Open Actively Recruiting

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


Brief 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, UCLA, and University of Utah; collaborators at Massachusetts General Hospital (MGH) will serve as the core facility for imaging.

Primary Purpose
Study Type
Phase II/III


Healthy Volunteers
Minimum Age
40 Years
Maximum Age

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 ≥ 100 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

Join this Trial

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Study Stats
Protocol No.
Infectious Diseases
Lisa Mark
  • UCLA Beverly Hills
For Providers
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