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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Azithromycin

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.