[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438840":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":76,"centralContacts":66,"locations":80,"responsibleParty":273,"collaborators":66,"id":275,"slug":276,"hasResults":277,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":277,"sex":283,"minAge":284,"maxAge":285,"enrollmentInfo":286,"targetDuration":66,"studyType":289,"phases":290,"briefSummary":292,"conditions":293,"keywords":66,"overallStatus":295,"whyStopped":66,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":304,"locationsCount":305},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,17,24,29,33],{"label":9,"type":10,"description":11,"interventionNames":12},"Randomized Blinded Phase: Lenacapavir","EXPERIMENTAL","Participants will receive lenacapavir (LEN) 927 mg injection, every 26 weeks starting on Day 1 for up to approximately 52 weeks. Participants will also receive loading dose of LEN 600 mg, tablet, once daily on Day 1 and Day 2. Participants will receive placebo to match (PTM) emtricitabine\u002Ftenofovir disoproxil fumarate (F\u002FTDF) or PTM emtricitabine\u002Ftenofovir alafenamide (F\u002FTAF), once daily, up to approximately 52 weeks.",[13,14,15,16],"Drug: Oral Lenacapavir (LEN)","Drug: Subcutaneous (SC) Lenacapavir (LEN)","Drug: PTM F\u002FTAF","Drug: PTM F\u002FTDF",{"label":18,"type":10,"description":19,"interventionNames":20},"Randomized Blinded Phase: F\u002FTAF","Participants will receive F\u002FTAF, once daily up to approximately 52 weeks. Participants will also receive PTM LEN injection, every 26 weeks, starting on Day 1 up to approximately 52 weeks. Participants will receive PTM LEN tablet, once daily on Day 1 and Day 2.",[21,22,23],"Drug: F\u002FTAF","Drug: Placebo SC LEN","Drug: PTM Oral LEN",{"label":25,"type":10,"description":26,"interventionNames":27},"Randomized Blinded Phase: F\u002FTDF","Participants will receive F\u002FTDF, once daily up to approximately 52 weeks. Participants will also receive PTM LEN injection, every 26 weeks starting on Day 1 up to approximately 52 weeks. Participants will receive PTM LEN tablet, once daily on Day 1 and Day 2.",[28,22,23],"Drug: F\u002FTDF",{"label":30,"type":10,"description":31,"interventionNames":32},"LEN Open-Label Extension (OLE) Phase","After completion of the Blinded phase, participants will be offered entry into the LEN OLE Phase.\n\nParticipants randomized to LEN will continue to receive LEN 927 mg injection, every 26 weeks until LEN becomes available or the sponsor elects to discontinue the study, whichever occurs first.\n\nParticipants randomized to F\u002FTAF or F\u002FTDF will receive LEN 927 mg injection on OLE Day 1, Week 26, and every 26 weeks thereafter. Participants will also receive LEN 600 mg tablet on OLE Days 1 and 2.",[13,14],{"label":34,"type":10,"description":35,"interventionNames":36},"Pharmacokinetic (PK) Tail Coverage Phase","Participants who prematurely discontinue study drug in the randomized blinded phase will transition into the PK Tail Coverage phase.\n\nParticipants will receive F\u002FTDF, once daily, for 78 weeks beginning 26 weeks after the last LEN injection.",[28],[38,45,52,58,63,67,70,73],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DRUG","Oral Lenacapavir (LEN)","Tablets administered orally without regard to food",[30,9],[44],"GS-6207",{"type":39,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Subcutaneous (SC) Lenacapavir (LEN)","Administered via SC injections",[30,9],[44,50,51],"Yeztugo®","Yeytuo®",{"type":39,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"F\u002FTAF","Tablets administered orally",[18],[57],"Descovy®",{"type":39,"name":59,"description":54,"armGroupLabels":60,"otherNames":61},"F\u002FTDF",[34,25],[62],"Truvada®",{"type":39,"name":64,"description":47,"armGroupLabels":65,"otherNames":66},"Placebo SC LEN",[18,25],null,{"type":39,"name":68,"description":54,"armGroupLabels":69,"otherNames":66},"PTM Oral LEN",[18,25],{"type":39,"name":71,"description":54,"armGroupLabels":72,"otherNames":66},"PTM F\u002FTAF",[9],{"type":39,"name":74,"description":54,"armGroupLabels":75,"otherNames":66},"PTM F\u002FTDF",[9],[77],{"name":78,"affiliation":5,"role":79},"Gilead Study Director","STUDY_DIRECTOR",[81,93,102,108,114,123,129,134,139,147,151,160,169,173,177,180,183,185,194,203,212,221,230,239,248,257,267,270],{"facility":82,"status":66,"city":83,"state":66,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":66},"Madibeng Centre for Research","Brits","2500","South Africa","ZA",{"type":88,"coordinates":89},"Point",[90,91],27.78022,-25.63473,{"lat":91,"lon":90},{"facility":94,"status":66,"city":95,"state":66,"zip":96,"country":85,"countryCode":86,"cosmosGeoPoint":97,"geoPoint":101,"contacts":66},"Emavundleni Research Centre","Cape Town","7750",{"type":88,"coordinates":98},[99,100],18.42322,-33.92584,{"lat":100,"lon":99},{"facility":103,"status":66,"city":95,"state":66,"zip":104,"country":85,"countryCode":86,"cosmosGeoPoint":105,"geoPoint":107,"contacts":66},"Vuka Research Clinic","7784",{"type":88,"coordinates":106},[99,100],{"lat":100,"lon":99},{"facility":109,"status":66,"city":95,"state":66,"zip":110,"country":85,"countryCode":86,"cosmosGeoPoint":111,"geoPoint":113,"contacts":66},"Desmond Tutu Health Foundation Clinical Trials Unit","7925",{"type":88,"coordinates":112},[99,100],{"lat":100,"lon":99},{"facility":115,"status":66,"city":116,"state":66,"zip":117,"country":85,"countryCode":86,"cosmosGeoPoint":118,"geoPoint":122,"contacts":66},"Botha's Hill Clinical Research Site, HIV Prevention Research Unit","Durban","3660",{"type":88,"coordinates":119},[120,121],31.0292,-29.8579,{"lat":121,"lon":120},{"facility":124,"status":66,"city":116,"state":66,"zip":125,"country":85,"countryCode":86,"cosmosGeoPoint":126,"geoPoint":128,"contacts":66},"CAPRISA eThekwini Clinical Research Site","4001",{"type":88,"coordinates":127},[120,121],{"lat":121,"lon":120},{"facility":130,"status":66,"city":116,"state":66,"zip":125,"country":85,"countryCode":86,"cosmosGeoPoint":131,"geoPoint":133,"contacts":66},"CAPRISA Vulindlela Clinical Research Site",{"type":88,"coordinates":132},[120,121],{"lat":121,"lon":120},{"facility":135,"status":66,"city":116,"state":66,"zip":125,"country":85,"countryCode":86,"cosmosGeoPoint":136,"geoPoint":138,"contacts":66},"MatCH Research Unit, Suite 1112, 11th Floor",{"type":88,"coordinates":137},[120,121],{"lat":121,"lon":120},{"facility":140,"status":66,"city":141,"state":66,"zip":66,"country":85,"countryCode":86,"cosmosGeoPoint":142,"geoPoint":146,"contacts":66},"Synergy Biomed Research Institute (SBRI)","East London",{"type":88,"coordinates":143},[144,145],27.91162,-33.01529,{"lat":145,"lon":144},{"facility":148,"status":66,"city":149,"state":66,"zip":150,"country":85,"countryCode":86,"cosmosGeoPoint":66,"geoPoint":66,"contacts":66},"Setshaba Research