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

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

Patrocinadores

Patrocinador principal: Bristol-Myers Squibb

Fuente Bristol-Myers Squibb
Resumen breve

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.

Estado general Completed
Fecha de inicio January 2001
Fecha de Terminación January 2005
Fecha de finalización primaria January 2005
Fase Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
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
Resultado secundario
Medida Periodo de tiempo
Efficacy: Changes in CD4 cell counts
Inscripción 900
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: stavudine, efavirenz, lamivudine

Elegibilidad

Criterios:

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

Género: All

Edad mínima: N/A

Edad máxima: N/A

Voluntarios Saludables: No

Ubicación
Instalaciones:
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 | Ft. 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, Argentina
Local Institution | Buenos Aires, Argentina
Local Institution | Cordoba, Argentina
Local Institution | Gent, Belgium
Local Institution | Liege, Belgium
Local Institution | Salvador, Bahia, Brazil
Local Institution | Belo Horizonte - MG, Minas Gerais, Brazil
Local Institution | Botucatu, Sao Paulo, Brazil
Local Institution | Santos, Sao Paulo, Brazil
Local Institution | Vancouver, British Columbia, Canada
Local Institution | Toronto, Ontario, Canada
Local Institution | Montreal, Quebec, Canada
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 | Mexico, Distrito Federal, Mexico
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 | 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 | Tygerberg, Western Cape, South Africa
Local Institution | Barcelona, Spain
Local Institution | Madrid, Spain
Local Institution | Bangkok, Thailand
Local Institution | Nontaburi, Thailand
Ubicacion Paises

Argentina

Belgium

Brazil

Canada

France

Israel

Italy

Mexico

Portugal

Puerto Rico

Russian Federation

Singapore

South Africa

Spain

Thailand

United States

Fecha de verificación

April 2011

Palabras clave
Condición Examinar
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov