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RECRUITING
NCT05488431
PHASE2

Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)

Sponsor: Priscilla Hsue, MD

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

121

Start Date

2023-03-01

Completion Date

2028-03-01

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DRUG

Bempedoic acid

Bempedoic Acid is an oral first-in-class small molecular adenosine triphosphate (ATP)-citrate lyase (ACL) inhibitor which lowers LDL-C by inhibition of cholesterol synthesis in the liver. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway. Inhibition of ACL by bempedoyl-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of LDL receptors and concomitant suppression of hepatic fatty acid biosynthesis. BA has been studied in \>4300 individuals and is currently being studied in \>14,000 individuals in CLEAR Outcomes (NCT02993406).

OTHER

Placebo

Placebo

Locations (3)

UCLA Center for Clinical AIDS Research and Education (CARE)

Los Angeles, California, United States

San Francisco General Hospital

San Francisco, California, United States

UT Health Houston

Houston, Texas, United States