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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: 25 Apr 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; ODYSSEY A; ODYSSEY B

Most Recent Events

  • 06 Mar 2024 Results (n=683) assessing the efficacy and safety of DTG versus SOC during extended follow-up at a time-point of 192 weeks in Africa and Thailand, presented at the 31st Conference on Retroviruses and Opportunistic Infections 2024
  • 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

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