Clinical Trial Details

Overview

Research Study Summary

A Phase 2/3, Multicenter, Open-label, Multicohort, Two-Part Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co), Administered with an Optimized Background Regimen (BR) in HIV-1 Infected, Treatment-Experienced, Virologically Suppressed Pediatric Subjects

Purpose

This study will evaluate the steady-state pharmacokinetics (PK) and confirm the dose of cobicistat-boosted atazanavir (ATV/co) or cobicistat-boosted darunavir (DRV/co) in HIV-1 infected antiretroviral treatment-experienced pediatric participants between the ages of 3 months to < 18 years of age. It will also evaluate the safety, tolerability, and efficacy of ATV/co or DRV/co each co-administered with a background regimen (BR) through 48 weeks and during long-term treatment (total of 5 years).

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CW ID: 203052
Date Last Changed: November 6, 2014

Clinical Trial Snapshot

Gender
Both Male and Female
Age
3 to 17 Years
Overall Status
Recruiting
Lead Sponsor
Gilead
Facility Type
N/A

Contact

Denise Casey
University of South Florida - Children's Medical Service Clinic
13101 Bruce B Downs Blvd
Tampa, FL 33612
Phone: (813)259-8674

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