[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100198088":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":36,"centralContacts":35,"locations":40,"responsibleParty":189,"collaborators":35,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":35,"eligibilityCriteria":197,"healthyVolunteers":198,"sex":199,"minAge":200,"maxAge":201,"enrollmentInfo":202,"targetDuration":35,"studyType":205,"phases":206,"briefSummary":209,"conditions":210,"keywords":213,"overallStatus":220,"whyStopped":35,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Age 12 to \u003C 18 Years and Weight ≥ 35 kg","EXPERIMENTAL","Treatment naive adolescents (12 to \\\u003C 18 years of age) living with human immunodeficiency virus (HIV) will receive E\u002FC\u002FF\u002FTAF (150\u002F150\u002F200\u002F10 mg) fixed-dose combination (FDC) once daily for 48 weeks. Participants who complete 48 weeks of study treatment will have the option to receive E\u002FC\u002FF\u002FTAF in an extension phase of the study until: a) the participant turns 18 years old and E\u002FC\u002FF\u002FTAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E\u002FC\u002FF\u002FTAF become commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E\u002FC\u002FF\u002FTAF in that country.",[13],"Drug: E\u002FC\u002FF\u002FTAF",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: Age 6 to \u003C 12 Years and Weight ≥ 25 kg","Children (6 to \\\u003C 12 years of age weighing ≥ 25 kg) with HIV who were virologically suppressed will receive E\u002FC\u002FF\u002FTAF (150\u002F150\u002F200\u002F10 mg) FDC once daily for 48 weeks. Participants who complete 48 weeks of study treatment will have the option to receive E\u002FC\u002FF\u002FTAF in an extension phase of the study until: a) the participant turns 18 years old and E\u002FC\u002FF\u002FTAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E\u002FC\u002FF\u002FTAF become commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E\u002FC\u002FF\u002FTAF in that country.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3: Age ≥2 Years and Weight ≥ 14 to \u003C25 kg","Children (≥ 2 years of age weighing ≥ 14 to \\\u003C 25 kg) with HIV who were virologically suppressed will receive E\u002FC\u002FF\u002FTAF (90\u002F90\u002F120\u002F6 mg) FDC once daily for 48 weeks. Participants who attain a weight of ≥ 25 kg during the course of the study will switch to adult E\u002FC\u002FF\u002FTAF (150\u002F150\u002F200\u002F10 mg) tablets administered orally, once daily with food. Participants who complete 48 weeks of study treatment will have the option to receive E\u002FC\u002FF\u002FTAF in an extension phase of the study until: a) the participant turns 18 years old and E\u002FC\u002FF\u002FTAF is commercially available for adults in the country in which the participant is enrolled; b) age-appropriate E\u002FC\u002FF\u002FTAF became commercially available in the country in which the participant is enrolled; or c) Gilead elects to terminate development of E\u002FC\u002FF\u002FTAF in that country.",[13,22],"Drug: E\u002FC\u002FF\u002FTAF (Low Dose)",[24,31],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","E\u002FC\u002FF\u002FTAF","Tablets administered orally with food.",[9,15,19],[30],"Genvoya®",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"E\u002FC\u002FF\u002FTAF (Low Dose)","90\u002F90\u002F120\u002F6 mg STR administered once daily orally with food.",[19],null,[37],{"name":38,"affiliation":5,"role":39},"Gilead Study Director","STUDY_DIRECTOR",[41,54,64,74,84,94,105,111,117,126,132,138,149,158,167,178],{"facility":42,"status":35,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":35},"Miller's Children Hospital","Long Beach","California","90806","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-118.18923,33.76696,{"lat":52,"lon":51},{"facility":55,"status":35,"city":56,"state":57,"zip":58,"country":46,"countryCode":47,"cosmosGeoPoint":59,"geoPoint":63,"contacts":35},"Children's Research Institute","Washington D.C.","District of Columbia","20010",{"type":49,"coordinates":60},[61,62],-77.03637,38.89511,{"lat":62,"lon":61},{"facility":65,"status":35,"city":66,"state":67,"zip":68,"country":46,"countryCode":47,"cosmosGeoPoint":69,"geoPoint":73,"contacts":35},"Emory University School of Medicine","Atlanta","Georgia","30322",{"type":49,"coordinates":70},[71,72],-84.38798,33.749,{"lat":72,"lon":71},{"facility":75,"status":35,"city":76,"state":77,"zip":78,"country":46,"countryCode":47,"cosmosGeoPoint":79,"geoPoint":83,"contacts":35},"St. Jude Children's Research Hospital","Memphis","Tennessee","38105",{"type":49,"coordinates":80},[81,82],-90.04898,35.14953,{"lat":82,"lon":81},{"facility":85,"status":35,"city":86,"state":87,"zip":88,"country":46,"countryCode":47,"cosmosGeoPoint":89,"geoPoint":93,"contacts":35},"Seattle Children's Hospital","Seattle","Washington","98105-0371",{"type":49,"coordinates":90},[91,92],-122.33207,47.60621,{"lat":92,"lon":91},{"facility":95,"status":35,"city":96,"state":35,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":104,"contacts":35},"KIDCRU Ward J8","Cape Town","7505","South Africa","ZA",{"type":49,"coordinates":101},[102,103],18.42322,-33.92584,{"lat":103,"lon":102},{"facility":106,"status":35,"city":96,"state":35,"zip":107,"country":98,"countryCode":99,"cosmosGeoPoint":108,"geoPoint":110,"contacts":35},"Be Part Yoluntu Centre","7646",{"type":49,"coordinates":109},[102,103],{"lat":103,"lon":102},{"facility":112,"status":35,"city":96,"state":35,"zip":113,"country":98,"countryCode":99,"cosmosGeoPoint":114,"geoPoint":116,"contacts":35},"Desmond Tutu HIV Foundation","7705",{"type":49,"coordinates":115},[102,103],{"lat":103,"lon":102},{"facility":118,"status":35,"city":119,"state":35,"zip":120,"country":98,"countryCode":99,"cosmosGeoPoint":121,"geoPoint":125,"contacts":35},"Perinatal HIV Research Unit Baragwanath Hospital","Johannesburg","1862",{"type":49,"coordinates":122},[123,124],28.04363,-26.20227,{"lat":124,"lon":123},{"facility":127,"status":35,"city":119,"state":35,"zip":128,"country":98,"countryCode":99,"cosmosGeoPoint":129,"geoPoint":131,"contacts":35},"Clinical HIV Research Unit","2041",{"type":49,"coordinates":130},[123,124],{"lat":124,"lon":123},{"facility":133,"status":35,"city":119,"state":35,"zip":134,"country":98,"countryCode":99,"cosmosGeoPoint":135,"geoPoint":137,"contacts":35},"Empilweni Services and Research Unit (ESRU)","2092",{"type":49,"coordinates":136},[123,124],{"lat":124,"lon":123},{"facility":139,"status":35,"city":140,"state":35,"zip":141,"country":142,"countryCode":143,"cosmosGeoPoint":144,"geoPoint":148,"contacts":35},"The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)","Bangkok","10330","Thailand","TH",{"type":49,"coordinates":145},[146,147],100.50144,13.75398,{"lat":147,"lon":146},{"facility":150,"status":35,"city":151,"state":35,"zip":152,"country":142,"countryCode":143,"cosmosGeoPoint":153,"geoPoint":157,"contacts":35},"Queen Savang Vadhana Memorial Hospital","Chon Buri","20110",{"type":49,"coordinates":154},[155,156],100.98345,13.3622,{"lat":156,"lon":155},{"facility":159,"status":35,"city":160,"state":35,"zip":161,"country":142,"countryCode":143,"cosmosGeoPoint":162,"geoPoint":166,"contacts":35},"Department of Pediatrics, Faculty of Medicine, Khon Kaen University","Khon Kaen","40002",{"type":49,"coordinates":163},[164,165],102.833,16.44671,{"lat":165,"lon":164},{"facility":168,"status":35,"city":169,"state":35,"zip":170,"country":171,"countryCode":172,"cosmosGeoPoint":173,"geoPoint":177,"contacts":35},"Joint Clinical Research Centre","Kampala","PO Box 