[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100239637":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":58,"centralContacts":40,"locations":62,"responsibleParty":236,"collaborators":40,"id":238,"slug":239,"hasResults":240,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":40,"eligibilityCriteria":244,"healthyVolunteers":245,"sex":246,"minAge":247,"maxAge":40,"enrollmentInfo":248,"targetDuration":40,"studyType":251,"phases":252,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":261,"whyStopped":40,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":270},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,17,24],{"label":9,"type":10,"description":11,"interventionNames":12},"BIC + F\u002FTAF","EXPERIMENTAL","Participants will receive BIC + F\u002FTAF FDC + DTG placebo for 48 weeks.\n\n* Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide (B\u002FF\u002FTAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC\u002FF\u002FTAF.",[13,14,15,16],"Drug: BIC","Drug: F\u002FTAF","Drug: DTG Placebo","Drug: B\u002FF\u002FTAF",{"label":18,"type":19,"description":20,"interventionNames":21},"DTG + F\u002FTAF","ACTIVE_COMPARATOR","Participants will receive DTG + F\u002FTAF FDC + BIC placebo for 48 weeks.\n\n* Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B\u002FF\u002FTAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC\u002FF\u002FTAF.",[14,22,23,16],"Drug: DTG","Drug: BIC Placebo",{"label":25,"type":10,"description":26,"interventionNames":27},"Open Label Extension Phase","After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B\u002FF\u002FTAF.",[16],[29,36,41,47,51,54],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","BIC","75 mg tablet administered orally once 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Angeles","California","90036",{"type":70,"coordinates":80},[81,82],-118.24368,34.05223,{"lat":82,"lon":81},{"facility":40,"status":40,"city":76,"state":77,"zip":85,"country":67,"countryCode":68,"cosmosGeoPoint":86,"geoPoint":88,"contacts":40},"90069",{"type":70,"coordinates":87},[81,82],{"lat":82,"lon":81},{"facility":40,"status":40,"city":90,"state":77,"zip":91,"country":67,"countryCode":68,"cosmosGeoPoint":92,"geoPoint":96,"contacts":40},"Sacramento","95817",{"type":70,"coordinates":93},[94,95],-121.4944,38.58157,{"lat":95,"lon":94},{"facility":40,"status":40,"city":98,"state":99,"zip":100,"country":67,"countryCode":68,"cosmosGeoPoint":101,"geoPoint":105,"contacts":40},"Washington D.C.","District of Columbia","20009",{"type":70,"coordinates":102},[103,104],-77.03637,38.89511,{"lat":104,"lon":103},{"facility":40,"status":40,"city":98,"state":99,"zip":107,"country":67,"countryCode":68,"cosmosGeoPoint":108,"geoPoint":110,"contacts":40},"20036",{"type":70,"coordinates":109},[103,104],{"lat":104,"lon":103},{"facility":40,"status":40,"city":112,"state":113,"zip":114,"country":67,"countryCode":68,"cosmosGeoPoint":115,"geoPoint":119,"contacts":40},"Fort Lauderdale","Florida","33316",{"type":70,"coordinates":116},[117,118],-80.14338,26.12231,{"lat":118,"lon":117},{"facility":40,"status":40,"city":121,"state":113,"zip":122,"country":67,"countryCode":68,"cosmosGeoPoint":123,"geoPoint":127,"contacts":40},"Orlando","32803",{"type":70,"coordinates":124},[125,126],-81.37924,28.53834,{"lat":126,"lon":125},{"facility":40,"status":40,"city":129,"state":113,"zip":130,"country":67,"countryCode":68,"cosmosGeoPoint":131,"geoPoint":135,"contacts":40},"West Palm Beach","33401",{"type":70,"coordinates":132},[133,134],-80.05337,26.71534,{"lat":134,"lon":133},{"facility":40,"status":40,"city":137,"state":138,"zip":139,"country":67,"countryCode":68,"cosmosGeoPoint":140,"geoPoint":144,"contacts":40},"Atlanta","Georgia","30312",{"type":70,"coordinates":141},[142,143],-84.38798,33.749,{"lat":143,"lon":142},{"facility":40,"status":40,"city":146,"state":138,"zip":147,"country":67,"countryCode":68,"cosmosGeoPoint":148,"geoPoint":152,"contacts":40},"Decatur","30033",{"type":70,"coordinates":149},[150,151],-84.29631,33.77483,{"lat":151,"lon":150},{"facility":40,"status":40,"city":154,"state":155,"zip":156,"country":67,"countryCode":68,"cosmosGeoPoint":157,"geoPoint":161,"contacts":40},"Boston","Massachusetts","02115",{"type":70,"coordinates":158},[159,160],-71.05977,42.35843,{"lat":160,"lon":159},{"facility":40,"status":40,"city":163,"state":164,"zip":165,"country":67,"countryCode":68,"cosmosGeoPoint":166,"geoPoint":170,"contacts":40},"Berkley","Michigan","48072",{"type":70,"coordinates":167},[168,169],-83.18354,42.50309,{"lat":169,"lon":168},{"facility":40,"status":40,"city":172,"state":173,"zip":174,"country":67,"countryCode":68,"cosmosGeoPoint":175,"geoPoint":179,"contacts":40},"Newark","New