Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
Colección de datos
Enfermedades Transmisibles+10
+ Enfermedades Urogenitales
+ Infecciones Transmitidas por la Sangre
Resumen
Most HIV-infected infants acquire their disease via perinatal transmission. Since transmission of HIV-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of AZT susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies. HIV-infected pregnant women are enrolled at 20-36 weeks gestation. Patients have blood drawn for HIV culture at study entry and at delivery. Infants have blood drawn for HIV culture at delivery and at 1, 3, 6, and 18 months of age.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 250 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.De 13 a 60 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 Prior Medication: Required: * At least 6 months of prior AZT, including continuously during the current pregnancy. Patients must have: * HIV seropositivity. * CD4 count \<= 300 cells/mm3. * Gestational age of 20-36 weeks, with intention to carry pregnancy to term. * At least 6 months of prior AZT therapy, including continuous AZT therapy during the current pregnancy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Evidence of pre-existing fetal anomalies that would preclude survival to the end of the study, such as anencephaly, renal agenesis, or Potter's syndrome. Concurrent Medication: Excluded: * Antiretrovirals other than AZT.
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 29 ubicaciones
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, United StatesLong Beach Memorial (Pediatric)
Long Beach, United StatesLos Angeles County - USC Med Ctr
Los Angeles, United States