[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642421":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":54,"centralContacts":58,"locations":64,"responsibleParty":405,"collaborators":36,"id":407,"slug":408,"hasResults":409,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":36,"eligibilityCriteria":413,"healthyVolunteers":409,"sex":414,"minAge":415,"maxAge":36,"enrollmentInfo":416,"targetDuration":36,"studyType":419,"phases":420,"briefSummary":422,"conditions":423,"keywords":36,"overallStatus":67,"whyStopped":36,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":434},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,17,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"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 up to 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},"Part A: Group 2 of GS-3242 + LEN","Participants will be randomized to receive oral loading doses of GS-3242 in combination with LEN oral tablets, followed by a IM injections of GS-3242 (at a different dose than Group 1) and LEN up to 52 weeks.",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"Part A: Group 3 of B\u002FF\u002FTAF","Participants will be randomized to continue to receive 50\u002F200\u002F25 mg of B\u002FF\u002FTAF daily for up to 52 weeks.",[25],"Drug: B\u002FF\u002FTAF",{"label":27,"type":10,"description":28,"interventionNames":29},"Part B: Group 4 (Conditional) 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 injection of GS-3242 and LEN (at different doses than Groups 1 and 2) up to 52 weeks.",[13,14,15,16],[31,37,41,46,51],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","GS-3242 Tablet","Administered orally",[9,18,27],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"GS-3242 Injection","Administered intramuscularly (IM)",[9,18,27],{"type":32,"name":42,"description":34,"armGroupLabels":43,"otherNames":44},"Lenacapavir Tablet",[9,18,27],[45],"LEN",{"type":32,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Lenacapavir Injection","Administered IM",[9,18,27],[45],{"type":32,"name":52,"description":34,"armGroupLabels":53,"otherNames":36},"B\u002FF\u002FTAF",[22],[55],{"name":56,"affiliation":5,"role":57},"Gilead Study Director","STUDY_DIRECTOR",[59],{"name":60,"role":61,"phone":62,"phoneExt":36,"email":63},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",[65,79,88,94,104,113,122,131,140,149,158,168,177,186,196,206,215,225,234,244,254,264,274,284,293,302,308,317,326,336,346,358,367,372,382,394],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":36},"Pacific Oak Medical Group","RECRUITING","Beverly Hills","California","90211","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-118.40036,34.07362,{"lat":77,"lon":76},{"facility":80,"status":67,"city":81,"state":69,"zip":82,"country":71,"countryCode":72,"cosmosGeoPoint":83,"geoPoint":87,"contacts":36},"Optimus Medical Group","San Francisco","94102",{"type":74,"coordinates":84},[85,86],-122.41942,37.77493,{"lat":86,"lon":85},{"facility":89,"status":67,"city":81,"state":69,"zip":90,"country":71,"countryCode":72,"cosmosGeoPoint":91,"geoPoint":93,"contacts":36},"University of California San Francisco, Community and Clinical Research Center","94110",{"type":74,"coordinates":92},[85,86],{"lat":86,"lon":85},{"facility":95,"status":67,"city":96,"state":97,"zip":98,"country":71,"countryCode":72,"cosmosGeoPoint":99,"geoPoint":103,"contacts":36},"Midland Florida Clinical Research Center, LLC","DeLand","Florida","32720",{"type":74,"coordinates":100},[101,102],-81.30312,29.02832,{"lat":102,"lon":101},{"facility":105,"status":67,"city":106,"state":97,"zip":107,"country":71,"countryCode":72,"cosmosGeoPoint":108,"geoPoint":112,"contacts":36},"CAN