- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00000963
A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine
A Randomized Comparative Trial of Two Doses of 2',3'-Dideoxyinosine (ddI) in Children With Symptomatic HIV Infection Who Are Either Unresponsive to Zidovudine and/or Who Are Intolerant to Zidovudine
To evaluate the effectiveness, safety, and tolerance of two doses of didanosine (ddI) in the treatment of children with symptomatic HIV disease who have had to discontinue zidovudine (AZT) because of intolerance and/or who have experienced progressive disease while on AZT.
The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.
Descripción general del estudio
Descripción detallada
The progression of immunodeficiency due to HIV infection can be delayed by using AZT. The benefits of AZT in adults with AIDS and severe AIDS-related complex (ARC) appear to last for approximately 12 to 18 months, at which time most patients have progressive deterioration. Recently published literature has described a reduced sensitivity of HIV isolated from patients after prolonged AZT treatment. Although the clinical significance of this is unclear, it makes the development of new antiretroviral drugs important.
Children who show AZT intolerance and/or progressive disease after 6 months of AZT therapy receive oral ddI at 1 of 2 doses for a minimum of 48 weeks, with a 48-week extension. Patients are seen for clinical and laboratory evaluations at scheduled times during the study. (Per 5/12/92 amendment, new patients will not be enrolled in the pharmacokinetics studies.) Per 10/31/94 amendment: Patients are eligible to receive blinded study drug for an additional 8-16 weeks after the final on-study visit, but no later than 2/15/95.
Tipo de estudio
Inscripción
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Long Beach, California, Estados Unidos, 90801
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
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Los Angeles, California, Estados Unidos, 90033
- Usc La Nichd Crs
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Los Angeles, California, Estados Unidos
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
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Oakland, California, Estados Unidos, 94609
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
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San Diego, California, Estados Unidos, 92093
- UCSD Maternal, Child, and Adolescent HIV CRS
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San Francisco, California, Estados Unidos, 94143
- UCSF Pediatric AIDS CRS
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Torrance, California, Estados Unidos
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
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Connecticut
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Farmington, Connecticut, Estados Unidos, 06032
- Univ. of Connecticut Health Ctr., Dept. of Ped.
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New Haven, Connecticut, Estados Unidos, 06504
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010
- Children's National Med. Ctr., ACTU
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Washington, District of Columbia, Estados Unidos, 20060
- Howard Univ. Washington DC NICHD CRS
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Florida
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Miami, Florida, Estados Unidos, 33161
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
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Georgia
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Atlanta, Georgia, Estados Unidos, 30306
- Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Cook County Hosp.
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Chicago, Illinois, Estados Unidos, 60614
- Chicago Children's CRS
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Chicago, Illinois, Estados Unidos, 60637
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
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Chicago, Illinois, Estados Unidos, 60612
- Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
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Louisiana
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New Orleans, Louisiana, Estados Unidos
- Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
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New Orleans, Louisiana, Estados Unidos
- Tulane/LSU Maternal/Child CRS
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
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Boston, Massachusetts, Estados Unidos, 02118
- BMC, Div. of Ped Infectious Diseases
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Springfield, Massachusetts, Estados Unidos, 01199
- Baystate Health, Baystate Med. Ctr.
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Worcester, Massachusetts, Estados Unidos, 01655
- WNE Maternal Pediatric Adolescent AIDS CRS
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Children's Hospital of Michigan NICHD CRS
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New Jersey
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New Brunswick, New Jersey, Estados Unidos
- UMDNJ - Robert Wood Johnson
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Paterson, New Jersey, Estados Unidos
- St. Joseph's Hosp. & Med. Ctr. of New Jersey
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New York
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Albany, New York, Estados Unidos, 12208
- Children's Hospital at Albany Medical Center, Dept. of Peds.
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Bronx, New York, Estados Unidos, 10457
- Bronx-Lebanon Hosp. IMPAACT CRS
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Brooklyn, New York, Estados Unidos, 11203
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
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Great Neck, New York, Estados Unidos, 11021
- North Shore-Long Island Jewish Health System, Dept. of Peds.
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New Hyde Park, New York, Estados Unidos, 11040
- Schneider Children's Hosp., Div. of Infectious Diseases
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New York, New York, Estados Unidos, 10032
- Columbia IMPAACT CRS
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New York, New York, Estados Unidos, 10037
- Harlem Hosp. Ctr. NY NICHD CRS
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New York, New York, Estados Unidos, 10016
- NYU Med. Ctr., Dept. of Medicine
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New York, New York, Estados Unidos, 10032
- Incarnation Children's Ctr.
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New York, New York, Estados Unidos, 10029
- Metropolitan Hosp. NICHD CRS
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Rochester, New York, Estados Unidos, 14642
- Univ. of Rochester ACTG CRS
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Stony Brook, New York, Estados Unidos, 11794
- SUNY Stony Brook NICHD CRS
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Med. Univ., Dept. of Peds.
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- DUMC Ped. CRS
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- Case CRS
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- The Children's Hosp. of Philadelphia IMPAACT CRS
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Philadelphia, Pennsylvania, Estados Unidos, 19134
- St. Christopher's Hosp. for Children
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
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Texas
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Dallas, Texas, Estados Unidos, 75235
- Children's Med. Ctr. Dallas
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Houston, Texas, Estados Unidos, 77030
- Texas Children's Hosp. CRS
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Washington
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Seattle, Washington, Estados Unidos, 98105
- UW School of Medicine - CHRMC
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Bayamon, Puerto Rico, 00956
- Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
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San Juan, Puerto Rico
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
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San Juan, Puerto Rico, 00936
- San Juan City Hosp. PR NICHD CRS
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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
Concurrent Medication:
Allowed:
- Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).
- Immunoglobulin.
- Maintenance therapy with amphotericin B (l mg/kg) up to 5 days/week.
Concurrent Treatment:
Allowed:
- Blood transfusions.
Prior Medication:
Allowed:
- Prophylaxis treatment for Pneumocystis carinii pneumonia (PCP).
Patients enrolled in ACTG 128 and ACTG 138 must meet study end points or meet protocol definitions for being permanently off zidovudine (AZT) before enrolling in this study.
- Patients currently enrolled in ACTG 051 who have not reached the study end points but who meet the entry criteria for ACTG 144 may be co-enrolled in ACTG 144.
- Patient or guardian available to give written informed consent.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded.
- Hypersensitivity to didanosine (ddI).
- Symptomatic cardiomyopathy.
- Seizures that are not well controlled by ongoing anticonvulsant therapy.
- Symptomatic pancreatitis.
- Grade 1 or higher peripheral neuropathy.
- Active malignancy requiring chemotherapy.
Concurrent Medication:
Excluded:
- Zidovudine (AZT), other antiretroviral agents, biological modifiers, and investigational medications.
Avoid:
- Drugs with potential to cause peripheral neuropathy or pancreatitis.
Patients with the following are excluded:
- Active malignancy requiring concomitant chemotherapy.
Prior Medication:
Excluded:
- Antiretroviral agents other than zidovudine (AZT) or dideoxycytidine (ddC) within 4 weeks of study entry.
- Immunomodulating agents such as interferons, isoprinosine, or interleukin-2 within 2 weeks of entry.
- Any other experimental therapy within 1 week of entry.
- Drugs that have or will cause prolonged neutropenia, significant pancreatitis, significant nephrotoxicity, or peripheral neuropathy within 1 week of entry.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Colaboradores
Investigadores
- Silla de estudio: Frenkel LM
- Silla de estudio: Bryson Y
- Silla de estudio: Stiehm R
Publicaciones y enlaces útiles
Publicaciones Generales
- Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.
- Carey VJ, Yong F, Frenkel L, McKinney R. Enhancing the prognostic value of bodily growth histories in HIV-positive pediatric cohorts. Int Conf AIDS. 1996 Jul 7-12;11(2):134 (abstract no WeC3444)
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 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
- Enfermedades de virus lentos
- Infecciones por VIH
- Infecciones
- Síndrome de inmunodeficiencia adquirida
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de la transcriptasa inversa
- Inhibidores de la síntesis de ácidos nucleicos
- Inhibidores de enzimas
- Agentes Anti-VIH
- Agentes antirretrovirales
- Antimetabolitos
- Didanosina
Otros números de identificación del estudio
- ACTG 144
- 11119 (DAIDS ES Registry Number)
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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