Search / Trial NCT00000860

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Tumor Necrosis Factor Aids Related Opportunistic Infections Mycobacterium Avium Intracellulare Infection Drug Therapy, Combination Anti Hiv Agents

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 pr...

Gender

All

Eligibility 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.

Attachments

readout_NCT00000860_2024-07-23.pdf

4.5 MB

NCT00000860_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

San Francisco, California, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Seattle, Washington, United States

Cleveland, Ohio, United States

Baltimore, Maryland, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

Denver, Colorado, United States

Indianapolis, Indiana, United States

Washington, District Of Columbia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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