[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604011":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":209,"collaborators":24,"id":213,"slug":214,"hasResults":215,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":24,"eligibilityCriteria":219,"healthyVolunteers":215,"sex":220,"minAge":221,"maxAge":24,"enrollmentInfo":222,"targetDuration":24,"studyType":225,"phases":226,"briefSummary":228,"conditions":229,"keywords":24,"overallStatus":109,"whyStopped":24,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":241},{"fullName":5,"class":6},"Indiana University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Resmetirom - 80mg or 100mg based on participant weight",[13],"Drug: Resmetirom",{"label":15,"type":16,"description":15,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo Control",[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG","Resmetirom",[9],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Placebo Control","Placebo - an identical looking tablet with no medicinal properties",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Holly Crandall, BSN","CONTACT","13172786200","hrking1@iu.edu",[36,58,75,91,108,125,142,158,175,192],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University of Alabama Birmingham","NOT_YET_RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-86.80249,33.52066,{"lat":48,"lon":47},[51,55],{"name":52,"role":32,"phone":53,"phoneExt":24,"email":54},"Kristen Spraggins","1-205-934-9346","kspraggins@uabmc.edu",{"name":56,"role":57,"phone":24,"phoneExt":24,"email":24},"Sonya Heath, MD","PRINCIPAL_INVESTIGATOR",{"facility":59,"status":38,"city":60,"state":61,"zip":62,"country":42,"countryCode":43,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"UC San Diego Altman Clinical and Translational Research Institute","La Jolla","California","92037",{"type":45,"coordinates":64},[65,66],-117.2742,32.84727,{"lat":66,"lon":65},[69,73],{"name":70,"role":32,"phone":71,"phoneExt":24,"email":72},"Egbert Mandamba","1-858-246-2227","emandamba@health.ucsd.edu",{"name":74,"role":57,"phone":24,"phoneExt":24,"email":24},"Rohit Loomba, MD",{"facility":76,"status":38,"city":77,"state":61,"zip":78,"country":42,"countryCode":43,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"University of California, San Francisco","San Francisco","94143",{"type":45,"coordinates":80},[81,82],-122.41942,37.77493,{"lat":82,"lon":81},[85,89],{"name":86,"role":32,"phone":87,"phoneExt":24,"email":88},"Rosaura Camberos","1-415-619-9919","rosaura.camberos@ucsf.com",{"name":90,"role":57,"phone":24,"phoneExt":24,"email":24},"Jennifer Price, MD",{"facility":92,"status":38,"city":93,"state":94,"zip":95,"country":42,"countryCode":43,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Atlantic Clinical Research Institute","West Palm Beach","Florida","33409",{"type":45,"coordinates":97},[98,99],-80.05337,26.71534,{"lat":99,"lon":98},[102,106],{"name":103,"role":32,"phone":104,"phoneExt":24,"email":105},"Amanda Chavez","1-561-249-2279","achavez@midwaycare.org",{"name":107,"role":57,"phone":24,"phoneExt":24,"email":24},"Hector Bolivar, 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MD",{"facility":176,"status":38,"city":177,"state":178,"zip":179,"country":42,"countryCode":43,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"UT Health Houston","Houston","Texas","77030",{"type":45,"coordinates":181},[182,183],-95.36327,29.76328,{"lat":183,"lon":182},[186,190],{"name":187,"role":32,"phone":188,"phoneExt":24,"email":189},"Sarah Galloway","1-713-500-4363","sarah.galloway@uth.tmc.edu",{"name":191,"role":57,"phone":24,"phoneExt":24,"email":24},"Jordan Lake, MD",{"facility":193,"status":38,"city":194,"state":195,"zip":196,"country":42,"countryCode":43,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Virginia Commonwealth University","Richmond","Virginia","23298",{"type":45,"coordinates":198},[199,200],-77.46026,37.55376,{"lat":200,"lon":199},[203,207],{"name":204,"role":32,"phone":205,"phoneExt":24,"email":206},"Dianne Boyce Grogan","1-804-828-2988","dianne.boycegrogan@vcuhealth.org",{"name":208,"role":57,"phone":24,"phoneExt":24,"email":24},"Richard Sterling, MD",{"type":210,"investigatorFullName":211,"investigatorTitle":212,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Naga P. Chalasani","Professor of Medicine","100604011","phase-2-a-study-to-evaluate-the-use-of-resmetirom-in-participants-with-masld-and-hiv-100604011",false,"NCT07143968","A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV","A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Resmetirom for the Treatment of Metabolic Dysfunction- Associated Steatotic Liver Disease (MASLD) in People Living With Human Immunodeficiency Virus (HIV)","Inclusion Criteria:\n\n1. Adults (≥18 years of age) with documented HIV.