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TBTC Study 26: Weekly RFP/INH for 3 mo. vs. Daily INH for 9 mo. for the Treatment of LTBI

This study is enrolling participants by invitation only.
Study NCT00023452.   Last updated on July 29, 2008.   Information provided by Centers for Disease Control and Prevention

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † TBTC Study 26: Weekly RFP/INH for 3 mo. vs. Daily INH for 9 mo. for the Treatment of LTBI
Official Title † TBTC Study 26: Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for 3 Months Versus Daily Isoniazid for 9 Months for the Treatment of Latent Tuberculosis Infection
Brief Summary

The objectives of this open-label Phase III clinical trial is to compare the effectiveness and tolerability 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) to prevent tuberculosis (TB) among high-risk tuberculin skin-test reactors, including children and HIV-infected persons, who require treatment of latent TB infection (TLI).
Detailed Description

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) to prevent tuberculosis (TB) among high-risk tuberculin skin-test reactors, including children and HIV-infected persons, who require treatment of latent TB infection (TLI). The 3RPT/INH regimen will be given under direct observation and the 9INH regimen will be self-administered.

SECONDARY Objectives:

  • 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.
Study Phase Phase III
Study Type † Interventional
Study Design † Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure † Culture-confirmed tuberculosis in persons > 18 years old [ Time Frame: within 33 months of completion of LTBI therapy ] [ Designated as safety issue: No ]
Culture-confirmed or probable (clinical) tuberculosis in persons < 18 years old [ Time Frame: within 33 months of completion of LTBI therapy ] [ Designated as safety issue: No ]
Secondary Outcome Measure † Grade 3 or 4 drug-related toxicity [ Time Frame: during study therapy or within 60 days of the date of the last study dose ] [ Designated as safety issue: Yes ]
Death [ Time Frame: during study therapy or within 60 days of the date of the last study dose ] [ Designated as safety issue: Yes ]
Development of methadone withdrawal [ Time Frame: during study therapy or within 60 days of the date of the last study dose ] [ Designated as safety issue: Yes ]
Discontinuation of therapy for any reason [ Time Frame: during study therapy ] [ Designated as safety issue: Yes ]
Completion of the prescribed regimen [ Time Frame: within 33 months ] [ Designated as safety issue: Yes ]
Development of culture (+) TB among HIV-infected patients [ Time Frame: within 33 months of completion of LTBI therapy ] [ Designated as safety issue: No ]
Development of resistance to study medications in isolates during LTBI study therapy [ Time Frame: within 33 months ] [ Designated as safety issue: Yes ]
Discontinuation of study therapy due to AE [ Time Frame: during study therapy phase ] [ Designated as safety issue: Yes ]
Condition † Tuberculosis
Intervention † Drug: Rifapentine + Isoniazid once weekly for 3 months
Drug: Isoniazid daily for 9 months
MEDLINE PMIDs
Links (Click here for more information about the Tuberculosis Trials Consortium(TBTC) This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Enrolling by invitation
Enrollment † 8000
Start Date † June 2002
Completion Date December 2010
Eligibility Criteria †

INCLUSION criteria:

  • Males or nonpregnant, non-nursing females > 2 years old.

  • Tuberculin (PPD) skin test reactors at high risk for developing TB but without evidence of active TB. High-risk reactors are defined as:

    1. Household and other close contacts of persons with culture-confirmed TB who are TST-positive as part of a contact investigation conducted within two years of the date of enrollment. Close contact is defined as > 4 hours in a shared airspace during a one-week period. Among close contacts, a positive TST is defined as > 5 mm induration after 5 TU of PPD placed intradermally using the Mantoux technique.
    2. TST converters--converting from a documented negative to positive TST within a two-year period. This is defined as persons with a tuberculin skin test of > 10 mm within two years of a nonreactive test or persons with an increase of > 10 mm within a two-year period.
    3. HIV-seropositive, TST positive (> 5 mm induration) persons.
    4. Persons with > 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray, no prior history of TB treatment, > 5 mm induration on TST, and 3 sputum cultures negative for M. tuberculosis on final report.
  • HIV-seropositive close contacts of persons with culture-confirmed TB, regardless of TST status. In addition, HIV-seropositive close contacts of persons with culture-confirmed TB who have a documented history of completing an adequate course of treatment for active TB or latent TB infection, are also eligible.
  • Willing to provide signed informed consent, or parental consent and participant assent.

EXCLUSION criteria:

  • Current confirmed culture-positive or clinical TB
  • Suspected TB (as defined by the site investigator)
  • Tuberculosis resistant to isoniazid or rifampin in the source case
  • A history of treatment for > 14 consecutive days with a rifamycin or > 30 consecutive days with INH during the previous 2 years.
  • A documented history of a completing an adequate course of treatment for active TB or latent TB infection in a person who is HIV-seronegative.
  • History of sensitivity/intolerance to isoniazid or rifamycins
  • Serum aminotransferase aspartate (AST, SGOT) > 5x upper limit of normal among persons in whom AST is determined
  • Pregnant or nursing females
  • Persons currently receiving or planning to receive HIV-1 protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 90 days after enrollment.
  • Weight < 10.0 kg
Gender Both
Ages 2 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States,   Brazil,   Canada,   Spain
Administrative Information Fields
NCT ID † NCT00023452
Organization ID CDC-NCHSTP-3041
Secondary IDs †† TBTC Study 26
Study Sponsor † Centers for Disease Control and Prevention
Collaborators †† Department of Veterans Affairs
Investigators †
Study Director:     Elsa Villarino, MD, MPH     Centers for Disease Control and Prevention    
Study Chair:     Timothy Sterling, MD     Vanderbilt University    
Information Provided By Centers for Disease Control and Prevention
Verification Date July 2008
First Received Date † September 6, 2001
Last Updated Date July 29, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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