NCT00116298

Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)

A Study to Compare Long-Term Safety and Tolerability of Stavudine (d4T) Extended Release (ER) Versus Conventional (Immediate Release, IR) Formulations, Each In Combination With Lamivudine (3TC) and Efavirenz (EFV) in Subjects Who Have Completed BMS Studies AI455-096 and AI455-099

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (planned)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare long-term safety and tolerability of stavudine (d4T) extended release (ER) versus conventional (immediate release \[IR\]) formulations, each in combination with lamivudine (3TC) and efavirenz (EFV) in subjects who have completed Bristol-Myers Squibb (BMS) studies AI455-096 and AI455-099.

Conditions

• HIV Infections
• AIDS

Interventions

Type	Name	Description
DRUG	stavudine, efavirenz, lamivudine

Timeline

• Start date: 2001-01-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2005-06-29
• Last updated: 2011-04-25

Locations

63 sites across 16 countries: United States, Argentina, Belgium, Brazil, Canada, France, Israel, Italy, Mexico, Portugal, Puerto Rico, Russia, Singapore, South Africa, Spain, Thailand