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

Condition(s) targeted: HIV Infections; AIDS

Intervention: stavudine, efavirenz, lamivudine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

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.

Official title: 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

Study design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Safety: Frequency and severity of AEs, and treatment discontinuations for AEs; population trends for triglycerides and cholesterol. Primary efficacy outcome: proportion of subjects with HIVRNA <400, <50, and change in viral load over the study period

Secondary outcome: Efficacy: Changes in CD4 cell counts

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Local Institution, Buenos Aires, Argentina

Local Institution, Cordoba, Argentina

Local Institution, Gent, Belgium

Local Institution, Liege, Belgium

Local Institution, Bordeaux Cedex, France

Local Institution, Lyon Cedex 03, France

Local Institution, Nantes Cedex 01, France

Local Institution, Paris Cedex 13, France

Local Institution, Rennes Cedex 9, France

Local Institution, Rehovot, Israel

Local Institution, Tel Hashorner, Israel

Local Institution, Bari, Italy

Local Institution, Bergamo, Italy

Local Institution, Firenze, Italy

Local Institution, Milano, Italy

Local Institution, Napoli, Italy

Local Institution, Pisa, Italy

Local Institution, Torino, Italy

Local Institution, Coimbra, Portugal

Local Institution, Lisboa, Portugal

Local Institution, Cotto Laurel, Puerto Rico

Local Institution, San Juan, Puerto Rico

Local Institution, Moscow, Russian Federation

Local Institution, St. Petersburg, Russian Federation

Local Institution, Singapore, Singapore

Local Institution, Barcelona, Spain

Local Institution, Madrid, Spain

Local Institution, Bangkok, Thailand

Local Institution, Nontaburi, Thailand

Local Institution, Salvador, Bahia, Brazil

Local Institution, Vancouver, British Columbia, Canada

Local Institution, San Isidro, Buenos Aires, Argentina

Local Institution, Berkeley, California, United States

Local Institution, Los Angeles, California, United States

Local Institution, West Hollywood, California, United States

Local Institution, Washington, District of Columbia, United States

Local Institution, Mexico, Distrito Federal, Mexico

Local Institution, Ft. Lauderdale, Florida, United States

Local Institution, Orlando, Florida, United States

Local Institution, Tampa, Florida, United States

Local Institution, Bedford Gardens, Gauteng, South Africa

Local Institution, Hatfield, Gauteng, South Africa

Local Institution, JOhannesburg, Gauteng, South Africa

Local Institution, Westdene, Gauteng, South Africa

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, Belo Horizonte - MG, Minas Gerais, Brazil

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, Toronto, Ontario, Canada

Local Institution, Montreal, Quebec, Canada

Local Institution, Rosario, Santa Fe, Argentina

Local Institution, Botucatu, Sao Paulo, Brazil

Local Institution, Santos, Sao Paulo, Brazil

Local Institution, Dallas, Texas, United States

Local Institution, Houston, Texas, United States

Local Institution, Hampton, Virginia, United States

Local Institution, Tygerberg, Western Cape, South Africa

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: January 2001
Last updated: August 22, 2007