A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
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.
Mycobacterium Avium-Intracellulare Infection
Drug : Azithromycin
Primary Purpose: Treatment
|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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Anti-pneumocystis prophylactic therapy (dihydropteroate synthetase inhibitors with or without dihydrofolate reductase inhibitors, pentamidine).
- Concomitant anti-HIV therapy (AZT, ddI, ddC) or antifungal therapy (including azoles).
- 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.
- 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.
- 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.
- Any putative anti-MAC therapies including rifampin, rifabutin, clofazimine,
Patients must have:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
History of MAC or Mycobacterium tuberculosis (MTb) infection.
Excluded within the past 4 weeks:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002309
Locations Show More
|United States, California|
|San Diego Naval Hosp|
|San Diego, California, United States, 921345000|
|United States, North Carolina|
|Womack Army Med Ctr / Med Clinic|
|Fort Bragg, North Carolina, United States, 283075000|
|United States, Texas|
|United States Air Force Med Ctr|
|Lackland Air Force Base, Texas, United States, 782365300|
Sponsors and CollaboratorsPfizer
|ClinicalTrials.gov Identifier:||NCT00002309 History of Changes|
|Other Study ID Numbers:||058I|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Mycobacterium avium-intracellulare Infection
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
Mycobacterium avium-intracellulare Infection
ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.