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Ensayos clínicos

Ensayos clínicos

A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients with Advanced HIV Infection

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000895, ACTG 341
  • Concluido

Propósito del estudio

To determine whether tissue infection with Mycobacterium avium complex (MAC) occurs prior to sustained bacteremia by obtaining bone marrow biopsies and blood for quantitative cultures from patients at high risk for disseminated MAC (DMAC). To examine the relationship between immune dysregulation and MAC disease by identifying immune profiles correlated with risk for MAC disease. To determine whether abnormalities in immune cell populations and functions in MAC-infected patients and in asymptomatic patients with low CD4+ counts can be reversed by highly active antiretroviral treatment (HAART). To further evaluate the relationship between changes in HIV RNA levels after HAART and changes in relevant immune parameters. To evaluate the relationships between baseline plasma HIV-1 RNA levels, relevant immune function abnormalities, and MAC infection status. To evaluate the diagnostic utility of rapid and potentially more sensitive new MAC detection by correlation with quantitative cultures of blood and bone marrow. To examine the incidence of intestinal and respiratory colonization of subjects with DMAC and compare the strain identities and virulence properties of colonizing strain(s) with MAC isolate(s) obtained from blood and bone marrow.

Afección:
Mycobacterium Avium-intracellulare Infection
Infecciones por el VIH

Detalles del estudio

The intent of this study is to define more precisely the natural history and immunopathogenesis of MAC disease in the HIV-infected population. It is suggested that MAC disease in AIDS patients results both from specific immunologic deficiencies caused by HIV infection of the host and as a result of specific mycobacterial virulence properties. Therefore, aggressive antiretroviral drug treatment of HIV-infected patients at risk for DMAC due to specific immune deficiencies will improve these immune functions in such a manner as to resist DMAC.A total of 85 patients will be stratified at baseline into one of three groups: Group I - 40 patients at high risk for MAC infection are neither followed beyond baseline nor receive study treatment. Group II - 15 patients with DMAC, i.e., newly diagnosed MAC-bacteremic patients with no more than 72 hours prior treatment for MAC, receive individualized regimen of HAART for 48 weeks: nelfinavir (NEV), nevirapine (NVP), and nucleoside reverse transcriptase inhibitor(s) as per primary physician. Patients are evaluated through clinical, microbiologic, and virologic assessments, and intensive immunologic evaluations at Weeks 12, 24, and 48. Group III - 30 asymptomatic HIV-infected patients are further stratified (15 patients/stratum) by CD4 count (less than or equal to 50 cells/mm3 or 100-250 cells/mm3). Patients in Group III follow the same HAART regimen and evaluations as Group II patients and continue evaluations for up to 48 weeks, if an acceptable response is found within 12 weeks of entry. Patients in Stratum 1 of Group III receive MAC prophylaxis with azithromycin once weekly with follow-up evaluations as in Group II. Patients in Group III that have a positive MAC blood or bone marrow culture at any time during the study will, from that point on, follow the same schedule of evaluations as patients in Group II. [AS PER AMENDMENT 11/3/98: Up to 100 evaluable patients will now be studied. Group 2 is now modified to include up to an additional 15 evaluable patients with known MAC bacteremia and less than or equal to 7 days prior MAC treatment who are unable to commit to long-term follow-up (Group 2b); these patients will undergo only baseline evaluations. Group 2a consists of 15 evaluable patients with known MAC bacteremia and less than or equal to 7 days of prior MAC treatment who are willing and able to enter the follow-up phase.]

Criterios de exclusión

    You will not be eligible for this study if you: Have any active infection (except for MAC in Group 2 patients) or any cancer. Are unable to follow an acceptable anti-HIV drug regimen (Groups 2 and 3). Are pregnant or breast-feeding.

Centros de estudio/contactos

Alabama

    Univ of Alabama at Birmingham, Birmingham, Alabama, 35294, United States

California

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

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

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

District of Columbia

    Howard Univ, Washington, District of Columbia, 20059, United States

Florida

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

Georgia

    Emory Univ, Atlanta, Georgia, 30308, United States

Illinois

    Northwestern Univ Med School, Chicago, Illinois, 60611, United States

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

    Cook County Hosp, 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

New York

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

    St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr, New York, New York, 10021, 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

    Univ of Rochester Medical Center, Rochester, New York, 14642, United States

Ohio

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

    Case Western Reserve Univ, Cleveland, Ohio, 44106, United States

    Ohio State Univ Hosp Clinic, Columbus, Ohio, 432101228, United States

Pennsylvania

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

South Carolina

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

Texas

    Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas, 75235, United States

    Univ of Texas, Southwestern Med Ctr of Dallas, Dallas, Texas, 75390, United States

    Univ of Texas Galveston, Galveston, Texas, 775550435, United States

Washington

    Univ of Washington, Seattle, Washington, 98104, United States

Actualizado: 13 de octubre del 2004

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