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TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis

Primary Purpose

Tuberculosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rifapentine
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tuberculosis focused on measuring tuberculosis, tb, rifapentine, safety, dose

Eligibility Criteria

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

Inclusions: Drug susceptible culture-positive tuberculosis Adequate induction therapy Age >18 Normal screening labs Karnofsky >=60 Informed consent Birth control if of child bearing potential Exclusions: SilicoTB Skeletal or CNS TB Pregnant or breastfeeding Intolerance to INH or rifamycins Over 70 days TB treatment just prior to enrollment

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

Proportion of patients who fail to complete therapy in each of the dosing groups

Secondary Outcome Measures

1. Rate of serious adverse events in each of the dosing groups
2. Rate of total adverse events in each of the groups
3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups

Full Information

First Posted
September 6, 2001
Last Updated
September 9, 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
NCT00023426
Brief Title
TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis
Official Title
TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
July 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
Randomized, double-blind study of the tolerability of three different doses of rifapentine
Detailed Description
Prospective, randomized, double-blinded, comparative study. Patients are randomized at the completion of induction phase therapy. Sample-size is 50 HIV-seronegative patients with culture-positive, drug susceptible TB in each treatment arm. The first 75 patients will be randomized 2:1 to 900 mg:600 mg rifapentine. The second 75 patients will be randomized 2:1 to 1200 mg:600 mg rifapentine. The DSMB will review tolerability and safety data on the first 21 patients enrolled (at the 900 mg and 600 mg doses) and approve proceeding to enrollment at the 1200 mg dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
tuberculosis, tb, rifapentine, safety, dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rifapentine
Primary Outcome Measure Information:
Title
Proportion of patients who fail to complete therapy in each of the dosing groups
Secondary Outcome Measure Information:
Title
1. Rate of serious adverse events in each of the dosing groups
Title
2. Rate of total adverse events in each of the groups
Title
3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusions: Drug susceptible culture-positive tuberculosis Adequate induction therapy Age >18 Normal screening labs Karnofsky >=60 Informed consent Birth control if of child bearing potential Exclusions: SilicoTB Skeletal or CNS TB Pregnant or breastfeeding Intolerance to INH or rifamycins Over 70 days TB treatment just prior to enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Bock, MD
Organizational Affiliation
Centers for Disease Control & Prevention
Official's Role
Principal Investigator
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
12045127
Citation
Bock NN, Sterling TR, Hamilton CD, Pachucki C, Wang YC, Conwell DS, Mosher A, Samuels M, Vernon A; Tuberculosis Trials Consortium, Centers for Disease Control and Prevention, Atlanta, Georgia. A prospective, randomized, double-blind study of the tolerability of rifapentine 600, 900, and 1,200 mg plus isoniazid in the continuation phase of tuberculosis treatment. Am J Respir Crit Care Med. 2002 Jun 1;165(11):1526-30. doi: 10.1164/rccm.200201-047OC.
Results Reference
result
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 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis

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