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Kingdom","UK",{"type":47,"coordinates":619},[620,621],-0.13947,50.82838,{"lat":621,"lon":620},{"facility":27,"status":27,"city":624,"state":27,"zip":27,"country":616,"countryCode":617,"cosmosGeoPoint":625,"geoPoint":629,"contacts":27},"London",{"type":47,"coordinates":626},[627,628],-0.12574,51.50853,{"lat":628,"lon":627},{"facility":27,"status":27,"city":631,"state":27,"zip":27,"country":616,"countryCode":617,"cosmosGeoPoint":632,"geoPoint":636,"contacts":27},"Manchester",{"type":47,"coordinates":633},[634,635],-2.23743,53.48095,{"lat":635,"lon":634},{"type":638,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100229847","phase-3-study-to-evaluate-efficacy-and-safety-of-darunavircobicistatemtricitabinetenofovir-alafenamide-dcftaf-regimen-versus-boosted-protease-inhibitor-bpi-along-with-emtricitabinetenofovir-disoproxil-fumarate-ftctdf-regimen-in-virologically-suppressed-hiv-1-infected-participants-100229847",true,"NCT02269917","Study to Evaluate Efficacy and Safety of Darunavir\u002FCobicistat\u002FEmtricitabine\u002FTenofovir Alafenamide (D\u002FC\u002FF\u002FTAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine\u002FTenofovir Disoproxil Fumarate (FTC\u002FTDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants","A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir\u002F Cobicistat\u002F Emtricitabine\u002F Tenofovir Alafenamide (D\u002FC\u002FF\u002FTAF) Once-daily Single-tablet Regimen Versus Continuing the Current Regimen Consisting of a Boosted Protease Inhibitor (bPI) Combined With Emtricitabine\u002FTenofovir Disoproxil Fumarate (FTC\u002FTDF) in Virologically-suppressed, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects","Inclusion Criteria:\n\n* Currently being treated with a stable antiretroviral (ARV) regimen consisting of a boosted protease inhibitor (limited to darunavir \\[DRV\\] or atazanavir with low-dose ritonavir \\[rtv\\] or cobicistat \\[COBI\\], or lopinavir with rtv) combined with emtricitabine\u002Ftenofovir disoproxil fumarate (FTC\u002FTDF) only, for at least 6 consecutive months preceding the Screening visit\n* On-treatment plasma human immunodeficiency virus type 1 ribonucleic acid (HIV-1 RNA) concentrations less than (\\\u003C) 50 copies per milliliter (copies\u002FmL) or HIV-1 RNA undetectable by a local HIV-1 RNA test between 12 and 2 months prior to the Screening visit and have HIV-1 RNA \\\u003C50 copies\u002FmL at the Screening visit\n* A single virologic elevation of greater than or equal to (\\>=) 50 copies\u002FmL after previously reaching viral suppression between 12 and 2 months prior to Screening is acceptable, provided a subsequent test prior to Screening was \\\u003C50 copies\u002FmL\n* Absence of history of failure on DRV treatment and absence of DRV resistance-associated mutations (RAMs), if documented historical genotypes are available\n* Normal electrocardiogram (ECG) at Screening (or if abnormal, determined by the Investigator to be not clinically significant)\n\nExclusion Criteria:\n\n* A new acquired immunodeficiency syndrome (AIDS) - defining condition diagnosed within the 30 days prior to Screening\n* Proven or suspected acute hepatitis within 30 days prior to study entry\n* Hepatitis C antibody positive; however, participants previously cured of hepatitis C virus (HCV) infection, with documented sustained virologic response, that is, undetectable HCV RNA 24 weeks after the last dose of HCV treatment, are allowed to participate\n* Hepatitis B surface antigen (HBsAg) positive\n* Participants with cirrhosis as diagnosed based on local practices",false,"ALL","18 Years",{"count":650,"type":651},1149,"ACTUAL","INTERVENTIONAL",[654],"PHASE3","The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)\u002F cobicistat (COBI)\u002F emtricitabine (FTC)\u002F tenofovir alafenamide (TAF) (D\u002FC\u002FF\u002FTAF tablet) relative to continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir disoproxil fumarate (FTC\u002FTDF) in virologically-suppressed (human immunodeficiency virus type 1 ribonucleic acid \\[HIV-1 RNA\\] concentrations less than \\[\\\u003C\\] 50 copies per milliliter \\[copies\u002FmL\\]) HIV-1 infected participants.",[657],"Human Immunodeficiency Virus Type 1",[657,659,660,661,662,663],"Emerald","Darunavir","Cobicistat","Emtricitabine","Tenofovir Alafenamide","COMPLETED","2021-11-25",{"date":667,"type":651},"2021-12-09",{"date":669,"type":651},"2015-03",{"date":671,"type":651},"2020-10",{"name":5,"class":6},79]