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)

NCT00002090

Last updated date
Study Location
Beth Israel Hosp
Boston, Massachusetts, 02215, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mycobacterium Avium-Intracellulare Infection, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Mycobacterium Avium-Intracellulare Infection, HIV InfectionsA Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients
NCT00002309
  1. San Diego, California
  2. Fort Bragg, North Carolina
  3. Lackland Air Force Base, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Mycobacterium Avium-intracellulare Infection, HIV InfectionsA Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients
NCT00002140
  1. Berkeley, California
  2. Mill Valley, California
  3. Oakland, California
  4. Orange, California
  5. San Francisco, California
  6. San Jose, California
  7. Groton, Connecticut
  8. Washington, District of Columbia
  9. Washington, District of Columbia
  10. Miami, Florida
  11. St Petersburg, Florida
  12. Tampa, Florida
  13. Atlanta, Georgia
  14. Chicago, Illinois
  15. Chicago, Illinois
  16. New Orleans, Louisiana
  17. Kansas City, Missouri
  18. Durham, North Carolina
  19. Austin, Texas
  20. Austin, Texas
  21. Dallas, Texas
  22. Houston, Texas
  23. Houston, Texas
  24. Hampton, Virginia
ALL GENDERS
13 Years+
years
MULTIPLE SITES
Mycobacterium Avium-Intracellulare Infection, HIV InfectionsAn Open-Label Study of the Use of Azithromycin in Patients With Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection Failing Current Therapy
NCT00002089
  1. Groton, Connecticut
ALL GENDERS
0+
years
MULTIPLE SITES
Mycobacterium Avium-Intracellulare Infection, HIV InfectionsAn 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)
NCT00002090
  1. Boston, Massachusetts
  2. Bronx, New York
  3. Syracuse, New York
  4. Columbus, Ohio
  5. Lackland Air Force Base, Texas
  6. San Antonio, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections
Intervention  ICMJE Drug: Azithromycin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002090
Other Study ID Numbers  ICMJE 058H
066-148
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NIH AIDS Clinical Trials Information Service
Verification Date April 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP