Search / Trial NCT00001047

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

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

Trial Information

Current as of December 14, 2024

Completed

Keywords

Rifabutin Mycobacterium Avium Intracellulare Infection Drug Therapy, Combination Ethambutol Clofazimine Acquired Immunodeficiency Syndrome Clarithromycin

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

  • 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).

Trial Officials

Cohn D

Study Chair

Fisher E

Study Chair

Horsburgh CR

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Denver, Colorado, United States

Washington, District Of Columbia, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

New Orleans, Louisiana, United States

Detroit, Michigan, United States

Detroit, Michigan, United States

Camden, New Jersey, United States

Newark, New Jersey, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Richmond, Virginia, United States

San Francisco, California, United States

Portland, Oregon, United States

Baltimore, Maryland, United States

Albuquerque, New Mexico, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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