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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Bempedoic acid
DrugBempedoic Acid is an oral first-in-class small molecular adenosine triphosphate (ATP)-citrate lyase (ACL) inhibitor which lowers LDL-C by inhibition of cholesterol synthesis in the liver. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway. Inhibition of ACL by bempedoyl-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of LDL receptors and concomitant suppression of hepatic fatty acid biosynthesis. BA has been studied in \>4300 individuals and is currently being studied in \>14,000 individuals in CLEAR Outcomes (NCT02993406).
Placebo
Other interventionPlacebo
Treatment groups
121 Participants
are divided into 2 treatment groupsGroup A: Bempedoic acid (BA)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
FDG PET/CT Endpoint
Change in Target-to-background ratio from baseline to follow-up study at 52 weeks. The main arterial endpoint is the most diseased segment of the index vessel. These findings will be correlated to measurements in the secondary endpoint.
Time frame
Baseline and Week 52Secondary outcomes
1
Total Cholesterol Endpoint
Change in total cholesterol will be assessed from baseline to week 24 and week 52.
Time frame
Baseline, Week 24 and Week 522
HDL Endpoint
Change in HDL will be assessed from baseline to week 24 and week 52.
Time frame
Baseline, Week 24 and Week 523
LDL Endpoint
Change in LDL will be assessed from baseline to week 24 and week 52.
Time frame
Baseline, Week 24 and Week 524
Triglycerides Endpoint
Change in triglycerides will be assessed from baseline to week 24 and week 52.
Time frame
Baseline, Week 24 and Week 52Other outcomes
1
Coronary CTA Non-calcified Plaque Endpoint
Change in non-calcified plaque as measured by Coronary CTA from baseline to follow-up study at 52 weeks
Time frame
Baseline and Week 522
Coronary CTA High-risk Plaque Endpoint
Change in high-risk plaque as measured by Coronary CTA from baseline to follow-up study at 52 weeks.
Time frame
Baseline and Week 523
Coronary CTA Coronary Plaque Incidence Endpoint
Incidence of new coronary lesions as measured by Coronary CTA from baseline to follow-up study at 52 weeks
Time frame
Baseline and Week 52Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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