At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 108 enrolled
Drug / intervention
Atazanavir +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 of Atazanavir (ATV) Capsule Boosted With Ritonavir (RTV) With an Optimized NRTI Background Therapy, in HIV Infected, Antiretroviral Naive and Experienced Pediatric Subjects Greater Than or Equal to 6 Years to Less Than 18 Years
In Brief
A Phase 4 clinical trial evaluating Atazanavir and Ritonavir for HIV, Pediatric. Completed, enrolled 108 participants across 27 sites in 8 countries.
Detailed Summary
The purpose of this study is to collect safety clinical data in HIV-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, Pediatric
CountriesArgentina, Brazil, Chile, Mexico, Peru, Russia, South Africa, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 2012
Enrollment StartNov 2012
Primary CompletionOct 2014
Study CompletionFeb 2017
TodayJul 2026
First PostedSep 25, 2012
Enrollment StartNov 30, 2012
Primary CompletionOct 31, 2014
Study CompletionFeb 20, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.8 years ago
Interventions
Atazanavirdrug
Ritonavirdrug