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A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women

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

Didanosine

Medicamento
Quiénes están siendo reclutados

HIV Infections

+ Pregnancy
A partir de 13 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 29 de octubre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To assess the pharmacokinetics, safety, and toxicity of intravenous and oral didanosine (ddI) administration in third trimester pregnant women who are HIV positive but are either intolerant or resistant to zidovudine (AZT). To collect data on infant toxicity following maternal treatment with ddI during the third trimester of pregnancy. AZT may not be the optimal antiretroviral agent for all pregnant women requiring therapy for HIV infection. Although ddI has been approved for use in HIV-infected adults and older children, the safety and pharmacokinetics of ddI in pregnant women has not yet been determined. AZT may not be the optimal antiretroviral agent for all pregnant women requiring therapy for HIV infection. Although ddI has been approved for use in HIV-infected adults and older children, the safety and pharmacokinetics of ddI in pregnant women has not yet been determined. Patients receive a single IV dose of ddI on day 1 and pharmacokinetics values are determined. At least 48 hours but no more than 1 week after the IV dose, patients receive an oral dose, and oral pharmacokinetics are obtained for 8 hours. Oral ddI is then administered every 12 hours until labor commences and then after delivery, every 12 hours until 6 weeks postpartum. During labor and delivery, patients receive a loading dose of ddI followed by continuous infusion. Pharmacokinetics are obtained during infusion and also at 6 weeks postpartum. AS PER AMENDMENT 11/24/97: Maternal IV pharmacokinetic studies will not be performed after ddI IV formulation has expired (11/30/97). Maternal and cord samples will be required regardless of whether mother has received continuous IV ddI during labor.

Título OficialA Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 29 de octubre 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 12 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.
A partir de 13 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: * Aerosolized pentamidine. * IV AZT during labor. Patients must have: * HIV infection. * CD4 count \> 50 and \< 350 cells/mm3. * AZT intolerance or resistance. * Gestational age at least 26 weeks but not more than 36 weeks. * Consent of guardian if necessary. The father of the fetus must also provide consent if available after reasonable attempts have been made to contact him. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Multiple gestation. * Current obstetrical complication, such as major anomalies, growth retardation, abnormal fluid level, fetal hydrops, or placental abruption (placenta previa is allowed). * No access to a participating ACTU. Concurrent Medication: Excluded: * Drugs that might aggravate pancreatitis, such as steroids, isoniazid, and parenteral pentamidine. * Antiretrovirals other than ddI (although IV AZT is allowed during labor). Patients with the following prior conditions are excluded: * History of stillbirth, neonatal loss, or previous infant with anomaly (history of preeclampsia or preterm labor is permitted). * History of maternal medical complications including but not limited to malabsorption syndrome, pancreatitis, neurological complications including grade 2 or worse peripheral neuropathy, symptomatic cholelithiasis, or prior active CMV disease requiring ganciclovir or foscarnet. * History of poor medical compliance not related to access to medical care. Prior Medication: Excluded: * ddI within 24 hours prior to study entry.



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 13 ubicaciones
Suspendido
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRSLos Angeles, United StatesVer ubicación
Suspendido
UCSD Maternal, Child, and Adolescent HIV CRSSan Diego, United States
Suspendido
Univ. of Florida Jacksonville NICHD CRSJacksonville, United States
Suspendido
Univ. of Miami Ped. Perinatal HIV/AIDS CRSMiami, United States

Completado13 Centros de Estudio