NCT00089583

48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection

A 48 Week, Phase II, Non-Comparative, Open-label, Multi-Cohort, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GW433908/Ritonavir BID When Administered to HIV-1 Infected, PI-Naïve and Experienced, Pediatric Subjects, 2 to 18 Years Old and of GW433908 BID Administered to PI-Naïve, Pediatric Subjects 2 to < 6 Years Old

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection .

Detailed description

A 48 Week, Phase II, non-comparative, open-label, multi-cohort, multicenter study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of GW433908/Ritonavir BID when administered to HIV-1 infected PI-Naive and experienced, Pediatric Subjects 2 to 18 years old and of GW433908 BID Administered to PI-Naive Pediatric subjects 2 to \<6 years old

Conditions

• Infection, Human Immunodeficiency Virus I

Interventions

Type	Name	Description
DRUG	LEXIVA (GW433908)	Fosamprenavir suspension or tablet bid
DRUG	Ritonavir	Ritonavir solution bid

Timeline

• Start date: 2004-07-01
• Primary completion: 2011-03-01
• Completion: 2013-07-01
• First posted: 2004-08-10
• Last updated: 2017-03-07
• Results posted: 2012-06-21

Locations

39 sites across 7 countries: United States, Belgium, Canada, Romania, Russia, South Africa, Spain