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A Phase II/III Prospective, Multicenter, Randomized, Controlled Trial Comparing the Safety and Efficacy of Three Clarithromycin-Containing Combination Drug Regimens for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Disease in Persons With AIDS

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Qué se está evaluando

Colección de datos

Quiénes están siendo reclutados

Infecciones por Actinomicetales+18

+ Enfermedades Transmisibles

+ Enfermedades Urogenitales

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: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS. Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones. Patients are randomized to one of three treatment arms containing clarithromycin in combination with ethambutol, rifabutin, or both. Clarithromycin alone is taken on days 1 through 3 to determine tolerance and rifabutin and/or ethambutol is added on day 3. AS PER AMENDMENT 7/2/97: Patients may elect to add ritonavir or indinavir to their treatment regimen. Treatment continues daily for 48 weeks. In the absence of a dose-limiting toxicity, those patients who are determined to be complete or partial responders continue on the regimen to which they were originally assigned. Patients who have failed or relapsed on originally assigned MAC therapy, must have their therapy amended to receive clarithromycin and at least two other drugs not included in their originally assigned regimen. Patients are followed twice in the first week, then every 2 weeks for the first 2 months, then monthly for the next 4 months, and then every 2 months thereafter until the end of 12 months. PER AMENDMENT 10/10/96: NOTE: Any patient who develops a toxicity to rifabutin or ethambutol after week 12 or thereafter will be offered the option of being registered to a salvage regimen of 2 new drugs not previously received, plus clarithromycin to continue for the study duration.

Título OficialA Phase II/III Prospective, Multicenter, Randomized, Controlled Trial Comparing the Safety and Efficacy of Three Clarithromycin-Containing Combination Drug Regimens for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Disease in Persons With AIDS
NCT00001058
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 246 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 por ActinomicetalesEnfermedades TransmisiblesEnfermedades UrogenitalesSíndrome de Inmunodeficiencia AdquiridaInfecciones Transmitidas por la SangreEnfermedades GenitalesInfecciones Bacterianas y MicosisInfecciones bacterianasEnfermedades del sistema inmunitarioSíndromes de Deficiencia InmunológicaInfeccionesInfecciones por micobacterias no tuberculosasInfecciones por MicobacteriasInfecciones por RetroviridaeInfecciones por virus de ARNEnfermedades de Transmisión SexualEnfermedades por virus lentoEnfermedades ViralesEnfermedades de transmisión sexual, viralesInfección por Mycobacterium avium-intracellulareInfecciones por VIH

Criterios

Inclusion Criteria Concurrent Medication: Allowed: * Antiretroviral therapy. * Maintenance or prophylactic therapy for other opportunistic infections (with the exception of specifically excluded drugs). * Carbamazepine or theophylline. * Isoniazid for TB prophylaxis. PER AMENDMENT 10/10/96: * Therapy for acute infectious processes, other than MAC, provided that the patient is stable on the therapy. * Fluconazole therapy for maintenance or suppression of fungal infections, providing the patient has been on a stable dose for at least 4 weeks. PER AMENDMENT 7/02/97: * If a patient elects to receive indinavir, ORTHO/NOVUM 1/35 is an acceptable means of birth control. Patients must have: * HIV infection. * Disseminated MAC disease. * Life expectancy of at least 8 weeks. * Consent of parent or guardian if under 18 years of age. NOTE: * This protocol is approved for prisoner participation. Prior Medication: Allowed: PER AMENDMENT 10/10/96: * Therapy for acute infectious processes, other than MAC, prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Active mycobacterial infection other than MAC that requires treatment, with the exception of isoniazid used solely for TB prophylaxis. Concurrent Medication: Excluded: * Other antimycobacterial drugs (with the exception of isoniazid for TB prophylaxis). * Other investigational drugs unless approved by protocol chair. PER AMENDMENT 7/2/97: * For patients who elect to receive indinavir or ritonavir: * Terfenadine, astemizole, cisapride, triazolam, or midazolam. * For patients who elect to receive ritonavir: * alprazolam, amiodarone, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam, dihydroergotamine, ergotamine, estazolam, encainide, flecainide, flurazepam, meperidine, pimozide, piroxicam, propafenone, propoxyphene, quinidine or zolpidem. * For patients who elect to receive indinavir: * oral contraceptives other than ORTHO/NOVUM as a sole form of birth control. * For patients randomized to a rifabutin-containing arm: * oral contraceptives or Norplant as a sole form of birth control. Patients with the following prior condition are excluded: * History of severe hypersensitivity to erythromycin, clarithromycin, azithromycin, ethambutol, rifampin, or rifabutin (including Type 1 hypersensitivity reaction, Stevens-Johnson syndrome, hepatitis, optic neuritis, or exfoliative dermatitis). Prior Medication: Excluded: * Empiric or presumptive antimycobacterial therapy prior to study entry if \> 14 days, within 90 days prior to entry. NOTE: * Patients unwilling to discontinue presumptive therapy or empiric therapy may be enrolled with the permission of the protocol chairs, however, if they are without a MAC positive blood culture at baseline, they will have study medications discontinued (AS PER AMENDMENT 7/2/97). PER AMENDMENT 10/10/96: * Treatment with clarithromycin or ethambutol within 4 days of initiation of study medications. * Treatment with rifabutin or rifampin within 7 days of initiation of study medications.

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 34 ubicaciones

Suspendido

Alabama Therapeutics CRS

Birmingham, United StatesAbrir Alabama Therapeutics CRS en Google Maps
Suspendido

USC CRS

Los Angeles, United States
Suspendido

UCLA CARE Center CRS

Los Angeles, United States
Suspendido

Ucsd, Avrc Crs

San Diego, United States
Completado34 Centros de Estudio