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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed

Trial Profile

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Mar 2021

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At a glance

  • Drugs Bictegravir/emtricitabine/tenofovir alafenamide (Primary) ; Dolutegravir; Emtricitabine/tenofovir alafenamide; Emtricitabine/tenofovir disoproxil fumarate
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 19 Mar 2021 Status changed from active, no longer recruiting to completed.
    • 10 Mar 2021 Results assessing variability of DNA genotyping by quantifying the reproducibility of mutation reporting from multiple assays from a single blood draw from 3 studies (NCT03631732; NCT03110380; NCT03405935), presented at the 28th Conference on Retroviruses and Opportunistic Infections.
    • 08 Oct 2020 Results of pooled analysis from following clinical studies: GS-US380-1844, GS-US380-1878, GS-US380-4030, GS-US380-4580, GS-US380-1474 and GS-US380-4449 presented at the 15th International Congress on Drug Therapy and HIV Infection
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