MedPath

A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo

Phase 3
Completed
Conditions
Mycobacterium Avium-Intracellulare Infection
HIV Infections
Registration Number
NCT00002101
Lead Sponsor
Pharmacia
Brief Summary

To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.

Detailed Description

Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
450
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (43)

McDowell Clinic

🇺🇸

Phoenix, Arizona, United States

Maricopa Med Research Foundation

🇺🇸

Phoenix, Arizona, United States

Bay Harbor Hosp

🇺🇸

Harbor City, California, United States

Ctr for Special Immunology

🇺🇸

Miami Beach, Florida, United States

Combat Group

🇺🇸

Los Angeles, California, United States

Cedars Sinai Med Ctr

🇺🇸

Los Angeles, California, United States

Highland Gen Hosp / San Francisco Gen Hosp

🇺🇸

Oakland, California, United States

HIV Research Group

🇺🇸

San Diego, California, United States

UCSD / Ctr for Special Immunology

🇺🇸

San Diego, California, United States

Saint Francis Mem Hosp

🇺🇸

San Francisco, California, United States

Scroll for more (33 remaining)
McDowell Clinic
🇺🇸Phoenix, Arizona, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.