroHealth CRS (2503) - Cleveland
Pennsylvania
- Hosp. of the Univ. of Pennsylvania CRS (6201) - Philadelphia
- Pittsburgh CRS (1001) - Pittsburgh
Alabama
- Alabama Therapeutics CRS (5801) - Birmingham
California
- Ucsd, Avrc Crs (701) - San Diego
Colorado
- University of Colorado Hospital CRS (6101) - Aurora
District of Columbia
- Georgetown University CRS (GU CRS) (1008) - Washington D.C.
Maryland
- Johns Hopkins Adult AIDS CRS (201) - Baltimore
Massachusetts
- Massachusetts General Hospital ACTG CRS (101) - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2009-03 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT00819390 record still lists
NCT00819390 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (84% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00819390 lists 15 locations in 12 states (Ohio, Pennsylvania, Alabama).
Frequently Asked Questions
What is clinical trial NCT00819390 about?
NCT00819390 is a clinical study titled "Chloroquine for Reducing Immune Activation in HIV- Infected Individuals". 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 cell...
What is the current status of trial NCT00819390?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2009-03. Estimated completion is 2013-05.
What conditions does trial NCT00819390 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00819390?
The interventions under investigation include: Placebo (DRUG), Chloroquine (DRUG).
Who is sponsoring clinical trial NCT00819390?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00819390 being conducted?
This trial has 15 study locations across Alabama, California, Colorado, District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00819390's enrollment target sits among peer trials
70 313th of 542 higher than 228 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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