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CLEAR HIV Trial: Bempedoic Acid for Cholesterol and Inflammation in HIV

This study is testing Bempedoic acid, a medication that lowers cholesterol, in people living with HIV. It aims to see if Bempedoic acid can reduce inflammation in arteries and improve heart health. You might be able to join if you are at least 40 years old, have HIV that is well-controlled with medication, and have existing heart disease or a high risk factor for it, along with certain cholesterol levels. The study will compare Bempedoic acid to a placebo (an inactive substance). Researchers will look at changes in arterial inflammation using special scans to see if the treatment is successful. The current recruitment status is unclear.

Study design
This is a randomized, placebo-controlled study planning to enroll 121 participants. It compares Bempedoic acid to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, FDG PET/CT, is measured at baseline and Week 52, suggesting a follow-up period of at least 52 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05488431

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

Recruiting
PHASE2Ages 40+InterventionalTreatment
Priscilla Hsue, MD
~121 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Bempedoic acidPlacebo

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
FDG PET/CT Endpoint
Measured over Baseline and Week 52

Conditions

Dyslipidemias
Cardiovascular Diseases
HIV Infections
Atherosclerosis

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Where it's being run

3 sites across 2 states
California2
Texas1

Study leadership

  • Priscilla Hsue, MD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles

Who to contact

Marta Levkova
[email protected]
628-206-8037
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Documented HIV infection
On continuous antiretroviral therapy and virologically suppressed HIV infection for ≥12 weeks prior to study entry
CD4 T-cell count ≥ 200 cells/mm3
Male or female between the ages ≥ 40 years of age
LDL-C ≥ 50 mg/dL
Documented cardiovascular disease as defined by: 1. Prior myocardial infarction, 2. Prior cerebrovascular disease, 3. Prior peripheral arterial disease, 4. History of percutaneous coronary intervention, 5. History of coronary artery bypass graft OR 6. Angiographic evidence of \>50% stenosis in at least one coronary artery\] OR 1 CVD risk factor (T2DM, current smoking, hypertension, dyslipidemia, hsCRP≥2mg/L, family history)
TBR of \>1.6 of the MDS of the carotid/aorta at baseline. This baseline arterial TBR cutoff excludes the rare individual that lacks appreciable arterial inflammation. It is notable that while 5-10% of uninfected individuals will have lower TBRs, it is rare that an HIV infected individual will fall below this range.
Female subjects must either be of non-childbearing potential (defined as post-menopausal or amenorrhea \> 12 months) or agree to use two forms of contraception (one hormonal and one barrier) throughout the study and for at least one month following study completion and have a negative pregnancy test at screening and prior to the first dose of drug.
Males must use at least one method of contraception throughout the study.

Exclusion

Pregnant/nursing women (as there is no data on bempedoic acid in this setting)
Diabetes requiring insulin (as insulin treatment alters the uptake of 18FDG)
AST/ALT or alkaline phosphatase \>2x ULN
Triglycerides \>500 mg/dL at screening
Cancer within the last 5 years with exception of squamous cell carcinoma and basal cell carcinoma
Individuals on simvastatin \>20mg or pravastatin \>40mg. All other dosages and statins will be permitted with close monitoring for myopathies including assessment of CK levels
Nephrotic syndrome or eGFR \<30 mL/min/1.73m2
Cytopenias which include 1) WBC \<3.5 x103/uL 2) Platelet \<120 x103/uL 3) ANC \<1.5 x103/uL, and absolute lymphocytes \<0.8 x 103/uL
Anemia as fined by Hgb \<10 g/dL
Acute systemic infection within 30 days

What this trial measures

  • FDG PET/CT EndpointBaseline and Week 52

    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.