Community Health Fort Lauderdale","Fort Lauderdale","33316",{"type":74,"coordinates":109},[110,111],-80.14338,26.12231,{"lat":111,"lon":110},{"facility":114,"status":67,"city":115,"state":97,"zip":116,"country":71,"countryCode":72,"cosmosGeoPoint":117,"geoPoint":121,"contacts":36},"Midway Immunology and Research Center","Ft. Pierce","34982",{"type":74,"coordinates":118},[119,120],-80.32561,27.44671,{"lat":120,"lon":119},{"facility":123,"status":67,"city":124,"state":97,"zip":125,"country":71,"countryCode":72,"cosmosGeoPoint":126,"geoPoint":130,"contacts":36},"AIDS Healthcare Foundation -Coconut Grove","Miami","33133",{"type":74,"coordinates":127},[128,129],-80.19366,25.77427,{"lat":129,"lon":128},{"facility":132,"status":67,"city":133,"state":97,"zip":134,"country":71,"countryCode":72,"cosmosGeoPoint":135,"geoPoint":139,"contacts":36},"AHF - Pensacola","Pensacola","32504",{"type":74,"coordinates":136},[137,138],-87.21691,30.42131,{"lat":138,"lon":137},{"facility":141,"status":67,"city":142,"state":97,"zip":143,"country":71,"countryCode":72,"cosmosGeoPoint":144,"geoPoint":148,"contacts":36},"CAN Community Health Inc.","Sarasota","34237",{"type":74,"coordinates":145},[146,147],-82.53065,27.33643,{"lat":147,"lon":146},{"facility":150,"status":67,"city":151,"state":97,"zip":152,"country":71,"countryCode":72,"cosmosGeoPoint":153,"geoPoint":157,"contacts":36},"Triple O Research Institute, PA","West Palm Beach","33407",{"type":74,"coordinates":154},[155,156],-80.05337,26.71534,{"lat":156,"lon":155},{"facility":159,"status":67,"city":160,"state":161,"zip":162,"country":71,"countryCode":72,"cosmosGeoPoint":163,"geoPoint":167,"contacts":36},"Metro Infectious Disease Consultants, P.L.L.C.","Decatur","Georgia","30033",{"type":74,"coordinates":164},[165,166],-84.29631,33.77483,{"lat":166,"lon":165},{"facility":169,"status":67,"city":170,"state":161,"zip":171,"country":71,"countryCode":72,"cosmosGeoPoint":172,"geoPoint":176,"contacts":36},"Mercer University, Department of Internal Medicine","Macon","31201",{"type":74,"coordinates":173},[174,175],-83.6324,32.84069,{"lat":175,"lon":174},{"facility":178,"status":67,"city":179,"state":161,"zip":180,"country":71,"countryCode":72,"cosmosGeoPoint":181,"geoPoint":185,"contacts":36},"Chatham County Health Department","Savannah","31401",{"type":74,"coordinates":182},[183,184],-81.09983,32.08354,{"lat":184,"lon":183},{"facility":187,"status":67,"city":188,"state":189,"zip":190,"country":71,"countryCode":72,"cosmosGeoPoint":191,"geoPoint":195,"contacts":36},"Be Well Medical Center","Berkley","Michigan","48072",{"type":74,"coordinates":192},[193,194],-83.18354,42.50309,{"lat":194,"lon":193},{"facility":197,"status":67,"city":198,"state":199,"zip":200,"country":71,"countryCode":72,"cosmosGeoPoint":201,"geoPoint":205,"contacts":36},"KC CARE Health Center","Kansas City","Missouri","64111",{"type":74,"coordinates":202},[203,204],-94.57857,39.09973,{"lat":204,"lon":203},{"facility":207,"status":67,"city":208,"state":199,"zip":209,"country":71,"countryCode":72,"cosmosGeoPoint":210,"geoPoint":214,"contacts":36},"Southampton Community Healthcare","St Louis","63139",{"type":74,"coordinates":211},[212,213],-90.19789,38.62727,{"lat":213,"lon":212},{"facility":216,"status":67,"city":217,"state":218,"zip":219,"country":71,"countryCode":72,"cosmosGeoPoint":220,"geoPoint":224,"contacts":36},"ID care","Hillsborough","New Jersey","08844",{"type":74,"coordinates":221},[222,223],-74.62682,40.4776,{"lat":223,"lon":222},{"facility":226,"status":67,"city":227,"state":218,"zip":228,"country":71,"countryCode":72,"cosmosGeoPoint":229,"geoPoint":233,"contacts":36},"South