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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Priscilla Hsue, MD
Study ID
NCT05488431
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bempedoic acid — DRUG
    Bempedoic 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
    Placebo

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
Dec 2025
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
121 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bempedoic acid (BA)
    Patients randomized into the BA arm will receive 180 mg BA administered orally once daily without food for 52 weeks.
  • Placebo Comparator: Placebo
    Patients randomized into the placebo arm will receive 180 mg placebo administered orally once daily without food for 52 weeks.

Primary Outcome Measure

FDG PET/CT Endpoint [ Time Frame: Baseline and Week 52 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UCLA Center for Clinical AIDS Research and Education (CARE)Los AngelesCalifornia90095
Aleen Khodabakhshian
[email protected]
(310) 557-3798
Priscilla Hsue, MD (PRINCIPAL_INVESTIGATOR)
Judith Currier, MD (PRINCIPAL_INVESTIGATOR)
San Francisco General HospitalSan FranciscoCalifornia94110
Marta Levkova
[email protected]
628-206-8037
Priscilla Hsue, MD (PRINCIPAL_INVESTIGATOR)
Ahmed Tawakol, MD (SUB_INVESTIGATOR)
Adam Spivak, MD (SUB_INVESTIGATOR)
Steven Deeks, MD (SUB_INVESTIGATOR)
John Kornak, MD (SUB_INVESTIGATOR)
Miguel Pampaloni, MD (SUB_INVESTIGATOR)
Michael Lu, MD (SUB_INVESTIGATOR)
Yoojin Lee, MD (SUB_INVESTIGATOR)
Borek Foldyna, MD (SUB_INVESTIGATOR)
UT Health HoustonHoustonTexas77030
Brenda Lastra Bojorguez
[email protected]
Jordan Lake, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
HIV
By specialty
Infectious disease
By research site
UCLA Center for Clinical AIDS Research and Education (CARE)· Los Angeles, CASan Francisco General Hospital· San Francisco, CAUT Health Houston· Houston, TX

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