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NCT00843713 · ClinicalTrials.gov registry record · Phase 4
Effect of Raltegravir on Endothelial Function in HIV-Infected Patients
A Phase 4 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
NCT00843713: Completed Phase 4 study, sponsored by University of California, San Francisco.
NCT00843713 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 56 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00843713, a Phase 4 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
Study Summary
Recent studies suggest that HIV patients are at increased risk for cardiovascular events; however, the mechanisms underlying this increased risk remain unclear. Our group was one of the first to demonstrate that HIV infection is independently associated with accelerated atherosclerosis, as measured by carotid artery-intima media thickness (IMT), and that HIV-associated inflammation may be driving this accelerated atherosclerosis. The mechanism by which HIV disease independent of any drug-specific toxicity increases the risk of cardiovascular disease during HAART is not known. We hypothesize that even well controlled HIV infection is independently associated with cardiovascular risk and that further decreasing HIV-associated inflammation adding newer antiretroviral agents will also decrease cardiovascular risk. We will perform a small clinical trial of approximately 50 HIV-infected patients each to study the relationship between HIV infection, inflammation, thrombosis, atherogenic lipoproteins, and measures of atherosclerosis. We propose the following specific aims: Aim 1: To determine the influence of traditional and novel markers of inflammation on endothelial function and IMT progression; Aim 2: To determine if "intensification" with raltegravir in subjects on long-term antiretroviral therapy with clinically undetectable HIV RNA levels will improve endothelial function, and to determine if this effect is mediated by alterations in inflammatory markers, lipoproteins and/or thrombotic factors. For Aim 2, subjects from 2 randomized, double-blind, placebo-controlled raltegravir intensification studies will be asked to co-enroll in this cardiovascular study.
Primary Outcome
Measurements in the change of brachial artery diameter from pre and post treatment.
Interventions
- DRUG Placebo
- DRUG raltegravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2009-01 |
| Est. Completion | 2014-02 |
| Phase | Phase 4 |
What the finished NCT00843713 record still lists
NCT00843713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00843713 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00843713 about?
NCT00843713 is a clinical study titled "Effect of Raltegravir on Endothelial Function in HIV-Infected Patients". Recent studies suggest that HIV patients are at increased risk for cardiovascular events; however, the mechanisms underlying this increased risk remain unclear. Our group was one of the first to demonstrate that HIV infection is independently associated with accelerated atherosclerosis, as measured ...
What is the current status of trial NCT00843713?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2009-01. Estimated completion is 2014-02.
What interventions are being tested in trial NCT00843713?
The interventions under investigation include: Placebo (DRUG), raltegravir (DRUG).
Who is sponsoring clinical trial NCT00843713?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00843713's enrollment target sits among peer trials
56 1213th of 2000 higher than 783 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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