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A Phase I Concentration-Targeted Multidose Study of Atevirdine Mesylate ( U-87201E ), AZT, and ddI or ddC

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Qué se está evaluando

Atevirdine mesylate

+ Zidovudine

+ Zalcitabine

Medicamento
Quiénes están siendo reclutados

Infecciones Transmitidas por la Sangre+13

+ Enfermedades Urogenitales

+ Enfermedades Genitales

A partir de 13 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 4 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Since the use of non-nucleoside reverse transcriptase inhibitors such as U-87201E has been associated with the rapid development of resistant HIV isolates, an initial evaluation of this drug in patients was made in combination with AZT. Because of the inability to detect resistance after 6 weeks of combined AZT/U-87201E therapy, this protocol will initially investigate U-87201E administered alone and then investigate the effect of this drug with AZT and ddI or ddC. Ten patients are treated at each of three targeted concentration ranges of U-87201E. Patients in the second cohort are enrolled immediately after patients in the first cohort are accrued; patients in the third cohort are enrolled when 5 of 10 patients in the second cohort have tolerated that dose for at least 4 weeks. The MTD will be the dose below that which produces dose-limiting grade 3 or 4 toxicity in five out of 10 patients. At least two women and five antiretroviral naive patients must be enrolled in each dose concentration range. Patients receive at least 8 weeks of monotherapy with U-87201E, with possible extension to at least 24 weeks with the same dose of U-87201E alone or in combination with zidovudine plus either ddI or ddC. Patients are followed weekly for at least 8 weeks and, if applicable, at weeks 10, 12, 16, 20, and 24 and monthly thereafter, up to 1 month following the last dose. Patients on combination therapy will have an indwelling venous catheter inserted for the first 2 days of combination therapy. Per 10/15/93 amendment, if no MTD is established with the first three cohorts, then 10 additional patients will be enrolled at a fourth concentration.

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 4 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 30 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 13 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Infecciones Transmitidas por la SangreEnfermedades UrogenitalesEnfermedades GenitalesEnfermedades TransmisiblesSíndromes de Deficiencia InmunológicaEnfermedades del sistema inmunitarioInfeccionesInfecciones por RetroviridaeInfecciones por virus de ARNEnfermedades de Transmisión SexualEnfermedades por virus lentoEnfermedades ViralesEnfermedades de transmisión sexual, viralesSíndrome de Inmunodeficiencia AdquiridaComplejo Relacionado con el SIDAInfecciones por VIH

Criterios

Inclusion Criteria Concurrent Medication: Allowed: PCP prophylaxis with pentamidine, TMP/SMX, or dapsone (if appropriate). Clotrimazole troches or nystatin oral suspension for oral candidiasis. Acyclovir (up to 1000 mg/day) for herpes lesions. Supportive care as deemed necessary for toxicities . Patients must have: HIV infection. CD4 count <= 500 cells/mm3. No active opportunistic infections. Consent of parent, guardian, or person with power of attorney, if less than 18 years of age. NOTE: Participation of women in the study is encouraged. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Acute medical problems, including opportunistic infections (e.g., active cryptococcosis, Pneumocystis carinii, herpes zoster, histoplasmosis, and CMV) or nonopportunistic diseases (e.g., liver or renal disease or lymphoma). Current diagnosis of malignancy for which systemic therapy would be required during the study. Active gastrointestinal disorders. Concurrent Medication: Excluded: Investigational drugs. Systemic therapy for malignancy. Phenobarbital, phenytoin, ketoconazole, rifampin, rifabutin, cimetidine, beta blockers, chronic antacids, antiarrhythmic agents, or other medications known to affect cardiac conduction or seizure threshold. Patients with the following prior conditions are excluded: History of any cardiovascular disease, including conduction disturbances, arrhythmias or atherosclerotic heart disease. History of CNS disease such as seizure disorder, AIDS Dementia Complex, progressive multifocal leukoencephalopathy, or any other active neurological disorder. History of chronic gastrointestinal disorders such as chronic diarrhea (> 4 weeks duration). Prior Medication: Excluded: Antiretroviral or immunomodulator agents (such as AZT, ddI, ddC, interferon, etc.) within 15 days prior to study entry. Cytotoxic chemotherapy within 1 month prior to study entry. Prior U-87201E or other non-nucleoside reverse transcriptase inhibitors (i.e., nevirapine, TIBO, L697,661). Present use of alcohol or illicit drugs.

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 6 ubicaciones

USC CRS

Los Angeles, United StatesAbrir USC CRS en Google Maps

Univ. of Miami AIDS CRS

Miami, United States

St. Louis ConnectCare, Infectious Diseases Clinic

St Louis, United States

Washington U CRS

St Louis, United States
Completado6 Centros de Estudio