NCT00363142

A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects

See Detailed Description.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.

Detailed description

A Phase IIIB, randomized, open-label, parallel group, multi-center, non-inferiority, 24-week study to evaluate the safety, efficacy and tolerability of switching from a 200mg ritonavir-boosted regimen of LEXIVA (700mg/100mg BID or 1400mg/200mg QD) to a once-daily, 100mg ritonavir-boosted regimen of LEXIVA (1400mg/100mg QD)

Conditions

• HIV Infection
• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Half-boosted Fosamprenavir	Once daily, reduced dose ritonavir-boosted fosamprenavir
DRUG	Full Boosted Fosamprenavir	Full ritonavir-boosted fosamprenavir

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-08-15
• Last updated: 2010-11-05
• Results posted: 2009-09-24

Locations

51 sites across 2 countries: United States, Puerto Rico