An Open-Label, Randomized Trial of Four Treatment Regimens for Patients With Disseminated Mycobacterium Avium Complex Disease and Acquired Immunodeficiency Syndrome (AIDS)

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).

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety