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

NCT00001047 Phase 3 COMPLETED

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.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 3
Status	COMPLETED
Enrolment	400
Completion	1996-08

Conditions

• Mycobacterium Avium-intracellulare Infection
• HIV Infections

Interventions

• Ethambutol hydrochloride
• Clarithromycin
• Clofazimine
• Rifabutin

Countries

United States