[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647445":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":64,"centralContacts":68,"locations":74,"responsibleParty":154,"collaborators":44,"id":156,"slug":157,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":44,"eligibilityCriteria":162,"healthyVolunteers":158,"sex":163,"minAge":164,"maxAge":44,"enrollmentInfo":165,"targetDuration":44,"studyType":168,"phases":169,"briefSummary":172,"conditions":173,"keywords":44,"overallStatus":77,"whyStopped":44,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,17,21,26,30,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 2: Part A: Group 1 of GS-3242 + LEN","EXPERIMENTAL","Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by intramuscular (IM) injections of GS-3242 and LEN for at least 52 weeks.",[13,14,15,16],"Drug: GS-3242 Tablet","Drug: GS-3242 Injection","Drug: Lenacapavir Tablet","Drug: Lenacapavir Injection",{"label":18,"type":10,"description":19,"interventionNames":20},"Phase 2: Part A: Group 2 of GS-3242 + LEN","Participants will be randomized oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 (at a different dose than Group 1) and LEN for at least 52 weeks.",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"Phase 2: Part A: Group 3 of B\u002FF\u002FTAF","Participants will be randomized to receive 50\u002F200\u002F25 mg of B\u002FF\u002FTAF daily for at least 52 weeks.",[25],"Drug: B\u002FF\u002FTAF",{"label":27,"type":10,"description":28,"interventionNames":29},"Phase 2: Part B: Group 4 of GS-3242 + LEN","Participants will be enrolled (non-randomized) to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed IM injections of GS-3242 and LEN (at different doses than Group 1 and 2) for at least 52 weeks.",[13,14,15,16],{"label":31,"type":10,"description":32,"interventionNames":33},"Phase 3: Group 1 of GS-3242 + LEN","Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by IM injections of GS-3242 and LEN for at least 104 weeks.",[13,14,15,16],{"label":35,"type":10,"description":36,"interventionNames":37},"Phase 3: Group 2 of B\u002FF\u002FTAF","Participants will be randomized to receive 50\u002F200\u002F25 mg of B\u002FF\u002FTAF daily for at least 104 weeks.",[25],[39,45,49,54,59],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","GS-3242 Tablet","Administered orally",[9,18,27,31],null,{"type":40,"name":46,"description":47,"armGroupLabels":48,"otherNames":44},"GS-3242 Injection","Administered intramuscularly (IM)",[9,18,27,31],{"type":40,"name":50,"description":42,"armGroupLabels":51,"otherNames":52},"Lenacapavir Tablet",[9,18,27,31],[53],"LEN",{"type":40,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Lenacapavir Injection","Administered IM",[9,18,27,31],[53],{"type":40,"name":60,"description":42,"armGroupLabels":61,"otherNames":62},"B\u002FF\u002FTAF",[22,35],[63],"Biktarvy",[65],{"name":66,"affiliation":5,"role":67},"Gilead Study Director","STUDY_DIRECTOR",[69],{"name":70,"role":71,"phone":72,"phoneExt":44,"email":73},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","leadClinicalTrials@gilead.com",[75,89,98,108,118,128,137,143],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":44},"Midway Immunology and Research Center","RECRUITING","Ft. Pierce","Florida","34982","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-80.32561,27.44671,{"lat":87,"lon":86},{"facility":90,"status":77,"city":91,"state":79,"zip":92,"country":81,"countryCode":82,"cosmosGeoPoint":93,"geoPoint":97,"contacts":44},"Triple O Research Institute, P.A.","West Palm Beach","33401",{"type":84,"coordinates":94},[95,96],-80.05337,26.71534,{"lat":96,"lon":95},{"facility":99,"status":77,"city":100,"state":101,"zip":102,"country":81,"countryCode":82,"cosmosGeoPoint":103,"geoPoint":107,"contacts":44},"Metro Infectious Disease Consultants, P.L.L.C","Decatur","Georgia","30033",{"type":84,"coordinates":104},[105,106],-84.29631,33.77483,{"lat":106,"lon":105},{"facility":109,"status":77,"city":110,"state":111,"zip":112,"country":81,"countryCode":82,"cosmosGeoPoint":113,"geoPoint":117,"contacts":44},"KC care Health Center","Kansas City","Missouri","64111",{"type":84,"coordinates":114},[115,116],-94.57857,39.09973,{"lat":116,"lon":115},{"facility":119,"status":77,"city":120,"state":121,"zip":122,"country":81,"countryCode":82,"cosmosGeoPoint":123,"geoPoint":127,"contacts":44},"St Hope Foundation, Inc,","Bellaire","Texas","77401",{"type":84,"coordinates":124},[125,126],-95.45883,29.70579,{"lat":126,"lon":125},{"facility":129,"status":77,"city":130,"state":121,"zip":131,"country":81,"countryCode":82,"cosmosGeoPoint":132,"geoPoint":136,"contacts":44},"Prism Health North Texas","Dallas","75208",{"type":84,"coordinates":133},[134,135],-96.80667,32.78306,{"lat":135,"lon":134},{"facility":138,"status":77,"city":130,"state":121,"zip":139,"country":81,"countryCode":82,"cosmosGeoPoint":140,"geoPoint":142,"contacts":44},"North Texas Infectious Diseases Consultants, PA","75246",{"type":84,"coordinates":141},[134,135],{"lat":135,"lon":134},{"facility":144,"status":77,"city":145,"state":146,"zip":147,"country":148,"countryCode":146,"cosmosGeoPoint":149,"geoPoint":153,"contacts":44},"HOPE Clinical Research","San Juan","PR","00909","Puerto Rico",{"type":84,"coordinates":150},[151,152],-66.10572,18.46633,{"lat":152,"lon":151},{"type":155,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100647445","phase-2-study-of-an-injectable-regimen-of-gs-3242-with-lenacapavir-compared-to-biktarvy-in-people-new-to-hiv-1-treatment-100647445",false,"NCT07708727","Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment","An Operationally Seamless Phase 2\u002F3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide) in Treatment-Naive People With HIV-1","Key Inclusion Criteria:\n\n* HIV-1 ribonucleic acid (RNA) ≥ 500 copies\u002FmL at screening.\n* Antiretroviral (ARV) treatment-naive, except for prior use of oral daily pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) up to 1 month prior to screening.\n\nKey Exclusion Criteria:\n\n* Prior usage of, or exposure to LEN or GS-3242\n* Prior use of any long-acting parenteral ARV therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":166,"type":167},700,"ESTIMATED","INTERVENTIONAL",[170,171],"PHASE2","PHASE3","The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B.\n\nThe goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide (B\u002FF\u002FTAF)), in people with HIV-1 (PWH) who are new to treatment. This will be done in Treatment Groups 1, 2 and 3 at Week 35.\n\nThe goal of Phase 2, Part B is to compare the effectiveness of study drugs, GS-3242 and LEN versus B\u002FF\u002FTAF in Groups 4 and 3 at Week 26.\n\nThe goal of Phase 3 is to assess the long-term effectiveness of study drug GS-3242 and LEN versus B\u002FF\u002FTAF, at Week 52.\n\nThe primary objectives of this study are:\n\nPhase 2, Part A: To evaluate the efficacy of intramuscular (IM) GS-3242 plus IM LEN versus B\u002FF\u002FTAF in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35. Phase 2, Part B: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B\u002FF\u002FTAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26.\n\nPhase 3: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B\u002FF\u002FTAF in treatment-naive PWH at Week 52.",[174],"HIV-1-infection","2026-08-12",{"date":177,"type":178},"2026-08-14","ACTUAL",{"date":180,"type":178},"2026-07-29",{"date":182,"type":167},"2033-04",{"name":5,"class":6},8]