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

NCT ID: NCT00002309

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

Brief 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.

Conditions

Mycobacterium Avium-Intracellulare Infection; HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Azithromycin

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Locations

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

Countries

United States

References

Oldfield EC, Dickinson G, Chung R, Wallace MR, Craig DB, Fessel WJ, Joyce MP, Mckee KT, Melcher G, Wagner KF, Williams WJ, Zajdowicz M, Heifits L, Dunne MW, Berman J. Once weekly azithromycin for the prevention of Mycobacterium avium complex (MAC) infection in AIDS patients. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:90

Reference Type: BACKGROUND

Other Identifiers

066-155

Identifier Type: -

Identifier Source: secondary_id

058I

Identifier Type: -

Identifier Source: org_study_id