[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640344":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":80,"collaborators":83,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":10,"enrollmentInfo":107,"targetDuration":10,"studyType":110,"phases":10,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,12,15,18,21],{"label":9,"type":10,"description":11,"interventionNames":10},"Treatment-naive chronic HBV monoinfection and eligible for antiviral therapy",null,"Adults who are HBsAg-positive, HIV-positive, eligible for HBV antiviral therapy and has not yet or just started taking therapy",{"label":13,"type":10,"description":14,"interventionNames":10},"Treatment-naive acute HBV monoinfection","Adults who are HBsAg-positive, HIV-negative, and have the syndrome of acute hepatitis",{"label":16,"type":10,"description":17,"interventionNames":10},"Treatment-naive HBV\u002FHIV coinfection","Adults who are both HBsAg and HIV positive, and are not yet or just started taking HBV-active ART",{"label":19,"type":10,"description":20,"interventionNames":10},"Treatment-experienced HBV\u002FHIV coinfection with persistent HBsAg-emia","Adults with HBV\u002FHIV coinfection and persistent HBsAg-emia after at least 4 years of HBV-active ART",{"label":22,"type":10,"description":23,"interventionNames":10},"Treatment-experienced HBV infection with HBsAg loss","Adults with and without HIV coinfection who have a documented history of chronic HBV infection that subsequently resolved (i.e., HBsAg loss) during antiviral therapy",[25],{"name":26,"affiliation":5,"role":27},"Michael Vinikoor, MD","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Michael J Vinikoor, MD","CONTACT","205-934-5191","mjv3@uab.edu",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"Ike Oyewole","205-996-0441","ikeoluwaoyewole@uabmc.edu",[39,60,69],{"facility":40,"status":41,"city":42,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Kanyama Level 1 Hospital","RECRUITING","Lusaka","Zambia","ZM",{"type":46,"coordinates":47},"Point",[48,49],28.28713,-15.40669,{"lat":49,"lon":48},[52,56],{"name":53,"role":31,"phone":54,"phoneExt":10,"email":55},"Carolyn Chibundi","260 (contact) 977541659","carolyn.chibundi@cidrz.org",{"name":57,"role":31,"phone":58,"phoneExt":10,"email":59},"Taonga Musonda, MS","260 (country) 971964760","taonga@tropgan.com",{"facility":61,"status":41,"city":42,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Matero Level 1 Hospital",{"type":46,"coordinates":63},[48,49],{"lat":49,"lon":48},[66,68],{"name":53,"role":31,"phone":67,"phoneExt":10,"email":55},"260 (country) 977541659",{"name":57,"role":31,"phone":58,"phoneExt":10,"email":59},{"facility":70,"status":41,"city":42,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"University Teaching Hospital",{"type":46,"coordinates":72},[48,49],{"lat":49,"lon":48},[75,79],{"name":76,"role":31,"phone":77,"phoneExt":10,"email":78},"Edford Sinkala, MBChB, PhD","260 (country) 974 662 483","sinkalaeddie@yahoo.com",{"name":57,"role":31,"phone":58,"phoneExt":10,"email":59},{"type":27,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Michael Vinikoor","Professor of Medicine",[84,87,89,92,94,96],{"name":85,"class":86},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":88,"class":6},"Centre for Infectious Disease Research in Zambia",{"name":90,"class":91},"Tropical Gastroenterology and Nutrition Group","UNKNOWN",{"name":93,"class":6},"University of Zambia",{"name":95,"class":6},"Massachusetts General Hospital",{"name":97,"class":6},"Weill Medical College of Cornell University","100640344","hep-mec-cohort-in-zambia-100640344",false,"NCT07589985","Hep Mec Cohort in Zambia","Hep Mec","Inclusion Criteria:\n\nMust meet the inclusion criteria for one of 5 groups, as follows:\n\n* Group 1 (rx-naive chronic hbv mono): 18+ years old, HBsAg-positive, HIV-negative, eligible for tenofovir-based therapy, reports taking therapy no more than 7 days (could have previously taken if has stopped \\>1 year ago).\n* Group 2 (acute hbv mono): 18+ years old, HBsAg-positive, HIV-negative, acute\u002Fsubacute onset of hepatitis signs and symptoms and ALT \\>10 times upper limit of normal\n* Group 3 (rx-naive hbv\u002Fhiv coinfection): 18+ years old, HBsAg-positive, HIV-negative, eligible for tenofovir-based therapy, reports taking therapy no more than 7 days (could have previously taken if has stopped \\>1 year ago).\n* Group 4 (rx-experienced coinfection with hbv persistence): 18+ years old, history of chronic HBV infection based on two tests 6 months apart, HIV-positive, at least 4 years of tenofovir-based antiviral therapy, currently HBsAg-positive\n* Group 5 (hbsag loss): 18+ years old, HIV-positive or negative, history of chronic HBV infection based on two tests 6 months apart, Currently HBsAg-negative confirmed by sensitive assay\n\nExclusion Criteria:\n\n* Hepatitis C coinfection (antibody-positive and RNA-positive), current or recent (past 6 weeks) pregnancy, decompensated cirrhosis on physical examination, unlikely to remain in Lusaka for study duration","ALL","18 Years",{"count":108,"type":109},390,"ESTIMATED","OBSERVATIONAL","Observational cohort of adults with acute and chronic hepatitis B infection in Zambia, with and without HIV coinfection. Participants join the study at the time of diagnosis and before or at the time when they are starting antiviral treatments and then they are followed up over multiple years to assess changes to their liver and evolution of HBV (and HIV if applicable) infection. All treatments for HBV and HIV are standard per local Ministry of Health guidelines.",[113,114],"Hepatitis B","HIV",[116,117,118,119,120,121,122,123,124],"HBV\u002FHIV coinfection","HBV immunology","Liver sampling","Africa","Tenofovir","T cell immunology","Omics analysis","Acute HBV infection","Liver immunology","2026-05-09",{"date":127,"type":128},"2026-05-15","ACTUAL",{"date":130,"type":128},"2020-09-28",{"date":132,"type":109},"2030-08-31",{"name":5,"class":6},3]