Back to resultsA 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
Primary Purpose
Mycobacterium Avium-intracellulare Infection, HIV Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ethambutol hydrochloride
Clarithromycin
Azithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Mycobacterium Avium-intracellulare Infection focused on measuring Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Azithromycin, Clarithromycin
Eligibility Criteria
Inclusion Criteria Patients must have: HIV seropositivity. Disseminated MAC. No MAC therapy between time of last positive blood culture draw and study entry (single-agent prophylaxis allowed). Life expectancy of at least 2 months. Consent of parent or guardian if below legal age of consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known hypersensitivity to macrolide antibiotics (erythromycin, azithromycin, or clarithromycin) or ethambutol. Inability to take oral medications. Condition likely to interfere with drug absorption (e.g., gastrectomy, malabsorption syndromes). Concurrent Medication: Excluded: Another investigational drug started in the week prior to study entry. Prior Medication: Excluded: MAC therapy between time of last positive blood culture draw and study entry (although single-agent prophylaxis is allowed).
Sites / Locations
- East Bay AIDS Ctr
- Dr Milton Estes
- Infectious Disease Med Group / Adult Immunology Clinic
- UCI Med Ctr
- Kaiser Permanente Med Ctr
- Santa Clara Valley Med Ctr
- Pfizer Central Research
- Georgetown Univ Med Ctr
- Whitman - Walker Clinic
- Med Service
- Dr Robert Wallace
- Bay Area AIDS Consortium
- West Paces Clinical Research Inc
- Northwestern Univ Med School
- Dr Neel French / Louis A Weiss Memorial Hosp
- Oschner Clinic
- Trinity Lutheran Hosp / Infectious Disease Clinic
- Duke Univ Med Ctr
- Austin Infectious Disease Consultants
- Central Texas Med Foundation
- Univ of Texas Southwestern Med Ctr of Dallas
- Thomas Street Clinic / Baylor College of Medicine
- Dr Gary Brewton
- Hampton Roads Med Specialists
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002140
Brief Title
A 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
Official Title
A 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 1998
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 different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, and to determine whether an azithromycin-containing regimen is at least as safe and effective as the same regimen containing clarithromycin..
Detailed Description
Patients are randomized to receive azithromycin at one of two doses in combination with ethambutol or clarithromycin in combination with ethambutol for 24 weeks, after which they are evaluated for entry into a maintenance phase of treatment. Clinical, microbiologic, and safety assessments are performed every 3 weeks for the first 12 weeks, then monthly for the remaining 12 weeks.
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, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Azithromycin, Clarithromycin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ethambutol hydrochloride
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Intervention Type
Drug
Intervention Name(s)
Azithromycin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients must have:
HIV seropositivity.
Disseminated MAC.
No MAC therapy between time of last positive blood culture draw and study entry (single-agent prophylaxis allowed).
Life expectancy of at least 2 months.
Consent of parent or guardian if below legal age of consent.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Known hypersensitivity to macrolide antibiotics (erythromycin, azithromycin, or clarithromycin) or ethambutol.
Inability to take oral medications.
Condition likely to interfere with drug absorption (e.g., gastrectomy, malabsorption syndromes).
Concurrent Medication:
Excluded:
Another investigational drug started in the week prior to study entry.
Prior Medication:
Excluded:
MAC therapy between time of last positive blood culture draw and study entry (although single-agent prophylaxis is allowed).
Facility Information:
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Dr Milton Estes
City
Mill Valley
State/Province
California
ZIP/Postal Code
94941
Country
United States
Facility Name
Infectious Disease Med Group / Adult Immunology Clinic
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
UCI Med Ctr
City
Orange
State/Province
California
ZIP/Postal Code
92668
Country
United States
Facility Name
Kaiser Permanente Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Santa Clara Valley Med Ctr
City
San Jose
State/Province
California
ZIP/Postal Code
951282699
Country
United States
Facility Name
Pfizer Central Research
City
Groton
State/Province
Connecticut
ZIP/Postal Code
06340
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Whitman - Walker Clinic
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Med Service
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Dr Robert Wallace
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Bay Area AIDS Consortium
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
West Paces Clinical Research Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Dr Neel French / Louis A Weiss Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Oschner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Trinity Lutheran Hosp / Infectious Disease Clinic
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Austin Infectious Disease Consultants
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Central Texas Med Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Thomas Street Clinic / Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
Dr Gary Brewton
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11073759
Citation
Dunne M, Fessel J, Kumar P, Dickenson G, Keiser P, Boulos M, Mogyros M, White AC Jr, Cahn P, O'Connor M, Lewi D, Green S, Tilles J, Hicks C, Bissett J, Schneider MM, Benner R. A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus. Clin Infect Dis. 2000 Nov;31(5):1245-52. doi: 10.1086/317468. Epub 2000 Nov 6. Erratum In: Clin Infect Dis 2001 May 1;32(9):1386.
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A 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
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