NCT00002090

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 1996

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Mycobacterium Avium-Intracellulare InfectionHIV Infections

Keywords

Mycobacterium avium-intracellulare InfectionAcquired Immunodeficiency SyndromeAzithromycin

Interventions

AzithromycinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Beth Israel Hosp

Boston, Massachusetts, 02215, United States

Location

SUNY / Health Sciences Ctr at Syracuse

Syracuse, New York, 13210, United States

Location

Bronx Veterans Affairs Med Ctr

The Bronx, New York, 10468, United States

Location

Ohio State Univ Hosp

Columbus, Ohio, 43210, United States

Location

United States Air Force Med Ctr

Lackland Air Force Base, Texas, 78236, United States

Location

Audie L Murphy Veterans Administration Hosp

San Antonio, Texas, 78284, United States

Location

MeSH Terms

Conditions

Mycobacterium avium-intracellulare InfectionHIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1996-04

Locations

US(6)