10005","Uganda","UG",{"type":49,"coordinates":174},[175,176],32.58219,0.31628,{"lat":176,"lon":175},{"facility":179,"status":35,"city":180,"state":35,"zip":181,"country":182,"countryCode":183,"cosmosGeoPoint":184,"geoPoint":188,"contacts":35},"University of Zimbabwe - Clinical Research Centre","Belgravia","263","Zimbabwe","ZW",{"type":49,"coordinates":185},[186,187],31.04972,-17.80306,{"lat":187,"lon":186},{"type":190,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100198088","phase-2-study-to-evaluate-the-pharmacokinetics-safety-and-antiviral-activity-of-the-elvitegravircobicistatemtricitabinetenofovir-alafenamide-ecftaf-single-tablet-regimen-str-in-hiv-1-infected-antiretroviral-treatment-naive-adolescents-and-virologically-suppressed-children-100198088",true,"NCT01854775","Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir\u002FCobicistat\u002FEmtricitabine\u002FTenofovir Alafenamide (E\u002FC\u002FF\u002FTAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children","A Phase 2\u002F3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir\u002FCobicistat\u002FEmtricitabine\u002FTenofovir Alafenamide (E\u002FC\u002FF\u002FTAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children","Key Inclusion Criteria:\n\n* Cohort 1\n\n  * Age at baseline: 12 years to \\\u003C 18 years old\n  * Weight at screening: ≥ 35 kg (77 lbs)\n  * Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies\u002FmL at screening (Roche COBAS TaqMan v2.0)\n  * Screening genotype report shows sensitivity to EVG, emtricitabine (FTC) and tenofovir (TFV)\n  * No prior use of any approved or experimental anti-HIV-1 drug for any length of time\n* Cohort 2\n\n  * Age at baseline: 6 years to \\\u003C 12 years old\n  * Weight at screening: ≥ 25 kg (55 lbs)\n  * Plasma HIV-1 RNA of \\\u003C 50 copies\u002FmL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \\> 50 copies\u002FmL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E\u002FC\u002FF\u002FTAF STR.\n* Cohort 3\n\n  * Age at baseline: ≥ 2 years old\n  * Weight at screening: ≥ 14 kg (31 lbs) to \\\u003C 25 kg (55 lbs)\n  * Plasma HIV-1 RNA: \\\u003C 50 copies\u002FmL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \\> 50 copies\u002FmL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E\u002FC\u002FF\u002FTAF STR\n\nKey Exclusion Criteria:\n\n* Hepatitis B or hepatitis C virus infection\n* Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit.\n* Individuals experiencing decompensated cirrhosis\n* Pregnant or lactating females\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",false,"ALL","2 Years","17 Years",{"count":203,"type":204},129,"ACTUAL","INTERVENTIONAL",[207,208],"PHASE2","PHASE3","The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir\u002Fcobicistat\u002Femtricitabine\u002Ftenofovir alafenamide (E\u002FC\u002FF\u002FTAF) STR (Part A) and to evaluate the safety and tolerability of E\u002FC\u002FF\u002FTAF STR through Week 24 (Part B) in human immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive adolescents.\n\nThe primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF (Part A), and to evaluate the safety and tolerability of E\u002FC\u002FF\u002FTAF through Week 24 (Part B) in virologically suppressed HIV-1 infection children 6 to \\\u003C 12 years weighing \\>= 25 kg.\n\nThe primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose of the STR, and to evaluate the safety and tolerability of E\u002FC\u002FF\u002FTAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to \\\u003C 25 kg.",[211,212],"Acquired Immune Deficiency Syndrome (AIDS)","HIV Infections",[214,215,216,217,218,219],"Adolescents","HIV-1","HIV","Treatment-naive","Virologically suppressed","Children","COMPLETED","2025-12-17",{"date":223,"type":204},"2026-01-09",{"date":225,"type":204},"2013-05-06",{"date":227,"type":204},"2025-06-18",{"name":5,"class":6},16]