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Ensayos clínicos

Ensayos clínicos

A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000907, ACTG 393
  • Concluido

Propósito del estudio

To determine if anti-mycobacterial therapy can be withdrawn from patients who meet the following conditions: prior treatment with macrolide-based therapy over 12 months; asymptomatic for Mycobacterium avium complex (MAC) for at least 16 weeks; CD4+ counts of at least 100 cells/mm3; receipt of antiretroviral therapy for 16 weeks. To estimate the duration of time patients remain free of MAC infection.

Afección:
Mycobacterium Avium-Intracellulare Infection
Infecciones por el VIH

Detalles del estudio

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.

Criterios de exclusión

    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 de estudio/contactos

California

    Univ of Southern California / LA County USC Med Ctr, Los Angeles, California, 900331079, United States

    Willow Clinic, Menlo Park, California, 94025, United States

    Univ of California / San Diego Treatment Ctr, San Diego, California, 921036325, United States

    San Francisco Gen Hosp, San Francisco, California, 941102859, United States

    San Francisco AIDS Clinic / San Francisco Gen Hosp, San Francisco, California, 941102859, United States

    Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium, San Jose, California, 951282699, United States

    San Mateo AIDS Program / Stanford Univ, Stanford, California, 943055107, United States

    Stanford Univ Med Ctr, Stanford, California, 943055107, United States

Colorado

    Univ of Colorado Health Sciences Ctr, Denver, Colorado, 80262, United States

Florida

    Univ of Miami School of Medicine, Miami, Florida, 331361013, United States

Georgia

    Emory Univ, Atlanta, Georgia, 30308, United States

Hawaii

    Univ of Hawaii, Honolulu, Hawaii, 96816, United States

Illinois

    Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois, 60612, United States

Indiana

    Indiana Univ Hosp, Indianapolis, Indiana, 462025250, United States

    Division of Inf Diseases/ Indiana Univ Hosp, Indianapolis, Indiana, 46202, United States

Maryland

    Johns Hopkins Hosp, Baltimore, Maryland, 21287, United States

New York

    SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York, 14215, United States

    Mount Sinai Med Ctr, New York, New York, 10029, United States

    Bellevue Hosp / New York Univ Med Ctr, New York, New York, 10016, United States

    Beth Israel Med Ctr, New York, New York, 10003, United States

North Carolina

    Univ of North Carolina, Chapel Hill, North Carolina, 275997215, United States

Ohio

    Univ of Cincinnati, Cincinnati, Ohio, 452670405, United States

Pennsylvania

    Univ of Pennsylvania at Philadelphia, Philadelphia, Pennsylvania, 19104, United States

South Carolina

    Julio Arroyo, West Columbia, South Carolina, 29169, United States

Actualizado: 13 de octubre del 2004

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