- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00000628
A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine
Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661.
L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
Part 1: Twelve patients are randomly assigned to one of two groups. Group 1 patients receive AZT for 7 days, followed by AZT plus L-697,661 with food for 56 days. Group 2 patients receive no drug for 7 days, followed by L-697,661 with food for 56 days. Antipyrine is administered 1 hour prior to study drug on days 8, 22, and 35.
Part 2: Fifteen patients receive L-697,661 with food, for 8 weeks. Therapy with L-697,661 may be extended beyond 8 weeks for up to 24 weeks.
Tipo de estudio
Inscripción
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 941102859
- San Francisco Gen Hosp
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Colorado
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Denver, Colorado, Estados Unidos, 80262
- Univ of Colorado Health Ctr / Denver Gen Hosp
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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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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
Patients must have:
- HIV infection.
Prior Medication: Included:
- Patients in Part 1 must have received no previous zidovudine (AZT) or a stable dose of at least 500 mg/day without evidence of toxicity.
- Patients in Part 2 must have received no previous AZT or = or > 300 mg/day for < 6 consecutive weeks within 1 year prior to study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Acute HIV-related opportunistic infection requiring ongoing treatment.
- Diarrhea defined as 3 or more liquid stools/day for one week.
- Wilson's or Gilbert's disease, porphyria, or other chronic or acute hepatic disease.
- Potentially life-threatening allergic reactions to any of the components of zidovudine.
- Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study.
Concurrent Medication:
Excluded:
- Systemic bronchodilators, acetaminophen, aspirin.
Prior Medication:
Excluded:
- Didanosine (ddI) or dideoxycytidine (ddC) within 14 days prior to entry.
- Immune modulators or investigational drugs within 30 days prior to entry.
- Drugs known to induce hepatocellular enzymes, such as phenobarbital, phenytoin, warfarin, ketoconazole, and oral contraceptives, within 30 days prior to entry.
Patients in Part 2 only:
Excluded:
- Zidovudine within 4 weeks prior to receiving first dose of study drug.
Risk Behavior:
Excluded:
- Patients who the investigator feels would not comply with study requirements.
Patients may not have the following prior conditions:
- Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study.
- Potentially life-threatening allergic reactions to any of the components of zidovudine.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Modelo Intervencionista: Asignación paralela
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: RT Schooley
Publicaciones y enlaces útiles
Publicaciones Generales
- Kuritzkes DR, Curtis S, Rosandich M, Stein DS, Schooley RT. Delayed emergence of resistance to L-697,661 in patients receiving concomitant zidovudine. The ACTG 184 Study Team. Int Conf AIDS. 1993 Jun 6-11;9(1):467 (abstract no PO-B26-1994)
- Schooley RT, Campbell TB, Kuritzkes DR, Blaschke T, Stein DS, Rosandich ME, Phair J, Pottage JC, Messari F, Collier A, Kahn J. Phase 1 study of combination therapy with L-697,661 and zidovudine. The ACTG 184 Protocol Team. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Aug 1;12(4):363-70. doi: 10.1097/00042560-199608010-00006.
- Campbell TB, Routh JA, Bakhtiari M, Schooley RT, Kuritzkes DR. Detection of genotypic changes in reverse transcriptase during combination therapy with zidovudine and L-697,661. Detection of genotypic changes in reverse transcriptase during combination therapy with zidovudine and L-697,661. Int Conf AIDS. 1993 Jun 6-11;9(1):239 (abstract no PO-A26-0630)
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
- 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
- L-697661
Otros números de identificación del estudio
- ACTG 184
- Merck Protocol 020-00
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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