Jersey Infectious Disease","Somers Point","08244",{"type":74,"coordinates":230},[231,232],-74.5946,39.31762,{"lat":232,"lon":231},{"facility":235,"status":67,"city":236,"state":237,"zip":238,"country":71,"countryCode":72,"cosmosGeoPoint":239,"geoPoint":243,"contacts":36},"AXCES Research Group, LLC","Santa Fe","New Mexico","87505",{"type":74,"coordinates":240},[241,242],-105.9378,35.68698,{"lat":242,"lon":241},{"facility":245,"status":67,"city":246,"state":247,"zip":248,"country":71,"countryCode":72,"cosmosGeoPoint":249,"geoPoint":253,"contacts":36},"Brooklyn Clinical Research","Brooklyn","New York","11226",{"type":74,"coordinates":250},[251,252],-73.94958,40.6501,{"lat":252,"lon":251},{"facility":255,"status":67,"city":256,"state":257,"zip":258,"country":71,"countryCode":72,"cosmosGeoPoint":259,"geoPoint":263,"contacts":36},"Rosedale Health and Wellness","Huntersville","North Carolina","28078",{"type":74,"coordinates":260},[261,262],-80.84285,35.41069,{"lat":262,"lon":261},{"facility":265,"status":67,"city":266,"state":267,"zip":268,"country":71,"countryCode":72,"cosmosGeoPoint":269,"geoPoint":273,"contacts":36},"Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center","Philadelphia","Pennsylvania","19107",{"type":74,"coordinates":270},[271,272],-75.16362,39.95238,{"lat":272,"lon":271},{"facility":275,"status":67,"city":276,"state":277,"zip":278,"country":71,"countryCode":72,"cosmosGeoPoint":279,"geoPoint":283,"contacts":36},"Central Texas Clinical Research","Austin","Texas","78705",{"type":74,"coordinates":280},[281,282],-97.74306,30.26715,{"lat":282,"lon":281},{"facility":285,"status":67,"city":286,"state":277,"zip":287,"country":71,"countryCode":72,"cosmosGeoPoint":288,"geoPoint":292,"contacts":36},"St. Hope Foundation","Bellaire","77401",{"type":74,"coordinates":289},[290,291],-95.45883,29.70579,{"lat":291,"lon":290},{"facility":294,"status":67,"city":295,"state":277,"zip":296,"country":71,"countryCode":72,"cosmosGeoPoint":297,"geoPoint":301,"contacts":36},"Prism Health North Texas","Dallas","75208",{"type":74,"coordinates":298},[299,300],-96.80667,32.78306,{"lat":300,"lon":299},{"facility":303,"status":67,"city":295,"state":277,"zip":304,"country":71,"countryCode":72,"cosmosGeoPoint":305,"geoPoint":307,"contacts":36},"North Texas Infectious Disease Consultants, P.A.","75246",{"type":74,"coordinates":306},[299,300],{"lat":300,"lon":299},{"facility":309,"status":67,"city":310,"state":277,"zip":311,"country":71,"countryCode":72,"cosmosGeoPoint":312,"geoPoint":316,"contacts":36},"The Crofoot Research Center, INC.","Houston","77098",{"type":74,"coordinates":313},[314,315],-95.36327,29.76328,{"lat":315,"lon":314},{"facility":318,"status":67,"city":319,"state":277,"zip":320,"country":71,"countryCode":72,"cosmosGeoPoint":321,"geoPoint":325,"contacts":36},"Diagnostic Clinic of Longview","Longview","75605",{"type":74,"coordinates":322},[323,324],-94.74049,32.5007,{"lat":324,"lon":323},{"facility":327,"status":67,"city":328,"state":329,"zip":330,"country":71,"countryCode":72,"cosmosGeoPoint":331,"geoPoint":335,"contacts":36},"Clinical Alliance for Research& Education - Infectious Diseases, LLC(CARE-ID","Annandale","Virginia","22003",{"type":74,"coordinates":332},[333,334],-77.19637,38.83039,{"lat":334,"lon":333},{"facility":337,"status":67,"city":338,"state":339,"zip":340,"country":71,"countryCode":72,"cosmosGeoPoint":341,"geoPoint":345,"contacts":36},"TribalMed