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

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Efavirenz; Lamivudine; Stavudine

Criteria

Inclusion Criteria:

• Completed d4T studies AI455-096 or AI455-099

• Have demonstrated compliance with the study medication and treatment visits

• Provide written informed consent

• Agree to use a barrier method of birth control (such as condoms) during the study

• Have a negative pregnancy test within 72 hours prior to start of study medication

Exclusion Criteria:

• Are pregnant or breast-feeding

• Need to take certain medications that have systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential

• Have active alcohol or substance abuse which may prevent compliance or increase risk of developing pancreatitis

• Have certain other conditions or prior treatments that might interfere with study continuation

• Need to take certain medications that should not be taken with EFV