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A Study of the Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for Three Months Versus Daily Isoniazid for Nine Months for the Treatment of Latent Tuberculosis Infection - Article


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Clinical Trial: A Study of the Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for Three Months Versus Daily Isoniazid for Nine Months for the Treatment of Latent Tuberculosis Infection

This study is currently recruiting patients.

Sponsors and Collaborators: Centers for Disease Control and Prevention
Department of Veterans Affairs
Information provided by: Centers for Disease Control and Prevention

Purpose

The primary objective of this open-label Phase III clinical trial is to compare the effectiveness of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month (270-dose) regimen of daily isoniazid (9INH). This trial will be conducted among high-risk tuberculin skin-test reactors, including children and HIV-infected persons, who require treatment of latent infection (TLI) to prevent tuberculosis (TB). The 3RPT/INH regimen will be given under direct observation and the 9INH regimen will be self-administered.

Secondary Objective: Compare the rates of drug discontinuation due to adverse drug reactions associated with 3RPT/INH and 9INH. Compare the rates of drug discontinuation for any reason associated with 3RPT/INH and 9INH. Compare the rates of any grade 3, 4, or 5 drug toxicity associated with 3RPT/INH and 9INH. Compare treatment completion rates of 3RPT/INH and 9INH. Compare the efficacy (i.e., among persons who complete study-phase therapy) of 3RPT/INH and 9INH. Compare the effectiveness and tolerability of 3RPT/INH and 9INH in HIV-infected persons. Compare the effectiveness and tolerability of 3RPT/INH and 9INH in children < 18 years old. Compare the rates of methadone withdrawal associated with 3RPT/INH and 9INH among persons concomitantly receiving methadone. Describe patterns of antibiotic resistance among M. tuberculosis isolates in patients who develop TB despite treatment of latent infection.

Condition Treatment or Intervention Phase
Tuberculosis
  Drug: Rifapentine + Isoniazid once weekly for 3 months
 Drug: Isoniazid daily for 9 months
 Phase III

MedlinePlus related topics:  Tuberculosis

Study Type: Interventional
Study Design: Treatment, Open Label, Efficacy Study

Eligibility

Genders Eligible for Study:  Both

Criteria

  • High-risk tuberculin skin-reactors requiring treatment of latent infection to prevent TB

Location and Contact Information

Research and Evaluation Branch , Division of TB Elimination, CDC      404-639-8123    tbtc@cdc.gov

Arkansas
      Central Arkansas Veterans Health System, Little Rock,  Arkansas,  72205,  United States; Recruiting
Rebecca Edge Martin, MD  501-257-5778    martinrebeccae@exchange.uams.edu 
Rebecca Edge Martin, MD,  Principal Investigator

California
      LA County/USC Medical Center, Los Angeles,  California,  90033,  United States; Recruiting
Brenda E Jones, MD  323-343-8300    bejones@hsc.usc.edu 
Brenda E Jones, MD,  Principal Investigator

      University of California, San Francisco, San Francisco,  California,  94110,  United States; Recruiting
Charles Daley, MD  415-206-4694    cdaley@itsa.ucsf.edu 
Charles Daley, MD,  Principal Investigator

Colorado
      Denver Department of Public Health and Hospitals, Denver,  Colorado,  80204,  United States; Recruiting
Randall Reves, MD  303-436-7297    rreves@dhha.org 
Randall Reves, MD,  Principal Investigator

District of Columbia
      Washington, D.C. VAMC, Washington,  District of Columbia,  20422,  United States; Recruiting
Fred M Gordin, MD  202-745-8301    fred.gordin@med.va.gov 
Fred M Gordin, MD,  Principal Investigator

Illinois
      Hines VA Medical Center, Hines,  Illinois,  60141,  United States; Recruiting
Constance T Pachucki, MD  708-202-2763    constance.pachucki@med.va.gov 
Constance T Pachucki, MD,  Principal Investigator

      Chicago VA Medical Center (Lakeside), Chicago,  Illinois,  60611,  United States; Recruiting
Mondira Bhattacharya, MD  312-469-3847    m-bhattacharya@nwu.edu 
Mondira Bhattacharya, MD,  Principal Investigator

