Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03207945
The ClinicalTrials.gov registry entry for NCT03207945 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (74% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1
RECRUITING · Phase 3
-
Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention
RECRUITING · Phase 3
-
SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder
RECRUITING · Phase 3
-
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF
ACTIVE NOT RECRUITING · Phase 3
-
The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
ACTIVE NOT RECRUITING · Phase 3
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.