NCT00298350

Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.

Phase 2 Study of the Treatment of Antiretroviral Treatment-Experienced Subjects Comparing Ritonavir-Boosted GS-9137 (GS-9137/r) vs. a Comparator Ritonavir-Boosted Protease Inhibitor (CPI/r) in Combination With Background ART.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137 relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of combination antiretroviral regimens in subjects who have failed, or are failing, protease inhibitor therapy.

Conditions

• HIV
• HIV-1
• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	GS-9137 - A Novel HIV-1 Integrase Inhibitor

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-06-01
• Completion: 2007-07-01
• First posted: 2006-03-02
• Last updated: 2008-07-29

Locations

54 sites across 2 countries: United States, Puerto Rico