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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 ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

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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 ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2024

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At a glance

  • Drugs Bictegravir/emtricitabine/tenofovir alafenamide (Primary) ; Abacavir/dolutegravir/lamivudine
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 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.
    • 30 Oct 2021 Results (n=2079) of pooled analysis assessing the safety and efficacy of switching adults with suppressed HIV to bictegravir/emtricitabine/tenofo - vir alafenamide (B/F/TAF) from 5 studies (Studies 1844, 1878, 4030, 4449, and 4580) presented at the 18th European AIDS Conference
    • 21 Jul 2021 Results assessimg long-term efficacy in patients who switched to bictegravir/emtricitabinetTenofovir alafenamide from DTG/ABC/3TC with preexisting resistance and viral blips, presented at the 11th International AIDS Society Conference on HIV Science

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