RecruitingPhase 2NCT05488431

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


Sponsor

Priscilla Hsue, MD

Enrollment

121 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a cholesterol-lowering drug called bempedoic acid in people living with HIV who also have cardiovascular disease or risk factors. People with HIV often have higher levels of inflammation in their arteries, which raises the risk of heart attacks and strokes. Researchers want to see if this drug can reduce both cholesterol and artery inflammation. **You may be eligible if...** - You are living with HIV, aged 40 or older - Your HIV has been well-controlled on antiretroviral therapy for at least 12 weeks - Your CD4 cell count is at least 200 - Your LDL (bad cholesterol) is at least 50 mg/dL - You have a history of heart attack, stroke, peripheral artery disease, or a heart procedure, OR you have at least one cardiovascular risk factor - Women must be post-menopausal or using reliable contraception **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have diabetes requiring insulin - Your blood pressure is severely uncontrolled - You have significant liver, kidney, or blood count problems - You have had cancer in the last 5 years (except certain skin cancers) - You had an acute infection in the last 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBempedoic 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).

OTHERPlacebo

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

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NCT05488431


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