Overview

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

Status:
Completed
Trial end date:
1996-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Clarithromycin
Clofazimine
Ethambutol
Rifabutin
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).