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A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in Infants and Children With Documented HIV-1 Infection

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

CD4-IgG

Medicamento
Quiénes están siendo reclutados

HIV Infections

Hasta 5 Años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 24 de junio de 2005
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To determine the safety profile, assess pharmacokinetic properties (blood levels), and obtain preliminary indication of the antiviral and immunologic effects of recombinant CD4 immunoglobulin G (CD4-IgG). CD4-IgG may be effective in blocking HIV transmission and spread, that is, CD4-IgG has antiviral effects. Studies done in adult patients with AIDS and AIDS related complex (ARC) have shown that rCD4 can be safely administered by intravenous bolus, intramuscular or subcutaneous injection. No serious or dose-limiting, drug-related toxicities have been observed to date. CD4-IgG may be effective in blocking HIV transmission and spread, that is, CD4-IgG has antiviral effects. Studies done in adult patients with AIDS and AIDS related complex (ARC) have shown that rCD4 can be safely administered by intravenous bolus, intramuscular or subcutaneous injection. No serious or dose-limiting, drug-related toxicities have been observed to date. Patients receive one intravenous injection the first week, followed by a 6 day washout period and then intravenous injections on a twice weekly basis from week 2 to week 12. The dose per injection may vary. The study evaluates 2 groups: (1) Children 3 months to 5 years of age; (2) Infants 0-3 months of age.

Título OficialA Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in Infants and Children With Documented HIV-1 Infection 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 24 de junio de 2005
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 18 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
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
Hasta 5 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
Criterios

Inclusion Criteria Patients must have the following: * HIV-1 infection, or if less than 15 months old, born to mother with HIV-1 infection. * Legally qualified guardian with the ability to sign a written, informed consent form. * Willingness to abstain from all other experimental therapy for HIV-1 infection during the first 12 weeks of the study period. * Anticipated life expectancy of at least 3 months. Prior Medication: Allowed: * Prophylactic anti-Pneumocystis carinii pneumonia (PCP) or antifungal therapy. * Gamma globulin as prophylaxis for measles and varicella. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Past or present history of neurological abnormalities including withdrawal syndrome or seizures. * Past or present history of any serious active opportunistic infection including Pneumocystis carinii pneumonia (PCP). * Echocardiogram values \> 2 standard deviations from normal. * Hematologic, renal, or hepatic insufficiency. Concurrent Medication: Excluded: * Zidovudine (AZT). * Intravenous gamma globulin (IVIG) except as prophylaxis for measles and varicella. * Cancer chemotherapy. * Corticosteroids. * Other known immunomodulatory agents. * Other experimental therapy not specifically allowed. Patients with the following are excluded: * Hematologic, renal, or hepatic insufficiency. * Past or present history of any serious active opportunistic infection. Prior Medication: Excluded for a minimum of 3 weeks prior to study entry: * Zidovudine (AZT). * Intravenous gamma globulin (IVIG). * Cancer chemotherapy. * Immunomodulatory agents. * Acyclovir and other experimental therapy. Risk Behavior: Excluded: * Patients born to substance abusing mothers (including alcohol) during the pregnancy.



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 7 ubicaciones
Suspendido
UCSD Treatment CtrSan Diego, United StatesVer ubicación
Suspendido
Univ of Miami School of MedicineMiami, United States
Suspendido
Cook County HospChicago, United States
Suspendido
Tulane Univ Med SchoolNew Orleans, United States

Completado7 Centros de Estudio