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

Completed · Not applicable

Conditions studied: Mycobacterium Avium-Intracellulare Infection, HIV Infections

In brief

To evaluate the efficacy and safety of azithromycin administered once a week in the prevention of disseminated Mycobacterium avium complex (MAC) in severely immunocompromised HIV-infected patients with a CD4 count \< 100 cells/mm3.

Key facts

Study ID

NCT00002309

Run by

Pfizer

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 < 100 cells/mm3.
• 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.

You may not qualify if…

• 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 < 5 mm 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.

Where it is running

• San Diego Naval Hosp — San Diego, California, United States
• Womack Army Med Ctr / Med Clinic — Fort Bragg, North Carolina, United States
• United States Air Force Med Ctr — Lackland Air Force Base, Texas, United States

Full record on ClinicalTrials.gov

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