search
Back to results

TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine

Primary Purpose

Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Rifapentine
25-desacetyl Rifapentine
Isoniazid
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

Eligibility Criteria

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

Inclusion: Patients enrolled in TBTC Study 25 Informed consent Exclusion: Severe anemia (Hct <25%) Any severe adverse event related to study drugs in TBTC Study 25

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

Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg

Secondary Outcome Measures

Describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.

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
search

1. Study Identification

Unique Protocol Identification Number
NCT00023387
Brief Title
TBTC Study 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine
Official Title
Intensive Pharmacokinetic Study of Three Doses of Rifapentine (600, 900 and 1200mg) During Continuation Phase Therapy of Tuberculosis in HIV-Negative Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2001 (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 compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three different doses: 600 mg, 900 mg, and 1200 mg. Secondary objective: To describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.
Detailed Description
We will enroll 24-36 patients, 8-12 at each dose of 600, 900 and 1200 mg rifapentine Admissions for pharmacokinetic studies will take place during the continuation phase of tuberculosis therapy. Patients participating in a double-blinded trial of the tolerability and safety of higher doses of rifapentine during continuation phase therapy and consenting to participate in the pharmacokinetic study may be admitted to a Clinical Research Center (CRC) to allow for frequent blood sampling over a 24-hour period. Otherwise, patients will be evaluated in the clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rifapentine
Intervention Type
Drug
Intervention Name(s)
25-desacetyl Rifapentine
Intervention Type
Drug
Intervention Name(s)
Isoniazid
Primary Outcome Measure Information:
Title
Compare the pharmacokinetics of rifapentine and 25-desacetyl rifapentine at three difference doses: 600 mg, 900 mg, and 1200 mg
Secondary Outcome Measure Information:
Title
Describe any correlation between pharmacokinetic parameters of three different doses of rifapentine plus a standard dose of isoniazid and the occurrence of toxicity attributed to anti-tuberculosis treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: Patients enrolled in TBTC Study 25 Informed consent Exclusion: Severe anemia (Hct <25%) Any severe adverse event related to study drugs in TBTC Study 25
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Weiner, MD
Organizational Affiliation
Audie L. Murphy VA Medical Center, San Antonio TX
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
14962821
Citation
Weiner M, Bock N, Peloquin CA, Burman WJ, Khan A, Vernon A, Zhao Z, Weis S, Sterling TR, Hayden K, Goldberg S; Tuberculosis Trials Consortium. Pharmacokinetics of rifapentine at 600, 900, and 1,200 mg during once-weekly tuberculosis therapy. Am J Respir Crit Care Med. 2004 Jun 1;169(11):1191-7. doi: 10.1164/rccm.200311-1612OC. Epub 2004 Feb 12.
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 25PK: Intensive Pharmacokinetic Study of Three Doses of Rifapentine and 25-Desacetyl Rifapentine

We'll reach out to this number within 24 hrs