TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis

September 1, 2005 updated by: Centers for Disease Control and Prevention

TBTC Study 22: Efficacy and Safety of Once-Weekly Rifapentine and Isoniazid Compared to Efficacy and Safety of Once-Weekly Rifapentine and Isoniazid Compared to Twice-Weekly Rifampin and Isoniazid in the Continuation Phase of Therapy for Pulmonary Tuberculosis

Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens.

Secondary Objectives:

To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy.

To compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for M. tuberculosis.

To compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy.

To compare mortality rates of the two study regimens. To compare the rates of completion of therapy within 22 weeks for the two study regimens.

To compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses.

To compare all of the above performance characteristics for the two study regimens in a small subset of HIV seropositive patients.

To compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1000

Phase

  • Phase 3

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

  • Culture-positive, drug-susceptible pulmonary tuberculosis

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: None (Open Label)

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

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

April 1, 1995

Study Completion

March 1, 2001

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 5, 2005

Last Update Submitted That Met QC Criteria

September 1, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCHSTP-1427
  • TBTC Study 22

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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