Completado

Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis

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

Sulfamethoxazole-Trimethoprim

Medicamento
Quiénes están siendo reclutados

Pneumonia, Pneumocystis Carinii

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

Estudio de Tratamiento

Fase 4
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 determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces the incidence of treatment-limiting adverse reactions compared to the routine initiation of the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients. Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred. Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred. Patients are randomized to receive either gradually increasing doses of SMX/TMP suspension or routine daily initiation of SMX/TMP double strength (DS) tablets for 2 weeks. All patients will then be switched over to receive open-label SMX/TMP DS tablets daily for 10 weeks.

Título OficialGradual Initiation of Trimethoprim/Sulfamethoxazole as Primary Pneumocystis Carinii Pneumonia Prophylaxis 
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 370 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.

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 if clinically indicated: * Recombinant erythropoietin (rEPO) and G-CSF. Allowed for symptomatic treatment of mild study drug toxicity: * Antipyretics and analgesics (ibuprofen). * Antihistamines (diphenhydramine HCl). * Terfenadine or astemizole (but not allowed with concomitant antifungal or macrolide use). * Systemic steroids. Patients must have: * HIV infection. * CD4 count \<= 250 cells/mm3 OR history or presence of thrush. * No history of confirmed or probable pneumocystosis. NOTE: * Pregnant women are not excluded, but safety issues should be discussed with patient prior to enrollment. * This study is appropriate for prisoner participation. * Coenrollment in ongoing ACTG antiretroviral studies is permitted provided no new study drugs are added to the patient's drug regimen for 4 weeks before or after initiation of SMX/TMP. Prior Medication: Allowed: * Prior aerosolized pentamidine and dapsone for primary PCP prophylaxis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Known adverse reactions to sulfa, trimethoprim, or SMX/TMP. * Inability to comply with dosing schedule or complete dosing record. Concurrent Medication: Excluded: * Procysteine. * Glutathione. * N-acetylcysteine (NAC). * Antihistamines (unless used for symptomatic treatment of study drug toxicity). * Systemic corticosteroids (unless used for replacement purposes). * Leucovorin calcium (unless used for symptomatic treatment of study drug toxicity). * TMP or sulfa drugs outside of the study. Prior Medication: Excluded at any time: * Prior SMX/TMP as primary PCP prophylaxis. Excluded within 4 weeks prior to study entry: * Initiation of antiretroviral agents. * Initiation of anti-infective agents (including SMX/TMP for another indication). Excluded within 2 weeks prior to study entry: * Antihistamines. * Procysteine. * Glutathione. * N-acetylcysteine (NAC). * Systemic corticosteroids (unless used for replacement purposes). * Leucovorin calcium. * TMP and sulfa drugs separately.



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 42 ubicaciones
Suspendido
USC CRSLos Angeles, United StatesVer ubicación
Suspendido
Stanford CRSPalo Alto, United States
Suspendido
Ucsf Aids CrsSan Francisco, United States
Suspendido
Santa Clara Valley Med. Ctr.San Jose, United States

Completado42 Centros de Estudio