[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100154782":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":27,"responsibleParty":193,"collaborators":26,"id":195,"slug":196,"hasResults":197,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":26,"eligibilityCriteria":201,"healthyVolunteers":202,"sex":203,"minAge":204,"maxAge":26,"enrollmentInfo":205,"targetDuration":26,"studyType":208,"phases":209,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":218,"whyStopped":26,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FTC\u002FRPV\u002FTDF","EXPERIMENTAL","Participants switched from their existing treatment regimen of EFV\u002FFTC\u002FTDF to the FTC\u002FRPV\u002FTDF STR.",[13],"Drug: FTC\u002FRPV\u002FTDF",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Emtricitabine (FTC) 200 mg\u002Frilpivirine (RPV) 25 mg\u002Ftenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily",[9],[20,21],"Complera","Eviplera",[23],{"name":24,"affiliation":5,"role":25},"David Pugatch, MD","STUDY_DIRECTOR",null,[28,41,50,56,65,75,80,86,96,105,115,124,134,144,154,164,174,183],{"facility":29,"status":26,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":26},"Living Hope Clinical Foundation","Long Beach","California","90814","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-118.18923,33.76696,{"lat":39,"lon":38},{"facility":42,"status":26,"city":43,"state":31,"zip":44,"country":33,"countryCode":34,"cosmosGeoPoint":45,"geoPoint":49,"contacts":26},"Peter J. Ruane MD Inc","Los Angeles","90036",{"type":36,"coordinates":46},[47,48],-118.24368,34.05223,{"lat":48,"lon":47},{"facility":51,"status":26,"city":43,"state":31,"zip":52,"country":33,"countryCode":34,"cosmosGeoPoint":53,"geoPoint":55,"contacts":26},"Anthony Mills MD, Inc.","90069",{"type":36,"coordinates":54},[47,48],{"lat":48,"lon":47},{"facility":57,"status":26,"city":58,"state":31,"zip":59,"country":33,"countryCode":34,"cosmosGeoPoint":60,"geoPoint":64,"contacts":26},"La Playa Medical Group and Clinical Research","San Diego","92103",{"type":36,"coordinates":61},[62,63],-117.16472,32.71571,{"lat":63,"lon":62},{"facility":66,"status":26,"city":67,"state":68,"zip":69,"country":33,"countryCode":34,"cosmosGeoPoint":70,"geoPoint":74,"contacts":26},"Dupont Circle Physicians Group, P.C.","Washington D.C.","District of Columbia","20009",{"type":36,"coordinates":71},[72,73],-77.03637,38.89511,{"lat":73,"lon":72},{"facility":76,"status":26,"city":67,"state":68,"zip":69,"country":33,"countryCode":34,"cosmosGeoPoint":77,"geoPoint":79,"contacts":26},"Whitman Walker Clinic",{"type":36,"coordinates":78},[72,73],{"lat":73,"lon":72},{"facility":81,"status":26,"city":67,"state":68,"zip":82,"country":33,"countryCode":34,"cosmosGeoPoint":83,"geoPoint":85,"contacts":26},"Capital Medical Associates, PC","20036",{"type":36,"coordinates":84},[72,73],{"lat":73,"lon":72},{"facility":87,"status":26,"city":88,"state":89,"zip":90,"country":33,"countryCode":34,"cosmosGeoPoint":91,"geoPoint":95,"contacts":26},"The Kinder Medical Group","Miami","Florida","33133",{"type":36,"coordinates":92},[93,94],-80.19366,25.77427,{"lat":94,"lon":93},{"facility":97,"status":26,"city":98,"state":89,"zip":99,"country":33,"countryCode":34,"cosmosGeoPoint":100,"geoPoint":104,"contacts":26},"Orlando Immunology Center","Orlando","32803",{"type":36,"coordinates":101},[102,103],-81.37924,28.53834,{"lat":103,"lon":102},{"facility":106,"status":26,"city":107,"state":108,"zip":109,"country":33,"countryCode":34,"cosmosGeoPoint":110,"geoPoint":114,"contacts":26},"Atlanta ID