search
Back to results

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)

Primary Purpose

Mycobacterium Avium-Intracellulare Infection, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycobacterium Avium-Intracellulare Infection focused on measuring Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, Azithromycin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beth Israel Hosp
  • Bronx Veterans Affairs Med Ctr
  • SUNY / Health Sciences Ctr at Syracuse
  • Ohio State Univ Hosp
  • United States Air Force Med Ctr
  • Audie L Murphy Veterans Administration Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00002090
Brief 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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Avium-Intracellulare Infection, HIV Infections
Keywords
Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, Azithromycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Azithromycin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Beth Israel Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Bronx Veterans Affairs Med Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Ohio State Univ Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
United States Air Force Med Ctr
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Facility Name
Audie L Murphy Veterans Administration Hosp
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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)

We'll reach out to this number within 24 hrs