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.

Condition	Treatment or Intervention
Mycobacterium avium-intracellulare Infection HIV Infections	Drug: Azithromycin

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

California
      San Diego Naval Hosp, San Diego,  California,  921345000,  United States
North Carolina
      Womack Army Med Ctr / Med Clinic, Fort Bragg,  North Carolina,  283075000,  United States
Texas
      United States Air Force Med Ctr, Lackland Air Force Base,  Texas,  782365300,  United States

Study ID Numbers:  058I; 066-155
Record last reviewed:  April 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002309
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08