drugset / Trial / NCT00116298

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

NCT00116298

Phase 3 Completed 900 enrolled Bristol-Myers Squibb
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2001-01
Primary completion
2005-01
Completion
2005-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Stavudine Other / unclassified
Background Efavirenz Other / unclassified
Background Lamivudine Other / unclassified

Indications