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A Phase III, Randomised, Double Blind, Multicentre, Parallel Group, Non Inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in Human Immunodeficiency Virus 1 Infected Treatment naive Adults

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Trial Profile

A Phase III, Randomised, Double Blind, Multicentre, Parallel Group, Non Inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in Human Immunodeficiency Virus 1 Infected Treatment naive Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Apr 2024

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At a glance

  • Drugs Dolutegravir (Primary) ; Lamivudine (Primary) ; Emtricitabine/tenofovir disoproxil fumarate
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms Gemini 1
  • Sponsors ViiV Healthcare

    • Most Recent Events

    • 08 Apr 2024 According to a viiv healthcare media release, U.S. Food and Drug Administration approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen .This approval is supported by data from the DANCE, GEMINI1, GEMINI2 and TANGO
    • 03 Oct 2023 Last checked against European Clinical Trials Database record.
    • 26 Oct 2022 Results0f 48 week subgroup analyses of the GEMINI-1/-2 and STAT trials, presented at the 16th International Congress on Drug Therapy and HIV Infection
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