[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476783":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":111,"collaborators":114,"id":118,"slug":30,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":30,"eligibilityCriteria":122,"healthyVolunteers":119,"sex":123,"minAge":124,"maxAge":30,"enrollmentInfo":125,"targetDuration":30,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":30,"overallStatus":45,"whyStopped":30,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bempedoic acid (BA)","EXPERIMENTAL","Patients randomized into the BA arm will receive 180 mg BA administered orally once daily without food for 52 weeks.",[13],"Drug: Bempedoic acid",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Patients randomized into the placebo arm will receive 180 mg placebo administered orally once daily without food for 52 weeks.",[19],"Other: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bempedoic acid","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).",[9],[27],"BA",{"type":6,"name":15,"description":15,"armGroupLabels":29,"otherNames":30},[15],null,[32],{"name":33,"affiliation":34,"role":35},"Priscilla Hsue, MD","University of California, Los Angeles","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":30,"email":41},"Marta Levkova","CONTACT","628-206-8037","marta.levkova@ucsf.edu",[43,65,95],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"UCLA Center for Clinical AIDS Research and Education (CARE)","RECRUITING","Los Angeles","California","90095","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-118.24368,34.05223,{"lat":55,"lon":54},[58,62,63],{"name":59,"role":39,"phone":60,"phoneExt":30,"email":61},"Aleen Khodabakhshian","(310) 557-3798","akhodabakhshian@mednet.ucla.edu",{"name":33,"role":35,"phone":30,"phoneExt":30,"email":30},{"name":64,"role":35,"phone":30,"phoneExt":30,"email":30},"Judith Currier, MD",{"facility":66,"status":45,"city":67,"state":47,"zip":68,"country":49,"countryCode":50,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"San Francisco General Hospital","San Francisco","94110",{"type":52,"coordinates":70},[71,72],-122.41942,37.77493,{"lat":72,"lon":71},[75,77,78,81,83,85,87,89,91,93],{"name":38,"role":39,"phone":40,"phoneExt":30,"email":76},"Marta.levkova@ucsf.edu",{"name":33,"role":35,"phone":30,"phoneExt":30,"email":30},{"name":79,"role":80,"phone":30,"phoneExt":30,"email":30},"Ahmed Tawakol, MD","SUB_INVESTIGATOR",{"name":82,"role":80,"phone":30,"phoneExt":30,"email":30},"Adam Spivak, MD",{"name":84,"role":80,"phone":30,"phoneExt":30,"email":30},"Steven Deeks, MD",{"name":86,"role":80,"phone":30,"phoneExt":30,"email":30},"John Kornak, MD",{"name":88,"role":80,"phone":30,"phoneExt":30,"email":30},"Miguel Pampaloni, MD",{"name":90,"role":80,"phone":30,"phoneExt":30,"email":30},"Michael Lu, MD",{"name":92,"role":80,"phone":30,"phoneExt":30,"email":30},"Yoojin Lee, MD",{"name":94,"role":80,"phone":30,"phoneExt":30,"email":30},"Borek Foldyna, MD",{"facility":96,"status":45,"city":97,"state":98,"zip":99,"country":49,"countryCode":50,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"UT Health Houston","Houston","Texas","77030",{"type":52,"coordinates":101},[102,103],-95.36327,29.76328,{"lat":103,"lon":102},[106,109],{"name":107,"role":39,"phone":30,"phoneExt":30,"email":108},"Brenda Lastra Bojorguez","brenda.lastrabojorquez@uth.tmc.edu",{"name":110,"role":35,"phone":30,"phoneExt":30,"email":30},"Jordan Lake, MD",{"type":112,"investigatorFullName":33,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Dr. Priscilla Hsue",[115,116],{"name":34,"class":6},{"name":117,"class":6},"Massachusetts General Hospital","100476783",false,"NCT05488431","Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)","Inclusion Criteria:\n\n* Documented HIV infection\n* On continuous antiretroviral therapy and virologically suppressed HIV infection for ≥12 weeks prior to study entry\n* CD4 T-cell count ≥ 200 cells\u002Fmm3\n* Male or female between the ages ≥ 40 years of age\n* LDL-C ≥ 50 mg\u002FdL\n* 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\u002FL, family history)\n* TBR of \\>1.6 of the MDS of the carotid\u002Faorta 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.\n* 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.\n* Males must use at least one method of contraception throughout the study.\n\nExclusion Criteria:\n\n* Pregnant\u002Fnursing women (as there is no data on bempedoic acid in this setting)\n* Diabetes requiring insulin (as insulin treatment alters the uptake of 18FDG)\n* Uncontrolled HTN as defined by baseline blood pressure reading of ≥160 mmHg systolic OR ≥100 mmHg diastolic (exclusion criteria in other studies with BA)\n* AST\u002FALT or alkaline phosphatase \\>2x ULN\n* Triglycerides \\>500 mg\u002FdL at screening\n* Cancer within the last 5 years with exception of squamous cell carcinoma and basal cell carcinoma\n* 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\n* Nephrotic syndrome or eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2\n* Cytopenias which include 1) WBC \\\u003C3.5 x103\u002FuL 2) Platelet \\\u003C120 x103\u002FuL 3) ANC \\\u003C1.5 x103\u002FuL, and absolute lymphocytes \\\u003C0.8 x 103\u002FuL\n* Anemia as fined by Hgb \\\u003C10 g\u002FdL\n* Acute systemic infection within 30 days","ALL","40 Years",{"count":126,"type":127},121,"ESTIMATED","INTERVENTIONAL",[130],"PHASE2","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\u002FCT, 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.",[133,134,135,136],"Dyslipidemias","Cardiovascular Diseases","HIV Infections","Atherosclerosis","2025-12-11",{"date":139,"type":140},"2025-12-17","ACTUAL",{"date":142,"type":140},"2023-03-01",{"date":144,"type":127},"2028-03-01",{"name":33,"class":6},3]