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

Launched by PRISCILLA HSUE, MD · Aug 2, 2022

Keywords

ClinConnect Summary

The CLEAR HIV Trial is studying the effects of a medication called Bempedoic acid in people who have HIV and are at risk for heart disease. This trial focuses on individuals aged 40 and older who have been successfully treated for HIV for at least 12 weeks and have either a history of heart disease or one risk factor for heart disease, such as high cholesterol or diabetes. Researchers want to see if Bempedoic acid can help lower cholesterol levels, reduce inflammation in the arteries, and improve overall heart health.

To participate in the trial, individuals must meet certain criteria, including being on stable HIV treatment with a healthy immune system and having specific cholesterol levels. Participants will undergo various tests, such as imaging scans, to assess their heart health before and during the study. This trial is currently recruiting at UCSF and UCLA, and it's important to note that women who can become pregnant must use contraception during the study. Overall, this research aims to find new ways to improve heart health for those living with HIV.

Gender

ALL

Eligibility criteria

• 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 ≥ 70 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