A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycobacterium Avium-Intracellulare Infection; HIV Infections
Intervention: Azithromycin (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer
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.
Clinical Details
Official title: A Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Azithromycin as Prophylaxis Against the Development of Mycobacterium Avium Complex Disease in HIV-Infected People
Study design: Treatment, Double-Blind, Safety Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
San Diego Naval Hosp, San Diego, California 921345000, United States
Womack Army Med Ctr / Med Clinic, Fort Bragg, North Carolina 283075000, United States
United States Air Force Med Ctr, Lackland Air Force Base, Texas 782365300, United States
Additional Information
Related publications: 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
Last updated: June 23, 2005
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