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A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Nevirapine

Medicamento
Quiénes están siendo reclutados

HIV Infections

+ Pregnancy
De 13 a 60 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 4 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To determine the bioavailability, pharmacokinetics, and short-term safety and tolerance of nevirapine in HIV-1 infected pregnant women and their newborns when nevirapine is given to the mother during active labor, and when their neonates are dosed during the first week of life. To determine the short-term safety profile of mothers receiving zidovudine (AZT) who received nevirapine during active labor, and their neonates who received no dose, a single dose, or multiple doses of nevirapine and who are receiving AZT during the first 6 weeks of life. Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection. Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection. Pregnant women in active labor receive single doses of oral nevirapine. The neonates of the first 4-6 (PER AMENDMENT 8/27/96, was 4) mothers receive no drug, while the neonates of the second 4-6 (PER AMENDMENT 8/27/96, was 4) patient cohort receive a single dose of nevirapine. If neonatal antiviral levels of nevirapine are not sustained for 7 days after the single dose, a third cohort of 4-6 (PER AMENDMENT 8/27/96, was 4) pregnant women will receive a single dose of nevirapine and their neonates will receive multiple doses of nevirapine to maintain an antiviral effect for 7 days.

Título OficialA Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 4 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño
Se reclutarán 49 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.
Estudio de Tratamiento
Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
MujerSexo biológico de los participantes elegibles para inscribirse.
De 13 a 60 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
HIV Infections
Pregnancy
Criterios

Inclusion Criteria Concurrent Medication: Allowed: * AZT (mothers and neonates). * Oral asthma inhalers (mothers). Concurrent Treatment: Allowed: * Phototherapy (neonates). MOTHERS must have: * HIV infection. * Estimated gestational age \>= 34 weeks. * No active opportunistic infection at study entry. PER AMENDMENT 8/27/96: * A pre-enrollment plasma HIV-1 RNA level greater than 10,000 copies/ml. Exclusion Criteria Co-existing Condition: MOTHERS with the following symptoms or conditions are excluded: * Intrauterine growth retardation. * Fetal anomaly incompatible with life as determined by pre-entry ultrasound. * Participation during current pregnancy in any other therapeutic or vaccine perinatal trial. * Known hypersensitivity to any benzodiazepine. * Serious bacterial infection. Concurrent Medication: Excluded: * Any antiretroviral other than AZT. * Corticosteroids (other than oral asthma inhalers). * Anticoagulants. * Any clavulanic acid-containing formulation (e.g., Augmentin, Timentin). * Benzodiazepines other than study drug. * Phenobarbital. * Barbiturates. * Antacids. * Magnesium sulfate. Prior Medication: Excluded: * Prior nevirapine. Current use of illicit substances and/or active chronic alcohol use.



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 16 ubicaciones
Suspendido
UCSD Med Ctr / Pediatrics / Clinical SciencesLa Jolla, United StatesVer ubicación
Suspendido
Los Angeles County - USC Med CtrLos Angeles, United States
Suspendido
UCLA Med Ctr / PediatricLos Angeles, United States
Suspendido
Harbor - UCLA Med Ctr / UCLA School of MedicineLos Angeles, United States

Completado16 Centros de Estudio