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A Study of Ribavirin in the Treatment of Patients With AIDS and AIDS-Related Problems

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

Ribavirin

Medicamento
Quiénes están siendo reclutados

HIV Infections

A partir de 18 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 1 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To determine the maximum long-term dosage of ribavirin (RBV) that is safe and free of serious side effects in patients with AIDS or AIDS related illnesses. Also, to determine what effect different dosage levels have on biologic markers of efficacy, such as the amount of the AIDS virus (HIV) or number of T cells in the patient's blood. RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC). RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC). Patients are selected from three patient groups: * Patients with AIDS, who have not taken zidovudine (AZT) within 30 days of entry into the study and who have not been discontinued from AZT because of intolerance. * Patients with AIDS related diseases who have not taken AZT within 30 days of entry into the study, and who have not been discontinued from AZT because of intolerance. * Patients with AIDS or AIDS related diseases who have had AZT intolerance that required cessation of therapy. This is an outpatient study; patients are seen weekly for the first 4 weeks, every other week through week 12, and then every 4 weeks for the duration of the 24 weeks of the treatment portion of the study. Patients from each of the three diagnostic groups are enrolled at each dose level. For the first 3 days after entry into the study, all patients receive the lowest dose of RBV every 6 hours. Subsequent dosages increase until the maximum tolerated dose (MTD) is reached. The MTD for a group is defined as the dose at which 4 or more of the 8 patients in the group develop toxicity which requires a change or discontinuation of the dosage. Patients who experience significant toxicity may continue in the study at lower dose to determine the long-term tolerance.

Título OficialA Multicenter Phase I Clinical Trial of Ribavirin in the Treatment of Patients With AIDS and Advanced AIDS Related Illnesses 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 1 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 96 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 18 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
HIV Infections
Criterios

Inclusion Criteria Concurrent Medication: Allowed: * Short-course therapy (7 days) with oral acyclovir. * Short-course therapy (7 days) with ketoconazole. * Topical medications. * Aerosolized pentamidine for prophylactic purposes. Concurrent Treatment: Allowed: * Blood transfusions for hemoglobin toxicity. Patients must have two positive HIV p24 antigen tests with titers = or \> 70 picograms at least 72 hours apart and within 1 month prior to entry, the last of which must be within 2 weeks of starting therapy. Prior Medication: Allowed: * Zidovudine (AZT), without cessation of therapy required due to intolerance. * AZT therapy must be discontinued at least 30 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: * Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or \> 3 liquid stools per day within the past week. Concurrent Medication: Excluded: * Ongoing systemic therapy and/or prophylaxis for an AIDS-defining opportunistic infection. * Antineoplastic therapy. * Other experimental medications. * Systemic chemoprophylaxis for Pneumocystis carinii pneumonia. * Chronic (\> 7 days) oral acyclovir therapy. Concurrent Treatment: Excluded: * Blood transfusions unless they are for = or \> grade 3 hemoglobin toxicity. Patients with the following are excluded: * Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to entry into the study, neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Significant diarrhea, defined as = or \> 3 liquid stools per day within the past week. Prior Medication: Excluded within 30 days of study entry: * Antiretroviral agents including zidovudine (AZT). * Biologic modifiers. * Systemic corticosteroids. Prior Treatment: Excluded within 2 months of study entry: * Blood transfusion except for those who have taken zidovudine (AZT) who may not have received a transfusion within the previous month. Active drug or alcohol abuse.



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 5 ubicaciones
Suspendido
Univ of California / San Diego Treatment CtrSan Diego, United StatesVer ubicación
Suspendido
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, United States
Suspendido
Harvard (Massachusetts Gen Hosp)Boston, United States
Suspendido
Bellevue Hosp / New York Univ Med CtrNew York, United States

Completado5 Centros de Estudio