[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642421":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":54,"centralContacts":58,"locations":36,"responsibleParty":64,"collaborators":36,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":36,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":36,"enrollmentInfo":75,"targetDuration":36,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":36,"overallStatus":84,"whyStopped":36,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":36},{"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",{"type":65,"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":76,"type":77},175,"ESTIMATED","INTERVENTIONAL",[80],"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.",[83],"HIV-1-infection","NOT_YET_RECRUITING","2026-06-08",{"date":87,"type":88},"2026-06-12","ACTUAL",{"date":90,"type":77},"2026-06",{"date":92,"type":77},"2033-04",{"name":5,"class":6}]