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TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen

Primary Purpose

HIV Infections, Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Rifabutin
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring tuberculosis, TB

Eligibility Criteria

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

Inclusion Criteria Clinical diagnosis of pulmonary &/or extrapulmonary TB confirmed by a positive culture and susceptibility to rifampin. Patients having isoniazid or pyrazinamide (PZA)-resistant isolates are eligible to continue in the study on a modified regimen Evidence of HIV infection confirmed by a positive serologic test (ELISA and Western Blot). Absolute neutrophil count >500/mm3 (use of colony stimulating factors, filgrastim, or sargramostim is allowed) > 18 years of age Willingness to practice effective contraception if applicable Signed informed consent Exclusion Criteria Pregnancy or breastfeeding AST > 10 times the upper limit of normal Bilirubin > 3.0 times the upper limit of normal Creatinine > 3.0 times the upper limit of normal Intolerance to any of the study drugs except isoniazid or pyrazinamide Concomitant disorder that is contraindication to the use of the study drugs More than 28 days of treatment for active tuberculosis within the 6 months prior to this course of therapy Bone/joint tuberculosis or silicotuberculosis

Sites / Locations

  • Central Arkansas Veterans Health System
  • LA County/USC Medical Center
  • University of California, San Francisco
  • Denver Department of Public Health and Hospitals
  • Washington, D.C. VAMC
  • Chicago VA Medical Center (Lakeside)
  • Hines VA Medical Center
  • Johns Hopkins University School of Medicine
  • Boston Medical Center
  • New Jersey Medical School
  • New York University School of Medicine
  • Columbia University/Presbyterian Medical Center
  • Harlem Hospital Center
  • Carolinas Medical Center
  • Duke University Medical Center
  • Nashville VA Medical Center
  • University of North Texas Health Science Center
  • Thomas Street Clinic
  • Audi L. Murphy VA Hospital
  • Seattle King County Health Department
  • University of British Columbia
  • University of Manitoba
  • Montreal Chest Institute McGill University

Outcomes

Primary Outcome Measures

Rate of confirmed treatment failure and relapse

Secondary Outcome Measures

Safety and tolerability
Response of HIV RNA to TB treatment
Paradoxical reactions

Full Information

First Posted
September 6, 2001
Last Updated
September 1, 2005
Sponsor
Centers for Disease Control and Prevention
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00023361
Brief Title
TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
Official Title
TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
US Department of Veterans Affairs

4. Oversight

5. Study Description

Brief Summary
Primary objective: To determine the rate of confirmed treatment failure and relapse with an intermittent rifabutin-based regimen for the treatment of isoniazid and rifamycin-susceptible HIV-related tuberculosis (TB).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Tuberculosis
Keywords
tuberculosis, TB

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
215 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rifabutin
Primary Outcome Measure Information:
Title
Rate of confirmed treatment failure and relapse
Secondary Outcome Measure Information:
Title
Safety and tolerability
Title
Response of HIV RNA to TB treatment
Title
Paradoxical reactions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Clinical diagnosis of pulmonary &/or extrapulmonary TB confirmed by a positive culture and susceptibility to rifampin. Patients having isoniazid or pyrazinamide (PZA)-resistant isolates are eligible to continue in the study on a modified regimen Evidence of HIV infection confirmed by a positive serologic test (ELISA and Western Blot). Absolute neutrophil count >500/mm3 (use of colony stimulating factors, filgrastim, or sargramostim is allowed) > 18 years of age Willingness to practice effective contraception if applicable Signed informed consent Exclusion Criteria Pregnancy or breastfeeding AST > 10 times the upper limit of normal Bilirubin > 3.0 times the upper limit of normal Creatinine > 3.0 times the upper limit of normal Intolerance to any of the study drugs except isoniazid or pyrazinamide Concomitant disorder that is contraindication to the use of the study drugs More than 28 days of treatment for active tuberculosis within the 6 months prior to this course of therapy Bone/joint tuberculosis or silicotuberculosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Burman, MD
Organizational Affiliation
Denver Health and Hospitals
Official's Role
Study Chair
Facility Information:
Facility Name
Central Arkansas Veterans Health System
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
LA County/USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Denver Department of Public Health and Hospitals
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Washington, D.C. VAMC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Chicago VA Medical Center (Lakeside)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Hines VA Medical Center
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0003
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07107-3001
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University/Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Harlem Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
34222
Country
United States
Facility Name
Nashville VA Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States
Facility Name
University of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107-2699
Country
United States
Facility Name
Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
Audi L. Murphy VA Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Seattle King County Health Department
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
Canada V5Z 4R4
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
CANADA R3A 1R8
Country
Canada
Facility Name
Montreal Chest Institute McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4Pq Canada
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15844071
Citation
Weiner M, Benator D, Burman W, Peloquin CA, Khan A, Vernon A, Jones B, Silva-Trigo C, Zhao Z, Hodge T; Tuberculosis Trials Consortium. Association between acquired rifamycin resistance and the pharmacokinetics of rifabutin and isoniazid among patients with HIV and tuberculosis. Clin Infect Dis. 2005 May 15;40(10):1481-91. doi: 10.1086/429321. Epub 2005 Apr 14.
Results Reference
background
Links:
URL
http://www.cdc.gov/nchstp/tb/tbtc/
Description
(Click here for more information about the Tuberculosis Trials Consortium(TBTC)

Learn more about this trial

TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen

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