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

Launched by PFIZER · Aug 30, 2001

Keywords

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Gender

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Eligibility criteria

• • Inclusion Criteria
• 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.
• • Exclusion Criteria
• 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.