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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002309 |
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: | 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 |
Eligibility| 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:
Contacts and 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 | |
More Information
| 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 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 |