[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100330071":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":10,"locations":34,"responsibleParty":183,"collaborators":10,"id":185,"slug":186,"hasResults":187,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":187,"sex":193,"minAge":194,"maxAge":10,"enrollmentInfo":195,"targetDuration":10,"studyType":198,"phases":10,"briefSummary":199,"conditions":200,"keywords":10,"overallStatus":202,"whyStopped":10,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},{"fullName":5,"class":6},"Janssen-Cilag S.p.A.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1",null,"Participants will not receive any intervention as a part of this study. This group will include participants in treatment with Darunavir\u002F Cobicistat\u002F Emtricitabine\u002F Tenofovir Alafenamide (D\u002FC\u002FF\u002FTAF), who were always being treated with boosted-darunavir (DRV)-based regimen. The primary data source will be the medical records of each participant participating in this study.",[13],"Drug: D\u002FC\u002FF\u002FTAF Fixed-Dose Combination (FDC)",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2","Participants will not receive any intervention as a part of this study. This group will include participants who started their antiretroviral (ARV) treatment with any combination excluding DRV before starting D\u002FC\u002FF\u002FTAF treatments, who were always being treated with ARV treatment with any combination excluding DRV before starting D\u002FC\u002FF\u002FTAF treatments. The primary data source will be the medical records of each participant participating in this study.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group 3","Participants will not receive any intervention as a part of this study. This group will include participants started with D\u002FC\u002FF\u002FTAF as naive. The primary data source will be the medical records of each participant participating in this study.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","D\u002FC\u002FF\u002FTAF Fixed-Dose Combination (FDC)","Participants in treatment with D\u002FC\u002FF\u002FTAF FDC, coming from different treatment histories will be observed in this study. No interventions will be administered as a part of this study.",[9,15,19],[29],"Symtuza",[31],{"name":32,"affiliation":5,"role":33},"Janssen-Cilag S.p.A., Italy Clinical Trial","STUDY_DIRECTOR",[35,47,56,65,74,83,89,95,100,109,118,127,136,145,151,157,166,175],{"facility":36,"status":10,"city":37,"state":10,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":10},"Azienda Ospedaliera Papa Giovanni XXIII","Bergamo","24127","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],9.66721,45.69601,{"lat":45,"lon":44},{"facility":48,"status":10,"city":49,"state":10,"zip":50,"country":39,"countryCode":40,"cosmosGeoPoint":51,"geoPoint":55,"contacts":10},"Azienda Ospedaliera Spedali Civili di Brescia","Brescia","25123",{"type":42,"coordinates":52},[53,54],10.21472,45.53558,{"lat":54,"lon":53},{"facility":57,"status":10,"city":58,"state":10,"zip":59,"country":39,"countryCode":40,"cosmosGeoPoint":60,"geoPoint":64,"contacts":10},"ASST Valle Olona - P.O. di Busto Arsizio","Busto Arsizio","21052",{"type":42,"coordinates":61},[62,63],8.84914,45.61128,{"lat":63,"lon":62},{"facility":66,"status":10,"city":67,"state":10,"zip":68,"country":39,"countryCode":40,"cosmosGeoPoint":69,"geoPoint":73,"contacts":10},"Ente Ospedaliero Ospedeli Galliera","Genova","16128",{"type":42,"coordinates":70},[71,72],11.87211,45.21604,{"lat":72,"lon":71},{"facility":75,"status":10,"city":76,"state":10,"zip":77,"country":39,"countryCode":40,"cosmosGeoPoint":78,"geoPoint":82,"contacts":10},"Ospedale San Raffaele","Milan","20127",{"type":42,"coordinates":79},[80,81],12.59836,42.78235,{"lat":81,"lon":80},{"facility":84,"status":10,"city":76,"state":10,"zip":85,"country":39,"countryCode":40,"cosmosGeoPoint":86,"geoPoint":88,"contacts":10},"Ospedale San Paolo Clinica Universitaria Malattie Infettive E Tropicali","20142",{"type":42,"coordinates":87},[80,81],{"lat":81,"lon":80},{"facility":90,"status":10,"city":76,"state":10,"zip":91,"country":39,"countryCode":40,"cosmosGeoPoint":92,"geoPoint":94,"contacts":10},"A.O. Ospedale L. Sacco - Polo Universitario","20157",{"type":42,"coordinates":93},[80,81],{"lat":81,"lon":80},{"facility":96,"status":10,"city":76,"state":10,"zip":91,"country":39,"countryCode":40,"cosmosGeoPoint":97,"geoPoint":99,"contacts":10},"Div Malattie Infettive - Ospedale L. Sacco",{"type":42,"coordinates":98},[80,81],{"lat":81,"lon":80},{"facility":101,"status":10,"city":102,"state":10,"zip":103,"country":39,"countryCode":40,"cosmosGeoPoint":104,"geoPoint":108,"contacts":10},"Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato","Monserrato","09042",{"type":42,"coordinates":105},[106,107],9.1444,39.25642,{"lat":107,"lon":106},{"facility":110,"status":10,"city":111,"state":10,"zip":112,"country":39,"countryCode":40,"cosmosGeoPoint":113,"geoPoint":117,"contacts":10},"Azienda Ospedaliera dei Colli - P.O. 