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A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate Containing Regimen to Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Elderly, Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 65 Years

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Trial Profile

A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate Containing Regimen to Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Elderly, Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 65 Years

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) ; Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide; 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.
    • 01 Jan 2023 Results (of 96-week) assessing safety and tolerability of Bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed people ≥65 years of age with HIV published in the HIV Medicine
    • 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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