Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS

Last updated: October 28, 2021
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Overall Status: Completed

Phase

3

Condition

Mac Infection (Mycobacterium Avium Complex)

Hiv Infections

Hiv/aids

Treatment

N/A

Clinical Study ID

NCT00001047
CPCRA 027
11577
  • Ages > 13
  • All Genders

Study Summary

To compare the safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium Complex (MAC) disease in AIDS patients.

Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.

Eligibility Criteria

Inclusion

Inclusion Criteria

Concurrent Medication:

Recommended in patients with CD4 count <= 200 cells/mm3:

  • Antiretroviral therapy.

  • PCP prophylaxis.

Allowed in all patients:

  • Isoniazid preventive therapy.

Patients must have:

  • HIV infection.

  • Evidence of disseminated MAC infection.

NOTE:

  • Pregnant women are permitted to enroll following counseling by their clinician regarding the potential negative side effects of the study medications. These drugs should be used in pregnancy only when the potential benefits outweigh the risks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Known hypersensitivity to the study drugs.

  • Other concurrent mycobacterial disease requiring therapy, i.e., disseminated nontuberculous mycobacterial infection or active tuberculosis.

Concurrent Medication:

Excluded:

  • Additional medications with antimycobacterial activity (unless patient is failing or intolerant of assigned study regimen).

  • Drugs with potential additive toxicity or with potential interaction with study drugs (e.g., fluconazole).

Study Design

Total Participants: 400
Study Start date:
Estimated Completion Date:
August 31, 1996

Study Description

Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.

Patients are randomized to receive clarithromycin at one of two doses plus ethambutol and either rifabutin or clofazimine. Patients are followed at 1, 2, and 4 months and every 4 months thereafter for a minimum of 1.5 years to a common closing date.

Connect with a study center

  • Community Consortium of San Francisco

    San Francisco, California 94110
    United States

    Site Not Available

  • Denver CPCRA / Denver Public Hlth

    Denver, Colorado 802044507
    United States

    Site Not Available

  • Veterans Administration Med Ctr / Regional AIDS Program

    Washington, District of Columbia 20422
    United States

    Site Not Available

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • AIDS Research Alliance - Chicago

    Chicago, Illinois 60657
    United States

    Site Not Available

  • Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Baltimore Trials

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Comprehensive AIDS Alliance of Detroit

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Henry Ford Hosp

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Southern New Jersey AIDS Cln Trials / Dept of Med

    Camden, New Jersey 08103
    United States

    Site Not Available

  • North Jersey Community Research Initiative

    Newark, New Jersey 071032842
    United States

    Site Not Available

  • Partners Research

    Albuquerque, New Mexico 871315271
    United States

    Site Not Available

  • Harlem AIDS Treatment Group / Harlem Hosp Ctr

    New York, New York 10037
    United States

    Site Not Available

  • Portland Veterans Adm Med Ctr / Rsch & Education Grp

    Portland, Oregon 972109951
    United States

    Site Not Available

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Richmond AIDS Consortium

    Richmond, Virginia 23298
    United States

    Site Not Available

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