'D. Cotugno'","Naples","80131",{"type":42,"coordinates":114},[115,116],14.26811,40.85216,{"lat":116,"lon":115},{"facility":119,"status":10,"city":120,"state":10,"zip":121,"country":39,"countryCode":40,"cosmosGeoPoint":122,"geoPoint":126,"contacts":10},"Azienda Ospedaliera di Padova","Padova","35128",{"type":42,"coordinates":123},[124,125],11.14261,44.38225,{"lat":125,"lon":124},{"facility":128,"status":10,"city":129,"state":10,"zip":130,"country":39,"countryCode":40,"cosmosGeoPoint":131,"geoPoint":135,"contacts":10},"Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone","Palermo","90127",{"type":42,"coordinates":132},[133,134],13.3636,38.1166,{"lat":134,"lon":133},{"facility":137,"status":10,"city":138,"state":10,"zip":139,"country":39,"countryCode":40,"cosmosGeoPoint":140,"geoPoint":144,"contacts":10},"Policlinico Tor Vergata","Roma","00133",{"type":42,"coordinates":141},[142,143],11.10642,44.99364,{"lat":143,"lon":142},{"facility":146,"status":10,"city":138,"state":10,"zip":147,"country":39,"countryCode":40,"cosmosGeoPoint":148,"geoPoint":150,"contacts":10},"Istituto nazionale malattie infettive 'L. Spallanzani'","00149",{"type":42,"coordinates":149},[142,143],{"lat":143,"lon":142},{"facility":152,"status":10,"city":138,"state":10,"zip":153,"country":39,"countryCode":40,"cosmosGeoPoint":154,"geoPoint":156,"contacts":10},"Universita Di Roma 'La Sapienza'","00161",{"type":42,"coordinates":155},[142,143],{"lat":143,"lon":142},{"facility":158,"status":10,"city":159,"state":10,"zip":160,"country":39,"countryCode":40,"cosmosGeoPoint":161,"geoPoint":165,"contacts":10},"Istituto di Ematologia - Clinica Universitaria","Sassari","07100",{"type":42,"coordinates":162},[163,164],8.55552,40.72586,{"lat":164,"lon":163},{"facility":167,"status":10,"city":168,"state":10,"zip":169,"country":39,"countryCode":40,"cosmosGeoPoint":170,"geoPoint":174,"contacts":10},"A O Universitaria Senese Ospedale Santa Maria alle Scotte","Siena","53100",{"type":42,"coordinates":171},[172,173],11.33064,43.31822,{"lat":173,"lon":172},{"facility":176,"status":10,"city":177,"state":10,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":178,"geoPoint":182,"contacts":10},"Ospedale Amedeo di Savoia","Torino",{"type":42,"coordinates":179},[180,181],11.99138,44.88856,{"lat":181,"lon":180},{"type":184,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100330071","an-italian-observation-of-antiretroviral-treatment-in-participants-taking-darunavir-cobicistat-plus-emtricitabine-and-tenofovir-alafenamide-fumarate-100330071",false,"NCT03577470","An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir\u002F Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate","Italian Retrospective and Prospective Observation of Antiretroviral Treatment in Patients Taking DarunavIr\u002FcobicistAt Plus eMtricitabine and Tenofovir AlafeNamide fumaraTE - DIAMANTE","DIAMANTE","Inclusion Criteria:\n\n* Having a confirmed diagnosis of Human Immunodeficiency Virus-1 (HIV-1)\n* Must sign a participation agreement\u002FInformed Consent Form (ICF) allowing data collection and source data verification in accordance with local requirements\n* Taking Darunavir\u002F Cobicistat\u002F Emtricitabine\u002F Tenofovir Alafenamide (D\u002FC\u002FF\u002FTAF) as per Summary of Product Characteristics (SmPCs) since at least one month before enrollment:\n\n  i) Experienced participants \\[Group 1 and 2\\]: a) started their antiretroviral (ARV) treatment not before 1\u002F1\u002F2015, b) having at least 1 year of ARV treatment history at study enrollment, c) Group 1, having always been treated with Darunavir (DRV) since the start of ARV treatment as naïve, d) Group 2, not having been treated with DRV before starting of D\u002FC\u002FF\u002FTAF, ii.) Naive (any Viral Load (VL) participants (Group 3)\n\nExclusion Criteria:\n\n* Participants unable to read, to write, to understand and sign the ICF\n* Currently enrolled in an interventional study\n* Currently enrolled in an observational study sponsored or supported by Janssen\n* Chemotherapy scheduled during study observation","ALL","18 Years",{"count":196,"type":197},246,"ACTUAL","OBSERVATIONAL","The purpose of this study is to describe the effectiveness of Darunavir\u002F Cobicistat\u002F Emtricitabine\u002F Tenofovir Alafenamide (D\u002FC\u002FF\u002FTAF), measured as virological response at Week 48 as per Food and Drug Administration (FDA) snapshot algorithm through collection of daily practice data in the Italian setting.",[201],"Human Immunodeficiency Virus (HIV)","COMPLETED","2024-10-11",{"date":205,"type":197},"2024-10-15",{"date":207,"type":197},"2018-06-13",{"date":209,"type":197},"2020-09-28",{"name":5,"class":6},18]