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A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo

Primary Purpose

Mycobacterium Avium-Intracellulare Infection, HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ethambutol hydrochloride
Clarithromycin
Rifabutin
Sponsored by
Pharmacia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycobacterium Avium-Intracellulare Infection focused on measuring Rifabutin, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Clarithromycin

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Isoniazid for TB prophylaxis ONLY. Patients must have: HIV infection. MAC infection. Life expectancy of at least 16 weeks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Perceived unreliability or unavailability for frequent monitoring. Concurrent Medication: Excluded: Antimycobacterial drugs other than the study drugs. Carbamazepine. Terfenadine. Theophylline. Patients with the following prior condition are excluded: History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol. Prior Medication: Excluded within 7 days prior to study entry: Rifabutin. Rifampin. Ethionamide. Cycloserine. Clofazimine. Ethambutol. Amikacin. Ciprofloxacin. Ofloxacin. Sparfloxacin. Azithromycin. Clarithromycin. Pyrazinamide. Excluded within 14 days prior to study entry: Carbamazepine. Terfenadine. Theophylline.

Sites / Locations

  • McDowell Clinic
  • Maricopa Med Research Foundation
  • Bay Harbor Hosp
  • Ctr for Special Immunology
  • Combat Group
  • Cedars Sinai Med Ctr
  • Highland Gen Hosp / San Francisco Gen Hosp
  • HIV Research Group
  • UCSD / Ctr for Special Immunology
  • Saint Francis Mem Hosp
  • San Francisco Veterans Administration Med Ctr
  • Sunnyvale Med Clinic
  • George Washington Univ Med Ctr
  • Veterans Administration Med Ctr
  • Infectious Disease Consultants
  • TheraFirst Med Ctrs Inc
  • Dr Frank Tornaka
  • Gary Richmond MD
  • Dr Nelson Zide
  • Ctr for Special Immunology
  • Dr Barry Rodwick
  • Bay Area AIDS Consortium
  • Infectious Disease Research Consortium of Georgia
  • Dr Daniel Berger
  • Univ of Kansas School of Medicine
  • Tulane Univ Med School
  • Dr Arnold Markowitz
  • Univ of Nebraska Med Ctr / HIV Clinic
  • East Orange Veterans Administration Med Ctr
  • North Jersey Community Research Initiative
  • Long Island Jewish Med Ctr
  • Chelsea Village Med Ctr / Saint Vincent's Hosp
  • Community Health Network
  • Nalle Clinic
  • Polyclinic Med Ctr
  • Buckley Braffman Stern Med Associates
  • Charleston Veterans Administration Med Ctr
  • Dr Alfred F Burnside Jr
  • Central Texas Med Foundation
  • Houston Veterans Administration Med Ctr
  • Univ TX San Antonio Health Science Ctr
  • Infectious Disease Physicians Inc
  • Univ of Wisconsin School of Medicine
  • Milwaukee County Med Complex

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pharmacia
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1. Study Identification

Unique Protocol Identification Number
NCT00002101
Brief Title
A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo
Official Title
A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
June 1999
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
Pharmacia

4. Oversight

5. Study Description

Brief Summary
To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.
Detailed Description
Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.

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
Rifabutin, Mycobacterium avium-intracellulare Infection, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Clarithromycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
450 (false)

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)
Rifabutin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Isoniazid for TB prophylaxis ONLY. Patients must have: HIV infection. MAC infection. Life expectancy of at least 16 weeks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Perceived unreliability or unavailability for frequent monitoring. Concurrent Medication: Excluded: Antimycobacterial drugs other than the study drugs. Carbamazepine. Terfenadine. Theophylline. Patients with the following prior condition are excluded: History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol. Prior Medication: Excluded within 7 days prior to study entry: Rifabutin. Rifampin. Ethionamide. Cycloserine. Clofazimine. Ethambutol. Amikacin. Ciprofloxacin. Ofloxacin. Sparfloxacin. Azithromycin. Clarithromycin. Pyrazinamide. Excluded within 14 days prior to study entry: Carbamazepine. Terfenadine. Theophylline.
Facility Information:
Facility Name
McDowell Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Maricopa Med Research Foundation
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Bay Harbor Hosp
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
Ctr for Special Immunology
City
Irvine
State/Province
California
ZIP/Postal Code
92718
Country
United States
Facility Name
Combat Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
Cedars Sinai Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Highland Gen Hosp / San Francisco Gen Hosp
City
Oakland
State/Province
California
ZIP/Postal Code
946021018
Country
United States
Facility Name
HIV Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
UCSD / Ctr for Special Immunology
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Saint Francis Mem Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
San Francisco Veterans Administration Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Sunnyvale Med Clinic
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94086
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Veterans Administration Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Infectious Disease Consultants
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
TheraFirst Med Ctrs Inc
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Dr Frank Tornaka
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Gary Richmond MD
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Dr Nelson Zide
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Ctr for Special Immunology
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Dr Barry Rodwick
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Bay Area AIDS Consortium
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Infectious Disease Research Consortium of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30345
Country
United States
Facility Name
Dr Daniel Berger
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Dr Arnold Markowitz
City
Keego Harbor
State/Province
Michigan
ZIP/Postal Code
48320
Country
United States
Facility Name
Univ of Nebraska Med Ctr / HIV Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
681985130
Country
United States
Facility Name
East Orange Veterans Administration Med Ctr
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
North Jersey Community Research Initiative
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032842
Country
United States
Facility Name
Long Island Jewish Med Ctr
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Chelsea Village Med Ctr / Saint Vincent's Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States
Facility Name
Community Health Network
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Nalle Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Polyclinic Med Ctr
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Charleston Veterans Administration Med Ctr
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
294015799
Country
United States
Facility Name
Dr Alfred F Burnside Jr
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Central Texas Med Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Houston Veterans Administration Med Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ TX San Antonio Health Science Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
Facility Name
Univ of Wisconsin School of Medicine
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Milwaukee County Med Complex
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo

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