[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100186943":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":43,"centralContacts":34,"locations":47,"responsibleParty":162,"collaborators":34,"id":164,"slug":165,"hasResults":166,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":172,"sex":173,"minAge":174,"maxAge":34,"enrollmentInfo":175,"targetDuration":34,"studyType":178,"phases":179,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":194,"whyStopped":34,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},{"fullName":5,"class":6},"Janssen-Cilag International NV","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","Patients will receive fixed dose combination (FDC) tablet of tenofovir disoproxil fumarate\u002Femtricitabine\u002Frilpivirine with a meal, until Week 48.",[13,14,15],"Drug: Rilpivirine","Drug: Tenofovir disoproxil fumarate","Drug: Emtricitabine",{"label":17,"type":18,"description":19,"interventionNames":20},"Group 2","ACTIVE_COMPARATOR","Patients will receive FDC tablet of tenofovir disoproxil fumarate\u002Femtricitabine \u002Fefavirenz on an empty stomach at bedtime, until Week 48.",[21,14,15],"Drug: Efavirenz",[23,30,35,39],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Rilpivirine","Type=exact number, unit=mg, number=25, form=tablet, route=oral. Rilpivirine will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.",[9],[29],"EDURANT",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Efavirenz","Type=exact number, unit=mg, number=600, form=tablet, route=oral. Efavirenz will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.",[17],null,{"type":24,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Tenofovir disoproxil fumarate","Type=exact number, unit=mg, number=300, form=tablet, route=oral. Tenofovir disoproxil fumarate will be administered in a fixed dose combination along with rilpivirine and emtricitabine in Group 1, and along with efavirenz and emtricitabine in Group 2.",[9,17],{"type":24,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"Emtricitabine","Type=exact number, unit=mg, number=200, form=tablet, route=oral. Emtricitabine will be administered in a fixed dose combination along with rilpivirine and tenofovir disoproxil fumarate in Group 1, and along with efavirenz and tenofovir disoproxil fumarate in Group 2.",[9,17],[44],{"name":45,"affiliation":5,"role":46},"Janssen-Cilag International NV Clinical Trial","STUDY_DIRECTOR",[48,58,65,74,76,83,85,94,101,110,117,124,126,128,132,139,146,155],{"facility":34,"status":34,"city":49,"state":34,"zip":34,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":34},"Douala","Cameroon","CM",{"type":53,"coordinates":54},"Point",[55,56],9.70428,4.04827,{"lat":56,"lon":55},{"facility":34,"status":34,"city":59,"state":34,"zip":34,"country":50,"countryCode":51,"cosmosGeoPoint":60,"geoPoint":64,"contacts":34},"Yaoundé",{"type":53,"coordinates":61},[62,63],11.51667,3.86667,{"lat":63,"lon":62},{"facility":34,"status":34,"city":66,"state":34,"zip":34,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":34},"Eldoret","Kenya","KE",{"type":53,"coordinates":70},[71,72],35.26993,0.52036,{"lat":72,"lon":71},{"facility":34,"status":34,"city":75,"state":34,"zip":34,"country":67,"countryCode":68,"cosmosGeoPoint":34,"geoPoint":34,"contacts":34},"Kangemi, Nairobi",{"facility":34,"status":34,"city":77,"state":34,"zip":34,"country":67,"countryCode":68,"cosmosGeoPoint":78,"geoPoint":82,"contacts":34},"Nairobi",{"type":53,"coordinates":79},[80,81],36.81667,-1.28333,{"lat":81,"lon":80},{"facility":34,"status":34,"city":84,"state":34,"zip":34,"country":67,"countryCode":68,"cosmosGeoPoint":34,"geoPoint":34,"contacts":34},"Nyanza",{"facility":34,"status":34,"city":86,"state":34,"zip":34,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":93,"contacts":34},"Dakar","Senegal","SN",{"type":53,"coordinates":90},[91,92],-17.44406,14.6937,{"lat":92,"lon":91},{"facility":34,"status":34,"city":95,"state":34,"zip":34,"country":87,"countryCode":88,"cosmosGeoPoint":96,"geoPoint":100,"contacts":34},"Pikine",{"type":53,"coordinates":97},[98,99],-17.39071,14.76457,{"lat":99,"lon":98},{"facility":34,"status":34,"city":102,"state":34,"zip":34,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":109,"contacts":34},"Bloemfontein","South