- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00000663
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
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.
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Inscripción
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Diego, California, Estados Unidos, 92103
- UCSD Treatment Ctr
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Florida
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Miami, Florida, Estados Unidos, 33136
- Univ of Miami School of Medicine
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Cook County Hosp
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane Univ Med School
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New York
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Great Neck, New York, Estados Unidos, 11021
- North Shore Univ Hosp
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New York, New York, Estados Unidos, 10032
- Columbia Univ Babies' Hosp
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Texas
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Houston, Texas, Estados Unidos, 77030
- Texas Children's Hosp / Baylor Univ
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Colaboradores
Investigadores
- Silla de estudio: W Shearer
- Silla de estudio: R Yogev
Publicaciones y enlaces útiles
Publicaciones Generales
- Weintrub P, Yogev R, Conner E, Wilfert K, Mordenti J, Ammann AJ. Safety and pharmacokinetics of recombinant CD4 in children with HIV infection. Int Conf AIDS. 1990 Jun 20-23;6(2):95 (abstract no FB23)
- Shearer WT, Israel RJ, Starr S, Fletcher CV, Wara D, Rathore M, Church J, DeVille J, Fenton T, Graham B, Samson P, Staprans S, McNamara J, Moye J, Maddon PJ, Olson WC. Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children: phase 1/2 study. The Pediatric AIDS Clinical Trials Group Protocol 351 Study Team. J Infect Dis. 2000 Dec;182(6):1774-9. doi: 10.1086/317622. Epub 2000 Oct 27.
Fechas de registro del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ACTG 139
- D0172g
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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