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Open Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Interferon beta-1b

+ Zidovudine
Medicamento
Quiénes están siendo reclutados

Sarcoma, Kaposi

+ HIV Infections
A partir de 12 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 2 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To determine the highest tolerated dose of the safety and tolerance of interferon beta (IFN-B) when it is given at the same time as zidovudine (AZT) to patients with early AIDS related Kaposi's sarcoma. In addition, the studies will determine preliminary data on response, immune function, and subcutaneous absorption. IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV reverse transcriptase; Phase I and II study benefits of AZT treatment include increased objective clinical improvement, decreased mortality rate, and decreased incidence of opportunistic infections. Long-term AZT use, however, presents possible limitations secondary to intolerance. This study, therefore, will investigate the potential antiviral activities of a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy consisting of low doses of each drug will reduce the potential of toxicity, treatment failures, and disease recurrences resulting from drug-resistant virus mutants. IFN-B has demonstrated a dose-dependent ability to suppress the replication of HIV in the test tube. In addition, previous studies have shown AZT to be an effective inhibitor of HIV reverse transcriptase; Phase I and II study benefits of AZT treatment include increased objective clinical improvement, decreased mortality rate, and decreased incidence of opportunistic infections. Long-term AZT use, however, presents possible limitations secondary to intolerance. This study, therefore, will investigate the potential antiviral activities of a combination of IFN-B and AZT to determine the safety and efficacy of such treatment in patients with AIDS related Kaposi's sarcoma. It is believed that combination drug therapy consisting of low doses of each drug will reduce the potential of toxicity, treatment failures, and disease recurrences resulting from drug-resistant virus mutants. Patients undergo evaluations to determine the extent of their disease and the status of their immune system. Patients then receive IFN-B subcutaneously once a day at one of three different dose levels. Patients also take AZT at 1 of 2 doses. The first 12 patients are treated with the lower dose of AZT. The first 4 patients are entered at level 1 of IFN-B. If no dose-limiting toxicity is seen in these 4 patients after 2 weeks of therapy, 4 patients are then enrolled at level 2 of IFN-B. The study proceeds in this manner until the highest tolerated dose or level 3 is reached. If both drugs are tolerated, patients then remain on both medications as long as they continue to tolerate the medications and show some improvement in either antiviral response, immune response, or clinical response for as long as 24 weeks. The initial three doses of IFN-B are given to each patient at the study site during which time the patient is trained to self-administer the IFN-B. Patients are then seen weekly for 4 months and every 2 weeks thereafter.

Título OficialOpen Label Phase I Study To Evaluate the Safety of Combination Therapy With AZT and Interferon-Beta in Patients With AIDS Related Kaposi's Sarcoma 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 2 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 36 pacientesNúmero 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.

Cómo se mantiene la confidencialidad de las intervenciones asignadas a los participantes
Todos los involucrados en el estudio saben qué tratamiento se está administrando. Esto se utiliza cuando no es posible o necesario ocultar los detalles del tratamiento a los participantes o investigadores.

Otras formas de enmascarar la información
Simple ciego
: Los participantes no saben qué tratamiento están recibiendo, pero los investigadores sí.

Doble ciego
: Ni los participantes ni los investigadores saben qué tratamiento se está administrando.

Triple ciego
: Participantes, investigadores y evaluadores de resultados no saben qué tratamiento se está administrando.

Cuádruple ciego
: Participantes, investigadores, evaluadores de resultados y personal de atención no saben qué tratamiento se está administrando.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
A partir de 12 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
Sarcoma, Kaposi
HIV Infections
Criterios

Inclusion Criteria Concurrent Treatment: Allowed: * Local radiotherapy or laser therapy to cosmetically apparent Kaposi's lesions, provided the dose to any one lesion does not exceed 3000 gray and the total surface area of all lesions treated does not exceed 10 cm2 during the course of the trial. Patients must demonstrate the following clinical and laboratory findings: * Positive for HIV by federally licensed ELISA test. * Acceptable bone marrow function. * Acceptable renal function. * Acceptable hepatic function. Exclusion Criteria Concurrent Medication: Excluded: * Other potentially antiretroviral compounds. Patients will be excluded from the study for the following reasons: * Concurrent, active opportunistic infections requiring therapy. * Extensive Kaposi's sarcoma with more than 100 cutaneous lesions, requiring systemic chemotherapy, prior treatment with more than one chemotherapy regimen, excluding intralesional therapy, or symptomatic visceral Kaposi's sarcoma. * Evidence of clinically significant cardiac dysfunction (New York Heart Association grade III or IV). * History of malignant neoplasms other than nonmelanomatous skin cancer or cancer in situ of the cervix. * Proteinuria of 2+ or greater and/or 24-hour urine protein of greater than 1. Prior Medication: Excluded: * More than one chemotherapy regimen for Kaposi's sarcoma. * Any interferon preparation or zidovudine (AZT). * Excluded within 30 days of study entry: * Other immunomodifiers. * Acyclovir. * Other investigational drugs. * Excluded within 60 days of study entry: * Cytotoxic therapy. Patients may not have any of the following diseases or symptoms: * Development of an AIDS-defining opportunistic infection, other than oral thrush or localized zoster. * Non-Kaposi's sarcoma, AIDS-defining malignancy.



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 4 ubicaciones
Suspendido
Los Angeles County - USC Med CtrLos Angeles, United StatesVer ubicación
Suspendido
USC School of Medicine / Norris Cancer HospLos Angeles, United States
Suspendido
UCLA CARE CtrLos Angeles, United States
Suspendido
Northwestern Univ Med SchoolChicago, United States

Completado4 Centros de Estudio