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A Randomized, Comparative, Double-Blind Trial of Trimetrexate (CI-898) With Leucovorin Calcium Rescue Versus Trimethoprim / Sulfamethoxazole for Moderately Severe Pneumocystis Carinii Pneumonia in Patients With AIDS

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Qué se está evaluando

Colección de datos

Quiénes están siendo reclutados

Complejo Relacionado con el SIDA+22

+ Enfermedades Transmisibles

+ Enfermedades Urogenitales

A partir de 12 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 3
Intervencional
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

New treatments are needed to reduce the mortality rate from PCP in AIDS patients and to reduce the high relapse rate found after conventional therapy. Trimetrexate (TMTX) was chosen for this trial because it was found to be much more potent than sulfamethoxazole/trimethoprim (SMX/TMP) against the PCP organism in laboratory tests. Also TMTX, in combination with leucovorin (LCV), did not cause severe toxicity in a preliminary trial. It is believed that TMTX will be more effective than SMX/TMP in treating PCP and in preventing a recurrence of PCP. Preliminary studies suggest that aerosolized pentamidine (PEN) is likely to be effective in preventing a recurrence of PCP. Patients entered in the study are randomly assigned to TMTX / LCV or to SMX/TMP for a 21-day trial. For the first 10 days, the trial is double-blind (neither patient nor physician knows which drugs the patient is receiving), and drugs are given by intravenous infusion. TMTX is given once every 24 hours and LCV every 6 hours; SMX/TMP is given every 6 hours. Doses are determined by body size. After the first 10 days, LCV and SMX/TMP may be given orally. Doses are adjusted or treatment is changed to intravenous PEN if side effects are too severe. During the 21-day trial, zidovudine (AZT) may not be used because of possible increased bone marrow toxicity. AZT may be resumed as soon as the patient's white cell count is acceptable. Aerosolized PEN therapy is begun 7 - 10 days after completion of therapy for the acute episode. PEN is inhaled once weekly for 4 weeks, then every 2 weeks for 48 weeks.

Título OficialA Randomized, Comparative, Double-Blind Trial of Trimetrexate (CI-898) With Leucovorin Calcium Rescue Versus Trimethoprim / Sulfamethoxazole for Moderately Severe Pneumocystis Carinii Pneumonia in Patients With AIDS
NCT00001013
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 28 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 364 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 12 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

Complejo Relacionado con el SIDAEnfermedades TransmisiblesEnfermedades UrogenitalesSíndrome de Inmunodeficiencia AdquiridaInfecciones Transmitidas por la SangreEnfermedades GenitalesInfecciones Bacterianas y MicosisEnfermedades del sistema inmunitarioSíndromes de Deficiencia InmunológicaInfeccionesEnfermedades Pulmonares FúngicasEnfermedades del pulmónMicosisInfecciones OportunistasNeumoníaNeumonía por PneumocystisInfecciones del Tracto RespiratorioEnfermedades del Tracto RespiratorioInfecciones por RetroviridaeInfecciones por virus de ARNEnfermedades de Transmisión SexualEnfermedades por virus lentoEnfermedades ViralesEnfermedades de transmisión sexual, viralesInfecciones por VIH

Criterios

Inclusion Criteria Concurrent Medication: Allowed: * Acetaminophen: * 650 mg prescribed as necessary for temperature \> 38.7 degrees C. Acetaminophen should not be prescribed as a standing order for more than 48 hours. Prior Medication: Allowed: * Zidovudine (AZT) as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed and the patient's white blood cell count is acceptable. * Other myelosuppressive therapies which may be handled in the same manner as AZT. * Prophylaxis for Pneumocystis carinii pneumonia (PCP). * Unequivocal diagnosis of Pneumocystis carinii pneumonia (PCP) by morphologic confirmation of three or more typical P. carinii organisms in sputum, bronchoalveolar lavage fluid, or lung tissue obtained by transbronchial or open-lung biopsy within 3 days before or after randomization. If morphologic confirmation is not possible prior to therapy, patients may be randomized if the investigator believes there is a high suspicion of PCP based on clinical presentation. If morphologic diagnosis cannot be established within 6 days of randomization, the patient will be withdrawn from study therapy. Resting (A-a) DO2 \< 30 torr on room air. Patient, parent, guardian, or person with power of attorney gives informed consent. Exclusion Criteria Co-existing Condition: Patients will be excluded for the following reasons: * History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reaction secondary to antibiotics containing sulfa, trimethoprim, or trimetrexate. * History of life-threatening pentamidine toxicity. Concurrent Medication: Excluded: * Other drugs for the treatment or prevention of AIDS or Pneumocystis carinii pneumonia (PCP). * Disalcid. * Aspirin. * Acetaminophen q4h as a standing order for more than 48 hours. Prior Medication: Excluded within 14 days of study entry: * Systemic steroids exceeding physiological replacement. * Other investigational drugs including ganciclovir. * Excluded within 6 weeks of study entry: * Another antiprotozoal regimen for this episode for therapy of active Pneumocystis carinii pneumonia (PCP). * Patients who are unable to have arterial blood gas analysis (ABG's) on room air. * Patients for whom a liter of intravenous fluid (5 percent dextrose in water) per 24 hours, which is required to maintain blinding, would be medically inadvisable.

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 23 ubicaciones

Suspendido

Los Angeles County - USC Med Ctr

Los Angeles, United StatesAbrir Los Angeles County - USC Med Ctr en Google Maps
Suspendido

George Washington Univ Med Ctr

Washington D.C., United States
Suspendido

Univ of Miami School of Medicine

Miami, United States
Suspendido

Northwestern Univ Med School

Chicago, United States
Completado23 Centros de Estudio