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

September 9, 2005 updated by: Centers for Disease Control and Prevention

TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine

Randomized, double-blind study of the tolerability of three different doses of rifapentine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, Canada V5Z 4R4
        • University of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, CANADA R3A 1R8
        • University of Manitoba
    • Quebec
      • Montreal, Quebec, Canada, H2X 2P4Pq Canada
        • Montreal Chest Institute McGill University
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Central Arkansas Veterans Health System
    • California
      • Los Angeles, California, United States, 90033
        • LA County/USC Medical Center
      • San Francisco, California, United States, 94110
        • University of California, San Francisco
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Department of Public Health and Hospitals
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Washington, D.C. VAMC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Chicago VA Medical Center (Lakeside)
      • Hines, Illinois, United States, 60141
        • Hines VA Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287-0003
        • Johns Hopkins University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07107-3001
        • New Jersey Medical School
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine
      • New York, New York, United States, 10037
        • Harlem Hospital Center
      • New York, New York, United States, 10032
        • Columbia University/Presbyterian Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
      • Durham, North Carolina, United States, 34222
        • Duke University Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37212-2637
        • Nashville VA Medical Center
    • Texas
      • Fort Worth, Texas, United States, 76107-2699
        • University of North Texas Health Science Center
      • Houston, Texas, United States, 77009
        • Thomas Street Clinic
      • San Antonio, Texas, United States, 78284
        • Audi L. Murphy VA Hospital
    • Washington
      • Seattle, Washington, United States, 98104
        • Seattle King County Health Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusions:

  1. Drug susceptible culture-positive tuberculosis
  2. Adequate induction therapy
  3. Age >18
  4. Normal screening labs
  5. Karnofsky >=60
  6. Informed consent
  7. Birth control if of child bearing potential

Exclusions:

  1. SilicoTB
  2. Skeletal or CNS TB
  3. Pregnant or breastfeeding
  4. Intolerance to INH or rifamycins
  5. Over 70 days TB treatment just prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Naomi Bock, MD, Centers for Disease Control & Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Study Completion

February 1, 2003

Study Registration Dates

First Submitted

September 6, 2001

First Submitted That Met QC Criteria

September 8, 2001

First Posted (Estimate)

September 10, 2001

Study Record Updates

Last Update Posted (Estimate)

September 13, 2005

Last Update Submitted That Met QC Criteria

September 9, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCHSTP-2404
  • 25
  • HCK45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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