[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541989":3},{"organization":4,"armGroups":7,"interventions":46,"overallOfficials":147,"centralContacts":151,"locations":157,"responsibleParty":297,"collaborators":58,"id":299,"slug":300,"hasResults":301,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":58,"eligibilityCriteria":305,"healthyVolunteers":301,"sex":306,"minAge":307,"maxAge":58,"enrollmentInfo":308,"targetDuration":58,"studyType":311,"phases":312,"briefSummary":314,"conditions":315,"keywords":58,"overallStatus":184,"whyStopped":58,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,20,26,42],{"label":9,"type":10,"description":11,"interventionNames":12},"Rollover from Parent Study: GS-US-311-1269: Parent Study Drug (F\u002FTAF) or B\u002FF\u002FTAF","EXPERIMENTAL","Participants will continue to take the study drug they were taking in the parent study, emtricitabine\u002Ftenofovir alafenamide (F\u002FTAF) along with a 3rd antiretroviral (ARV) agent. The dose of F\u002FTAF will be based on the weight of the participant, ranging between 120\u002F15 mg to 200\u002F25 mg. The dose of F\u002FTAF will be different when given with the boosted and the unboosted 3rd ARV agent: F\u002FTAF (High Dose Tablet) for unboosted 3rd ARV agent; F\u002FTAF (Low Dose Tablet) for the boosted 3rd ARV agent.\n\nParticipants may switch to B\u002FF\u002FTAF, at a dose based on participant's weight.",[13,14,15,16,17,18,19],"Drug: F\u002FTAF (High Dose Tablet)","Drug: F\u002FTAF (Low Dose Tablet)","Drug: F\u002FTAF (Lowest Dose Tablet)","Drug: B\u002FF\u002FTAF (High Dose)","Drug: B\u002FF\u002FTAF (Low Dose)","Drug: B\u002FF\u002FTAF (High Dose TOS)","Drug: 3rd ARV Agent",{"label":21,"type":10,"description":22,"interventionNames":23},"Rollover from Parent Study: GS-US-292-0106: Parent Study Drug (E\u002FC\u002FF\u002FTAF) or B\u002FF\u002FTAF","Participants will continue to take the study drug they were taking in the parent study, elvitegravir\u002Fcobicistat\u002Femtricitabine\u002Ftenofovir alafenamide (E\u002FC\u002FF\u002FTAF). The dose of E\u002FC\u002FF\u002FTAF will be based on the weight of the participant, ranging between 90\u002F90\u002F120\u002F6 mg to 150\u002F150\u002F200\u002F10 mg.\n\nParticipants may switch to B\u002FF\u002FTAF at a dose based on participant's weight.",[24,25,16,17],"Drug: E\u002FC\u002FF\u002FTAF","Drug: E\u002FC\u002FF\u002FTAF (Low Dose)",{"label":27,"type":10,"description":28,"interventionNames":29},"Rollover Parent Study GS-US-216-0128: Parent Study Drug (Combination Drugs) or B\u002FF\u002FTAF","Participants will continue to take the following study drugs they were taking in the parent study:\n\n* Cobicistat (COBI) + DRV + NRTI backbone\n* COBI + ATV + NRTI backbone\n* F\u002FTAF + DRV+ COBI\n* F\u002FTAF + ATV+ COBI\n* F\u002FTAF + LPV\u002Fr\n* F\u002FTAF + 3rd unboosted agent\n\nThe dose of F\u002FTAF will be based on the weight of the participant, ranging between 15\u002F1.88 mg and 200\u002F25 mg, once daily. Additionally, the dose of COBI will be based on the weight of the participant, ranging between 30 mg and 150 mg, once or twice daily.\n\nParticipants may switch to B\u002FF\u002FTAF at a dose based on participant's weight.",[13,15,30,31,32,33,34,35,16,17,18,36,37,19,38,39,40,41],"Drug: F\u002FTAF (High Dose TOS)","Drug: F\u002FTAF (Low Dose TOS)","Drug: F\u002FTAF (Lowest Dose TOS)","Drug: Cobicistat (High Dose)","Drug: Cobicistat (Low Dose)","Drug: Cobicistat (TOS)","Drug: B\u002FF\u002FTAF (Low Dose TOS)","Drug: B\u002FF\u002FTAF (Lowest Dose TOS)","Drug: Nucleos(t)ide reverse transcriptase inhibitors (NRTI)","Drug: ATV","Drug: DRV","Drug: Lopinavir Boosted with ritonavir (LPV\u002Fr)",{"label":43,"type":10,"description":44,"interventionNames":45},"Rollover from Parent Studies: GS-US-380-1474 and CO-US-380-5578: Parent Study Drug (B\u002FF\u002FTAF)","Participants will continue to take the study drug they were taking in the parent study, B\u002FF\u002FTAF. Participants who are diagnosed with HIV-1 infection in parent study CO-US-380-5578 and complete the study drug will continue to take the study drug they were taking in the parent study, B\u002FF\u002FTAF. The dose of B\u002FF\u002FTAF will be based on the weight of the participant.",[16,17,18,36,37],[47,54,59,63,67,71,75,81,85,92,97,102,109,114,119,124,129,133,137,141,144],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"DRUG","F\u002FTAF (High Dose Tablet)","200\u002F25 mg fixed-dose combination (FDC) tablet administered orally",[27,9],[53],"Descovy®",{"type":48,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"F\u002FTAF (Low Dose Tablet)","200\u002F10 mg FDC tablet administered orally",[9],null,{"type":48,"name":60,"description":61,"armGroupLabels":62,"otherNames":58},"F\u002FTAF (Lowest Dose Tablet)","120\u002F15 mg FDC tablet administered orally",[27,9],{"type":48,"name":64,"description":65,"armGroupLabels":66,"otherNames":58},"F\u002FTAF (High Dose TOS)","60\u002F7.5 mg tablet for oral suspension (TOS) administered orally",[27],{"type":48,"name":68,"description":69,"armGroupLabels":70,"otherNames":58},"F\u002FTAF (Low Dose TOS)","30\u002F3.75 mg TOS administered orally",[27],{"type":48,"name":72,"description":73,"armGroupLabels":74,"otherNames":58},"F\u002FTAF (Lowest Dose TOS)","15\u002F1.88 mg TOS administered orally",[27],{"type":48,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"E\u002FC\u002FF\u002FTAF","150\u002F150\u002F200\u002F10 mg tablet administered orally",[21],[80],"Genvoya®",{"type":48,"name":82,"description":83,"armGroupLabels":84,"otherNames":58},"E\u002FC\u002FF\u002FTAF (Low Dose)","90\u002F90\u002F120\u002F6 mg tablet administered orally",[21],{"type":48,"name":86,"description":87,"armGroupLabels":88,"otherNames":89},"Cobicistat (High Dose)","150 mg tablet administered orally",[27],[90,91],"GS-9350","Tybost®",{"type":48,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"Cobicistat (Low Dose)","90 mg tablet administered orally",[27],[90],{"type":48,"name":98,"description":99,"armGroupLabels":100,"otherNames":101},"Cobicistat (TOS)","30 mg TOS administered orally",[27],[90],{"type":48,"name":103,"description":104,"armGroupLabels":105,"otherNames":106},"B\u002FF\u002FTAF (High Dose)","50\u002F200\u002F25 mg FDC tablet administered orally",[27,43,21,9],[107,108],"Biktarvy®","GS-9883\u002FF\u002FTAF",{"type":48,"name":110,"description":111,"armGroupLabels":112,"otherNames":113},"B\u002FF\u002FTAF (Low Dose)","30\u002F120\u002F15 mg FDC tablet administered orally",[27,43,21,9],[108],{"type":48,"name":115,"description":116,"armGroupLabels":117,"otherNames":118},"B\u002FF\u002FTAF (High Dose TOS)","15\u002F60\u002F7.52 mg TOS administered orally",[27,43,9],[108],{"type":48,"name":120,"description":121,"armGroupLabels":122,"otherNames":123},"B\u002FF\u002FTAF (Low Dose TOS)","7.5\u002F30\u002F3.76 mg TOS administered orally",[27,43],[108],{"type":48,"name":125,"description":126,"armGroupLabels":127,"otherNames":128},"B\u002FF\u002FTAF (Lowest Dose TOS)","3.76\u002F15\u002F1.88 mg TOS administered orally",[27,43],[108],{"type":48,"name":130,"description":131,"armGroupLabels":132,"otherNames":58},"3rd ARV Agent","A 3rd antiretroviral (ARV) agent administered as defined by the investigator, according to the prescribing information. A 3rd ARV agent may include: boosted atazanavir (ATV), boosted lopinavir (LPV\u002Fr), boosted darunavir (DRV), unboosted efavirenz (EFV), unboosted nevirapine (NVP), unboosted raltegravir (RAL), or unboosted dolutegravir (DTG), or any other unspecified agent that is available in a participant's country",[27,9],{"type":48,"name":134,"description":135,"armGroupLabels":136,"otherNames":58},"Nucleos(t)ide reverse transcriptase inhibitors (NRTI)","NRTIs administered as defined by the investigator, according to the prescribing information. NRTIs may include zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), or emtricitabine (FTC)",[27],{"type":48,"name":138,"description":139,"armGroupLabels":140,"otherNames":58},"ATV","Administered according to the prescribing information",[27],{"type":48,"name":142,"description":139,"armGroupLabels":143,"otherNames":58},"DRV",[27],{"type":48,"name":145,"description":139,"armGroupLabels":146,"otherNames":58},"Lopinavir Boosted with ritonavir (LPV\u002Fr)",[27],[148],{"name":149,"affiliation":5,"role":150},"Gilead Study Director","STUDY_DIRECTOR",[152],{"name":153,"role":154,"phone":155,"phoneExt":58,"email":156},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",[158,171,182,194,203,212,218,227,236,245,256,265,276,282,287],{"facility":159,"status":160,"city":161,"state":58,"zip":162,"country":163,"countryCode":164,"cosmosGeoPoint":165,"geoPoint":170,"contacts":58},"Helios Salud","ACTIVE_NOT_RECRUITING","Buenos Aires","C1141 ACG","Argentina","AR",{"type":166,"coordinates":167},"Point",[168,169],-58.37723,-34.61315,{"lat":169,"lon":168},{"facility":172,"status":160,"city":173,"state":58,"zip":174,"country":175,"countryCode":176,"cosmosGeoPoint":177,"geoPoint":181,"contacts":58},"Hospital del Niño","Panama City","0816-00383","Panama","PA",{"type":166,"coordinates":178},[179,180],-79.51973,8.9936,{"lat":180,"lon":179},{"facility":183,"status":184,"city":185,"state":58,"zip":186,"country":187,"countryCode":188,"cosmosGeoPoint":189,"geoPoint":193,"contacts":58},"University of Stellenbosch","RECRUITING","Cape Town","7505","South Africa","ZA",{"type":166,"coordinates":190},[191,192],18.42322,-33.92584,{"lat":192,"lon":191},{"facility":195,"status":184,"city":196,"state":58,"zip":197,"country":187,"countryCode":188,"cosmosGeoPoint":198,"geoPoint":202,"contacts":58},"Enhancing Care Foundation","Durban","3629",{"type":166,"coordinates":199},[200,201],31.0292,-29.8579,{"lat":201,"lon":200},{"facility":204,"status":184,"city":205,"state":58,"zip":206,"country":187,"countryCode":188,"cosmosGeoPoint":207,"geoPoint":211,"contacts":58},"WITS RHI Research Centre","Johannesburg","2038",{"type":166,"coordinates":208},[209,210],28.04363,-26.20227,{"lat":210,"lon":209},{"facility":213,"status":184,"city":205,"state":58,"zip":214,"country":187,"countryCode":188,"cosmosGeoPoint":215,"geoPoint":217,"contacts":58},"Rahima Moosa Mother and Child Hospital","2112",{"type":166,"coordinates":216},[209,210],{"lat":210,"lon":209},{"facility":219,"status":184,"city":220,"state":58,"zip":221,"country":187,"countryCode":188,"cosmosGeoPoint":222,"geoPoint":226,"contacts":58},"Be Part Yoluntu Centre","Paarl","7626",{"type":166,"coordinates":223},[224,225],18.97523,-33.73378,{"lat":225,"lon":224},{"facility":228,"status":184,"city":229,"state":58,"zip":230,"country":187,"countryCode":188,"cosmosGeoPoint":231,"geoPoint":235,"contacts":58},"The Aurun Institute","Pretoria","0087",{"type":166,"coordinates":232},[233,234],28.18783,-25.74486,{"lat":234,"lon":233},{"facility":237,"status":184,"city":238,"state":58,"zip":239,"country":187,"countryCode":188,"cosmosGeoPoint":240,"geoPoint":244,"contacts":58},"Perinatal HIV Research