[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641883":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":41,"locations":28,"responsibleParty":50,"collaborators":28,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":28,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":28,"enrollmentInfo":61,"targetDuration":28,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":78,"whyStopped":28,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":28},{"fullName":5,"class":6},"ViiV Healthcare","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"CAB ULA+ RPV ULA","EXPERIMENTAL","Participants will receive CAB ULA+RPV ULA.",[13,14],"Drug: CAB ULA","Drug: RPV ULA",{"label":16,"type":17,"description":18,"interventionNames":19},"CAB LA+ RPV LA","ACTIVE_COMPARATOR","Participants will receive CAB LA+RPV LA.",[20,21],"Drug: CAB LA","Drug: RPV LA",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","CAB ULA","CAB ULA will be administered.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"RPV ULA","RPV ULA will be administered.",[9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"CAB LA","CAB LA will be administered.",[16],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"RPV LA","RPV LA will be administered.",[16],[42,47],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":48,"role":44,"phone":49,"phoneExt":28,"email":46},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",{"type":51,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100641883","phase-3-a-study-to-investigate-cabotegravir-ultra-long-acting-cab-ula-plus-rilpivirine-ultra-long-acting-rpv-ula-in-adults-and-adolescents-with-hiv-who-are-virologically-suppressed-100641883",false,"NCT07650916","A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed","A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents With HIV Who Are Virologically Suppressed on ART","Inclusion criteria:\n\nPatient Study Participant (PSP) Inclusion criteria:\n\n* Adults and adolescents with HIV-1 infection aged 12 years or older with a weight \\>35 kg.\n* Documented HIV-1 RNA measurements \\\u003C50 copies\u002FmL in the 12 months prior to Screening.\n* HIV-1 RNA \\\u003C50 copies\u002FmL at screening assessment.\n* Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening.\n* Any prior switch in therapy must have occurred due to tolerability\u002Fsafety, access to medications, or convenience\u002Fsimplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies\u002FmL).\n\nExclusion criteria:\n\nPatient Study Participant (PSP) Exclusion criteria:\n\n* Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation.\n* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.\n* Any history of receiving long-acting therapy for HIV.\n* Previous exposure to CAB and\u002For RPV for treatment or prevention of HIV-1 infection.\n* Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","12 Years",{"count":62,"type":63},564,"ESTIMATED","INTERVENTIONAL",[66],"PHASE3","This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).",[69],"HIV Infections",[71,72,73,74,75,76,77],"Cabotegravir","Rilpivirine","HIV","Non-inferiority","Efficacy","Safety","Tolerability","NOT_YET_RECRUITING","2026-06-19",{"date":81,"type":82},"2026-06-23","ACTUAL",{"date":84,"type":63},"2026-06-29",{"date":86,"type":63},"2029-09-04",{"name":5,"class":6}]