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)

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Mar 2018

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
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top