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Clinical trial Recruiting at 3 sites Phase 2 Interventional Ages 40 and up

Lowering cholesterol and inflammation in HIV patients using Bempedoic acid

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

Run by University of California, San Francisco · NCT05488431 · Data updated 2026-11-12

This study is testing if a medication called Bempedoic acid can lower cholesterol and inflammation in people over 40 with HIV who have heart disease or are at risk for it.

Quick facts

PhasePhase 2
Study typeInterventional
Ages40 Years and up
SexAll
Enrollment121 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Locations3 sites (Los Angeles, California and 2 other locations)
StatusRecruiting
StartedMarch 1, 2023
Main results expectedMarch 1, 2028
Study endsMarch 1, 2028
Registry record updatedDecember 17, 2025
Trial IDNCT05488431 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are HIV-infected individuals aged 40 and older who are on antiretroviral therapy and have either known cardiovascular disease or at least one cardiovascular risk factor.

Probably not a fit

Patients who are not living with HIV or those under 40 years of age may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effects of Bempedoic acid (BA) on individuals aged 40 and older living with HIV who have cardiovascular disease (CVD) or risk factors for CVD. It is a randomized, placebo-controlled study that aims to assess the safety and efficacy of BA in reducing arterial inflammation, lipid levels, and other cardiometabolic indices. Participants will undergo imaging assessments using FDG-PET/CT and coronary CT angiography to evaluate changes in arterial health. The study is conducted at UCSF and UCLA, with imaging support from Massachusetts General Hospital.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option to reduce cardiovascular risks in HIV-infected individuals.

How similar studies have gone: Other studies have shown promising results with similar approaches in managing cardiovascular risks in HIV patients, but this specific use of Bempedoic acid is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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)
* Uncontrolled HTN as defined by baseline blood pressure reading of ≥160 mmHg systolic OR ≥100 mmHg diastolic (exclusion criteria in other studies with BA)
* 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

Where it's running

  • UCLA Center for Clinical AIDS Research and Education (CARE)
    Los Angeles, California, United States     Recruiting
  • San Francisco General Hospital
    San Francisco, California, United States     Recruiting
  • UT Health Houston
    Houston, Texas, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Dyslipidemias 34Cardiovascular Diseases 365HIV Infections 98Atherosclerosis 328University of California, San Francisco 3127
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.