Maryland
      Johns Hopkins University School of Medicine, Baltimore,  Maryland,  21287-0003,  United States; Recruiting
Richard E Chaisson, MD  410-955-1754    rchaiss@jhmi.edu 
Richard E Chaisson, MD,  Principal Investigator

Massachusetts
      Boston Medical Center, Boston,  Massachusetts,  02118,  United States; Recruiting
John Bernardo, MD  617-638-4860    jbernardo@lung.bumc.bu.edu 
John Bernardo, MD,  Principal Investigator

New Jersey
      New Jersey Medical School, Newark,  New Jersey,  07107-3001,  United States; Recruiting
Bonita T Mangura, MD  973-972-3270    mangurbt@umdnj.edu 
Bonita T Mangura, MD,  Principal Investigator

New York
      New York University School of Medicine, New York,  New York,  10016,  United States; Recruiting
William N Rom, MD, MPH  212-263-6479    ROMW01@GCRC.MED.NYU.EDU 
William N Rom, MD,MPH,  Principal Investigator

      Columbia University/Presbyterian Medical Center, New York,  New York,  10032,  United States; Recruiting
Neil W Schluger, MD  212-305-9817    ns311@columbia.edu 
Neil W Schluger, MD,  Principal Investigator

      Harlem Hospital Center, New York,  New York,  10037,  United States; Recruiting
Wafaa El-Sadr, MD  212-939-2936    wme1@columbia.edu 
Wafaa El-Sadr, MD,  Principal Investigator

North Carolina
      Duke University Medical Center, Durham,  North Carolina,  34222,  United States; Recruiting
Carol S Dukes Hamilton  919-684-3279    dukes002@mc.duke.edu 
Carol S Dukes Hamilton,  Principal Investigator

      Carolinas Medical Center, Charlotte,  North Carolina,  28203,  United States; Recruiting
James Horton, MD  704-355-3165    jhorton@carolinas.org 
James Horton, MD,  Principal Investigator

Tennessee
      Nashville VA Medical Center, Nashville,  Tennessee,  37212-2637,  United States; Recruiting
Doug Kernodle, MD  615-327-4751    doug.kernodle@vanderbilt.edu 

Texas
      University of North Texas Health Science Center, Fort Worth,  Texas,  76107-2699,  United States; Recruiting
Stephen Weis, DO  817-871-7262    sweis@veriomail.com 
Stephen Weis, DO,  Principal Investigator

      Thomas Street Clinic, Houston,  Texas,  77009,  United States; Recruiting
Christopher Lahart, MD  713-793-4083    clahart@bcm.tmc.edu 
Christopher Lahart, MD,  Principal Investigator

      Audi L. Murphy VA Hospital, San Antonio,  Texas,  78284,  United States; Recruiting
Marc H Weiner, MD  210-617-5111    weiner@uthscsa.edu 
Marc H Weiner, MD,  Principal Investigator

Washington
      Seattle King County Health Department, Seattle,  Washington,  98104,  United States; Recruiting
Charles M Nolan, MD  206-731-4582    Charles.Nolan@metrokc.gov 
Charles M Nolan, MD,  Principal Investigator

Canada, British Columbia
      University of British Columbia, Vancouver,  British Columbia,  Canada V5Z 4R4,  Canada; Recruiting
J M FitzGerald, MD  604-660-6127    markf@interchange.ubc.ca 
J M FitzGerald, MD,  Principal Investigator

Canada, Manitoba
      University of Manitoba, Winnipeg,  Manitoba,  CANADA R3A 1R8,  Canada; Recruiting
Earl Hershfield, MD  204-787-2977    ehersh@ccu.umanitoba.ca 
Earl Hershfield, MD,  Principal Investigator

Canada, Quebec
      Montreal Chest Institute McGill University, Montreal,  Quebec,  H2X 2P4Pq Canada,  Canada; Recruiting
Richard I Menzies, MD  514-398-8122    menzies@meakins.lan.mcgill.ca 
Richard I Menzies, MD,  Principal Investigator

More Information

(Click here for more information about the Tuberculosis Trials Consortium(TBTC)

Study ID Numbers:  3041; TBTC Study 26
Record last reviewed:  March 2002
Last Updated:  October 13, 2004
Record first received:  September 6, 2001
ClinicalTrials.gov Identifier:  NCT00023452
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 27, 2009


Page Updated: June 1, 2005
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