- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00001025
Evaluation of Patients Who Have Not Had Success With Zidovudine
A Study to Evaluate the Short-Term Clinical and Virologic Significance of Zidovudine Resistance
To determine the relationship of viral susceptibility to zidovudine (AZT) and baseline viral load (as determined by plasma viremia and quantitative endpoint dilution). To determine the relationship between viral load and susceptibility during different antiretroviral therapy strategies. To correlate measures of viral load and short term clinical and laboratory markers (such as weight, CD4 count, p24 antigenemia, and beta2 microglobulin) on the different therapy arms.
High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent of individuals with AIDS who received AZT for at least 1 year. To elucidate the clinical significance of in vitro AZT resistance, it is necessary to distinguish between clinical failure caused by AZT resistance and clinical decompensation caused by other factors.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent of individuals with AIDS who received AZT for at least 1 year. To elucidate the clinical significance of in vitro AZT resistance, it is necessary to distinguish between clinical failure caused by AZT resistance and clinical decompensation caused by other factors.
One hundred-twenty patients who have been receiving AZT for at least 1 year are randomized to 1) continue with AZT, 2) switch to treatment with didanosine at 1 of 2 doses, or 3) receive both AZT and ddI. Treatment is given for 16 weeks, with a possible extension to 32 weeks. Patients are followed at weeks 2, 4, 8, 12, and 16. For analysis purposes only, patients are stratified according to degree of susceptibility of HIV isolates to AZT.
Tipo de estudio
Inscripción
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- Univ of Alabama at Birmingham
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California
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San Francisco, California, Estados Unidos, 941102859
- San Francisco Gen Hosp
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San Jose, California, Estados Unidos, 951282699
- Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
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Stanford, California, Estados Unidos, 943055107
- San Mateo AIDS Program / Stanford Univ
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Colorado
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Denver, Colorado, Estados Unidos, 80262
- Univ of Colorado Health Sciences Ctr
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Denver, Colorado, Estados Unidos, 80262
- Kaiser Permanente Franklin Med Ctr
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern Univ Med School
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Chicago, Illinois, Estados Unidos, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
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Chicago, Illinois, Estados Unidos, 60612
- Cook County Hosp
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Chicago, Illinois, Estados Unidos, 60611
- Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
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Massachusetts
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Springfield, Massachusetts, Estados Unidos, 01199
- Baystate Med Ctr of Springfield
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- Univ of Minnesota
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Nebraska
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Omaha, Nebraska, Estados Unidos, 681985130
- Univ of Nebraska Med Ctr
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New York
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Brooklyn, New York, Estados Unidos, 112032098
- SUNY / Health Sciences Ctr at Brooklyn
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Buffalo, New York, Estados Unidos, 14215
- SUNY / Erie County Med Ctr at Buffalo
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Rochester, New York, Estados Unidos, 14642
- Univ of Rochester Medical Center
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Syracuse, New York, Estados Unidos, 13210
- SUNY / State Univ of New York
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Washington
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Seattle, Washington, Estados Unidos, 981224304
- Univ of Washington
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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:
- Chemoprophylaxis against Pneumocystis carinii pneumonia (PCP), Mycobacterium tuberculosis, or Herpes simplex virus, or against other opportunistic infections as indicated.
- Corticosteroids for no longer than 21 days (only as part of PCP therapy).
- Erythropoietin and G-CSF.
Patients must have:
- Documented HIV-seropositivity.
- CD4 count 100 - 300 cells/mm3.
- Prior continuous AZT dose = or > 300 mg/day for 1 year or longer.
Prior Medication: Required:
- AZT for at least 1 year prior to study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Medical contraindication or is considered noncompliant in the opinion of the investigator.
- Peripheral neuropathy = or > grade 2.
Concurrent Medication:
Excluded:
- Anti-HIV agents other than study drugs.
- Biologic response modifiers (other than erythropoietin or G-CSF).
- Systemic cytotoxic chemotherapy.
- Regularly prescribed medications (such as antipyretics, analgesics, allergy medications) that are associated with an increased risk of pancreatitis, peripheral neuropathy, or bone marrow suppression.
Concurrent Treatment:
Excluded:
- Radiation therapy.
Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis, gout, or uric acid nephropathy.
Prior Medication:
Excluded:
- Other antiretrovirals besides AZT.
- ddI or ddC for more than 30 days within the past year or any time within 3 months prior to study entry.
- Acute therapy for an infection or other medical illness within 14 days prior to study entry.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Investigadores
- Silla de estudio: Coombs R
- Silla de estudio: Cavert W
Publicaciones y enlaces útiles
Publicaciones Generales
- Cavert W, Coombs RW, Kuritzkes D, Grimes J, Stein D, Rojo W, Beatty C, Winters M, Corey L. Baseline zidovudine (ZDV) susceptibility, codon 215 mutation, viral load and syncytium-inducting characteristics(SI) of HIV isolates from ACTG protocol 194. Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:137
- Reichelderfer PS, Coombs RW. Multifactorial analysis of the inverse relationship between viral load and CD4+ cell count. Int Conf AIDS. 1996 Jul 7-12;11(2):277 (abstract no ThB4148)
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
- 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
- Zidovudina
- Didanosina
Otros números de identificación del estudio
- ACTG 194
- 11170 (Identificador de registro: 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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