Completado

A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT)

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

Anti-HIV Immune Serum Globulin (Human)

+ Globulin, Immune
+ Zidovudine
Medicamento
Quiénes están siendo reclutados

HIV Infections

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

Estudio de Tratamiento

Fase 3
Intervencional

Resumen

Patrocinador PrincipalEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Última actualización: 30 de septiembre de 2008
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To evaluate the effect of anti-HIV immune serum globulin (HIVIG) versus immune globulin (IVIG) administered during pregnancy and to the newborn, in combination with zidovudine (AZT) administered intrapartum and to the newborn, on incidence of HIV infection in infants born to HIV-infected women who received AZT during pregnancy for medical indications. Vertical transmission of HIV from mother to child may occur before, during, or after parturition (via breast-feeding). It is believed that therapy administered both during pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive short-term antiretroviral therapy for the newborn, following the intensive viral exposure presumed to occur at birth, may be necessary. Vertical transmission of HIV from mother to child may occur before, during, or after parturition (via breast-feeding). It is believed that therapy administered both during pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive short-term antiretroviral therapy for the newborn, following the intensive viral exposure presumed to occur at birth, may be necessary. Pregnant women who are currently receiving AZT are randomized at 20-30 weeks of gestation to begin receiving either HIVIG or IVIG every 28 days up to delivery. Within 12 hours after birth, the infant receives an infusion of matching study drug. During labor, all women receive an intravenous loading dose of AZT administered over 1 hour, followed by continuous infusion during the intrapartum period until the umbilical cord is clamped. All infants receive AZT syrup every 6 hours, beginning as soon as oral fluids are tolerated but within 8-12 hours after birth and continuing for 6 weeks. Women are followed until 26 weeks postpartum. Infants are followed at weeks 1, 2, 4, and then every 4 weeks through week 24, every 12 weeks through week 60, at week 78 (18 months), and at week 104 (24 months).

Título OficialA Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT) 
Patrocinador PrincipalEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Última actualización: 30 de septiembre de 2008
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 1600 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.

Cómo se administran los tratamientos a los participantes
Los participantes se dividen en diferentes grupos, y cada uno recibe un tratamiento específico al mismo tiempo. Esto ayuda a los investigadores a comparar la eficacia de los distintos tratamientos entre sí.

Otras formas de asignar tratamientos
Asignación a un solo grupo
: Todos reciben el mismo tratamiento.

Asignación cruzada
: Los participantes cambian de tratamiento durante el estudio.

Asignación factorial
: Los participantes reciben diferentes combinaciones de tratamientos.

Asignación secuencial
: Los participantes reciben tratamientos uno tras otro en un orden específico, posiblemente según su respuesta individual.

Otra asignación
: La asignación de tratamientos no sigue un diseño estándar o predefinido.

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: * Women - Medications as required for obstetrical management of HIV infection (e.g., acyclovir, ketoconazole, isoniazid, antibiotics, or other antiretroviral therapy if intolerant or failing on AZT), unless specifically excluded. * Infants - Drug treatment for signs of drug withdrawal (phenobarbital, chlorpromazine, tincture of opium, paregoric or Valium). * Infants - Medications as indicated for management of an HIV-exposed infant (e.g., hepatitis B vaccine, syphilis treatment, Pneumocystis carinii pneumonia prophylaxis). Patients must have: * Documented HIV infection. * Been receiving AZT during current pregnancy for medical indications. * Gestational age between 20 and 30 weeks. * Intention to carry pregnancy to term. * Available venous access (placement of central line or Hickman catheter not indicated for study purposes). * Willingness to be followed by a participating site for study duration. NOTE: * Father of fetus (if available after a reasonable attempt to contact him) must also provide informed consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Illness associated with excessive protein loss, e.g., severe proteinuria (protein \>= 4 g protein in a 24-hour urine collection). Patients with the following prior conditions are excluded: * Evidence of pre-existing fetal anomalies (e.g., anencephaly, renal agenesis, or Potter's syndrome) that may result in a high probability that the fetus-infant would not survive to the end of the study period. * Chorionic villus sampling (CVS) or percutaneous umbilical blood sampling (PUBS) occurring in this pregnancy prior to study entry. * Illness associated with excessive protein loss, e.g., chronic diarrhea with no documented weight gain in a 3-month period during pregnancy. * Pre-existing conditions such as hypogammaglobulinemia or immune thrombocytopenia that are felt to require IVIG therapy. Prior Medication: Excluded: * Receipt of anti-HIV vaccines or passive immunotherapy with HIVIG or IVIG during this pregnancy prior to study entry. * Receipt of antiretroviral agents other than AZT during this pregnancy prior to study entry (e.g., rCD4, CD4-IgG, d4T, ddC, ddI).



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 51 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

Completado51 Centros de Estudio