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An Open-Label Study of the Use of Azithromycin in Patients With Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection Failing Current Therapy

Last updated on March 15, 2019

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Study Location
Pfizer Central Research
Groton, Connecticut, 06340 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mycobacterium Avium-Intracellulare Infection, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Patients must have:

- Disseminated MAC as defined by current (within the last month) positive blood, bone
marrow, or liver biopsy culture for MAC, and considered symptomatic (fever, night
sweats, anorexia, weight loss, fatigue, or malaise).

- At least 2 months of prior treatment with available combination MAC therapy or less
than 2 months of such accompanied by unacceptable adverse effects.

- Life expectancy of more than 2 weeks.

- Approval of eligibility from Pfizer Clinical Monitor.

- Consent of parent or guardian if under legal age of consent.

NOTE:

- Patients who have completed acute treatment with azithromycin for MAC in protocol
066-131 or 066-148 will be exempt from inclusion criteria 1 and 2 and can continue
therapy through this protocol if their physician feels they have benefitted from prior
azithromycin therapy.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

- Known hypersensitivity or intolerance to macrolide antibiotics.

- Inability to take oral medications or current condition that is likely to interfere
with absorption (e.g., gastrectomy).

Concurrent Medication:

Excluded:

- Other MAC therapy instituted during the first 2 months of the study.

- Other investigational drugs, with the exception of those available through a Treatment
IND program.

Patients with the following prior conditions are excluded:

History of hypersensitivity or intolerance to azithromycin.

Prior Medication:

Excluded:

- Other investigational drugs within 7 days of enrollment, with the exception of
Treatment IND drugs (such as ddC).

NCT00002089
Pfizer
Completed
An Open-Label Study of the Use of Azithromycin in Patients With Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection Failing Current Therapy

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[email protected]

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