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A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants

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Trial Profile

A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Oct 2024

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At a glance

  • Drugs Bictegravir/emtricitabine/tenofovir alafenamide (Primary) ; Abacavir; Atazanavir; Cobicistat; Darunavir; Delavirdine; Didanosine; Dolutegravir; Doravirine; Efavirenz; Elvitegravir; Emtricitabine; Lamivudine; Lopinavir; Maraviroc; Nelfinavir; Nevirapine; Raltegravir; Rilpivirine; Ritonavir; Saquinavir; Stavudine; Tenofovir alafenamide; Tenofovir disoproxil fumarate; Tipranavir; Zidovudine
  • Indications HIV-1 infections
  • Focus Therapeutic Use
  • Acronyms BRAAVE 2020
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 01 Oct 2024 Results assessing the efficacy of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) among Black individuals with suppressed HIV through 48 weeks were published in the Journal of Medical Virology.
    • 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.
    • 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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