[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655605":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":11,"studyPopulation":11,"armGroups":44,"interventions":70,"overallOfficials":11,"centralContacts":83,"locations":11,"responsibleParty":92,"collaborators":11,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":11,"enrollmentInfo":104,"targetDuration":11,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":118,"whyStopped":11,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":11},{"fullName":5,"class":6},"ViiV Healthcare","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Number of participants with plasma HIV-1 RNA \u003C50 copies\u002FmL as per FDA snapshot algorithm",null,"At Month 7",[14,16,19,21,25,28,31,34],{"measure":10,"description":11,"timeFrame":15},"At Month 13 and Month 25",{"measure":17,"description":11,"timeFrame":18},"Number of participants with plasma HIV-1 RNA \u003C50 copies\u002FmL as per observed data","At Month 7, Month 13 and Month 25",{"measure":20,"description":11,"timeFrame":18},"Change from baseline (Day 1) in cluster of differentiation (CD) 4+ T-cell count",{"measure":22,"description":23,"timeFrame":24},"Number of participants with injection site reaction adverse events of special interest (ISR AESIs) by grade","The ISR AESIs will be graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.","Through Month 7, Month 13 and Month 25",{"measure":26,"description":27,"timeFrame":24},"Duration of ISR AESIs by grade","The ISR AESIs will be graded using the DAIDS grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.",{"measure":29,"description":30,"timeFrame":24},"Number of participants with serious adverse events (SAEs) by grade","An SAE is defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability\u002Fincapacity, caused a congenital anomaly\u002Fbirth defect, or was any other situation identified according to medical or scientific judgment. The SAEs will be graded using the DAIDS grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.",{"measure":32,"description":33,"timeFrame":24},"Number of participants with adverse events (AEs) leading to study treatment discontinuation, by grade","The AEs leading to treatment discontinuation will be graded using the DAIDS grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.",{"measure":35,"description":11,"timeFrame":36},"Plasma concentrations of VH4011499","Through Months 7, 13 and 25",{"allocation":38,"interventionModel":39,"interventionModelDescription":11,"primaryPurpose":40,"observationalModel":11,"timePerspective":11,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":43,"whoMasked":11},"NONE","This is an open-label study.",[45,52,56,60,64],{"label":46,"type":47,"description":48,"interventionNames":49},"VH4011499 dose Group 1 + CAB","EXPERIMENTAL","Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 1, which differs from all other arms) and cabotegravir (CAB).",[50,51],"Drug: VH4011499","Drug: CAB",{"label":53,"type":47,"description":54,"interventionNames":55},"VH4011499 dose Group 2 + CAB","Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 2, which differs from all other arms) and CAB.",[50,51],{"label":57,"type":47,"description":58,"interventionNames":59},"VH4011499 dose Group 3 + CAB","Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 3, which differs from all other arms) and CAB.",[50,51],{"label":61,"type":47,"description":62,"interventionNames":63},"VH4011499 dose Group 4 + CAB","Investigational long-acting injectable regimen consisting of VH4011499 (dose Group 4, which differs from all other arms) and CAB.",[50,51],{"label":65,"type":66,"description":67,"interventionNames":68},"DTG\u002F3TC","ACTIVE_COMPARATOR","Active control arm receiving daily oral standard of care antiretroviral therapy (dolutegravir 50 mg \u002F lamivudine 300 mg single-tablet regimen).",[69],"Drug: DTG\u002F3TC",[71,76,80],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":11},"DRUG","VH4011499","Participants receive injectable VH4011499 at different dose groups.",[46,53,57,61],{"type":72,"name":77,"description":78,"armGroupLabels":79,"otherNames":11},"CAB","Participants receive injectable CAB.",[46,53,57,61],{"type":72,"name":65,"description":81,"armGroupLabels":82,"otherNames":11},"Participants receive DTG\u002F3TC orally once daily.",[65],[84,89],{"name":85,"role":86,"phone":87,"phoneExt":11,"email":88},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":90,"role":86,"phone":91,"phoneExt":11,"email":88},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",{"type":93,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100655605","phase-2-a-phase-2b-study-evaluating-vh4011499-capsid-inhibitor-long-acting-injectable-plus-cabotegravir-in-treatment-nave-adults-cinergy-100655605",false,"NCT07816250","A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY)","A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of 2-drug Injectable Regimens of VH4011499 Plus Cabotegravir in Treatment Naïve Viremic Adult Participants With HIV-1 (CINERGY)","CINERGY","Inclusion Criteria:\n\n* Participant must be at least 18 years of age (or older, if required for adults by local regulations).\n* Screening CD4+ T-cell count ≥ 200 cells\u002FµL.\n* Documented HIV-1 infection and screening plasma HIV-1 RNA ≥\n\n  1 000 and ≤ 100 000 copies\u002FmL.\n* Treatment-naïve. Prior use of oral pre-exposure prophylaxis (PrEP) or oral post-exposure prophylaxis (PEP) that is not INSTI or CAI based is permitted.\n* Body weight ≥ 50.0 kg (110 lbs) for participants assigned male at birth and ≥ 45.0 kg (99 lbs) for participants assigned female at birth.\n* Agrees to adequate birth control if a participant of childbearing potential\n\nExclusion Criteria:\n\n* Participants with acute HIV-1 infection\n* Prior exposure to any HIV-1 capsid inhibitor or any HIV-1 INSTI for any reason is prohibited.\n* Participants with known or suspected presence of major virologic resistance mutations to study drugs\n* Unstable liver disease\n* Participants with HCV co-infection\n* Participant has evidence of chronic active HBV infection\n* Clinically significant cardiovascular disease","ALL","18 Years",{"count":105,"type":106},200,"ESTIMATED","INTERVENTIONAL",[109],"PHASE2","The purpose of this Phase 2b study is to evaluate the efficacy and therapeutic window of chronically dosed VH4011499 paired with an integrase strand transfer inhibitor (INSTI). This study will explore 4 different regimens of VH4011499 when paired with cabotegravir (CAB) as an initial two-drug regimen.",[112],"HIV Infections",[73,114,115,116,117],"Cabotegravir (CAB)","Dolutegravir\u002FLamivudine (DTG\u002F3TC)","Efficacy","People with HIV (PWH)","NOT_YET_RECRUITING","2026-09-06",{"date":121,"type":122},"2026-09-11","ACTUAL",{"date":124,"type":106},"2026-10-19",{"date":126,"type":106},"2032-06-11",{"name":5,"class":6}]