\n2. Documented diagnosis of MASLD established by imaging (ultrasound, CT scan or MRI) or vibration-controlled transient elastography (VCTE) or liver biopsy within 12 months before screening.\n3. Hepatic fat fraction ≥8% by MRI-PDFF.\n4. Liver stiffness by VCTE ≥8 kPa and CAP≥263 dB\u002Fm\n5. HIV-1 RNA \\\u003C200 copies\u002FmL for ≥6 months on antiretroviral therapy (ART) (must have screening HIV-1 RNA value and one clinical care value within 6 months prior to screening and up to the randomization that meet the criteria).\n6. Stable ART regimen for ≥3 months prior to screening and stable up to the randomization and no active plans to change ART while on study.\n7. Willingness to participate in the study.\n\nExclusion Criteria:\n\n1. History of significant alcohol consumption (defined as \\>2 drinks\u002Fday on average for men, \\>1 drinks\u002Fday on average for women) for at least 3 consecutive months (12 consecutive weeks) within 5 year before screening\n2. History of other acute or chronic liver disease, including, but not limited to autoimmune, primary biliary cholangitis, Wilson's disease, alpha 1 antitrypsin deficiency, hemochromatosis, hepatitis B virus (HBV), and ongoing or recent (within the past 3 years) hepatitis C RNA positivity.\n3. History of liver transplant.\n4. Liver biopsy or radiologic imaging consistent with the clinical presence of cirrhosis or portal hypertension at screening.\n5. Participants whose Visit 2 ALT, AST, or alkaline phosphatase (ALP) values exceed their Visit 1 values by more than 50%.\n6. Inability to undergo MRI testing\n7. Uncontrolled T2DM defined as glycated hemoglobin (HbA1c) \\>9.5% at screening.\n8. Any of the following laboratory values at screening:\n\n   1. ALT or AST \\>250 U\u002FL.\n   2. Total bilirubin (TBL) \\>1.5 mg\u002FdL and direct bilirubin \\> 0.5 mg\u002FdL (unless due to Gilbert's disease or atazanavir use, per the opinion of the site investigator).\n   3. Platelet count \\\u003C150,000\u002Fmm3.\n   4. Estimated glomerular filtration rate (e-GFR) \\\u003C60 mL\u002Fmin\u002F1.73m2 using the chronic kidney disease-epidemiology collaboration (CKD-EPI) equation\n   5. International normalized ratio (INR) \\>1.3.\n   6. Albumin \\\u003C 3.6 g\u002FdL\n9. Liver stiffness measurement (LSM) by VCTE \\> 20 kPa\n10. Further exclusion criteria apply","ALL","18 Years",{"count":223,"type":224},120,"ESTIMATED","INTERVENTIONAL",[227],"PHASE2","The purpose of this research study is to test the safety and effectiveness of the study drug, resmetirom, in participants with MASLD and HIV. This is a research study to test a drug that is already on the market with a population that was not included in the original clinical trials. Participants will be people over age 18 with HIV who are on antiretroviral therapy and have been diagnosed with MASLD.\n\nResearchers will compare resmetirom to placebo (a look-alike substance that contains no drug) to see if resmetirom decreases the amount of fat in the liver.\n\nParticipants will:\n\n* Complete 3 screening visits to determine eligibility.\n* Take resmetirom or placebo every day for 24 weeks if eligible.\n* Have 2 MRI scans to measure the amount of fat on the liver. One will be before treatment starts and one will be at the end of 24 weeks of treatment.\n* Attend 3 scheduled clinic visits while on treatment for bloodwork and safety assessments.\n* Participate in 3 phone calls while on treatment and one phone call 4 weeks after treatment is completed to check for safety and any health changes.",[230,231],"MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","HIV (Human Immunodeficiency Virus)","2026-05-04",{"date":234,"type":235},"2026-05-06","ACTUAL",{"date":237,"type":235},"2026-04-23",{"date":239,"type":224},"2027-11",{"name":211,"class":6},10]