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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

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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 Apr 2024

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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

    • 06 Mar 2024 Results assessing longitudinal analysis of preexisting Resistance-Associated mutations prior to bictegravir/emtricitabine/tenofovir alafenamide switch, presented at the 31st Conference on Retroviruses and Opportunistic Infections 2024.
    • 26 Feb 2024 According to a Gilead Sciences, Inc. media release, U.S. FDA approves expanded indication for Gilead's Biktarvy to treat people with HIV with suppressed viral loads, pre-existing resistance, and the expanded label is based on Week 48 data of clinical study 4030.
    • 10 Dec 2021 Results of pooled analysis (n=1906) assessing virologic outcomes through 48 weeks of B/F/TAF treatment in individuals with pre-existing primary INSTI-R from 7 bictegravir/emtricitabine/tenofovir alafenamide studies (GS-US-380-1489/NCT02607930 and GS-US-380-1490/NCT02607956), (GS-US-380-1844/NCT02603120; GS-US-380-1878/NCT02603107; GS-US-380-4580/NCT03631732; GS-US-380-4030/NCT03110380 and GS-US-380-4449/NCT03405935), published in the JAIDS.

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