drugset
drugset / Trial / NCT01335698

Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients

NCT01335698 ↗

Phase 3 Completed 160 enrolled Bristol-Myers Squibb
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-05-27
Primary completion
2014-09-10
Completion
2018-01-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Atazanavir Other / unclassified 150 mg Oral
Subject Atazanavir Other / unclassified 200 mg Oral
Subject Atazanavir Other / unclassified 250 mg Oral
Subject Atazanavir Other / unclassified 300 mg Oral
Background Ritonavir Other / unclassified 80 mg Oral
Background Ritonavir Other / unclassified 100 mg Oral

Indications

HIV infectious disease