A Multicenter, Open-Labeled, 96-Week Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Indinavir in Combination With Stavudine and Lamivudine in Pediatric Patients With HIV-1 Infection
Indinavir sulfate
+ Lamivudine
+ Stavudine
Infecciones Transmitidas por la Sangre+10
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
In this multicenter, open-label study patients receive a combined drug regimen of indinavir, stavudine, and lamivudine over 48 weeks. Patients are evaluated at Weeks 0, 2, 4, every 4 weeks until Week 24, and every 8 weeks thereafter until study completion. [AS PER AMENDMENT 4/27/99: The study has been extended for an additional 48 weeks for a total of 96 weeks.]
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 24 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 3 a 15 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria Your child may be eligible for this study if he/she: Is 3 - 15 years old and has consent of a parent or legal guardian who is able to return with the child for follow-up visits. Is HIV-positive. Is generally healthy. Is able to swallow medication in capsule form. Has never taken d4T or has never taken 3TC. Agrees to use barrier methods of birth control (such as condoms) during the study. The pill is not allowed during the study. Exclusion Criteria Your child will not be eligible for this study if he/she: Has a serious infection at the time of study entry. Has a history of severe diarrhea. Is unable to take any of the medications in this study for any reason. Has a history of certain serious illnesses. Has taken any protease inhibitors (PIs). Has taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz (EFV), within 2 weeks prior to study entry. Has taken certain medications. Is pregnant or breast-feeding.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 19 ubicaciones
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, United StatesAbrir UCSD Med Ctr / Pediatrics / Clinical Sciences en Google MapsUCSF / Moffitt Hosp - Pediatric
San Francisco, United StatesYale Univ Med School
New Haven, United StatesUniv of Florida Gainesville
Gainesville, United States