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Phase I/II, open-label, pharmacokinetic and safety study of a novel protease inhibitor (BMS 232632, atazanavir, ATV, Reyataz) in combination regimens in antiretroviral therapy (ART)-naive and -experienced HIV-infected infants, children, and adolescents

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Trial Profile

Phase I/II, open-label, pharmacokinetic and safety study of a novel protease inhibitor (BMS 232632, atazanavir, ATV, Reyataz) in combination regimens in antiretroviral therapy (ART)-naive and -experienced HIV-infected infants, children, and adolescents

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 08 Nov 2021

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At a glance

  • Drugs Atazanavir (Primary) ; Ritonavir
  • Indications HIV infections; HIV-1 infections
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Acronyms IMPAACT

    • Most Recent Events

    • 05 Jul 2010 Response rates (HIV RNA <50 copies per/mL) were reported for the atazanavir+ ritonavir combination treatment group in a Bristol-Myers Squibb media release.
    • 05 Jul 2010 Status changed from active, no longer recruiting to completed according to BMS media release.
    • 05 Jul 2010 According to a Bristol-Myers Squibb media release, atazanavir capsules have been approved by the European Commission for paediatric use, as part of combination HIV therapy, based on clinical data from patients in this trial.

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