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

About

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

Treatment

Study Type

Interventional

Phase

Phase II/III

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

40 Years

Maximum Age

N/A

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

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