A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, and to determine whether an azithromycin-containing regimen is at least as safe and effective as the same regimen containing clarithromycin..

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Azithromycin; Clarithromycin; Ethambutol

Criteria

Inclusion Criteria

Patients must have:

• HIV seropositivity.

• Disseminated MAC.

• No MAC therapy between time of last positive blood culture draw and study entry (single-agent prophylaxis allowed).

• Life expectancy of at least 2 months.

• Consent of parent or guardian if below legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Known hypersensitivity to macrolide antibiotics (erythromycin, azithromycin, or clarithromycin) or ethambutol.

• Inability to take oral medications.

• Condition likely to interfere with drug absorption (e.g., gastrectomy, malabsorption syndromes).

Concurrent Medication:

Excluded:

• Another investigational drug started in the week prior to study entry.

Prior Medication:

Excluded:

• MAC therapy between time of last positive blood culture draw and study entry (although single-agent prophylaxis is allowed).