[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100303261":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":19,"locations":24,"responsibleParty":177,"collaborators":19,"id":179,"slug":180,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":19,"eligibilityCriteria":185,"healthyVolunteers":186,"sex":187,"minAge":188,"maxAge":19,"enrollmentInfo":189,"targetDuration":19,"studyType":192,"phases":193,"briefSummary":195,"conditions":196,"keywords":19,"overallStatus":198,"whyStopped":19,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},{"fullName":5,"class":6},"Janssen Scientific Affairs, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC","EXPERIMENTAL","Participants will receive oral tablet containing Darunavir 800 milligram (mg)\u002F Cobicistat 150 mg\u002F Emtricitabine 200 mg\u002F Tenofovir Alafenamide 10 mg (D\u002FC\u002FF\u002FTAF) fixed-dose combination (FDC) once daily within 24 hours of the screening\u002Fbaseline visit.",[13],"Drug: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Participants will receive oral tablet containing D 800 mg \u002FC 150 mg \u002FF 200 mg \u002FTAF 10 mg FDC once daily within 24 hours of the screening\u002F baseline visit.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Janssen Scientific Affairs, LLC Clinical Trial","STUDY_DIRECTOR",[25,38,48,57,67,77,86,95,105,115,125,135,143,153,162,171],{"facility":26,"status":19,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":19},"Spectrum Medical Group","Phoenix","Arizona","85012","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-112.07404,33.44838,{"lat":36,"lon":35},{"facility":39,"status":19,"city":40,"state":41,"zip":42,"country":30,"countryCode":31,"cosmosGeoPoint":43,"geoPoint":47,"contacts":19},"The Office of Franco Felizarta, MD","Bakersfield","California","93301",{"type":33,"coordinates":44},[45,46],-119.01871,35.37329,{"lat":46,"lon":45},{"facility":49,"status":19,"city":50,"state":41,"zip":51,"country":30,"countryCode":31,"cosmosGeoPoint":52,"geoPoint":56,"contacts":19},"Jeffrey Goodman Clinic - DBA Los Angeles Gay and Lesbian Center","Los Angeles","90028",{"type":33,"coordinates":53},[54,55],-118.24368,34.05223,{"lat":55,"lon":54},{"facility":58,"status":19,"city":59,"state":60,"zip":61,"country":30,"countryCode":31,"cosmosGeoPoint":62,"geoPoint":66,"contacts":19},"Whitman Walker Health","Washington D.C.","District of Columbia","20009",{"type":33,"coordinates":63},[64,65],-77.03637,38.89511,{"lat":65,"lon":64},{"facility":68,"status":19,"city":69,"state":70,"zip":71,"country":30,"countryCode":31,"cosmosGeoPoint":72,"geoPoint":76,"contacts":19},"Midway Immunology and Research Center","Ft. Pierce","Florida","34982",{"type":33,"coordinates":73},[74,75],-80.32561,27.44671,{"lat":75,"lon":74},{"facility":78,"status":19,"city":79,"state":70,"zip":80,"country":30,"countryCode":31,"cosmosGeoPoint":81,"geoPoint":85,"contacts":19},"University of Miami","Miami","33136",{"type":33,"coordinates":82},[83,84],-80.19366,25.77427,{"lat":84,"lon":83},{"facility":87,"status":19,"city":88,"state":70,"zip":89,"country":30,"countryCode":31,"cosmosGeoPoint":90,"geoPoint":94,"contacts":19},"Orlando Immunology Center","Orlando","32803",{"type":33,"coordinates":91},[92,93],-81.37924,28.53834,{"lat":93,"lon":92},{"facility":96,"status":19,"city":97,"state":98,"zip":99,"country":30,"countryCode":31,"cosmosGeoPoint":100,"geoPoint":104,"contacts":19},"Chatham County Health Department","Savannah","Georgia","31401",{"type":33,"coordinates":101},[102,103],-81.09983,32.08354,{"lat":103,"lon":102},{"facility":106,"status":19,"city":107,"state":108,"zip":109,"country":30,"countryCode":31,"cosmosGeoPoint":110,"geoPoint":114,"contacts":19},"The Ruth M. Rothstein CORE Center","Chicago","Illinois","60612",{"type":33,"coordinates":111},[112,113],-87.65005,41.85003,{"lat":113,"lon":112},{"facility":116,"status":19,"city":117,"state":118,"zip":119,"country":30,"countryCode":31,"cosmosGeoPoint":120,"geoPoint":124,"contacts":19},"Saint Michaels Medical Center - Infectious Disease","Newark","New Jersey","07102",{"type":33,"coordinates":121},[122,123],-74.17237,40.73566,{"lat":123,"lon":122},{"facility":126,"status":19,"city":127,"state":128,"zip":129,"country":30,"countryCode":31,"cosmosGeoPoint":130,"geoPoint":134,"contacts":19},"Southwest CARE Center","Albuquerque","New Mexico","87109",{"type":33,"coordinates":131},[132,133],-106.65114,35.08449,{"lat":133,"lon":132},{"facility":126,"status":19,"city":136,"state":128,"zip":137,"country":30,"countryCode":31,"cosmosGeoPoint":138,"geoPoint":142,"contacts":19},"Santa