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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
United States
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. Females of childbearing potential must also sign a special informed consent. 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

  • Ctr for Special Immunology
  • Olive View Med Ctr
  • Denver Public Health Dept
  • Veterans Administration Med Ctr
  • Ctr for Special Immunology
  • TheraFirst Med Ctrs Inc
  • Mem Hosp Hollywood
  • VP Med Services / HHCS Research Institute Inc
  • AIDS Research Consortium of Atlanta
  • Grady Memorial Hosp / Hughs Spalding Med Ctr
  • Dr Winkler Weinberg
  • Johns Hopkins School of Medicine
  • CRI of New England
  • Univ of Missouri at Kansas City School of Medicine
  • Research Med Ctr
  • Brooklyn Veterans Administration
  • Maimonides Med Ctr
  • Nassau County Med Ctr
  • Long Island Jewish Med Ctr
  • Community Research Initiative
  • Chelsea Village Med Ctr
  • Mem Sloan - Kettering Cancer Ctr
  • Univ Hosp of Cleveland / Case Western Reserve Univ
  • Ohio State Univ Med Ctr
  • Central Texas Med Foundation
  • Nelson Tebedo Community Clinic
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Texas Tech Health Sciences Ctr
  • Baylor College of Medicine
  • Houston Clinical Research Network
  • Univ TX San Antonio Health Science Ctr
  • Scott and White Hosp
  • Dr Scott Lea

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
NCT00002032
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
January 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 objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in these patients. A secondary objective is to compare clinical response, quality of life (Karnofsky), and survival between these two groups.

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. Females of childbearing potential must also sign a special informed consent. 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
Ctr for Special Immunology
City
Irvine
State/Province
California
ZIP/Postal Code
92718
Country
United States
Facility Name
Olive View Med Ctr
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Denver Public Health Dept
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
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
Ctr for Special Immunology
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
TheraFirst Med Ctrs Inc
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Mem Hosp Hollywood
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
VP Med Services / HHCS Research Institute Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Grady Memorial Hosp / Hughs Spalding Med Ctr
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30335
Country
United States
Facility Name
Dr Winkler Weinberg
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
CRI of New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Facility Name
Univ of Missouri at Kansas City School of Medicine
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Research Med Ctr
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Brooklyn Veterans Administration
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11209
Country
United States
Facility Name
Maimonides Med Ctr
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Nassau County Med Ctr
City
East Meadow
State/Province
New York
ZIP/Postal Code
11554
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
Community Research Initiative
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Chelsea Village Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States
Facility Name
Mem Sloan - Kettering Cancer Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Univ Hosp of Cleveland / Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State Univ Med Ctr
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Central Texas Med Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Nelson Tebedo Community Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
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
Texas Tech Health Sciences Ctr
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Houston Clinical Research Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77266
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
Scott and White Hosp
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Dr Scott Lea
City
Waco
State/Province
Texas
ZIP/Postal Code
76708
Country
United States

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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