Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Bempedoic acid
  • Placebo

Treatment groups

121 Participants
are divided into 2 treatment groups

Locations

3
UCLA Center for Clinical AIDS Research and Education (CARE)90095, Los AngelesCalifornia, United States
San Francisco General Hospital94110, San FranciscoCalifornia, United States
UT Health Houston77030, HoustonTexas, United States

Sponsors and collaborators

Priscilla Hsue, MD

Lead sponsor

University of California, San Francisco

Sponsor institution

University of California, Los Angeles

Collaborator

Massachusetts General Hospital

Collaborator

Source ClinicalTrials.gov