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An Open-label, Single Arm Study to Evaluate the Week 48 Efficacy and Safety of a Two-drug Regimen of Dolutegravir/Lamivudine (DTG/3TC) as a Fixed Dose Combination (FDC), in Antiretroviral Therapy (ART)-Naive HIV-1-infected Adolescents, ≥12 to <18 Years of Age Who Weigh at Least 25 kg

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Trial Profile

An Open-label, Single Arm Study to Evaluate the Week 48 Efficacy and Safety of a Two-drug Regimen of Dolutegravir/Lamivudine (DTG/3TC) as a Fixed Dose Combination (FDC), in Antiretroviral Therapy (ART)-Naive HIV-1-infected Adolescents, ≥12 to <18 Years of Age Who Weigh at Least 25 kg

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Apr 2024

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At a glance

  • Drugs Dolutegravir/lamivudine (Primary)
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms DANCE
  • 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
    • 13 Feb 2024 Planned End Date changed from 29 Sep 2026 to 23 Feb 2024.
    • 07 Oct 2021 Planned End Date changed from 2 Oct 2026 to 29 Sep 2026.
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