HIV Infections, Mycobacterium Avium-Intracellulare Infection, Tuberculosis, Mycobacterium Infection
Conditions
Keywords
Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, Azithromycin, Mycobacterium Infections, Atypical
Brief summary
To evaluate the efficacy and safety of azithromycin given chronically for the treatment of serious nontuberculous mycobacterial infection in patients failing or intolerant of other available therapy.
Interventions
DRUGAzithromycin
Sponsors
Pfizer
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
1 Days to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: * Other antimicrobial drugs as long as documented on Case Report Form. Patients must have: * Serious nontuberculous mycobacterial infection. * Approval of eligibility from Pfizer Clinical Monitor. Patients below the legal age of consent must have consent of parent or guardian. NOTE: * Pregnant women, women of childbearing potential, and children will not be specifically excluded from participation. However, patients and physicians should be aware that the safety of azithromycin during pregnancy and in long-term use in children and adults has not been established. The risks and benefits of azithromycin use in these patients will be considered in consultation with the physician and the Pfizer Clinical Monitor.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Disseminated Mycobacterium avium complex (MAC) who are eligible for treatment with azithromycin under protocol 066-162. * Known hypersensitivity or intolerance to macrolide antibiotics. Patients with the following prior conditions are excluded: History of hypersensitivity or intolerance to azithromycin.
Countries
United States
Outcome results
None listed