Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Mycobacterium Avium-intracellulare Infection

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

PHASE3

Brief 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)...

Detailed 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 azithr...

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).

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

August 1 1996

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT00001047

End Date

August 1 1996

Last Update

November 4 2021

Active Locations (16)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (16 locations)

1

Community Consortium of San Francisco

San Francisco, California, United States, 94110

2

Denver CPCRA / Denver Public Hlth

Denver, Colorado, United States, 802044507

3

Veterans Administration Med Ctr / Regional AIDS Program

Washington D.C., District of Columbia, United States, 20422

4

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States, 30308