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Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection

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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 Prevención

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

Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals. Patients are chosen by a random selection process to either the INH or the rifampin / pyrazinamide arm of the dose. Patients on the INH arm receive INH plus vitamin B6 (pyridoxine hydrochloride ) daily for 12 months. Patients on the other arm receive rifampin plus pyrazinamide for 60 days. Dosage of rifampin and pyrazinamide depends on weight of patient.

Título OficialProphylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection 
NCT00000638
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 2000 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Prevención

Los estudios de prevención buscan evitar que se desarrolle una enfermedad. A menudo incluyen a personas en riesgo y evalúan vacunas, cambios en el estilo de vida o medicamentos preventivos.

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 MicobacteriasProcesos PatológicosInfecciones por RetroviridaeInfecciones por virus de ARNEnfermedades de Transmisión SexualEnfermedades por virus lentoTuberculosisEnfermedades ViralesEnfermedades de transmisión sexual, viralesInfecciones por VIH

Criterios

Inclusion Criteria Concurrent Medication: Allowed: * Antiretroviral treatment. * Pneumocystis carinii pneumonia prophylaxis. * Treatment for acute opportunistic infection. Patients must have: * HIV infection. * Current or documented history of positive PPD skin test. * Life expectancy of at least 6 months or, in the physician's opinion, patient has a reasonable chance of survival to end of study. Allowed: * Participation in other clinical trials as long as there is no potential activity of other study drugs against Mycobacterium tuberculosis (MTb), additive toxicities between study agents, or known possible drug interactions between study drugs. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Current active clinical tuberculosis, confirmed or suspected. * History of sensitivity / intolerance to any study medication. * Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse. * Unwilling or unable to have current therapy and/or concomitant medication changed to avoid serious interaction with study medication. * Acute hepatitis. * Unable to comply with the follow-up requirements of the protocol. Concurrent Medication: Excluded: * Treatment with quinolones, fluoroquinolones, aminoglycosides, or other agents that have activity against Mycobacterium tuberculosis. * Excluded as ongoing (i.e., continuous, chronic and/or recurring) treatment: * Aminoglycosides such as amikacin, aminosalicylic acid salts (PAS), capreomycin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid (INH) if randomized to rifampin/pyrazinamide arm of study, kanamycin, pyrazinamide if randomized to INH arm of study, and quinolones and fluoroquinolones, i.e., rifabutin, rifampin (if randomized to INH arm of study), ciprofloxacin, levofloxacin, ofloxacin, streptomycin, and thiacetazone. Prior Medication: Excluded: * More than 2 months of continuous treatment, after documentation of a positive PPD skin test, with agents that have known or potential antituberculous activity or any antimycobacterial medication for \> 1 month. Patients may not have the following prior conditions: * History of sensitivity / intolerance to any study medication. * Unwilling or unable to comply with the follow-up requirements of the protocol.

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 76 ubicaciones

Suspendido

Univ of Alabama at Birmingham

Birmingham, United StatesVer ubicación
Suspendido

Children's Hosp of Los Angeles

Los Angeles, United States
Suspendido

Univ of Southern California / LA County USC Med Ctr

Los Angeles, United States
Suspendido

Highland Gen Hosp / San Francisco Gen Hosp

Oakland, United States
Completado76 Centros de Estudio