[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07682961":3,"trial-entities:NCT07682961":180,"trial-summary:NCT07682961":184},{"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":69,"secondary_outcomes":73,"sex":105,"minimum_age":106,"maximum_age":17,"healthy_volunteers":107,"eligibility_criteria":108,"std_ages":137,"locations":140,"central_contacts":165,"overall_officials":171,"references":175,"see_also_links":176},"NCT07682961","GS-US-536-5938","Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy","A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy","RECRUITING","2033-03","2026-07","2026-07-22","2026-07-14","Gilead Sciences","INDUSTRY",true,"The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment.\n\nThe primary objective of this study are to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies\u002FmL at Week 52.",null,[19],"HIV Infections",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE3",{"count":26,"type":27},590,"ESTIMATED",[29,37,42,49,56,63],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Lenacapavir","Administered subcutaneously",[34],"Treatment Group 1: Lenacapavir(LEN)+ Teropavimab(TAB)+ Zinlirvimab (ZAB)",[36],"LEN",{"type":30,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Lenacapavir Tablet","Administered orally",[34],[36],{"type":30,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Teropavimab","Administered intravenously (IV)",[34],[47,48],"TAB","GS-5423",{"type":30,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Zinlirvimab","Administered IV",[34],[54,55],"ZAB","GS-2872",{"type":30,"name":57,"description":58,"armGroupLabels":59,"otherNames":61},"Cabotegravir","Administered intramuscular (IM)",[60],"Treatment Group 2: Cabotegravir (CAB) + Rilpivirine (RPV)",[62],"CAB",{"type":30,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"Rilpivirine","Administered IM",[60],[68],"RPV",[70],{"measure":71,"timeFrame":72},"Proportion of Participants With HIV-1 ribonucleic acid (RNA) ≥ 50 Copies\u002FmL at Week 52 as Defined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm.","Week 52",[74,77,79,81,84,87,90,92,95,97,100,103],{"measure":75,"timeFrame":76},"Proportion of Participants With HIV-1 RNA ≥ 50 Copies\u002FmL at Week 92 as Defined by the US FDA Snapshot Algorithm.","Week 92",{"measure":78,"timeFrame":72},"Proportion of Participants With HIV-1 RNA \u003C 50 Copies\u002FmL at Week 52 as Determined by the US FDA Snapshot Algorithm",{"measure":80,"timeFrame":76},"Proportion of Participants with HIV-1 RNA \u003C 50 copies\u002FmL at Week 92 as Determined by the US FDA Snapshot Algorithm.",{"measure":82,"timeFrame":83},"Change From Baseline in clusters of differentiation 4 (CD4) (CD4)+ T-cell Counts at Week 52","Baseline, Week 52",{"measure":85,"timeFrame":86},"Change From Baseline in CD4+ T-cell Counts at Week 92","Baseline, Week 92",{"measure":88,"timeFrame":89},"Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)","Up to Week 92",{"measure":91,"timeFrame":89},"Percentages of Participants Prematurely Discontinuing Their Study Treatment due to an AE",{"measure":93,"timeFrame":94},"Trough Concentrations for LEN, TAB, and ZAB at Week 26","Week 26",{"measure":96,"timeFrame":72},"Trough Concentrations for LEN, TAB, and ZAB at Week 52",{"measure":98,"timeFrame":99},"Trough Concentrations for LEN, TAB, and ZAB at Week 104","Week 104",{"measure":101,"timeFrame":102},"Percentages of Participants With Antidrug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) of TAB","Up to 92 Weeks",{"measure":104,"timeFrame":102},"Percentages of Participants With of ADAs and NAbs of ZAB","ALL","18 Years",false,{"inclusion":109,"exclusion":114,"raw_text":136},[110,111,112,113],"Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria:","At least 1 documented HIV-1 RNA level measured between 6 months and 12 months (+2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be \\\u003C 50 copies\u002FmL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies\u002FmL). A single virologic elevation of ≥ 50 copies\u002FmL and \\\u003C 400 copies\u002FmL (transient detectable viremia or \"blips\") prior to screening are acceptable if the subsequent plasma HIV-1 RNA level is \\\u003C 50 copies\u002FmL.","A plasma HIV-1 RNA test \\\u003C 50 copies\u002FmL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies\u002FmL) within the last 6 months