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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Pfizer


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002309

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
Purpose

Purpose

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 Intervention
Mycobacterium Avium-Intracellulare Infection
HIV Infections

Drug : Azithromycin

Study Type: Interventional
Study Design: Masking: Double
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:

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing 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

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 Collaborators

Pfizer
More Information

More Information


Responsible Party: Pfizer  
ClinicalTrials.gov Identifier: NCT00002309   History of Changes  
Other Study ID Numbers: 058I  
  066-155  
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
AIDS-Related Complex
Azithromycin

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.