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Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study

Trial Profile

Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 16 Dec 2022

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At a glance

  • Drugs Dolutegravir (Primary) ; Efavirenz; Emtricitabine; Lamivudine; Tenofovir
  • Indications HIV infections; HIV-1 infections
  • Focus Pharmacokinetics
  • Acronyms DOLPHIN-1
  • Most Recent Events

    • 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.
    • 12 Dec 2020 Results published in the Clinical Infectious Diseases
    • 10 Jul 2020 Results (N=1074), a meta-analysis of 5 clinical trials in pregnant women comparing the efficacy of dolutegravir versus efavirenz for faster virological suppression in pregnancy in the risk of HIV mother-to-child-transmission, presented at the 23rd International AIDS Conference
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