NCT00002331

The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS

A Randomized Open-Label Study of the Tolerability and Efficacy of Clarithromycin and Ethambutol in Combination With or Without Clofazimine for the Treatment of Disseminated MAC (dMAC) in Patients With AIDS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Abbott · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC). SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.

Conditions

• Mycobacterium Avium-intracellular Infection
• HIV Infections

Interventions

Type	Name	Description
DRUG	Ethambutol hydrochloride
DRUG	Clarithromycin
DRUG	Clofazimine

Timeline

• Start date: 1994-01-01
• Primary completion: 1995-03-01
• Completion: 1995-03-01
• First posted: 2001-08-31
• Last updated: 2015-01-16

Locations

18 sites across 2 countries: United States, Puerto Rico