Africa","ZA",{"type":53,"coordinates":106},[107,108],26.214,-29.12107,{"lat":108,"lon":107},{"facility":34,"status":34,"city":111,"state":34,"zip":34,"country":103,"countryCode":104,"cosmosGeoPoint":112,"geoPoint":116,"contacts":34},"Johannesburg",{"type":53,"coordinates":113},[114,115],28.04363,-26.20227,{"lat":115,"lon":114},{"facility":34,"status":34,"city":118,"state":34,"zip":34,"country":103,"countryCode":104,"cosmosGeoPoint":119,"geoPoint":123,"contacts":34},"Soweto",{"type":53,"coordinates":120},[121,122],27.85849,-26.26781,{"lat":122,"lon":121},{"facility":34,"status":34,"city":125,"state":34,"zip":34,"country":103,"countryCode":104,"cosmosGeoPoint":34,"geoPoint":34,"contacts":34},"Wentworth, Durban",{"facility":34,"status":34,"city":127,"state":34,"zip":34,"country":103,"countryCode":104,"cosmosGeoPoint":34,"geoPoint":34,"contacts":34},"Westville, KwaZulu",{"facility":34,"status":34,"city":129,"state":34,"zip":34,"country":130,"countryCode":131,"cosmosGeoPoint":34,"geoPoint":34,"contacts":34},"Amphur Mueang Nonthaburi","Thailand","TH",{"facility":34,"status":34,"city":133,"state":34,"zip":34,"country":130,"countryCode":131,"cosmosGeoPoint":134,"geoPoint":138,"contacts":34},"Bangkok",{"type":53,"coordinates":135},[136,137],100.50144,13.75398,{"lat":137,"lon":136},{"facility":34,"status":34,"city":140,"state":34,"zip":34,"country":130,"countryCode":131,"cosmosGeoPoint":141,"geoPoint":145,"contacts":34},"Chiang Mai",{"type":53,"coordinates":142},[143,144],98.98468,18.79038,{"lat":144,"lon":143},{"facility":34,"status":34,"city":147,"state":34,"zip":34,"country":148,"countryCode":149,"cosmosGeoPoint":150,"geoPoint":154,"contacts":34},"Entebbe","Uganda","UG",{"type":53,"coordinates":151},[152,153],32.47949,0.05621,{"lat":153,"lon":152},{"facility":34,"status":34,"city":156,"state":34,"zip":34,"country":148,"countryCode":149,"cosmosGeoPoint":157,"geoPoint":161,"contacts":34},"Kampala",{"type":53,"coordinates":158},[159,160],32.58219,0.31628,{"lat":160,"lon":159},{"type":163,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100186943","phase-3-a-clinical-trial-comparing-the-efficacy-of-tenofovir-disoproxil-fumarateemtricitabinerilpivirine-tdfftcrpv-versus-tdfftcefavirenz-tdfftcefv-in-patients-with-undetectable-plasma-hiv-1-rna-on-current-first-line-treatment-100186943",true,"NCT01709084","A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate\u002FEmtricitabine\u002FRilpivirine (TDF\u002FFTC\u002FRPV) Versus TDF\u002FFTC\u002FEfavirenz (TDF\u002FFTC\u002FEFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment","A Phase 3b, Randomized, Open-label Clinical Study to Demonstrate Non-inferiority in Virologic Response Rates of HIV-1 RNA Suppression \u003C400 Copies\u002FmL of TDF\u002FFTC\u002FRPV Versus TDF\u002FFTC\u002FEFV in First-line Antiretroviral NNRTI-based Suppressed Patients. Switching At Low HIV-1 RNA Into Fixed Dose Combinations (SALIF)","SALIF","Inclusion Criteria:\n\nDocumented human immunodeficiency virus-type 1 (HIV-1) infection Patients who have been receiving first line highly active antiretroviral therapy (HAART) for at least 1 year before the screening visit Patients who have been taking the same ARV combination for at least 8 weeks before the screening visit and are expected to continue on this regimen throughout the screening period.\n\nPatients who prefer to change the current HAART regimen for reasons of simplification and\u002For toxicity of nucleoside\u002Fnucleotide reverse transcriptase inhibitor (N\\[t\\]RTI) Plasma HIV-1 RNA less than 50 copies per mL and CD4+ cell count higher than 200 per mm3 at the screening visit Agrees to protocol-defined use of effective contraception\n\nExclusion Criteria:\n\nHistory of virologic failure (2 consecutive plasma HIV-1 ribonucleic acid (RNA) more than or equal to 400 copies per mL) while on previous or current ART History of immunologic failure (2 consecutive CD4+ cell counts during HAART treatment falling below the pre-HAART level) History of any primary N\\[t\\]RTI or NNRTI mutations Has a previously documented HIV-2 infection Significantly decreased hepatic function or hepatic insufficiency or diagnosed with acute clinical viral hepatitis Diagnosed with Mycobacterium tuberculosis infection Severe laboratory abnormalities Creatinine clearance less than 50 mL per minute Addicted to drug, including alcohol or recreational drugs",false,"ALL","18 Years",{"count":176,"type":177},426,"ACTUAL","INTERVENTIONAL",[180],"PHASE3","The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to standard treatment) in terms of the percentage of patients who have plasma human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per mL after 48 weeks of randomized treatment with tenofovir disoproxil fumarate\u002Femtricitabine\u002Frilpivirine (TDF\u002FFTC\u002FRPV) versus TDF\u002FFTC\u002Fefavirenz (TDF\u002FFTC\u002FEFV).",[183],"Human Immunodeficiency Virus-type 1 Infection",[185,186,187,188,189,36,40,25,31,190,191,192,193],"Human immunodeficiency virus-type 1 infection","HIV-1","Infectious diseases","Ribonucleic acid","RNA","Edurant","TMC278","R278474","Fixed dose combination","COMPLETED","2021-01-22",{"date":197,"type":177},"2021-02-11",{"date":199,"type":177},"2013-10-02",{"date":201,"type":177},"2020-07-02",{"name":5,"class":6},18]