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NCT03207945 · ClinicalTrials.gov registry record · Phase 3
Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study)
A Phase 3 study of HIV Infections and Cardiovascular Diseases, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 3
- Development phase
- 118
- Enrollment target
- 1
- Study location
NCT03207945: Completed Phase 3 study of HIV Infections and Cardiovascular Diseases, sponsored by University of California, San Francisco.
NCT03207945 is a Phase 3 study of HIV Infections and Cardiovascular Diseases that has completed, run by University of California, San Francisco. The registered enrollment target is 118 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03207945, a Phase 3 study of HIV Infections and Cardiovascular Diseases, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 118 participants
- Enrollment target
- 1
- Study location
Study Summary
Atherosclerosis in the setting of HIV infection is distinct and includes increased vascular inflammation, worsened endothelial function, and a predominance of non-calcified plaque. These outcomes can be assessed using specialized noninvasive imaging which strongly predict future CV events in the general population. PCSK9 has emerged as an important pharmacologic target for cholesterol lowering in the general population and recent studies among individuals without HIV have shown that PCSK9 inhibitor therapy is safely tolerated and significantly reduces major CV events in the general population. The investigators will perform a clinical trial of PCSK9 inhibition in the setting of HIV infection. This will be a randomized, placebo-controlled study to evaluate the effects of PCSK9 inhibition on vascular inflammation, endothelial function, and non-calcified plaque using a PCSK9 inhibitor called alirocumab. This study will recruit 140 treated individuals with HIV who are aged 40 and older, with known CVD or risk factors for CVD and who have evidence of vascular inflammation at baseline. The primary and secondary objective of this study is to determine whether PCSK9 inhibition can improve arterial inflammation as assessed by FDG-PET/CT and endothelial function as assessed by flow mediated vasodilation. The investigators will correlate changes in arterial inflammation and endothelial function with lipids and markers of inflammation and immune activation. The tertiary objective is to perform a pilot evaluation of the impact of PCSK9 inhibition on non-calcified plaque as measured by coronary CT angiography. Non-calcified plaque measurements will be correlated with changes in lipid parameters and markers of inflammation and immune activation.
Primary Outcome
Change in Target-to-background ratio from baseline to follow-up study at 52 weeks. The main arterial endpoint is the most diseased segment of the index vessel
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Alirocumab
Study Locations (1)
California
- San Francisco General Hospital - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2018-04-30 |
| Est. Completion | 2025-09-24 |
| Phase | Phase 3 |
What the finished NCT03207945 record still lists
NCT03207945 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (74% lower).
The record links to 3 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03207945 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03207945 about?
NCT03207945 is a clinical study titled "Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study)". Atherosclerosis in the setting of HIV infection is distinct and includes increased vascular inflammation, worsened endothelial function, and a predominance of non-calcified plaque. These outcomes can be assessed using specialized noninvasive imaging which strongly predict future CV events in the gen...
What is the current status of trial NCT03207945?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2018-04-30. Estimated completion is 2025-09-24.
What conditions does trial NCT03207945 study?
This clinical trial studies the following conditions: HIV Infections, Cardiovascular Diseases, Dyslipidemias.
What interventions are being tested in trial NCT03207945?
The interventions under investigation include: Placebo (OTHER), Alirocumab (DRUG).
Who is sponsoring clinical trial NCT03207945?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03207945 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03207945's enrollment target sits among peer trials
118 249th of 542 higher than 292 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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