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Sponsored by: |
Pfizer |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002309 |
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 |
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Mycobacterium Avium-Intracellulare Infection HIV Infections |
Drug: Azithromycin |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
History of MAC or Mycobacterium tuberculosis (MTb) infection.
Prior Medication:
Excluded within the past 4 weeks:
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 |
Study ID Numbers: | 058I, 066-155 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002309 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Mycobacterium avium-intracellulare Infection Acquired Immunodeficiency Syndrome AIDS-Related Complex Azithromycin |
Bacterial Infections Anti-Infective Agents Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome AIDS-Related Complex Mycobacterium Avium Complex Infection Immunologic Deficiency Syndromes Mycobacterium Infections, Atypical Mycobacterium avium-intracellulare Infection |
Virus Diseases Anti-Bacterial Agents Gram-Positive Bacterial Infections HIV Infections Azithromycin Sexually Transmitted Diseases Mycobacterium Infections Retroviridae Infections |
Bacterial Infections Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Pharmacologic Actions Mycobacterium Infections, Atypical Actinomycetales Infections |
Immunologic Deficiency Syndromes Mycobacterium avium-intracellulare Infection Virus Diseases Anti-Bacterial Agents Gram-Positive Bacterial Infections HIV Infections Therapeutic Uses Azithromycin Sexually Transmitted Diseases Lentivirus Infections Mycobacterium Infections Retroviridae Infections |