Group","Atlanta","Georgia","30309",{"type":36,"coordinates":111},[112,113],-84.38798,33.749,{"lat":113,"lon":112},{"facility":116,"status":26,"city":117,"state":108,"zip":118,"country":33,"countryCode":34,"cosmosGeoPoint":119,"geoPoint":123,"contacts":26},"Infectious Disease Specialists of Atlanta","Decatur","30033",{"type":36,"coordinates":120},[121,122],-84.29631,33.77483,{"lat":122,"lon":121},{"facility":125,"status":26,"city":126,"state":127,"zip":128,"country":33,"countryCode":34,"cosmosGeoPoint":129,"geoPoint":133,"contacts":26},"Northstar Medical Center","Chicago","Illinois","60657",{"type":36,"coordinates":130},[131,132],-87.65005,41.85003,{"lat":132,"lon":131},{"facility":135,"status":26,"city":136,"state":137,"zip":138,"country":33,"countryCode":34,"cosmosGeoPoint":139,"geoPoint":143,"contacts":26},"Community Research Initiative of New England","Boston","Massachusetts","02215",{"type":36,"coordinates":140},[141,142],-71.05977,42.35843,{"lat":142,"lon":141},{"facility":145,"status":26,"city":146,"state":147,"zip":148,"country":33,"countryCode":34,"cosmosGeoPoint":149,"geoPoint":153,"contacts":26},"Be Well Medical Center, P.C.","Berkley","Michigan","48072",{"type":36,"coordinates":150},[151,152],-83.18354,42.50309,{"lat":152,"lon":151},{"facility":155,"status":26,"city":156,"state":157,"zip":158,"country":33,"countryCode":34,"cosmosGeoPoint":159,"geoPoint":163,"contacts":26},"Southampton Healthcare, Inc.","St Louis","Missouri","63139",{"type":36,"coordinates":160},[161,162],-90.19789,38.62727,{"lat":162,"lon":161},{"facility":165,"status":26,"city":166,"state":167,"zip":168,"country":33,"countryCode":34,"cosmosGeoPoint":169,"geoPoint":173,"contacts":26},"Southwest Infectious Disease Clinical Research, Inc.","Addison","Texas","75001",{"type":36,"coordinates":170},[171,172],-96.82917,32.96179,{"lat":172,"lon":171},{"facility":175,"status":26,"city":176,"state":167,"zip":177,"country":33,"countryCode":34,"cosmosGeoPoint":178,"geoPoint":182,"contacts":26},"Central Texas Clinical Research","Austin","78705",{"type":36,"coordinates":179},[180,181],-97.74306,30.26715,{"lat":181,"lon":180},{"facility":184,"status":26,"city":185,"state":186,"zip":187,"country":33,"countryCode":34,"cosmosGeoPoint":188,"geoPoint":192,"contacts":26},"Peter Shalit, M.D.","Seattle","Washington","98104",{"type":36,"coordinates":189},[190,191],-122.33207,47.60621,{"lat":191,"lon":190},{"type":194,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100154782","phase-2-study-to-evaluate-switching-from-a-regimen-consisting-of-the-efavirenzemtricitabinetenofovir-disoproxil-fumarate-single-tablet-regimen-str-to-the-emtricitabinerilpivirinetenofovir-disoproxil-fumarate-str-100154782",true,"NCT01286740","Study to Evaluate Switching From a Regimen Consisting of the Efavirenz\u002FEmtricitabine\u002FTenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine\u002FRilpivirine\u002FTenofovir Disoproxil Fumarate STR","A Phase 2B Open Label Pilot Study to Evaluate Switching From a Regimen Consisting of a Efavirenz\u002FEmtricitabine\u002FTenofovir Disoproxil Fumarate (EFV\u002FFTC\u002FTDF) Single Tablet Regimen (STR) to Emtricitabine\u002FRilpivirine\u002FTenofovir Disoproxil Fumarate (FTC\u002FRPV\u002FTDF) STR in Virologically Suppressed, HIV 1 Infected Subjects","Inclusion Criteria:\n\n* Ability to understand and sign a written informed consent form\n* Receiving EFV\u002FFTC\u002FTDF continuously for ≥ 3 months preceding the screening visit\n* Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels for ≥ 8 weeks prior to the screening