HIV Infections Clinical Trial
Official title:
Effects of Treatment for MAC Infection on Cytokine Expression in HIV-Infected Persons.
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.
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.
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