At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 160 enrolled
Drug / intervention
Atazanavir Sulphate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Atazanavir Sulphate and Ritonavir for HIV. Completed, enrolled 160 participants across 32 sites in 11 countries.
Detailed Summary
The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to \<11 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesArgentina, Brazil, Chile, Mexico, Poland, Romania, Russia, South Africa, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2011
Enrollment StartMay 2011
Primary CompletionSep 2014
Study CompletionJan 2018
TodayJul 2026
First PostedApr 14, 2011
Enrollment StartMay 27, 2011
Primary CompletionSep 10, 2014
Study CompletionJan 22, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.2 years ago
Interventions
Atazanavir Sulphatedrug
Ritonavirdrug