Centre","Gauteng","152",{"facility":152,"status":66,"city":153,"state":66,"zip":154,"country":85,"countryCode":86,"cosmosGeoPoint":155,"geoPoint":159,"contacts":66},"Wits Reproductive Health & HIV Institute (Wits RHI)","Johannesburg","2038",{"type":88,"coordinates":156},[157,158],28.04363,-26.20227,{"lat":158,"lon":157},{"facility":161,"status":66,"city":162,"state":66,"zip":163,"country":85,"countryCode":86,"cosmosGeoPoint":164,"geoPoint":168,"contacts":66},"The Aurum Institute: Gavin J Churchyard Legacy Centre, Klerksdorp Clinical Research Centre","Klerksdorp","2571",{"type":88,"coordinates":165},[166,167],26.66672,-26.85213,{"lat":167,"lon":166},{"facility":170,"status":66,"city":171,"state":66,"zip":172,"country":85,"countryCode":86,"cosmosGeoPoint":66,"geoPoint":66,"contacts":66},"Perinatal HIV Research Unit (PHRU) Soweto Kliptown","Kliptown","1809",{"facility":174,"status":66,"city":175,"state":66,"zip":176,"country":85,"countryCode":86,"cosmosGeoPoint":66,"geoPoint":66,"contacts":66},"Phoenix Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit","Kwa Zulu Natal","4061",{"facility":178,"status":66,"city":175,"state":66,"zip":179,"country":85,"countryCode":86,"cosmosGeoPoint":66,"geoPoint":66,"contacts":66},"Verulam Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit","4340",{"facility":181,"status":66,"city":175,"state":66,"zip":182,"country":85,"countryCode":86,"cosmosGeoPoint":66,"geoPoint":66,"contacts":66},"Tongaat Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit","4400",{"facility":184,"status":66,"city":175,"state":66,"zip":66,"country":85,"countryCode":86,"cosmosGeoPoint":66,"geoPoint":66,"contacts":66},"Chatsworth Clinical Research Site, South African Medical Research Council, HIV and Other Infectious Disease Research Unit",{"facility":186,"status":66,"city":187,"state":66,"zip":188,"country":85,"countryCode":86,"cosmosGeoPoint":189,"geoPoint":193,"contacts":66},"Qhakaza Mbokodo Research Clinic","Ladysmith","3370",{"type":88,"coordinates":190},[191,192],29.77896,-28.55874,{"lat":192,"lon":191},{"facility":195,"status":66,"city":196,"state":66,"zip":197,"country":85,"countryCode":86,"cosmosGeoPoint":198,"geoPoint":202,"contacts":66},"Africa Health Research Institute","Mtubatuba","3935",{"type":88,"coordinates":199},[200,201],32.18483,-28.41789,{"lat":201,"lon":200},{"facility":204,"status":66,"city":205,"state":66,"zip":206,"country":85,"countryCode":86,"cosmosGeoPoint":207,"geoPoint":211,"contacts":66},"The Aurum Institute: Pretoria Clinical Research Centre","Pretoria","0087",{"type":88,"coordinates":208},[209,210],28.18783,-25.74486,{"lat":210,"lon":209},{"facility":213,"status":66,"city":214,"state":66,"zip":215,"country":85,"countryCode":86,"cosmosGeoPoint":216,"geoPoint":220,"contacts":66},"The Aurum Institute: Rustenburg Clinical Research Centre","Rustenburg","299",{"type":88,"coordinates":217},[218,219],27.24208,-25.66756,{"lat":219,"lon":218},{"facility":222,"status":66,"city":223,"state":66,"zip":224,"country":85,"countryCode":86,"cosmosGeoPoint":225,"geoPoint":229,"contacts":66},"Desmond Tutu Health Foundation - Masiphumelele Research Office","Sunnydale","7705",{"type":88,"coordinates":226},[227,228],26.66686,-30.4068,{"lat":228,"lon":227},{"facility":231,"status":66,"city":232,"state":66,"zip":233,"country":85,"countryCode":86,"cosmosGeoPoint":234,"geoPoint":238,"contacts":66},"The Aurum Institute: Tembisa Clinical Research