Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
Public ClinicalTrials.gov record NCT03474029. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is conducted to compare the safety and effectiveness of a novel short 6-week regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment (standard of care, control arm) of latent M. tuberculosis infection (LTBI). This trial is conducted among persons who are at increased risk of progression to tuberculosis (TB) and require treatment of LTBI. The study will be conducted in low, medium and high TB incidence settings that have treatment of LTBI as their standard of care and offer 12-16 week rifamycin-based therapy as standard of care. The hypothesis of this study is that the safety and effectiveness of the experimental treatment (6wP arm) is non-inferior to a comparator arm of 12-16 weeks of rifamycin-based treatment of LTBI (control arm). