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A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children

Trial Profile

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 21 Oct 2021

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At a glance

  • Drugs Bictegravir/emtricitabine/tenofovir alafenamide (Primary)
  • Indications HIV-1 infections
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 18 Oct 2021 According to a Gilead Sciences media release, based results from cohort 3 of this study, the U.S FDA has approved supplemental New Drug Application (sNDA) of low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.
    • 18 Oct 2021 Results presented in the Gilead Sciences Media Release.
    • 20 Aug 2021 Results characterizing the efficacy and safety of B/F/TAF in FWH, including young, elderly, and ART-naive participants, data from 5 clinical trials ((NCT02652624, NCT02607930, NCT02607956, NCT02881320, NCT03405935) were analyzed published in the JAIDS
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