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
261 weeks
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
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.
CONDITIONS
Official 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 prior to study entry
- CD4 T-cell count of 200 cells/mm3 or higher
- Male or female aged 40 years or older
- LDL cholesterol of 50 mg/dL or higher
- Documented cardiovascular disease (prior myocardial infarction, cerebrovascular disease, peripheral arterial disease, prior coronary interventions, or angiographic evidence of >50% coronary artery stenosis) OR at least one cardiovascular risk factor (type 2 diabetes, current smoking, hypertension, dyslipidemia, hsCRP of 2 mg/L or higher, family history)
- Target-to-background ratio (TBR) greater than 1.6 of the mean standardized uptake value of the carotid/aorta at baseline
- Females must be non-childbearing (post-menopausal or amenorrhea >12 months) or agree to use two forms of contraception during the study and one month after completion with a negative pregnancy test at screening and before first dose
- Males must use at least one method of contraception during the study
You will not qualify if you...
- Pregnant or nursing women
- Diabetes requiring insulin treatment
- Uncontrolled hypertension with blood pressure ≥160 mmHg systolic or ≥100 mmHg diastolic
- Elevated liver enzymes (AST/ALT or alkaline phosphatase >2 times upper limit of normal)
- Triglycerides over 500 mg/dL at screening
- Cancer within the last 5 years except squamous cell carcinoma and basal cell carcinoma
- Use of simvastatin over 20 mg or pravastatin over 40 mg; other statins allowed with monitoring
- Nephrotic syndrome or estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2
- Low blood cell counts including white blood cells, platelets, absolute neutrophil count, or lymphocytes below specified thresholds
- Anemia with hemoglobin below 10 g/dL
- Acute systemic infection within 30 days prior to enrollment
AI-Screening
AI-Powered Screening
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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
CONTACT
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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