Search / Trial NCT00002090

An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium Avium-Intracellulare Complex Infection (MAC) in Patients With Acquired Immune Deficiency Syndrome (AIDS)

Launched by PFIZER · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Mycobacterium Avium Intracellulare Infection Acquired Immunodeficiency Syndrome Azithromycin

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Medications allowed under a Treatment IND program.
  • Patients must have:
  • HIV infection.
  • Disseminated Mycobacterium avium Complex.
  • Fever (\> 100 degrees F) that cannot be attributed to another active infection, and at least one other constitutional symptom (such as fatigue, malaise, anorexia).
  • Life expectancy of at least the duration of the study.
  • Consent of parent or guardian if below the legal age of consent.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Known hypersensitivity or significant intolerance to macrolide antibiotics.
  • Inability to take oral medications or a current condition likely to interfere with drug absorption (e.g., gastrectomy).
  • Prior Medication:
  • Excluded:
  • Treatment with an immunostimulant or immunomodulator compound such as alpha-interferon, gamma-interferon, or any interleukin within 7 days prior to study entry.
  • Any other antibiotic with known activity against M. avium within 7 days prior to study entry.
  • Not expected to comply with the requirements of the protocol, in the opinion of the investigator.

About Pfizer

Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.

Locations

San Antonio, Texas, United States

Boston, Massachusetts, United States

Syracuse, New York, United States

Lackland Air Force Base, Texas, United States

Bronx, New York, United States

Columbus, Ohio, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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