Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000860
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Effects of Treatment for Mycobacterium Avium Complex MAC on the Cells of HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Effects of Treatment for MAC Infection on Cytokine Expression in HIV-Infected Persons
Status:
COMPLETED
Status Verified Date:
1999-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 subjects health care provider
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 subjects health care provider
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: