A Randomized, Comparative, Prospective Study of Monthly Aerosolized Pentamidine and Thrice Weekly Dapsone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant to Trimethoprim and/or Sulfonamides
Colección de datos
Complejo Relacionado con el SIDA+21
+ Enfermedades Transmisibles
+ Enfermedades Urogenitales
Estudio de Tratamiento
Resumen
Both aerosolized pentamidine and dapsone have been shown to prevent PCP, but both drugs cause side effects. This study attempts to determine which drug is more efficacious as prophylaxis against PCP in patients who cannot tolerate trimethoprim/sulfamethoxazole. Patients are evenly divided between two treatment arms to receive either aerosolized pentamidine every 4 weeks or dapsone orally three times weekly. Follow-up data is collected every 3 months, and patients are clinically evaluated every 6 months. Patients who develop PCP or a severe or persistent study drug toxicity may be switched to the alternative study drug at the clinician's discretion. Average duration of follow-up is 2 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 400 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.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
Criterios
Inclusion Criteria Patients must have: * HIV infection. * CD4 count \<= 200 cells/mm3 or \<= 15 percent of total lymphocytes OR a history of prior PCP. * History of intolerance to trimethoprim and/or sulfonamides. * No active pneumocystosis. Patient or guardian must sign informed consent. Pregnant patients are eligible at the clinician's discretion. Patients who do not meet required laboratory values may be eligible at the discretion of the clinician. Exclusion Criteria Concurrent Medication: Excluded: * Any medication with potential anti-PCP activity. Patients with the following prior conditions are excluded: * Treatment-limiting reaction to pentamidine or dapsone.
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 14 ubicaciones
Community Consortium of San Francisco
San Francisco, United StatesAbrir Community Consortium of San Francisco en Google MapsDenver CPCRA / Denver Public Hlth
Denver, United StatesWilmington Hosp / Med Ctr of Delaware
Wilmington, United StatesVeterans Administration Med Ctr / Regional AIDS Program
Washington D.C., United States