A Study of Discontinuing Maintenance Therapy in Subjects With Disseminated Mycobacterium Avium Complex (DMAC)
Colección de datos
Infecciones por Actinomicetales+19
+ Enfermedades Transmisibles
+ Enfermedades Urogenitales
Resumen
A growing body of evidence suggests AIDS-related morbidity and mortality significantly decrease where potent antiretroviral therapies are used. HAART (highly active antiretroviral therapy) seems to significantly reduce the incidence of MAC. This study tests the validity of those observations. Peripheral blood cultures and bone marrow (aspirate) samples from 50 eligible patients previously diagnosed with disseminated Mycobacterium avium complex (DMAC) are assessed for microbiologic sterilization of MAC at the time of study entry. If either bone marrow or blood cultures test positive for MAC, patients are discontinued from study. If cultures prove sterile, patients receive 6 weeks of treatment and then discontinue MAC therapy at Week 6 (entry into Step 2 of study). They are then monitored for clinical signs and symptoms of MAC recurrence and for the presence of mycobacteria in blood cultures. In cases of increased viral load during study, modification of antiretroviral therapy is allowed at the discretion of the patient's provider.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 50 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.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
Criterios
Inclusion Criteria Patients may be eligible for this study if they: * Are HIV-positive. * Have 2 CD4 cell counts greater than or equal to 100 cells/mm3 within 60 days and 14 days prior to entry. Measurements must be taken at least 24 hours apart. * Have been treated for DMAC with a drug regimen including at least 2 antimycobacterial drugs for at least 12 months, and have been free of symptoms for at least 16 weeks prior to study entry. * Have been on anti-HIV therapy for at least 16 weeks and have been on stable anti-HIV therapy for at least 8 weeks prior to study entry. * Are at least 13 years old (need consent of parent or guardian if under 18). Exclusion Criteria Patients will not be eligible for this study if they: * Have any active infection (unless they have been on stable chronic suppressive therapy for at least 3 months). * Are pregnant.
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 24 ubicaciones
Univ of Southern California / LA County USC Med Ctr
Los Angeles, United StatesAbrir Univ of Southern California / LA County USC Med Ctr en Google MapsWillow Clinic
Menlo Park, United StatesUniv of California / San Diego Treatment Ctr
San Diego, United StatesSan Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, United States