A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder With Ritonavir (RTV) With Optimal Background Therapy, in HIV Infected Pediatric Patients Greater Than or Equal to 3 Months to Less Than 6 Years (Pediatric Atazanavir International Clinical Evaluation: the PRINCE I Study)

Trial Profile

A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder With Ritonavir (RTV) With Optimal Background Therapy, in HIV Infected Pediatric Patients Greater Than or Equal to 3 Months to Less Than 6 Years (Pediatric Atazanavir International Clinical Evaluation: the PRINCE I Study)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2017

At a glance

  • Drugs Atazanavir (Primary) ; Ritonavir
  • Indications HIV-1 infections
  • Focus Adverse reactions; Registrational
  • Acronyms PRINCE I
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 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
    • 16 Oct 2017 This trial has been completed in Poland, according to European Clinical Trials Database record.
    • 10 Jun 2017 Biomarkers information updated
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