PLLC","Seattle","Washington","98104",{"type":74,"coordinates":342},[343,344],-122.33207,47.60621,{"lat":344,"lon":343},{"facility":347,"status":67,"city":348,"state":349,"zip":350,"country":351,"countryCode":352,"cosmosGeoPoint":353,"geoPoint":357,"contacts":36},"Taylor Square Private Clinic","Surry Hills","New South Wales","2010","Australia","AU",{"type":74,"coordinates":354},[355,356],151.21282,-33.88374,{"lat":356,"lon":355},{"facility":359,"status":67,"city":360,"state":349,"zip":361,"country":351,"countryCode":352,"cosmosGeoPoint":362,"geoPoint":366,"contacts":36},"Momentum Clinical Research Darlinghurst","Sydney","2010 NSW",{"type":74,"coordinates":363},[364,365],151.20732,-33.86785,{"lat":365,"lon":364},{"facility":368,"status":67,"city":360,"state":349,"zip":350,"country":351,"countryCode":352,"cosmosGeoPoint":369,"geoPoint":371,"contacts":36},"East Sydney Doctors",{"type":74,"coordinates":370},[364,365],{"lat":365,"lon":364},{"facility":373,"status":67,"city":374,"state":375,"zip":376,"country":351,"countryCode":352,"cosmosGeoPoint":377,"geoPoint":381,"contacts":36},"Prahran Market Clinic,","South Yarra","Victoria","3141",{"type":74,"coordinates":378},[379,380],144.99149,-37.83834,{"lat":380,"lon":379},{"facility":383,"status":384,"city":385,"state":36,"zip":386,"country":387,"countryCode":388,"cosmosGeoPoint":389,"geoPoint":393,"contacts":36},"Spectrum Health","ACTIVE_NOT_RECRUITING","Vancouver","V6Z2T1","Canada","CA",{"type":74,"coordinates":390},[391,392],-123.11934,49.24966,{"lat":392,"lon":391},{"facility":395,"status":67,"city":396,"state":397,"zip":398,"country":399,"countryCode":397,"cosmosGeoPoint":400,"geoPoint":404,"contacts":36},"Clinical Research Puerto Rico","San Juan","PR","00909","Puerto Rico",{"type":74,"coordinates":401},[402,403],-66.10572,18.46633,{"lat":403,"lon":402},{"type":406,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100642421","phase-2-a-study-of-gs-3242-in-combination-with-lenacapavir-versus-biktarvy-in-virologically-suppressed-people-with-hiv-1-100642421",false,"NCT07645287","A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1","A Phase 2 Randomized, 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 Virologically Suppressed People With HIV-1","Key Inclusion Criteria:\n\n* Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \\\u003C 50 copies\u002FmL for ≥ 6 months before screening.\n* Plasma HIV-1 RNA levels \\\u003C 50 copies\u002FmL at screening.\n* Receiving bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide (coformulated; Biktarvy®) (B\u002FF\u002FTAF) for ≥ 6 months prior to screening.\n* No documented resistance to GS-3242 (integrase mutation Q148H\u002FK\u002FR plus at least 2 of the following integrase mutations: L74I\u002FM, T97A, E138A\u002FK\u002FT, or G140A\u002FC\u002FS).\n\nKey Exclusion Criteria:\n\n* Prior use of, or exposure to GS-3242 or LEN.\n* History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen.\n* Prior use of any long-acting parenteral antiretroviral 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":417,"type":418},175,"ESTIMATED","INTERVENTIONAL",[421],"PHASE2","The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide (B\u002FF\u002FTAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B\u002FF\u002FTAF in Groups 4 and 3 at Week 26.\n\nThe primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B\u002FF\u002FTAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B\u002FF\u002FTAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.",[424],"HIV-1-infection","2026-08-04",{"date":427,"type":428},"2026-08-06","ACTUAL",{"date":430,"type":428},"2026-06-15",{"date":432,"type":418},"2033-04",{"name":5,"class":6},36]