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

• Status: Completed
• Trial end date: 1995-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Clarithromycin; Clofazimine; Ethambutol

Criteria

Inclusion Criteria

Patients must have:

• History of HIV seropositivity.

• Disseminated MAC.

• Positive blood culture for MAC within 4 weeks prior to study entry.

• Consent of parent or guardian if less than 18 years of age.

• Ability to complete the study.

NOTE:

• Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment.

Exclusion Criteria

Concurrent Medication:

Excluded:

• Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels.

• Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor.

• Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal).

• Amikacin.

• Azithromycin.

• Capreomycin.

• Ciprofloxacin.

• Cycloserine.

• Ethionamide.

• Gentamicin.

• Kanamycin.

• Levofloxacin.

• Lomefloxacin.

• Ofloxacin.

• Rifampin.

• Rifabutin.

• Sparfloxacin.

• Streptomycin.

• Any other aminoglycosides, quinolones, and macrolides.

Patients with the following prior conditions are excluded:

History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine.

Prior Medication:

Excluded:

• Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry.

• Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months.