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A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients

Last updated on March 14, 2019

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Study Location
San Diego Naval Hosp
San Diego, California, 921345000 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
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Concurrent Medication:

Required:

- Anti-pneumocystis prophylactic therapy (dihydropteroate synthetase inhibitors with or
without dihydrofolate reductase inhibitors, pentamidine).

Allowed:

- Concomitant anti-HIV therapy (AZT, ddI, ddC) or antifungal therapy (including azoles).

Patients must have:

- HIV infection.

- CD4 count

- No MAC positive blood cultures within 1 month prior to study entry.

- No symptoms suggestive of disseminated MAC infection (including unexplained diarrhea,
fever, and night sweats) within 1 month of study entry.

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 or conditions are excluded:

- Positive PPD within 3 months prior to study entry (negative PPD defined as induration).

- Chest x-ray suggestive of any active disease, in particular tuberculosis.

- Known hypersensitivity to macrolide antibiotics.

- Any other acute clinical condition likely to interfere with completion of the
protocol.

- Inability to care for self without considerable assistance and medical care.

Concurrent Medication:

Excluded:

- Other investigational new drugs (except for foscarnet or ddC) unless prior agreement
has been reached between the investigator and the Pfizer project physician.

- Concomitant putative immunostimulants.

Patients with the following prior conditions are excluded:

History of MAC or Mycobacterium tuberculosis (MTb) infection.

Prior Medication:

Excluded within the past 4 weeks:

- Any putative anti-MAC therapies including rifampin, rifabutin, clofazimine,
ethambutol, cycloserine, ethionamide, amikacin, and ciprofloxacin or other quinolones
thought to be active against MAC.

NCT00002309
Pfizer
Completed
A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients

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[email protected]

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