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A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once-daily Single-tablet Regimen Versus Continuing the Current Regimen Consisting of a Boosted Protease Inhibitor (bPI) Combined With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in Virologically-suppressed, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects

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Trial Profile

A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once-daily Single-tablet Regimen Versus Continuing the Current Regimen Consisting of a Boosted Protease Inhibitor (bPI) Combined With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in Virologically-suppressed, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Mar 2023

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At a glance

  • Drugs Cobicistat/darunavir/emtricitabine/tenofovir alafenamide (Primary) ; Atazanavir; Cobicistat; Darunavir; Emtricitabine/tenofovir disoproxil fumarate; Lopinavir; Ritonavir
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms EMERALD
  • Sponsors Janssen R&D Ireland; Janssen Research & Development

    • Most Recent Events

    • 01 Mar 2023 Results of subgroup analysis from AMBER and EMERALD evaluating the prevalence of pre-existing neurological and/or psychiatric comorbidities (NPCs) and efficacy/safety outcomes for participants with versus without baseline, published in the HIV Medicine
    • 26 Oct 2022 Results of pooled analysis assessing Long-term efficacy and resistance analyses of D/C/F/TAF in the phase III AMBER and EMERALD studies presented at the 16th International Congress on Drug Therapy and HIV Infection
    • 21 Jul 2021 Results of a post hoc analysis assessing the proportion of EMERALD patients with baseline and developing MetS and advanced hepatic fibrosis, presented at the 11th International AIDS Society Conference on HIV Science
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