Actively Recruiting
Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
Led by Priscilla Hsue, MD · Updated on 2025-12-17
121
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Priscilla Hsue, MD
Lead Sponsor
U
University of California, Los Angeles
Collaborating Sponsor
AI-Summary
What this Trial Is About
People living with HIV have a higher risk of heart disease and related complications. This research is a randomized, placebo-controlled trial studying Bempedoic acid (BA), a drug that may reduce cholesterol and inflammation in HIV-infected individuals aged 40 and older who have known cardiovascular disease (CVD) or at least one risk factor for CVD. The trial aims to understand how BA affects arterial inflammation, lipid levels, immune activation, cardiometabolic health, and non-calcified plaque in the coronary arteries using advanced imaging techniques. Participants in this study are randomly assigned to receive either 180 mg of Bempedoic acid or a placebo once daily by mouth for 52 weeks. The trial includes multiple locations with specialized imaging performed at a core facility. The Bempedoic acid works by inhibiting an enzyme involved in cholesterol production and is being studied for its effects on lipid lowering, inflammation, and glucose metabolism in this population. During the study, participants will undergo several assessments including FDG-PET/CT scans to measure arterial inflammation at the start and after 52 weeks. Blood tests will be performed at baseline, 24 weeks, and 52 weeks to monitor cholesterol types, blood sugar control, markers of inflammation, immune cell activation, and fat tissue volumes. Researchers will closely observe safety, treatment adherence, and the impact of BA on heart disease markers over the year-long study period.
CONDITIONS
Brief Title
Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented HIV infection
- On continuous antiretroviral therapy and virologically suppressed for at least 12 weeks before study entry
- CD4 T-cell count of 200 cells/mm3 or higher
- Male or female aged 40 years or older
- LDL cholesterol level of 50 mg/dL or higher
- Documented cardiovascular disease or at least one cardiovascular risk factor such as type 2 diabetes, current smoking, hypertension, dyslipidemia, elevated hsCRP (2 mg/L or higher), or family history of cardiovascular disease
- Arterial inflammation with target-to-background ratio (TBR) greater than 1.6 at baseline
- Female participants must be post-menopausal, have amenorrhea for more than 12 months, or agree to use two forms of contraception during the study and have a negative pregnancy test before starting treatment
- Males must use at least one form of contraception during the study
You will not qualify if you...
- Pregnant or nursing women
- Diabetes requiring insulin treatment
- Uncontrolled hypertension defined as systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher
- Liver enzyme levels (AST, ALT, alkaline phosphatase) more than twice the upper limit of normal
- Triglyceride level above 500 mg/dL at screening
- Cancer diagnosis within the past 5 years except for squamous cell or basal cell carcinoma
- Use of simvastatin over 20 mg or pravastatin over 40 mg
- Nephrotic syndrome or estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2
- Low blood cell counts including white blood cells, platelets, neutrophils, or lymphocytes below specified thresholds
- Anemia with hemoglobin less than 10 g/dL
- Acute systemic infection within 30 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 52 weeks
Participants receive either bempedoic acid or placebo orally once daily for 52 weeks to study the effect on arterial inflammation, lipid levels, and cardiometabolic measures.
Visits at baseline, Week 24, and Week 52 for assessments
Trial Site Locations
Total: 3 locations
1
UCLA Center for Clinical AIDS Research and Education (CARE)
Los Angeles, California, United States, 90095
Actively Recruiting
2
San Francisco General Hospital
San Francisco, California, United States, 94110
Actively Recruiting
3
UT Health Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Marta Levkova
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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