prior to screening.","On a stable oral ARV therapy (ART) for ≥ 6 months prior to screening.",[115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135],"History of an opportunistic infection or illness indicative of Stage 3 HIV disease.","History of treatment failure.","Known or suspected resistance to either CAB or RPV.","Individuals with a dermatologic condition or implanted prothesis overlying the gluteal injection site for CAB + RPV.","Known hypersensitivity to the study intervention, its metabolites, or formulation excipients.","Active, serious infections (other than HIV-1) requiring therapy \\\u003C 30 days prior to randomization.","Active tuberculosis infection.","Acute hepatitis of any cause \\\u003C 30 days before randomization.","History of, or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or severe hepatic impairment (Child-Pugh Class C).","Active malignancy requiring acute systemic therapy.","Have poor venous access that would limit phlebotomy or intravenous (IV) infusion of study drugs.","Prior use of, or exposure to, LEN or a broadly neutralizing antibody (bNAb) for HIV-1.","Prior use of, or exposure to, long-acting (LA) injectable CAB or LA injectable RPV.","Prior use of, or exposure to, ibalizumab, fostemsavir, or maraviroc.","Baseline regimen consisting of monotherapy with any single antiretroviral (ARV).","Treatment with immunosuppressant therapies (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) within 4 weeks of screening (with the exception of a single short course of corticosteroids lasting ≤ 7 days) or have a comorbid condition with an anticipated need ongoing immunosuppressive treatment during the study.","Hepatitis C virus (HCV) antibody positive and HCV RNA detectable.","Chronic hepatitis B virus (HBV) infection, as determined by either:","Severe renal impairment-estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin according to the Cockcroft-Gault formula.","Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant, as determined by the investigator.","Any of the following laboratory values at screening:","Key Inclusion Criteria:\n\n* Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria:\n\n  1\\) Proviral phenotypic susceptibility to both TAB and ZAB by the investigational protocol-defined assay at screening.\n* At least 1 documented HIV-1 RNA level measured between 6 months and 12 months (+2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be \\\u003C 50 copies\u002FmL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies\u002FmL). A single virologic elevation of ≥ 50 copies\u002FmL and \\\u003C 400 copies\u002FmL (transient detectable viremia or \"blips\") prior to screening are acceptable if the subsequent plasma HIV-1 RNA level is \\\u003C 50 copies\u002FmL.\n* A plasma HIV-1 RNA test \\\u003C 50 copies\u002FmL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies\u002FmL) within the last 6 months prior to screening.\n\n  1\\) If \\> 1 plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all must be \\\u003C 50 copies\u002FmL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies\u002FmL).\n* On a stable oral ARV therapy (ART) for ≥ 6 months prior to screening.\n\n  1. A change in ART regimen ≥ 3 months prior to the screening visit for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed; individuals with a change in ART regimen ≥ 3 months prior to screening must have been on the regimen for ≥ 3 months prior to screening, and all HIV-1 RNA measurements in that period must be \\\u003C 50 copies\u002FmL. There are no permitted changes to ART regimens between screening and Day 1.\n\nKey Exclusion Criteria:\n\n* History of an opportunistic infection or illness indicative of Stage 3 HIV disease.\n* History of treatment failure.\n* Known or suspected resistance to either CAB or RPV.\n\n  1. Resistance to CAB defined as the following mutations: G118R, Q148K, Q148R, T66K+L74M, E92Q+N155H, E138A+Q148R, E138K+Q148K\u002FR, G140C+Q148R, G140S+Q148H\u002FK\u002FR, Y143H+N155H, and Q148R+N155H.\n  2. Resistance to RPV defined as the following mutations: K101E and P; E138A, G, K, R, and Q; V179L; Y181C, I, and V; Y188L; H221Y; F227C; M230I and L, and the combination of L100I\u002FK103N.\n* Individuals with a dermatologic condition or implanted prothesis overlying the gluteal injection site for CAB + RPV.