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Kingdom","UK",{"type":62,"coordinates":638},[639,640],-0.13947,50.82838,{"lat":640,"lon":639},{"facility":30,"status":30,"city":643,"state":30,"zip":30,"country":635,"countryCode":636,"cosmosGeoPoint":644,"geoPoint":648,"contacts":30},"Bristol",{"type":62,"coordinates":645},[646,647],-2.59665,51.45523,{"lat":647,"lon":646},{"facility":30,"status":30,"city":650,"state":30,"zip":30,"country":635,"countryCode":636,"cosmosGeoPoint":651,"geoPoint":655,"contacts":30},"London",{"type":62,"coordinates":652},[653,654],-0.12574,51.50853,{"lat":654,"lon":653},{"type":657,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100242204","phase-3-a-study-to-evaluate-efficacy-and-safety-of-darunavircobicistatemtricitabinetenofovir-alafenamide-dcftaf-fixed-dose-combination-fdc-versus-a-regimen-consisting-of-darunavircobicistat-fdc-with-emtricitabinetenofovir-disoproxil-fumarate-fdc-in-treatment-naive-hiv-type-1-infected-subjects-100242204",true,"NCT02431247","A Study to Evaluate Efficacy and Safety of Darunavir\u002FCobicistat\u002FEmtricitabine\u002FTenofovir Alafenamide (D\u002FC\u002FF\u002FTAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir\u002FCobicistat FDC With Emtricitabine\u002FTenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects","A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir\u002FCobicistat\u002FEmtricitabine\u002FTenofovir Alafenamide (D\u002FC\u002FF\u002FTAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir\u002FCobicistat Fixed Dose Combination Coadministered With Emtricitabine\u002FTenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 Infected Subjects","Inclusion Criteria:\n\n* Subject must be antiretroviral (ARV) treatment-naive (never treated with an ARV including post-exposure prophylaxis and pre-exposure prophylaxis); no prior use of any approved or experimental anti- human immunodeficiency virus (anti-HIV) drug for any length of time\n* Screening plasma HIV-1 ribonucleic acid (RNA) level greater than or equal to \\>=1,000 copies per milliliter (copies\u002FmL)\n* Cluster of Differentiation 4+ (CD4+) cell count \\>50 cells\u002Fmicroliter (cells\u002FmcL)\n* Screening HIV-1 genotype report must show full sensitivity to DRV, TDF and FTC\n* Screening eGFRcreatinine \\>=70 mL\u002Fmin according to the Cockcroft-Gault formula for creatinine clearance\n\nExclusion Criteria:\n\n* Subject has been diagnosed with a new acquired immunodeficiency syndrome (AIDS)-defining condition within the 30 days prior to screening\n* Subject has proven or suspected acute hepatitis within 30 days prior to screening\n* Subject is hepatitis C or hepatitis B positive\n* Subject has a history of cirrhosis",false,"ALL","18 Years",{"count":669,"type":670},725,"ACTUAL","INTERVENTIONAL",[673],"PHASE3","The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir\u002Fcobicistat\u002Femtricitabine\u002Ftenofovir alafenamide (D\u002FC\u002FF\u002FTAF) fixed dose combination (FDC) tablet versus Darunavir\u002FCobicistat (DRV\u002FCOBI) FDC coadministered with Emtricitabine\u002Ftenofovir disoproxil fumarate (FTC\u002FTDF) FDC in human immunodeficiency virus-1 (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.",[676],"Immunodeficiency Virus Type 1, Human",[676,678,679,680,681,682],"Darunavir","Cobicistat","Tenofovir Alafenamide","Emtricitabine","Tenofovir Disoproxil Fumarate","COMPLETED","2022-09-27",{"date":686,"type":670},"2022-09-28",{"date":688,"type":670},"2015-07-06",{"date":690,"type":670},"2020-09-30",{"name":5,"class":6},80]