Fe","87505",{"type":33,"coordinates":139},[140,141],-105.9378,35.68698,{"lat":141,"lon":140},{"facility":144,"status":19,"city":145,"state":146,"zip":147,"country":30,"countryCode":31,"cosmosGeoPoint":148,"geoPoint":152,"contacts":19},"North Texas Infectious Diseases Consultants","Dallas","Texas","75246",{"type":33,"coordinates":149},[150,151],-96.80667,32.78306,{"lat":151,"lon":150},{"facility":154,"status":19,"city":155,"state":146,"zip":156,"country":30,"countryCode":31,"cosmosGeoPoint":157,"geoPoint":161,"contacts":19},"Texas Centers for Infectious Disease Associates","Fort Worth","76104",{"type":33,"coordinates":158},[159,160],-97.32085,32.72541,{"lat":160,"lon":159},{"facility":163,"status":19,"city":164,"state":146,"zip":165,"country":30,"countryCode":31,"cosmosGeoPoint":166,"geoPoint":170,"contacts":19},"Therapeutic Concepts - Donald R Watkins Foundation","Houston","77004",{"type":33,"coordinates":167},[168,169],-95.36327,29.76328,{"lat":169,"lon":168},{"facility":172,"status":19,"city":164,"state":146,"zip":173,"country":30,"countryCode":31,"cosmosGeoPoint":174,"geoPoint":176,"contacts":19},"Gordon Crofoot, MD","77098",{"type":33,"coordinates":175},[168,169],{"lat":169,"lon":168},{"type":178,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100303261","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-dcftaf-once-daily-fixed-dose-combination-fdc-regimen-in-newly-diagnosed-antiretroviral-treatment-naive-human-immunodeficiency-virus-type-1-hiv-1-infected-participants-receiving-care-in-a-test-and-treat-model-of-care-100303261",true,"NCT03227861","A Study to Evaluate the Efficacy and Safety of (D\u002FC\u002FF\u002FTAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care","A Phase 3, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir\u002F Cobicistat\u002F Emtricitabine\u002F Tenofovir Alafenamide (D\u002FC\u002FF\u002FTAF) Once Daily Fixed-dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects Receiving Care in a Test and Treat Model of Care","Inclusion Criteria:\n\n* Newly diagnosed with human immunodeficiency virus type 1 (HIV-1) evidenced by any of the following within 2 weeks of the screening\u002Fbaseline visit: a) HIV Rapid Antibody positive; or b) HIV Immunoassay positive; or c) Positive p24 antigen and a HIV-1 ribonucleic acid (RNA) viral load greater than or equal to (\\>=) 5,000 copies per milliliter (copies\u002F mL); or d) Non-reactive HIV-1 antibody\u002Fantigen assays and HIV-1 RNA viral load (\\>=) 5,000 copies\u002FmL. HIV-1 RNA viral load must be confirmed once within 1 week of initial HIV-1 RNA viral load test\n* Antiretroviral treatment-naïve, except for the use of TRUVADA® for pre-exposure prophylaxis (PrEP)\n* Must be able to swallow whole tablets\n* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 90 days after receiving the last dose of study drug\n* A woman of childbearing potential must have a negative urine pregnancy test at screening\n\nExclusion Criteria:\n\n* Known active cryptococcal infection, active toxoplasmic encephalitis, Mycobacterium tuberculosis infection, or another acquired immunodeficiency syndrome (AIDS) -defining condition that in the judgement of the investigator would increase the risk of morbidity or mortality\n* Known history of clinically relevant hepatic disease or hepatitis that in the investigator's judgement is not compatible with Darunavir\u002F Cobicistat\u002F Emtricitabine\u002F Tenofovir Alafenamide (D\u002FC\u002FF\u002FTAF FDC)\n* Known history of cirrhosis as diagnosed based on local practices\n* Known history of chronic (\\[\\>=\\] 3 months) renal insufficiency, defined as having an estimated glomerular filtration rate (eGFR) less than (\\\u003C) 50 milliliter per minute (mL\u002Fmin) according to the Modification of Diet in Renal Disease (MDRD) formula\n* Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study treatment",false,"ALL","18 Years",{"count":190,"type":191},109,"ACTUAL","INTERVENTIONAL",[194],"PHASE3","The purpose of this study is to assess the efficacy of Darunavir\u002F Cobicistat\u002F Emtricitabine\u002F Tenofovir Alafenamide (D\u002FC\u002FF\u002FTAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive participants as determined by the proportion of virologic responders defined as having (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies\u002FmL) at Week 48.",[197],"HIV-1","COMPLETED","2025-01-31",{"date":201,"type":191},"2025-02-04",{"date":203,"type":191},"2017-07-31",{"date":205,"type":191},"2019-09-04",{"name":5,"class":6},16]