Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
Completed · Phase 2/Phase 3
Conditions studied: Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
In brief
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/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in human immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive adolescents. The 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/C/F/TAF through Week 24 (Part B) in virologically suppressed HIV-1 infection children 6 to \< 12 years weighing \>= 25 kg. The 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/C/F/TAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to \< 25 kg.
Key facts
- Study ID
- NCT01854775
- Run by
- Gilead Sciences
- People needed
- 129
- Starts
- 2013-05-06
- Expected to finish
- 2025-06-18
- Last updated by the study team
- 2026-01-09
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Miller's Children Hospital — Long Beach, California, United States
- Children's Research Institute — Washington D.C., District of Columbia, United States
- Emory University School of Medicine — Atlanta, Georgia, United States
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
- Seattle Children's Hospital — Seattle, Washington, United States
- KIDCRU Ward J8 — Cape Town, South Africa
- Be Part Yoluntu Centre — Cape Town, South Africa
- Desmond Tutu HIV Foundation — Cape Town, South Africa
- Perinatal HIV Research Unit Baragwanath Hospital — Johannesburg, South Africa
- Clinical HIV Research Unit — Johannesburg, South Africa
- Empilweni Services and Research Unit (ESRU) — Johannesburg, South Africa
- The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT) — Bangkok, Thailand
- Queen Savang Vadhana Memorial Hospital — Chon Buri, Thailand
- Department of Pediatrics, Faculty of Medicine, Khon Kaen University — Khon Kaen, Thailand
- Joint Clinical Research Centre — Kampala, Uganda
- University of Zimbabwe - Clinical Research Centre — Belgravia, Zimbabwe
Full record on ClinicalTrials.gov
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