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Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants

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Trial Profile

Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Nov 2024

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At a glance

  • Drugs Dolutegravir (Primary) ; Emtricitabine/tenofovir alafenamide (Primary) ; Emtricitabine/tenofovir disoproxil fumarate (Primary) ; Efavirenz/emtricitabine/tenofovir-disoproxil-fumarate
  • Indications HIV-1 infections
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms IMPAACT 2010; VESTED

    • Most Recent Events

    • 22 Feb 2023 Results (n=4) of substudy evaluating HIV drug resistance in cases of Perinatal Transmission, presented at the 30th Conference on Retroviruses and Opportunistic Infections 2023
    • 26 Oct 2022 Data of adverse birth outcomes from 5 studies DolPHIN-1, DolPHIN-2, ADVANCE, NAMSAL and IMPAACT-2010 were presented at the 16th International Congress on Drug Therapy and HIV Infection.
    • 16 Feb 2022 Data from this study used to assess risk-benefit trade-off for pregnancy and infant outcomes presented at the 29th Conference on Retroviruses and Opportunistic Infections

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