Jersey","07102",{"type":70,"coordinates":176},[177,178],-74.17237,40.73566,{"lat":178,"lon":177},{"facility":40,"status":40,"city":181,"state":182,"zip":183,"country":67,"countryCode":68,"cosmosGeoPoint":184,"geoPoint":188,"contacts":40},"Austin","Texas","78705",{"type":70,"coordinates":185},[186,187],-97.74306,30.26715,{"lat":187,"lon":186},{"facility":40,"status":40,"city":190,"state":182,"zip":191,"country":67,"countryCode":68,"cosmosGeoPoint":192,"geoPoint":196,"contacts":40},"Dallas","75208",{"type":70,"coordinates":193},[194,195],-96.80667,32.78306,{"lat":195,"lon":194},{"facility":40,"status":40,"city":198,"state":182,"zip":199,"country":67,"countryCode":68,"cosmosGeoPoint":200,"geoPoint":204,"contacts":40},"Houston","77004",{"type":70,"coordinates":201},[202,203],-95.36327,29.76328,{"lat":203,"lon":202},{"facility":40,"status":40,"city":198,"state":182,"zip":206,"country":67,"countryCode":68,"cosmosGeoPoint":207,"geoPoint":209,"contacts":40},"77098",{"type":70,"coordinates":208},[202,203],{"lat":203,"lon":202},{"facility":40,"status":40,"city":211,"state":182,"zip":212,"country":67,"countryCode":68,"cosmosGeoPoint":213,"geoPoint":217,"contacts":40},"Longview","75605",{"type":70,"coordinates":214},[215,216],-94.74049,32.5007,{"lat":216,"lon":215},{"facility":40,"status":40,"city":219,"state":220,"zip":221,"country":67,"countryCode":68,"cosmosGeoPoint":222,"geoPoint":226,"contacts":40},"Annandale","Virginia","22003",{"type":70,"coordinates":223},[224,225],-77.19637,38.83039,{"lat":225,"lon":224},{"facility":40,"status":40,"city":228,"state":229,"zip":230,"country":67,"countryCode":68,"cosmosGeoPoint":231,"geoPoint":235,"contacts":40},"Seattle","Washington","98104",{"type":70,"coordinates":232},[233,234],-122.33207,47.60621,{"lat":234,"lon":233},{"type":237,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100239637","phase-2-safety-and-efficacy-of-bictegravir--emtricitabinetenofovir-alafenamide-versus-dolutegravir--emtricitabinetenofovir-alafenamide-in-hiv-1-infected-antiretroviral-treatment-naive-adults-100239637",true,"NCT02397694","Safety and Efficacy of Bictegravir + Emtricitabine\u002FTenofovir Alafenamide Versus Dolutegravir + Emtricitabine\u002FTenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults","A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9883 + Emtricitabine\u002FTenofovir Alafenamide Versus Dolutegravir + Emtricitabine\u002FTenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults","Key Inclusion Criteria:\n\n* Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent)\n* Plasma HIV-1 RNA levels ≥ 1,000 copies\u002FmL at screening\n* Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC)\n* Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL\u002Fmin according to the Cockcroft-Gault formula\n* CD4+ cell count ≥ 200 cells\u002FµL at screening\n\nKey Exclusion Criteria:\n\n* A new AIDS-defining condition diagnosed within the 30 days prior to screening as defined in the study protocol\n* Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP)\n* Chronic hepatitis B virus (HBV) infection\n* Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible)\n* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline\n* Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",false,"ALL","18 Years",{"count":249,"type":250},98,"ACTUAL","INTERVENTIONAL",[253],"PHASE2","This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine\u002Ftenofovir alafenamide (F\u002FTAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F\u002FTAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.",[256],"HIV-1 Infection",[258,259,260],"Adult","HIV","naive","COMPLETED","2020-03-25",{"date":264,"type":250},"2020-04-07",{"date":266,"type":250},"2015-03-23",{"date":268,"type":250},"2019-02-27",{"name":5,"class":6},21]