Status:
COMPLETED
Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infections
AIDS
Eligibility:
All Genders
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
January 1 2005
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00116298
Start Date
January 1 2001
End Date
January 1 2005
Last Update
April 25 2011
Active Locations (63)
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1
Local Institution
Berkeley, California, United States
2
Local Institution
Los Angeles, California, United States
3
Local Institution
West Hollywood, California, United States
4
Local Institution
Washington D.C., District of Columbia, United States