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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00116298Tipo: INTERVENTIONALInicio: 1 de ene de 2001Fin estimado: 1 de ene de 2005

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Sexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

stavudine, efavirenz, lamivudine

Ubicaciones

Local Institution

Córdoba, Argentina

Local Institution

San Isidro, Buenos Aires, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Local Institution

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Study to Compare Long-Term Safety and Tolerability of S... | EligiMed