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Study of Rifapentine for Latent Tuberculosis

This study is looking at different ways to treat latent tuberculosis (LTBI), which means you have the bacteria that causes TB in your body but don't have active disease. Researchers want to see if a shorter 6-week daily treatment with rifapentine is as safe and effective as longer standard treatments. These standard treatments include rifapentine and isoniazid weekly for 12 weeks, rifampin and isoniazid daily for 12 weeks, or rifampin daily for 16 weeks. You could be eligible if you have LTBI and are at a higher risk of developing active TB. The study will measure if people stop treatment due to side effects and if they develop active TB within 24 months.

Study design
This study is comparing different drug treatments for latent tuberculosis in about 3400 participants. It's an interventional study, meaning participants will receive one of the specified drug regimens.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 24 months from enrollment to see if they develop active tuberculosis.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03474029

Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI

Recruiting
PHASE2All AgesInterventionalTreatment
Centers for Disease Control and Prevention
~3,400 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Rifapentine daily for 6 weeksRifapentine and Isoniazid weekly for 12 weeksRifampin and Isoniazid daily for 12 weeksRifampin daily for 16 weeks

At a glance

Recruiting sites
18 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment discontinuation due to adverse drug reaction
Measured over from the date of enrollment to the date of scheduled completion of assigned treatment
+1 more outcome measured

Conditions

Latent Tuberculosis

Explore related trials

Tuberculosis InfectionHIV InfectionTHIOSULFATE SULFURTRANSFERASE

Where it's being run

21 sites across 15 states
Australia3
District of Columbia2
New York2
Alberta2
Vietnam2
Colorado1
Texas1
Washington1

Study leadership

  • Timothy Sterling, MD · STUDY_CHAIR · Vanderbilt University Medical Center
  • Robert Belknap, MD · STUDY_CHAIR · Denver Public Health (USA)
  • Amber Robinson, PhD · STUDY_DIRECTOR · Centers for Disease Control and Prevention
  • Rosanna M Boyd, PhD · STUDY_DIRECTOR · Centers for Disease Control (USA)
  • Dick Menzies, MD · STUDY_CHAIR · McGill University

Who to contact

Amber B Robinson, PhD
[email protected]
1-800-CDC-INFO
Email the study team

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Treatment discontinuation due to adverse drug reactionfrom the date of enrollment to the date of scheduled completion of assigned treatment

    1\. Safety: Drug discontinuation due to adverse drug reaction (ADR) associated with 6wP and the rifamycin-based comparator arm (3HP, 3HR, or 4R). • Attribution of an adverse event (AE) to study drugs will be initially determined by the local site investigator, reviewed by an independent, blinded adjudication panel and with final attribution determined by the sponsor.

  • Culture-confirmed tuberculosis (TB) in participants 18 years old and older and culture-confirmed or clinical TB in participants less then 18 years old.within 24 months from the date of enrollment

    2\. Effectiveness: Culture-confirmed TB in participants \> 18 years old and culture-confirmed or clinical TB in participants \< 18 years old. * Diagnosis of culture-confirmed TB will be performed using liquid and/or solid media. * An independent, blinded adjudication panel will review all TB events.