NCT05488431 Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
| NCT ID | NCT05488431 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Priscilla Hsue, MD |
| Condition | Dyslipidemias |
| Study Type | INTERVENTIONAL |
| Enrollment | 121 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 121 participants in total. It began in 2023-03-01 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Priscilla Hsue, MD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT05488431 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Dyslipidemias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05488431 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05488431 currently recruiting?
Yes, NCT05488431 is actively recruiting participants. Contact the research team at marta.levkova@ucsf.edu for enrollment information.
Where is the NCT05488431 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Francisco, United States, Houston, United States.
Who is sponsoring the NCT05488431 clinical trial?
NCT05488431 is sponsored by Priscilla Hsue, MD. The principal investigator is Priscilla Hsue, MD at University of California, Los Angeles. The trial plans to enroll 121 participants.