Completado

A Randomized, Double-Blind Study of 566C80 Versus Septra (Trimethoprim/Sulfamethoxazole) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients

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

Colección de datos

Quiénes están siendo reclutados

Infecciones Bacterianas y Micosis+6

+ Infecciones

+ Enfermedades Pulmonares Fúngicas

A partir de 13 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 18 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients. Patients are randomized into one of two treatment groups to receive either (1) 566C80 for 21 days, or (2) SMX/TMP for 21 days. Patients will be stratified according to severity of PCP. Group A will be those with an arterial-alveolar (A-a) DO2 < 35 mm Hg. Group B will have an A-a DO2 of 35-45 mm Hg., and will also be required to receive therapy with Corticosteroids. All doses are taken with food. During the 21 days of treatment, patients are examined clinically for adverse effects and have hematology (blood-related) and clinical chemistry studies conducted a minimum of 2 times weekly. More frequent monitoring may be required at the discretion of the investigator. To evaluate the effectiveness of study medication, the clinical status of each patient is evaluated 2 to 3 times per week (e.g., dyspnea score, cough score, chest tightness/pain score, vital signs). Also, on days 7 and 21 of treatment, an arterial blood gas measurement and chest X-ray are performed. Patients who experience severe toxicities will be discontinued from the study and placed on alternative therapy. Patients will also be removed from study if they show significant clinical deterioration within the first 7 days of therapy or if there is no improvement after 10 days of therapy. This study involves a double placebo with one group randomized to receive oral 566C80 and placebo tablets which look like SMX/TMP while the other group will receive SMX/TMP and placebo tablets looking like 566C80.

Título OficialA Randomized, Double-Blind Study of 566C80 Versus Septra (Trimethoprim/Sulfamethoxazole) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients 
NCT00000655
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 18 de enero de 2026
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 300 pacientes

Número 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 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

Infecciones Bacterianas y MicosisInfeccionesEnfermedades Pulmonares FúngicasEnfermedades del pulmónMicosisNeumoníaNeumonía por PneumocystisInfecciones del Tracto RespiratorioEnfermedades del Tracto Respiratorio

Criterios

Inclusion Criteria Patient must have the following: * Presumptive diagnosis of AIDS as defined by the CDC. * Untreated Pneumocystis carinii pneumonia (PCP). * Willingness and ability to give informed consent. Prior Medication: Allowed: * Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) including aerosolized pentamidine or sulfamethoxazole/trimethoprim (SMX/TMP) (at a dose no greater than two DS tablets twice daily). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Judged by the investigator to be in impending respiratory failure. * Malabsorption or vomiting that would, in the judgment of investigator, potentially limit the retention and absorption of an oral therapy. * Concurrent bacterial, fungal, or viral pneumonitis, pulmonary Kaposi's sarcoma or other concurrent illness, or chronic pulmonary disease that, in the investigator's opinion, would make interpretation of drug efficacy difficult. Concurrent Medication: Excluded: * Corticosteroid treatment (except replacement therapy or patients in Group B). * Ganciclovir. * Zidovudine (AZT). * Investigational agents including antiretroviral agents (didanosine (ddI), dideoxycytidine (ddC), etc.). Drugs likely to have anti-pneumocystis effect such as: * Sulfonamides. * Pentamidine. * Dapsone. * Trimethoprim. * Other DHFR inhibitors. * Primaquine. * Clindamycin. * Sulfonylureas. Patients with the following are excluded: * Judged by the investigator to be in impending respiratory failure. * Prior therapy for this episode of PCP or treatment within 4 weeks of entry for a prior episode of PCP. * Unable to or refuse to discontinue zidovudine, ganciclovir, or other antiretroviral agents during the 21 day treatment period. * Unable to take medication orally or unwilling or unable to take study medication with food. * Significant psychosis or emotional disorder such that, in the investigator's opinion, the patient would not be compliant with the study protocol. * Prior documented glucose-6-phosphate dehydrogenase (G6PD) deficiency. * Prior history of life-threatening toxicity to SMX/TMP such as severe rash or Stevens-Johnson syndrome. Prior Medication: Excluded: * Prior therapy for this episode of Pneumocystis carinii pneumonia (PCP) or treatment within 4 weeks for a prior episode of PCP. * Blood transfusions.

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 38 ubicaciones

Suspendido

Univ of Alabama at Birmingham

Birmingham, United StatesVer ubicación
Suspendido

Kaiser Foundation Hosp

Harbor City, United States
Suspendido

USC

Los Angeles, United States
Suspendido

Dr Richard Meyer

Los Angeles, United States
Completado38 Centros de Estudio