Centre","Tembisa","1632",{"type":88,"coordinates":235},[236,237],28.22762,-26.00979,{"lat":237,"lon":236},{"facility":240,"status":66,"city":241,"state":66,"zip":242,"country":85,"countryCode":86,"cosmosGeoPoint":243,"geoPoint":247,"contacts":66},"CAPRISA Umlazi Clinical Research Site","Umlazi","4066",{"type":88,"coordinates":244},[245,246],30.88333,-29.96667,{"lat":246,"lon":245},{"facility":249,"status":66,"city":250,"state":66,"zip":251,"country":85,"countryCode":86,"cosmosGeoPoint":252,"geoPoint":256,"contacts":66},"FPD-DTHF Ndevana Community Research Site","Vincent","5217",{"type":88,"coordinates":253},[254,255],27.90566,-32.97902,{"lat":255,"lon":254},{"facility":258,"status":66,"city":259,"state":66,"zip":66,"country":260,"countryCode":261,"cosmosGeoPoint":262,"geoPoint":266,"contacts":66},"Makerere-Kalangala Clinical Research site","Kalangala","Uganda","UG",{"type":88,"coordinates":263},[264,265],32.225,-0.30889,{"lat":265,"lon":264},{"facility":268,"status":66,"city":269,"state":66,"zip":66,"country":260,"countryCode":261,"cosmosGeoPoint":66,"geoPoint":66,"contacts":66},"AMBSO Masaka Clinical Research site","Kyotera- Masaka Region",{"facility":271,"status":66,"city":272,"state":66,"zip":66,"country":260,"countryCode":261,"cosmosGeoPoint":66,"geoPoint":66,"contacts":66},"Makerere University- John Hopkins University (MU-JHU) Mityana Research Site (MU-JHU) Care Ltd","Mityana Town",{"type":274,"investigatorFullName":66,"investigatorTitle":66,"investigatorAffiliation":66,"oldNameTitle":66,"oldOrganization":66},"SPONSOR","100438840","phase-3-pre-exposure-prophylaxis-study-of-lenacapavir-and-emtricitabinetenofovir-alafenamide-in-adolescent-girls-and-young-women-at-risk-of-hiv-infection-100438840",true,"NCT04994509","Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine\u002FTenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection","A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine\u002FTenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection","PURPOSE 1","Key Inclusion Criteria:\n\n* Incidence Phase\n\n  * HIV-1 status unknown at initial screening and no prior human immunodeficiency virus (HIV)-1 testing within the last 3 months.\n  * Sexually active (has had \\> 1 vaginal intercourse within the last 3 months) with cisgender male individuals (CGM).\n* Randomized Phase\n\n  * Negative fourth generation HIV-1 antibody (Ab)\u002Fantigen (Ag) test confirmed with central HIV-1 testing.\n  * Estimated glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin at screening.\n  * Body weight ≥ 35 kg.\n\nKey Exclusion Criteria:\n\n* Prior receipt of an HIV vaccine.\n* Prior use of any long-acting systemic HIV pre-exposure prophylaxis (PrEP) or prior HIV postexposure prophylaxis (PEP) in the past 12 weeks.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","FEMALE","16 Years","25 Years",{"count":287,"type":288},5368,"ACTUAL","INTERVENTIONAL",[291],"PHASE3","The goal of this study is to evaluate the efficacy of the study drugs, lenacapavir (LEN) and emtricitabine\u002Ftenofovir alafenamide (F\u002FTAF) in preventing HIV infection, in adolescent girls and young women (AGYW).\n\nThe primary objective of this study is to evaluate the efficacy of LEN and F\u002FTAF for HIV-1 PrEP in AGYW at risk of HIV-1 infection.",[294],"Pre-Exposure Prophylaxis of HIV Infection","ACTIVE_NOT_RECRUITING","2026-07-15",{"date":298,"type":288},"2026-08-07",{"date":300,"type":288},"2021-08-30",{"date":302,"type":303},"2028-01","ESTIMATED",{"name":5,"class":6},28]