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)
Phase of Trial: Phase III
Latest Information Update: 26 May 2018
At a glance
- Drugs Atazanavir (Primary) ; Ritonavir
- Indications HIV-1 infections
- Focus Adverse reactions; Registrational
- Acronyms PRINCE I
- Sponsors Bristol-Myers Squibb
- 21 Dec 2017 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
- 16 Oct 2017 This trial has been completed in Poland, according to European Clinical Trials Database record.