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Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents

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Trial Profile

Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 05 Aug 2023

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At a glance

  • Drugs Cabotegravir (Primary) ; Cabotegravir (Primary) ; Rilpivirine (Primary) ; Rilpivirine (Primary) ; Antiretrovirals
  • Indications HIV-1 infections
  • Focus Adverse reactions
  • Acronyms MOCHA

    • Most Recent Events

    • 15 Dec 2022 Planned End Date changed from 30 Jul 2025 to 17 Jun 2025.
    • 15 Dec 2022 Planned primary completion date changed from 30 Dec 2022 to 28 Feb 2023.
    • 02 Aug 2022 Results of population PK modelling to support extrapolation from adults to adolescents and bridge dose regimens and therapeutic use from interim PK from MOCHA (8 adolescents) was compared to adult PK to establish PK similarity and determine feasibility of extrapolation, presented at the 24th International AIDS Conference.
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