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
- Conditions
- Mycobacterium Avium-intracellulare InfectionHIV Infections
- Registration Number
- NCT00002140
- Lead Sponsor
- Pfizer
- Brief 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..
- Detailed Description
Patients are randomized to receive azithromycin at one of two doses in combination with ethambutol or clarithromycin in combination with ethambutol for 24 weeks, after which they are evaluated for entry into a maintenance phase of treatment. Clinical, microbiologic, and safety assessments are performed every 3 weeks for the first 12 weeks, then monthly for the remaining 12 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
East Bay AIDS Ctr
🇺🇸Berkeley, California, United States
Dr Milton Estes
🇺🇸Mill Valley, California, United States
Infectious Disease Med Group / Adult Immunology Clinic
🇺🇸Oakland, California, United States
UCI Med Ctr
🇺🇸Orange, California, United States
Kaiser Permanente Med Ctr
🇺🇸San Francisco, California, United States
Santa Clara Valley Med Ctr
🇺🇸San Jose, California, United States
Pfizer Central Research
🇺🇸Groton, Connecticut, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Whitman - Walker Clinic
🇺🇸Washington, District of Columbia, United States
Med Service
🇺🇸Miami, Florida, United States
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