\n* Known hypersensitivity to the study intervention, its metabolites, or formulation excipients.\n* Active, serious infections (other than HIV-1) requiring therapy \\\u003C 30 days prior to randomization.\n* Active tuberculosis infection.\n* Acute hepatitis of any cause \\\u003C 30 days before randomization.\n* History of, or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or severe hepatic impairment (Child-Pugh Class C).\n* Active malignancy requiring acute systemic therapy.\n* Have poor venous access that would limit phlebotomy or intravenous (IV) infusion of study drugs.\n* Prior use of, or exposure to, LEN or a broadly neutralizing antibody (bNAb) for HIV-1.\n* Prior use of, or exposure to, long-acting (LA) injectable CAB or LA injectable RPV.\n* Prior use of, or exposure to, ibalizumab, fostemsavir, or maraviroc.\n* Baseline regimen consisting of monotherapy with any single antiretroviral (ARV).\n* Treatment with immunosuppressant therapies (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) within 4 weeks of screening (with the exception of a single short course of corticosteroids lasting ≤ 7 days) or have a comorbid condition with an anticipated need ongoing immunosuppressive treatment during the study.\n* Hepatitis C virus (HCV) antibody positive and HCV RNA detectable.\n* Chronic hepatitis B virus (HBV) infection, as determined by either:\n\n  1. Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.\n  2. Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.\n* Severe renal impairment-estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin according to the Cockcroft-Gault formula.\n* Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant, as determined by the investigator.\n* Any of the following laboratory values at screening:\n\n  1. Alanine aminotransferase \\> 5 x upper limit of normal (ULN).\n  2. Direct bilirubin \\> 1.5 x ULN.\n  3. Platelets \\\u003C 50,000\u002Fmm\\^3.\n  4. Hemoglobin \\\u003C 8.0 g\u002FdL.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",[138,139],"ADULT","OLDER_ADULT",[141,150,157],{"facility":142,"status":8,"city":143,"state":144,"zip":145,"country":146,"geoPoint":147},"CAN Community Health Fort Lauderdale","Fort Lauderdale","Florida","33316","United States",{"lat":148,"lon":149},26.12231,-80.14338,{"facility":151,"status":8,"city":152,"state":144,"zip":153,"country":146,"geoPoint":154},"Midway Immunology and Research Center","Ft. Pierce","34982",{"lat":155,"lon":156},27.44671,-80.32561,{"facility":158,"status":8,"city":159,"state":160,"zip":161,"country":146,"geoPoint":162},"Be Well Medical Center","Berkley","Michigan","48072",{"lat":163,"lon":164},42.50309,-83.18354,[166],{"name":167,"role":168,"phone":169,"email":170},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",[172],{"name":173,"affiliation":13,"role":174},"Gilead Study Director","STUDY_DIRECTOR",[],[177],{"label":178,"url":179},"Gilead Clinical Trials Website","https:\u002F\u002Fwww.gileadclinicaltrials.com\u002Fstudy?nctid=NCT07682961",{"nct_id":4,"conditions":181,"biomarkers":183},[182],"HIV Infection",[],{"nct_id":4,"found":15,"summary":185,"prompt_version":195},{"design":186,"status":187,"heading":188,"summary":189,"follow_up":190,"word_count":191,"commitments":192,"compensation":193,"drugs_mentioned":194},"This is an interventional study planning to enroll 590 participants. It compares two different injectable HIV-1 treatments.","completed","Study of Lenacapavir, Teropavimab, and Zinlirvimab for HIV-1","This study is for adults with HIV-1 whose virus is well controlled on their current daily oral medication. It aims to see how effective a new long-acting injectable treatment, made up of lenacapavir, teropavimab, and zinlirvimab, is compared to another injectable treatment, cabotegravir and rilpivirine. Both treatments are given every 8 weeks. The main goal is to see if your HIV-1 virus remains suppressed (meaning the amount of virus in your blood, called HIV-1 RNA, stays below 50 copies\u002FmL) after 52 weeks (1 year) of treatment. To join, you must be at least 18 years old and have specific HIV-1 test results showing your virus is susceptible to certain study medications.","The primary outcome is measured at Week 52, indicating participants will be followed for at least one year.",111,"Not specified in the trial record.","Not stated in the trial record.",[31,43,50,57],"v2"]