visit and HIV-1 RNA \\\u003C 50 copies\u002FmL at the screening visit\n* On their first antiretroviral drug regimen, and no HIV-1 RNA \\> 50 copies\u002FmL measured at two consecutive time points after first achieving HIV RNA \\\u003C 50 copies\u002FmL\n* Had a genotype prior to starting FTC\u002FRPV\u002FTDF and no known resistance to any of the study agents\n* Normal ECG\n* Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 mg\u002FdL, or normal direct bilirubin\n* Adequate hematologic function (absolute neutrophil count ≥ 1,000\u002Fmm\\^3; platelets ≥ 50,000\u002Fmm\\^3; hemoglobin ≥ 8.5 g\u002FdL)\n* Serum amylase ≤ 5 x ULN (subjects with serum amylase \\> 5 x ULN eligible if serum lipase ≤ 5 x ULN)\n* Adequate renal function (estimated glomerular filtration rate ≥ 50 mL\u002Fmin according to the Cockcroft-Gault formula)\n* Males and Females of childbearing potential must have agreed to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be nonheterosexually active, practice sexual abstinence, or have a vasectomized partner) from screening throughout the duration of the study period and for 60 days following the last dose of study drug.\n* Age ≥ 18 years\n* Life expectancy ≥ 1 year\n\nExclusion Criteria:\n\n* A new AIDS-defining condition diagnosed within 21 days prior to screening\n* Females who were breastfeeding\n* Positive serum pregnancy test (female of childbearing potential)\n* Proven or suspected acute hepatitis in the 21 days prior to study entry\n* Subjects receiving drug treatment for Hepatitis C, or subjects anticipated to receive treatment for Hepatitis C during the course of the study, or with a history of liver disease\n* Was experiencing decompensated cirrhosis\n* Implanted defibrillator or pacemaker\n* Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance\n* History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma\n* Active, serious infections requiring parenteral antibiotic or antifungal therapy within 21 days prior to Baseline\n* All investigational drugs\n* Ongoing therapy or anticipated need to initiate drugs or herbal\u002Fnatural supplements during the study that were contraindicated or not recommended for use as indicated in the protocol, including drugs not to be used with FTC, RPV, and TDF; or subjects with known allergies to the excipients of the FTC\u002FRPV\u002FTDF STR\n* Participation in any other clinical trial without prior approval from the sponsor was prohibited while participating in this trial\n* Treatment with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)\n* Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements",false,"ALL","18 Years",{"count":206,"type":207},50,"ACTUAL","INTERVENTIONAL",[210],"PHASE2","The purpose of this Phase 2b study was to evaluate the efficacy and safety of the emtricitabine\u002Frilpivirine\u002Ftenofovir disoproxil fumarate (FTC\u002FRPV\u002FTDF) STR, after switching from the efavirenz (EFV)\u002FFTC\u002FTDF STR at baseline, in maintaining HIV-1 RNA \\\u003C 50 copies\u002FmL at Week 12. HIV-infected patients were enrolled if they had received EFV\u002FFTC\u002FTDF for ≥ 3 months prior to study start, were experiencing safety or tolerability concerns (in particular, EFV-related intolerance), and wished to change to an alternate, better-tolerated regimen.",[213],"HIV-1 Infection",[215,216,217],"HIV-1","HIV","Treatment Experienced","COMPLETED","2013-04-19",{"date":221,"type":222},"2013-04-26","ESTIMATED",{"date":224,"type":26},"2011-01",{"date":226,"type":207},"2012-03",{"name":5,"class":6},18]