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A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in Human Immunodeficiency Virus (HIV) Infected, Antiretroviral, Naive and Experienced Pediatric Subjects From 3 Months to Less Than 11 Years.(Pediatric Atazanavir International Clinical Evaluation: the PRINCE II Study)

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Trial Profile

A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in Human Immunodeficiency Virus (HIV) Infected, Antiretroviral, Naive and Experienced Pediatric Subjects From 3 Months to Less Than 11 Years.(Pediatric Atazanavir International Clinical Evaluation: the PRINCE II Study)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2022

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At a glance

  • Drugs Atazanavir (Primary) ; Nucleoside reverse transcriptase inhibitors; Ritonavir
  • Indications HIV-1 infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PRINCE II; PRINCE2
  • Sponsors Bristol-Myers Squibb

    • Most Recent Events

    • 01 Feb 2018 Status changed from active, no longer recruiting to completed.
    • 04 Dec 2017 Results of a pooled analysis assessing the pharmacokinetics and pharmacodynamics of Atazanavir across two studies (PRINCE-1 and -2; n=146) published in the Pediatric Infectious Disease Journal
    • 04 Dec 2017 Results (n=99) published in the Pediatric Infectious Disease Journal
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