Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
Recruiting · NCT05488431 · Interventional (participants receive a specific treatment) · Lead sponsor: Priscilla Hsue, MD
View the official record on ClinicalTrials.gov →Interventions studied
Bempedoic acidPlacebo
What this trial is about
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.
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 ≥ 50 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
Where it is running
3 locations listed across 2 US states.
- UCLA Center for Clinical AIDS Research and Education (CARE) - Los Angeles, California, United States
- San Francisco General Hospital - San Francisco, California, United States
- UT Health Houston - Houston, Texas, United States