Completed

The Effects of Treatment for Mycobacterium Avium Complex (MAC) on the Cells of HIV-Infected Patients

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What is being collected

Data Collection

Who is being recruted

Mycobacterium Avium-Intracellulare Infection

+ HIV Infections
Over 13 Years
How is the trial designed

Natural History

Observing the progression of a disease in untreated individuals in order to understand its typical course and outcomes.
Observational

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

Official TitleEffects of Treatment for MAC Infection on Cytokine Expression in HIV-Infected Persons. 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
24 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Natural History
These studies observe how a disease progresses over time without active treatment. They help researchers understand how conditions typically develop, change, and impact quality of life.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Mycobacterium Avium-Intracellulare Infection
HIV Infections
Criteria

Inclusion Criteria Concurrent Medication: Allowed: * Patients should have successfully completed therapy or be on stable therapy for any acute infectious processes other than MAC prior to study entry. Patients must have: * Documented HIV infection. * Either symptomatic MAC disease as defined by a history of clinical signs and symptoms, plus one blood culture positive for MAC or AFB obtained within the previous 90 days, OR asymptomatic MAC disease as defined by 2 blood cultures positive for MAC or AFB obtained within 90 days of entry. * Signed parental consent for patients less than 18 years of age. Prior Medication: Allowed: * Patients who have received presumptive or empiric antimycobacterial therapy prior to study entry may be enrolled if they have been treated for no more than 72 hours prior to study entry. * Patients who have been receiving prophylaxis with azithromycin, clarithromycin and/or rifabutin may be enrolled. * Patients should have successfully completed therapy or be on stable therapy for any acute infectious processes other than MAC prior to study entry. Required: * Patients must be on a stable antiretroviral regimen (same drug or combination drugs; dose modifications allowed) for at least 4 weeks prior to study entry. NOTE: * Patients will be requested NOT to modify or add new drugs to their stable ARV regimen for the duration of this study. Patients who absolutely require ARV changes at any time prior to week 8 will continue on study, however, their data will be analyzed separately. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Previous enrollment and permanent study drug discontinuation in ACTG 223. Note: * Co-enrollment in ACTG 223 and ACTG 853 is acceptable, however enrollment in both studies must be simultaneous. * This protocol does not meet federal requirements governing prisoner participation in clinical trials and should not be considered by local IRBs for the recruitment of prisoners. Concurrent Medication: Excluded: * Cytokine inhibitors. * Corticosteroids. * Thalidomide. * Pentoxifylline or any other immunomodulator. * Any interleukin. * Colony stimulating factors (G-CSF or GM-CSF) Patients with the following prior conditions will be excluded: * Subjects who have had an opportunistic infection (other than MAC) within 14 days immediately preceding study entry. Prior Medication: Excluded within the 14 days immediately preceding study entry: * Cytokine inhibitors. * Corticosteroids. * Thalidomide. * Pentoxifylline or any other immunomodulator. * Any interleukin. * Colony stimulating factors (G-CSF or GM-CSF) Prior Treatment: Excluded: * Patients who have received a blood transfusion within the 14 days immediately preceding study entry.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 11 locations
Suspended
San Francisco Gen HospSan Francisco, United StatesSee the location
Suspended
Univ of Colorado Health Sciences CtrDenver, United States
Suspended
Washington Reg AIDS Prog / Dept of Infect DisWashington, United States
Suspended
Northwestern Univ Med SchoolChicago, United States

Completed11 Study Centers