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Brief Title: The Effects of Treatment for Mycobacterium Avium Complex (MAC) on the Cells of HIV-Infected Patients
Official Title: Effects of Treatment for MAC Infection on Cytokine Expression in HIV-Infected Persons.
Study ID: NCT00000860
Brief Summary: To determine if treatment of MAC infection in HIV-1 infected persons is associated with the decreases in plasma levels of TNF-alpha. Infection with MAC is a poor prognostic indicator in persons with AIDS. Evidence suggests that this poor outcome is not simply a reflection of greater immune impairment in AIDS patients with MAC infection, but rather may be a direct or indirect consequence of infection with mycobacterium. Survival of AIDS patients with MAC is shorter than those without MAC. Studies show that treatment for MAC improves the survival of MAC infected patients to nearly the survival of AIDS patients without MAC. Treatment of MAC with clarithromycin containing regimens is associated with decreased symptoms and prolonged survival. There is evidence, however, that mycobacterial infection may enhance propagation of the human immunodeficiency virus through mechanisms that may involve enhanced expression of pro inflammatory cytokines. It is unclear to what extent cytokine abnormalities contribute to this symptom complex and to what extent treatment of MAC infection will reverse these cytokine abnormalities.
Detailed Description: Infection with MAC is a poor prognostic indicator in persons with AIDS. Evidence suggests that this poor outcome is not simply a reflection of greater immune impairment in AIDS patients with MAC infection, but rather may be a direct or indirect consequence of infection with mycobacterium. Survival of AIDS patients with MAC is shorter than those without MAC. Studies show that treatment for MAC improves the survival of MAC infected patients to nearly the survival of AIDS patients without MAC. Treatment of MAC with clarithromycin containing regimens is associated with decreased symptoms and prolonged survival. There is evidence, however, that mycobacterial infection may enhance propagation of the human immunodeficiency virus through mechanisms that may involve enhanced expression of pro inflammatory cytokines. It is unclear to what extent cytokine abnormalities contribute to this symptom complex and to what extent treatment of MAC infection will reverse these cytokine abnormalities. All patients diagnosed with MAC and who will initiate at least a 2 drug clarithromycin containing MAC treatment regimen will be eligible for participation. Blood and urine will be obtained from each patient at the following timepoints: Pre-Entry (within 7 days prior to study entry), week 4, and week 8. Sites will process and ship specific samples to Case Western Reserve University (CWRU). Various assays and analyses will be performed by CWRU. NOTE: Patients will receive no treatment on this study, however, all patients must be receiving at least a 2 drug clarithromycin containing treatment regimen for MAC either as part of participation in other studies or as prescribed by the subject's health care provider.
Minimum Age: 13 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
San Francisco Gen Hosp, San Francisco, California, United States
Univ of Colorado Health Sciences Ctr, Denver, Colorado, United States
Washington Reg AIDS Prog / Dept of Infect Dis, Washington, District of Columbia, United States
Northwestern Univ Med School, Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois, United States
Division of Inf Diseases/ Indiana Univ Hosp, Indianapolis, Indiana, United States
Johns Hopkins Hosp, Baltimore, Maryland, United States
Univ of Cincinnati, Cincinnati, Ohio, United States
Case Western Reserve Univ, Cleveland, Ohio, United States
Univ of Pennsylvania at Philadelphia, Philadelphia, Pennsylvania, United States
Univ of Washington, Seattle, Washington, United States
Name: MacArthur R
Affiliation:
Role: STUDY_CHAIR
Name: Benson C
Affiliation:
Role: STUDY_CHAIR
Name: Lederman M
Affiliation:
Role: STUDY_CHAIR