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)

HIV Infections Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002090
• Other study ID #: 058H
• Secondary ID: 066-148
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of two doses of azithromycin given chronically for the treatment of Mycobacterium avium bacteremia in AIDS patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection
• Mycobacterium Avium-Intracellulare Infection
• Mycobacterium Infections

Intervention

Drug:
• Azithromycin

Locations

Country	Name	City	State
United States	Beth Israel Hosp	Boston	Massachusetts
United States	Bronx Veterans Affairs Med Ctr	Bronx	New York
United States	Ohio State Univ Hosp	Columbus	Ohio
United States	United States Air Force Med Ctr	Lackland Air Force Base	Texas
United States	Audie L Murphy Veterans Administration Hosp	San Antonio	Texas
United States	SUNY / Health Sciences Ctr at Syracuse	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States,