RECRUITING

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

Conditions

Dyslipidemias Cardiovascular Diseases HIV Infections Atherosclerosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-01

Study Completion:2028-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05488431

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Marta Levkova

CONTACT

628-206-8037

marta.levkova@ucsf.edu

Principal Investigator

Priscilla Hsue, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

San Francisco General Hospital

San Francisco, California, 94110

United States

Collaborators and Investigators

Sponsor: Priscilla Hsue, MD

Priscilla Hsue, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01

Study Completion Date2028-03-01

Study Record Updates

Study Start Date2023-03-01

Study Completion Date2028-03-01

Terms related to this study

Additional Relevant MeSH Terms

Dyslipidemias
Cardiovascular Diseases
HIV Infections
Atherosclerosis