HIV Infections, Mycobacterium Avium-Intracellulare Infection
Conditions
Keywords
Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, Azithromycin
Brief summary
To evaluate the efficacy and safety of two doses of azithromycin given chronically for the treatment of Mycobacterium avium bacteremia in AIDS patients.
Interventions
DRUGAzithromycin
Sponsors
Pfizer
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: * Medications allowed under a Treatment IND program. Patients must have: * HIV infection. * Disseminated Mycobacterium avium Complex. * Fever (\> 100 degrees F) that cannot be attributed to another active infection, and at least one other constitutional symptom (such as fatigue, malaise, anorexia). * Life expectancy of at least the duration of the study. * Consent of parent or guardian if below the legal age of consent.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms and conditions are excluded: * Known hypersensitivity or significant intolerance to macrolide antibiotics. * Inability to take oral medications or a current condition likely to interfere with drug absorption (e.g., gastrectomy). Prior Medication: Excluded: * Treatment with an immunostimulant or immunomodulator compound such as alpha-interferon, gamma-interferon, or any interleukin within 7 days prior to study entry. * Any other antibiotic with known activity against M. avium within 7 days prior to study entry. Not expected to comply with the requirements of the protocol, in the opinion of the investigator.
Countries
United States
Outcome results
None listed