NCT00071760

Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects

A 48 Week, Phase II, Open-label, 2-cohort, Multicenter Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Antiviral Activity of GW433908 and GW433908/RTV When Administered to HIV-1 Infected Protease Inhibitor (PI) Naive and PI-experienced Pediatric Subjects Aged 4 Weeks to <2 Years.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 4 Weeks – 2 Years
• Healthy volunteers: Not accepted

Summary

This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to \< 2 years old.

Detailed description

A 48 week, Phase II, open-label, 2-cohort, multicenter study to evaluate the pharmacokinetics, safety, tolerability and antiviral activity of GW433908 and GW433908/RTV when administered to HIV-1 infected protease inhibitor (PI) naive and PI-experienced pediatric subjects aged 4 weeks to \<2 years.

Conditions

• Infection, Human Immunodeficiency Virus
• HIV Infections

Interventions

Type	Name	Description
DRUG	GW433908	Fosamprenavir suspension bid
DRUG	ritonavir	Ritonavir solution bid

Timeline

• Start date: 2003-10-23
• Primary completion: 2011-07-05
• Completion: 2022-03-29
• First posted: 2003-10-31
• Last updated: 2023-10-10
• Results posted: 2012-08-23

Locations

15 sites across 7 countries: United States, Argentina, Mexico, Portugal, Puerto Rico, Russia, South Africa