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

Completed · Phase 3

Conditions studied: HIV Infections, AIDS

In brief

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.

Key facts

Study ID

NCT00116298

Run by

Bristol-Myers Squibb

People needed

900

Starts

2001-01-01

Expected to finish

2005-01-01

Last updated by the study team

2011-04-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution — Los Angeles, California, United States
• Local Institution — West Hollywood, California, United States
• Local Institution — Washington D.C., District of Columbia, United States
• Local Institution — Fort Lauderdale, Florida, United States
• Local Institution — Orlando, Florida, United States
• Local Institution — Tampa, Florida, United States
• Local Institution — Indianapolis, Indiana, United States
• Local Institution — Wichita, Kansas, United States
• Local Institution — Louisville, Kentucky, United States
• Local Institution — Brookline, Massachusetts, United States
• Local Institution — Las Vegas, Nevada, United States
• Local Institution — Reno, Nevada, United States
• Local Institution — New York, New York, United States
• Local Institution — Winston-Salem, North Carolina, United States
• Local Institution — Oklahoma City, Oklahoma, United States
• Local Institution — Dallas, Texas, United States
• Local Institution — Houston, Texas, United States
• Local Institution — Hampton, Virginia, United States
• Local Institution — San Isidro, Buenos Aires, Argentina
• Local Institution — Rosario, Santa Fe Province, Argentina
• Local Institution — Buenos Aires, Argentina
• Local Institution — Córdoba, Argentina
• Local Institution — Ghent, Belgium
• Local Institution — Liège, Belgium
• Local Institution — Berkeley, California, United States

Full record on ClinicalTrials.gov

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