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)

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)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Sep 2017

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 Aug 2017 Planned End Date changed from 16 Jul 2018 to 28 Mar 2018.
    • 29 Jul 2017 Planned End Date changed from 1 Mar 2020 to 16 Jul 2018.
    • 29 Jun 2017 Status changed from completed to active, no longer recruiting.
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