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NCT05488431 · ClinicalTrials.gov registry record · Phase 2
Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
A Phase 2 study of HIV Infections and Cardiovascular Diseases, sponsored by Priscilla Hsue, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 121
- Enrollment target
- 3
- Study locations
NCT05488431: Recruiting Phase 2 study of HIV Infections and Cardiovascular Diseases, sponsored by Priscilla Hsue, MD.
NCT05488431 is a Phase 2 study of HIV Infections and Cardiovascular Diseases that is actively recruiting participants, run by Priscilla Hsue, MD. The registered enrollment target is 121 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05488431, a Phase 2 study of HIV Infections and Cardiovascular Diseases, is actively recruiting participants, sponsored by Priscilla Hsue, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 121 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a randomized placebo-controlled study in treated and suppressed HIV-infected individuals aged ≥40 years with either known CVD or 1 CVD risk factor to study the effect of Bempedoic acid (BA) on safety, arterial inflammation as assessed by FDG-PET/CT, lipids, inflammation, immune activation, cardiometabolic indices, and non-calcified plaque (NCP) in the coronary arteries (assessed by coronary CT angiography, CCTA). This trial will be enrolled at UCSF and UCLA. Collaborators at Massachusetts General Hospital (MGH) will serve as the core facility for imaging.
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. These findings will be correlated to measurements in the secondary endpoint.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Bempedoic acid
Study Locations (3)
California
- UCLA Center for Clinical AIDS Research and Education (CARE) - Los Angeles
- San Francisco General Hospital - San Francisco
Texas
- UT Health Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2028-03-01 |
| Phase | Phase 2 |
What NCT05488431 shows while recruiting
NCT05488431 is an interventional study that assigns participants to a tested intervention. The registered 121 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 (73% lower).
The record links to 4 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05488431 reports a single indexed study location in California, Texas.
Frequently Asked Questions
What is clinical trial NCT05488431 about?
NCT05488431 is a clinical study titled "Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)". This is a randomized placebo-controlled study in treated and suppressed HIV-infected individuals aged ≥40 years with either known CVD or 1 CVD risk factor to study the effect of Bempedoic acid (BA) on safety, arterial inflammation as assessed by FDG-PET/CT, lipids, inflammation, immune activation, c...
What is the current status of trial NCT05488431?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2023-03-01. Estimated completion is 2028-03-01.
What conditions does trial NCT05488431 study?
This clinical trial studies the following conditions: HIV Infections, Cardiovascular Diseases, Atherosclerosis, Dyslipidemias.
What interventions are being tested in trial NCT05488431?
The interventions under investigation include: Placebo (OTHER), Bempedoic acid (DRUG).
Who is sponsoring clinical trial NCT05488431?
This trial is sponsored by Priscilla Hsue, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05488431 being conducted?
This trial has 3 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05488431's enrollment target sits among peer trials
121 238th of 542 higher than 305 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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