[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07645287":3,"trial-entities:NCT07645287":156,"trial-summary:NCT07645287":160},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":55,"secondary_outcomes":62,"sex":99,"minimum_age":100,"maximum_age":17,"healthy_volunteers":101,"eligibility_criteria":102,"std_ages":113,"locations":116,"central_contacts":141,"overall_officials":147,"references":151,"see_also_links":152},"NCT07645287","GS-US-643-7710","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","RECRUITING","2033-04","2026-07","2026-07-10","2026-06-15","Gilead Sciences","INDUSTRY",true,"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.",null,[19],"HIV-1-infection",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},175,"ESTIMATED",[29,37,41,46,51],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","GS-3242 Tablet","Administered orally",[34,35,36],"Part A: Group 1 of GS-3242 + LEN","Part A: Group 2 of GS-3242 + LEN","Part B: Group 4 (Conditional) of GS-3242 + LEN",{"type":30,"name":38,"description":39,"armGroupLabels":40},"GS-3242 Injection","Administered intramuscularly (IM)",[34,35,36],{"type":30,"name":42,"description":32,"armGroupLabels":43,"otherNames":44},"Lenacapavir Tablet",[34,35,36],[45],"LEN",{"type":30,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Lenacapavir Injection","Administered IM",[34,35,36],[45],{"type":30,"name":52,"description":32,"armGroupLabels":53},"B\u002FF\u002FTAF",[54],"Part A: Group 3 of B\u002FF\u002FTAF",[56,59],{"measure":57,"timeFrame":58},"Part A: Proportion of Participants With HIV-1 RNA ≥ 50 Copies\u002FmL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm","Week 35",{"measure":60,"timeFrame":61},"Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies\u002FmL at Week 26 as Determined by the US FDA Snapshot Algorithm","Week 26",[63,66,68,70,73,76,78,81,84,87,90,93,95,97],{"measure":64,"timeFrame":65},"Part A and Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies\u002FmL at Week 52 as Determined by the US FDA Snapshot Algorithm","Week 52",{"measure":67,"timeFrame":58},"Part A: Proportion of Participants With HIV-1 RNA \u003C 50 Copies\u002FmL at Week 35 as Determined by the US FDA Snapshot Algorithm",{"measure":69,"timeFrame":65},"Part A and Part B: Proportion of Participants With HIV-1 RNA \u003C 50 Copies\u002FmL at Week 52 as Determined by the US FDA Snapshot Algorithm",{"measure":71,"timeFrame":72},"Part A: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 35","Baseline, Week 35",{"measure":74,"timeFrame":75},"Part A and Part B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 52","Baseline, Week 52",{"measure":77,"timeFrame":61},"Part B: Proportion of Participants With HIV-1 RNA \u003C 50 Copies\u002FmL at Week 26 as Determined by the US FDA Snapshot Algorithm",{"measure":79,"timeFrame":80},"Part B: Change From Baseline in CD4 Cell Count at Week 26","Baseline, Week 26",{"measure":82,"timeFrame":83},"Part A: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 35","Up to Week 35",{"measure":85,"timeFrame":86},"Part A and Part B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 52","Up to Week 52",{"measure":88,"timeFrame":89},"Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26","Up to Week 26",{"measure":91,"timeFrame":92},"Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 18","Week 18",{"measure":94,"timeFrame":58},"Part A: Group 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 35",{"measure":96,"timeFrame":65},"Part A: Group 1 and 2 and Part B: Groups 1 and 2:Trough Concentrations of GS-3242 and LEN at Week 52",{"measure":98,"timeFrame":61},"Part B: Trough Concentrations at GS-3242 and LEN at Week 26","ALL","18 Years",false,{"inclusion":103,"exclusion":108,"raw_text":112},[104,105,106,107],"Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \\\u003C 50 copies\u002FmL for ≥ 6 months before screening.","Plasma HIV-1 RNA levels \\\u003C 50 copies\u002FmL at screening.","Receiving bictegravir\u002Femtricitabine\u002Ftenofovir alafenamide (coformulated; Biktarvy®) (B\u002FF\u002FTAF) for ≥ 6 months prior to screening.","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).",[109,110,111],"Prior use of, or exposure to GS-3242 or LEN.","History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen.","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.","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.",[114,115],"ADULT","OLDER_ADULT",[117,126,134],{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":122,"geoPoint":123},"Midway Immunology and Research Center","Ft. Pierce","Florida","34982","United States",{"lat":124,"lon":125},27.44671,-80.32561,{"facility":127,"status":8,"city":128,"state":129,"zip":130,"country":122,"geoPoint":131},"North Texas Infectious Disease Consultants, P.A.","Dallas","Texas","75246",{"lat":132,"lon":133},32.78306,-96.80667,{"facility":135,"status":8,"city":136,"state":129,"zip":137,"country":122,"geoPoint":138},"Diagnostic Clinic of Longview","Longview","75605",{"lat":139,"lon":140},32.5007,-94.74049,[142],{"name":143,"role":144,"phone":145,"email":146},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",[148],{"name":149,"affiliation":13,"role":150},"Gilead Study Director","STUDY_DIRECTOR",[],[153],{"label":154,"url":155},"Gilead Clinical Trials Website","https:\u002F\u002Fwww.gileadclinicaltrials.com\u002Fstudy?nctid=NCT07645287",{"nct_id":4,"conditions":157,"biomarkers":159},[158],"HIV Infection",[],{"nct_id":4,"found":15,"summary":161,"prompt_version":171},{"design":162,"status":163,"heading":164,"summary":165,"follow_up":166,"word_count":167,"commitments":168,"compensation":169,"drugs_mentioned":170},"This is an interventional study comparing different treatment groups. It plans to enroll about 175 participants.","completed","A Study of GS-3242 and Lenacapavir for HIV-1","This study is for people with HIV-1 who are currently taking Biktarvy and have successfully kept their viral load (HIV-1 RNA) very low for at least six months. It aims to see if switching to a new combination of medicines, GS-3242 and Lenacapavir, is as effective as continuing Biktarvy. GS-3242 and Lenacapavir can be given as pills or injections. The study will compare how well these different treatments keep your HIV-1 RNA below 50 copies\u002FmL after 26 or 35 weeks. About 175 people are expected to join this study.","The study measures effectiveness at Week 26 or Week 35, depending on the part of the study you are in.",89,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]