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Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial

Primary Purpose

Mycobacterium Avium-intracellulare Infection, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
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, AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, Antitubercular Agents

Eligibility Criteria

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

Inclusion Criteria Patients must have the following: Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC). Written informed consent obtained, which must include a statement that treatment may involve risks to the embryo or fetus, which are currently unforeseeable, if the subject becomes pregnant. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI). Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation. Concurrent Medication: Excluded: Antiretroviral agents other than zidovudine (AZT). Didanosine (ddI). Antimycobacterial therapy. Rifampin. Isoniazid. Clofazimine. Ethambutol. Cycloserine. Ethionamide. Amikacin. Ciprofloxacin. Streptomycin. Other investigational drugs. If antimicrobial therapy is required to treat bacterial infections (= or < 14 days), Adria Laboratories must be contacted prior to initiation of therapy. Patients with the following are excluded: Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (AZT), or didanosine (ddI). Previous or current Mycobacterium avium complex (MAC) infection. Perceived patient unreliability or unavailability for frequent monitoring. Prior Medication: Excluded within 4 weeks of study entry: Antiretroviral agents other than zidovudine (AZT) or didanosine (ddI). Antimycobacterial therapy. Rifampin. Isoniazid. Clofazimine. Ethambutol. Cycloserine. Ethionamide. Amikacin. Ciprofloxacin. Required: Zidovudine (AZT). Antipneumocystis prophylactic therapy. Required for at least 4 weeks prior to study entry: Zidovudine (AZT) or didanosine (ddI). Antipneumocystis prophylaxis.

Sites / Locations

  • Maricopa County Med Ctr
  • East Bay AIDS Ctr
  • Pacific Oaks Med Group
  • AIDS Community Research Consortium
  • HIV Research Group
  • Dr Larry A Waites
  • Saint Francis Mem Hosp / HIV Care
  • Dr Marcus Conant
  • San Francisco Veterans Administration Med Ctr
  • Dr Marshall Kubota
  • Dr Jeffrey Galpin
  • Miami Veterans Administration Med Ctr
  • Community Research Initiative of South Florida
  • Northwestern Univ Med School
  • AIDS Research Alliance - Chicago
  • Tulane Univ School of Medicine
  • Comprehensive AIDS Alliance of Detroit / Harper Hosp
  • Univ of Minnesota
  • St Paul Ramsey Med Ctr
  • Univ of Nevada / Veterans Administration Med Ctr
  • North Jersey Community Research Initiative
  • Univ of New Mexico Hlth Sciences Ctr / Dept of Med
  • Dr Donald Romig
  • Albany Veterans Administration
  • AIDS Services Erie County Med Ctr
  • Community Health Network
  • Buckley Braffman Stern Med Associates
  • Thomas Jefferson Med College
  • Dr Alfred F Burnside Jr
  • Infectious Disease Physicians Inc
  • Milwaukee County Med Complex
  • Univ of Calgary Health Science Ctr
  • Univ of Alberta/Division of Inf Dis/Dept of Med
  • Saint Paul's Hosp
  • Victoria Gen Hosp
  • McMaster Univ Med Ctr
  • Ottawa Gen Hosp
  • Mount Sinai Hosp
  • Saint Michael's Hosp
  • Sunnybrook Health Science Ctr
  • Dr Emil Toma / Hotel Dieu de Montreal
  • Montreal Chest Institute
  • Montreal Gen Hosp

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
NCT00002267
Brief Title
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
Official Title
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 1992
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
The primary objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200, as compared to placebo, and to assess if survival is prolonged in patients who receive rifabutin prophylaxis.

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, AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, Antitubercular Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Enrollment
750 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rifabutin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have the following: Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC). Written informed consent obtained, which must include a statement that treatment may involve risks to the embryo or fetus, which are currently unforeseeable, if the subject becomes pregnant. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI). Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation. Concurrent Medication: Excluded: Antiretroviral agents other than zidovudine (AZT). Didanosine (ddI). Antimycobacterial therapy. Rifampin. Isoniazid. Clofazimine. Ethambutol. Cycloserine. Ethionamide. Amikacin. Ciprofloxacin. Streptomycin. Other investigational drugs. If antimicrobial therapy is required to treat bacterial infections (= or < 14 days), Adria Laboratories must be contacted prior to initiation of therapy. Patients with the following are excluded: Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (AZT), or didanosine (ddI). Previous or current Mycobacterium avium complex (MAC) infection. Perceived patient unreliability or unavailability for frequent monitoring. Prior Medication: Excluded within 4 weeks of study entry: Antiretroviral agents other than zidovudine (AZT) or didanosine (ddI). Antimycobacterial therapy. Rifampin. Isoniazid. Clofazimine. Ethambutol. Cycloserine. Ethionamide. Amikacin. Ciprofloxacin. Required: Zidovudine (AZT). Antipneumocystis prophylactic therapy. Required for at least 4 weeks prior to study entry: Zidovudine (AZT) or didanosine (ddI). Antipneumocystis prophylaxis.
Facility Information:
Facility Name
Maricopa County Med Ctr
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85010
Country
United States
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Pacific Oaks Med Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
AIDS Community Research Consortium
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
HIV Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Dr Larry A Waites
City
San Francisco
State/Province
California
ZIP/Postal Code
94108
Country
United States
Facility Name
Saint Francis Mem Hosp / HIV Care
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Dr Marcus Conant
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
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
Dr Marshall Kubota
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95404
Country
United States
Facility Name
Dr Jeffrey Galpin
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Miami Veterans Administration Med Ctr
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Community Research Initiative of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
AIDS Research Alliance - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Comprehensive AIDS Alliance of Detroit / Harper Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Univ of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
St Paul Ramsey Med Ctr
City
St Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Univ of Nevada / Veterans Administration Med Ctr
City
Reno
State/Province
Nevada
ZIP/Postal Code
89520
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
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Dr Donald Romig
City
Sante Fe
State/Province
New Mexico
ZIP/Postal Code
87501
Country
United States
Facility Name
Albany Veterans Administration
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
AIDS Services Erie County Med Ctr
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Community Health Network
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson Med College
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
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
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
Facility Name
Milwaukee County Med Complex
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Univ of Calgary Health Science Ctr
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Univ of Alberta/Division of Inf Dis/Dept of Med
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Saint Paul's Hosp
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Victoria Gen Hosp
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
McMaster Univ Med Ctr
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Ottawa Gen Hosp
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Mount Sinai Hosp
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Saint Michael's Hosp
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Science Ctr
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Dr Emil Toma / Hotel Dieu de Montreal
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal Chest Institute
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal Gen Hosp
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
8807071
Citation
Dautzenberg B, Castellani P, Pellegrin JL, Vittecoq D, Truffot-Pernot C, Pirotta N, Sassella D. Early bactericidal activity of rifabutin versus that of placebo in treatment of disseminated Mycobacterium avium complex bacteremia in AIDS patients. Antimicrob Agents Chemother. 1996 Jul;40(7):1722-5. doi: 10.1128/AAC.40.7.1722.
Results Reference
background
PubMed Identifier
8605053
Citation
Moore RD, Chaisson RE. Survival analysis of two controlled trials of rifabutin prophylaxis against Mycobacterium avium complex in AIDS. AIDS. 1995 Dec;9(12):1337-42. doi: 10.1097/00002030-199512000-00006.
Results Reference
background

Learn more about this trial

Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial

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