Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorPriscilla Hsue, MD
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 groupsSponsors 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