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Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents

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Trial Profile

Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 12 Mar 2023

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At a glance

  • Drugs Dolutegravir (Primary)
  • Indications HIV-1 infections
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Acronyms IMPAACT P1093

    • Most Recent Events

    • 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
    • 25 Oct 2021 Interim results (n=142; data cutoff: 12 Feb 2019) over 24-weeks characterizing pathways of INSTI resistance emerged among adolescents and children receiving dolutegravir published in the Antimicrobial Agents and Chemotherapy
    • 12 Oct 2021 Results assessing Development of Dolutegravir Single-entity and Fixed-dose Combination Formulations for Children from 5 pharmacokinetic studies published in the Pediatric Infectious Disease Journal
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