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Comparing a 6-week rifapentine treatment for latent tuberculosis to standard longer treatments

Six Weeks of Daily Rifapentine vs. a Comparator Arm of 12-16 Week Rifamycin-based Treatment of Latent M. Tuberculosis Infection: Assessment of Safety, Tolerability and Effectiveness

Phase2; Phase3 Interventional Centers for Disease Control and Prevention · NCT03474029

This study is testing if a new 6-week treatment with rifapentine can safely and effectively replace the standard 12-16 week treatment for people with latent tuberculosis.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment3400 (estimated)
SexAll
SponsorCenters for Disease Control and Prevention Federal
Locations21 sites (Denver, Colorado and 20 other locations)
Trial IDNCT03474029 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of a new 6-week regimen of daily rifapentine for treating latent tuberculosis infection (LTBI) compared to the standard 12-16 week rifamycin-based treatment. Participants at increased risk of progressing to tuberculosis will be randomly assigned to either the experimental group receiving rifapentine or the control group receiving standard treatment. The aim is to determine if the shorter regimen is as safe and effective as the longer standard treatment. The study will take place in various settings with different incidences of tuberculosis.

Who should consider this trial

Good fit: Ideal candidates include males or non-pregnant, non-breastfeeding females over 12 years old with latent tuberculosis and at increased risk of progression to active TB.

Not a fit: Patients with active tuberculosis disease or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a shorter and potentially more convenient treatment option for patients with latent tuberculosis.

How similar studies have performed: Previous studies have shown promise in shorter treatment regimens for LTBI, suggesting that this approach may be viable.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

1. Persons with LTBI who do not have evidence of TB disease (see exclusion criteria) and are at increased risk of progression to TB. LTBI or M. tuberculosis infection may be demonstrated by either a positive tuberculin skin test (TST) or a positive interferon gamma release assay (IGRA; e.g., QuantiFERON or T.SPOT.TB). Details of testing definitions and requirements for each risk factor are further described in the MOOP. Persons with LTBI at increased risk of progression to TB are those with at least one of the following:

   1. Household and other close contacts (\> 4 hours of exposure in a one-week period) within 2 years prior to enrollment, of persons with bacteriologically confirmed TB.

      o Acceptable testing approaches for bacteriologic confirmation are 1) culture with rifamycin DST; or, 2) nucleic acid amplification tests (NAATs) that detect M. tuberculosis and detect mutations associated with rifamycin resistance. Additional details on bacteriologic confirmation, including accepted NAATs, will be included in the MOOP.
   2. Recent M. tuberculosis infection, defined as converting from a documented negative to positive TST or IGRA within 2 years prior to enrollment. Persons without known close contact to someone with active pulmonary TB who have a conversion by IGRA may require additional evaluation to rule out a false conversion. Additional guidance and definitions of conversion are in the MOOP.
   3. HIV co-infection (with CD4+ T-lymphocyte count \> 100 cells/mm3)
   4. ≥ 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior history of treatment for TB or LTBI.
   5. Recent (within 3 years prior to enrollment) immigration to the United States or other country with low to moderate TB incidence, with abnormal chest X-ray, and no evidence of active TB.
   6. Recent (within 3 years prior to enrollment) immigration to the United States or other country with low to moderate TB incidence, from a country with an estimated incidence rate of TB \> 150 per 100,000 (see Appendix D) and either a positive IGRA or a TST ≥15 mm (TST \> 15 mm only applicable for those with recent immigration as their only risk factor for progression to TB).
   7. Recent (within 3 years prior to enrollment) immigration and seeking refugee/asylum status (see MOOP for additional details) to the United States or other country with low to moderate incidence from a country with an estimated incidence rate of TB \> 75 per 100,000 (see Appendix E) and either a positive IGRA or a TST ≥15 mm (TST \> 15 mm only applicable for those with recent immigration as their only risk factor for progression to TB).
   8. Individuals with an increased risk of TB due to medical conditions such as end-stage renal disease.
   9. Individuals currently using immunosuppressive medications such as chronic steroids.
   10. Individuals with planned use of TNF-α inhibitors.
   11. Individuals with planned solid organ or hematologic transplantation
2. Willing to provide signed informed consent, or parental permission and participant assent.
3. For the following special populations, both inclusion criteria above must be met AND the criteria below depending on stage:

   1. Pregnant women in their second or third trimester (≥14 weeks gestation).

      * Stage 1: Include only those who agree to participate in the semi-intensive PK component.
      * Stage 2: Include regardless of semi-intensive PK component participation.
   2. Children aged less than 12 years

      * Stage 1: Include only those who agree to participate in the semi-intensive PK component, based on enrollment strategy presented in Appendix I.
      * Stage 2: Include regardless of semi-intensive PK component participation, based on PK findings and enrollment strategy described in Appendix I.

Exclusion Criteria

1. Failure to document positive IGRA or TST
2. Current breastfeeding.
3. Women who are currently pregnant in their first trimester (\<14 weeks gestation) or intend to become pregnant within 120 days of enrollment.
4. Non-pregnant women of childbearing potential who refuse to practice an adequate method of contraception (barrier method or non-hormonal intrauterine device) or abstain from activities that could lead to pregnancy.
5. Current culture-positive TB, clinical TB, or suspected current TB. (Includes cases in which active TB cannot be excluded with reasonable clinical certainty by the site investigator. If sputum samples have been collected AND site investigators have suspicion of active TB, site investigators must wait to review culture results prior to enrollment.)
6. TB resistant to any rifamycin in the source case
7. A history of treatment for \> 7 consecutive days (if daily dosing) with a rifamycin or \>1 week (if weekly dosing) with a rifamycin and INH or \> 30 consecutive days with INH within 2 years prior to enrollment.
8. A documented history of completing an adequate course of treatment for TB disease or LTBI in a person who is HIV-seronegative.
9. History of allergy or intolerance to rifamycins.
10. Serum alanine aminotransferase (ALT; SGPT) or serum aspartate aminotransferase (AST; SGOT) \> 5x upper limit of normal among persons in whom screening ALT or AST is determined.
11. Receiving concomitant medications that are known to be contraindicated with any study drug.
12. Weight \< 25 kg for participants ≥ 12 years, and weight \< 3kg for participants \< 12 years

Where this trial is running

Denver, Colorado and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Latent Tuberculosislatent tuberculosisrifapentine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.