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

Completed · Phase 3

Conditions studied: Mycobacterium Avium-intracellulare Infection, HIV Infections

In brief

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..

Key facts

Study ID

NCT00002140

Run by

Pfizer

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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 D.C., District of Columbia, United States
• Whitman - Walker Clinic — Washington D.C., District of Columbia, United States
• Med Service — Miami, Florida, United States
• Dr Robert Wallace — St. Petersburg, Florida, United States
• Bay Area AIDS Consortium — Tampa, Florida, United States
• West Paces Clinical Research Inc — Atlanta, Georgia, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Dr Neel French / Louis A Weiss Memorial Hosp — Chicago, Illinois, United States
• Oschner Clinic — New Orleans, Louisiana, United States
• Trinity Lutheran Hosp / Infectious Disease Clinic — Kansas City, Missouri, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Austin Infectious Disease Consultants — Austin, Texas, United States
• Central Texas Med Foundation — Austin, Texas, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Thomas Street Clinic / Baylor College of Medicine — Houston, Texas, United States
• Dr Gary Brewton — Houston, Texas, United States
• Hampton Roads Med Specialists — Hampton, Virginia, United States

Full record on ClinicalTrials.gov

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