Unit","Soweto","2013",{"type":166,"coordinates":241},[242,243],27.85849,-26.26781,{"lat":243,"lon":242},{"facility":246,"status":160,"city":247,"state":58,"zip":248,"country":249,"countryCode":250,"cosmosGeoPoint":251,"geoPoint":255,"contacts":58},"Faculty of Medicine - Mahidol University","Bangkok Noi","10700","Thailand","TH",{"type":166,"coordinates":252},[253,254],100.47798,13.76266,{"lat":254,"lon":253},{"facility":257,"status":160,"city":258,"state":58,"zip":259,"country":249,"countryCode":250,"cosmosGeoPoint":260,"geoPoint":264,"contacts":58},"Khon Kaen University","Khon Kaen","40002",{"type":166,"coordinates":261},[262,263],102.833,16.44671,{"lat":263,"lon":262},{"facility":266,"status":184,"city":267,"state":58,"zip":268,"country":269,"countryCode":270,"cosmosGeoPoint":271,"geoPoint":275,"contacts":58},"Joint Clinical Research Centre","Kampala","10005","Uganda","UG",{"type":166,"coordinates":272},[273,274],32.58219,0.31628,{"lat":274,"lon":273},{"facility":277,"status":184,"city":267,"state":58,"zip":278,"country":269,"countryCode":270,"cosmosGeoPoint":279,"geoPoint":281,"contacts":58},"MU-JHU Research Collaboration\u002FMU-JHU Care Ltd","256",{"type":166,"coordinates":280},[273,274],{"lat":274,"lon":273},{"facility":283,"status":184,"city":267,"state":58,"zip":58,"country":269,"countryCode":270,"cosmosGeoPoint":284,"geoPoint":286,"contacts":58},"Baylor College of Medicine",{"type":166,"coordinates":285},[273,274],{"lat":274,"lon":273},{"facility":288,"status":184,"city":289,"state":58,"zip":58,"country":290,"countryCode":291,"cosmosGeoPoint":292,"geoPoint":296,"contacts":58},"University of Zimbabwe Clinical Research Centre","Harare","Zimbabwe","ZW",{"type":166,"coordinates":293},[294,295],31.05337,-17.82772,{"lat":295,"lon":294},{"type":298,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR","100541989","phase-4-a-study-to-provide-continued-access-to-study-drug-to-children-and-adolescents-who-have-completed-clinical-studies-involving-gilead-hiv-treatments-100541989",false,"NCT06337032","A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments","An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments","Key Inclusion Criteria:\n\n* Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation.\n\nKey Exclusion Criteria:\n\n* Individuals planning to switch to B\u002FF\u002FTAF on Day 1 with plasma HIV RNA ≥ 50 copies\u002FmL during the last parent study visit prior to screening\u002FDay 1 visit.\n\n  * Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies\u002FmL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies\u002FmL).\n* Individuals planning to switch to B\u002FF\u002FTAF with any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B\u002FF\u002FTAF prior to treatment switch.\n* For those on B\u002FF\u002FTAF or planning to switch to B\u002FF\u002FTAF: previous treatment discontinuation of any component of B\u002FF\u002FTAF due to toxicity or intolerance.\n* For those planning to switch to B\u002FF\u002FTAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.\n* Ongoing treatment with or prior use of any prohibited medications.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","1 Month",{"count":309,"type":310},350,"ESTIMATED","INTERVENTIONAL",[313],"PHASE4","The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.\n\nThe primary objectives of this study are as follows:\n\n* To provide continued access to the study drug received in the parent protocol or switch to bictegravir\u002Femtricitabine\u002Ftenofovir (B\u002FF\u002FTAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.\n* To evaluate the safety of the study drug(s) in participants with HIV-1.",[316],"HIV-1-infection","2026-06-09",{"date":319,"type":320},"2026-06-10","ACTUAL",{"date":322,"type":320},"2024-08-27",{"date":324,"type":310},"2034-03",{"name":5,"class":6},15]