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A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients

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

Pentamidine isethionate

+ Sulfamethoxazole-Trimethoprim
+ Dapsone
Medicamento
Quiénes están siendo reclutados

Pneumonia, Pneumocystis Carinii

+ HIV Infections
A partir de 13 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 3
Intervencional

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

To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with HIV infection and T4 cell count less than 200 cells/mm3. All persons completing at least 8 weeks of therapy on 081 will be offered the opportunity to participate in the nested study (ACTG 981) of systemic antifungal therapy (fluconazole) versus local therapy (Clotrimazole) for the prevention of serious fungal disease. Persons with HIV disease who are receiving AZT are at risk for PCP, toxoplasmosis, bacterial pneumonia, and other serious infections. It is therefore important to find drugs that can be given along with AZT to control these infections. Aerosolized pentamidine (PEN) has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP. Both sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective preventive treatment against PCP, and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis. Persons with HIV disease who are receiving AZT are at risk for PCP, toxoplasmosis, bacterial pneumonia, and other serious infections. It is therefore important to find drugs that can be given along with AZT to control these infections. Aerosolized pentamidine (PEN) has been shown to be useful in preventing PCP and is expected to lower the 2-year risk of PCP. Both sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective preventive treatment against PCP, and both may be useful in preventing toxoplasmosis and extrapulmonary pneumocystosis. All patients receive AZT. In addition, they are placed in one of three groups to receive either SMX/TMP, dapsone, or PEN. Stratification criteria are: Received first AZT equal to or less than 6 weeks prior to study entry. Received first AZT more than 6 weeks prior to study entry. Potential to participate in ACTG 981. ACTG center in which the patient is enrolled.

Título OficialA Randomized Trial of Three Anti-Pneumocystis Agents Plus Zidovudine for the Primary Prevention of Serious Infections in Patients With Advanced HIV Infection 
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 600 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 13 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
Pneumonia, Pneumocystis Carinii
HIV Infections
Criterios

Inclusion Criteria Concurrent Medication: Allowed: * Antifolate medication required to treat an intercurrent infection. * Treatment of intercurrent infections or malignancies. * Fluconazole. * Itraconazole. * Standard or investigational therapy for pneumocystosis (PCP) or toxoplasmosis. * Only the forms of primary prophylaxis for PCP or toxoplasmosis assigned to the participant under the protocol. Patients who develop intolerance to all forms of prophylaxis assigned in this protocol or who develop PCP or toxoplasmosis may receive alternate or investigation forms of prophylaxis with or without zidovudine but must continue to be followed under this protocol. * Discouraged but allowed: AL-721. * Chronic acyclovir. * Ketoconazole. * Amphotericin B. * Corticosteroids at greater than physiologic replacement doses are strongly discouraged. * They should be used as briefly as possible and only for definite specific indications. Patient must conform to the following: * Receiving or candidates for zidovudine therapy at least 500 mg/day under current labeled indications with no history of pneumocystosis (PCP) or toxoplasmosis. * Evidence of HIV infection documented by HIV antibody tests. * T4 cell count less than 200 cells/mm3 at any time prior to study entry. * Willing to sign informed consent. * Willing to be followed by a participating ACTG center for duration of the study. * Allowed: Concurrent enrollment in long-term follow-up studies in previously blinded trials of AZT (ACTG 016 and 019). Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: * History of documented or presumed pneumocystosis (PCP) or toxoplasmosis. * Active bacterial or mycobacterial infection. * History of type I hypersensitivity, exfoliative rash, or rash with mucosal involvement, severe bronchospasm, or other life-threatening reaction to any of the study drugs or to other sulfas, sulfones, or pentamidine. * History of intolerance causing dose interruption while receiving zidovudine at equal to or less than 600 mg/day or causing dose reduction to less than 500 mg/day within 4 weeks prior to entry. * Advanced Kaposi's sarcoma or other malignancy not specifically allowed that has been rapidly progressive during the month prior to enrollment or which may be expected to require chemotherapy within 90 days of study entry. Concurrent Medication: Excluded: * Active primary treatment for an infection or malignancy. * Other form of antifolate medication not specifically allowed. * Other antiretroviral or biologic response modifier. * Ganciclovir, if it causes intolerance to AZT equal to or more than 500 mg/day. * Foscarnet. Patients with the following are excluded: * Symptoms and conditions defined in Exclusion Coexisting Conditions. * Glucose 6-phosphate dehydrogenase deficiency (GPD). * History of pneumocystosis (PCP) or toxoplasmosis. * History of type I hypersensitivity, exfoliative rash, or rash with mucosal involvement, severe bronchospasm, or other life-threatening reaction to any of the study drugs or to other sulfas, sulfones, or pentamidine. * History of intolerance causing dose interruption while receiving zidovudine at equal to or less than 500 mg/day with 4 weeks pior to study entry. Prior Medication: Excluded within 4 weeks of study entry: * Any other form of pneumocystosis (PCP) chemoprophylaxis. * Active substance abuse, including alcohol.



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 21 ubicaciones
Suspendido
USC CRSLos Angeles, United StatesVer ubicación
Suspendido
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.Oakland, United States
Suspendido
Ucsd, Avrc CrsSan Diego, United States
Suspendido
Univ. of Miami AIDS CRSMiami, United States

Completado21 Centros de Estudio