- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00006325
Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children
Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of PEG-Intron in HIV-1 Infected Children
The purpose of this study is to see if PEG-Intron is safe and tolerated when given to children, to see how much gets into the blood and how long it stays in the blood, and to see how well it works to reduce viral load (level of HIV in the blood).
PEG-Intron is an experimental drug that works differently than other anti-HIV medications. It decreases the ability of HIV to infect the T cells (a special type of cell that helps fight infection). PEG-Intron has been approved by the Food and Drug Administration (FDA) to treat hepatitis C in adults, but in this study, it is being used as an investigational agent for the treatment of HIV/AIDS. It has not been tested in children before and experience with PEG-Intron in adults is limited. (This protocol has been changed to reflect FDA approval of PEG-Intron for treating hepatitic C in adults.)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The current optimal clinical management of HIV infection involves therapy with combinations of nucleoside and nonnucleoside reverse transcriptase inhibitors and HIV protease inhibitors. These regimens, though effective, do not completely eliminate HIV and the development of drug resistance is a major clinical problem. Interferons have been proposed as a possible treatment of HIV. Interferon-alfa inhibits HIV replication in vitro, and HIV-infected patients appear to have reduced production of interferons. Previous short-term clinical studies in adults showed anti-HIV activity, although there were safety and tolerability problems associated with the higher dose regimens used. This study will utilize a rising multiple-dose design to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of PEG-Intron in HIV-infected children.
In a dose-escalation study, patients add weekly PEG-Intron to their antiretroviral therapy for up to 6 weeks. The first 2 doses are received in the clinic where parents/guardians are trained to administer injections, and succeeding doses are given at home.
Patients are enrolled from 2 cohorts. An older cohort of ages 2 to 16 years receives PEG-Intron at the lowest drug level. If the dose is tolerated, patients are added and if safety criteria are met, patients are enrolled in the next higher dose level. The dose level will be increased similarly for up to 4 doses. An optimal dose level is chosen.
Cohort II patients are a younger group ranging from 3 months to under 2 years of age. Patients initially receive the next lower PEG-Intron dose to the optimal dose identified in Cohort I [AS PER AMENDMENT 07/23/01: or 1 microg/kg if the optimal dose proves to be 1 microg/kg]. If this dose is safely tolerated, additional patients are added. If this dose level meets safety criteria, patients are enrolled to receive the optimal dose level. Patients are evaluated with the same safety criteria as Cohort I. Patients in both cohorts who have at least a 0.5 log reduction in HIV RNA at 28 days of treatment are offered continued treatment for a total of 60 weeks.
Tipo de estudio
Inscripción
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Long Beach, California, Estados Unidos, 90801
- Long Beach Memorial (Pediatric)
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Los Angeles, California, Estados Unidos, 900276016
- Children's Hosp of Los Angeles/UCLA Med Ctr
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Los Angeles, California, Estados Unidos, 90033
- Los Angeles County - USC Med Ctr
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San Francisco, California, Estados Unidos, 941430105
- UCSF / Moffitt Hosp - Pediatric
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Connecticut
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Farmington, Connecticut, Estados Unidos, 060303805
- Connecticut Children's Med Ctr
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Florida
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Jacksonville, Florida, Estados Unidos, 32209
- Univ of Florida Health Science Ctr / Pediatrics
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Miami, Florida, Estados Unidos, 33161
- Univ of Miami (Pediatric)
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 021155724
- Children's Hosp of Boston
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Springfield, Massachusetts, Estados Unidos, 01199
- Baystate Med Ctr of Springfield
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Worcester, Massachusetts, Estados Unidos, 016550001
- Univ of Massachusetts Med School
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New Jersey
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Newark, New Jersey, Estados Unidos, 071032714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
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New York
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New Hyde Park, New York, Estados Unidos, 11040
- Schneider Children's Hosp
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New York, New York, Estados Unidos, 10037
- Harlem Hosp Ctr
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Syracuse, New York, Estados Unidos, 13210
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
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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 may be eligible for this study if they:
- Are HIV-infected infants and children aged 3 months to 16 years.
- Have been on stable anti-HIV drugs for at least 16 weeks if over 6 months of age. Infants aged 3 to 6 months must be on stable anti-HIV drugs for at least 6 weeks. Children should be receiving at least 3 anti-HIV drugs.
- Have a viral load of more than 5,000 copies/ml.
- Have written informed consent from parent or guardian and, if able, can give written consent themselves.
- Are able to follow the schedule in the protocol.
- Have a parent/guardian who is willing to comply with study requirements.
- (This study has been changed to allow any combination of 3 anti-HIV drugs and to remove CD4 requirements.)
Exclusion Criteria
Patients will not be eligible for this study if they:
- Are breast-feeding or pregnant or not using birth control, if a female.
- Have abnormal thyroid activity.
- Have severe HIV symptoms.
- Have opportunistic (AIDS-related) infections or history of such infections within the preceding 2 months.
- Have participated in a clinical trial of an experimental drug in the previous month.
- Have a positive test result for hepatitis B or C.
- Have an allergy to E. coli.
- Have a mental disorder.
- Have a history of drug dependence and measure positive when screened.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Colaboradores
Investigadores
- Silla de estudio: Andrea Kovacs
- Silla de estudio: Katherine Luzuriaga
Fechas de registro del estudio
Fechas importantes del estudio
Finalización del estudio (Actual)
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 (Actual)
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
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Infecciones por VIH
- Agentes antiinfecciosos
- Agentes Antivirales
- Peginterferón alfa-2b
Otros números de identificación del estudio
- P1017
- 11652 (Identificador de registro: DAIDS ES Registry Number)
- PACTG P1017
- ACTG P1017
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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