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A randomised trial of dolutegravir (DTG)-based antiretroviral therapy vs standard of care (SOC) in children with HIV infection starting first-line or switching to second-line ART

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Trial Profile

A randomised trial of dolutegravir (DTG)-based antiretroviral therapy vs standard of care (SOC) in children with HIV infection starting first-line or switching to second-line ART

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 20 Feb 2024

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At a glance

  • Drugs Abacavir/dolutegravir/lamivudine (Primary) ; Dolutegravir (Primary) ; Antiretrovirals; Atazanavir; Efavirenz; Lamivudine/abacavir; Lamivudine/zidovudine; Lopinavir; Lopinavir/ritonavir; Nevirapine; Raltegravir
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ODYSSEY

    • Most Recent Events

    • 05 Sep 2023 According to Viatris Inc. media release, the company announced U.S. Food and Drug Administration (FDA) tentative approval for a New Drug Application for abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension for the treatment of HIV-1 infection in paediatric patients.
    • 22 Feb 2023 Results of PopPK model developed using data from IMPAACT P1093 and PENTA ODYSSEY; evaluating DTG BID dosing in 1st generation INSTI-r (raltegravir or elvitegravir) and extrapolating efficacy and safety from adults to pediatric population, presented at the 30th Conference on Retroviruses and Opportunistic Infections 2023
    • 30 Mar 2022 According to a ViiV Healthcare media release, U.S. Food and Drug Administration has approved a new drug application for a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine for the treatment of pediatric patients weighing 10kgs to <25 kgs with HIV-1. In addition, a supplemental new drug application has been approved for Triumeq tablet, lowering the minimum weight that a child with HIV-1 can be prescribed this medicine to 25kgs from 40kgs.
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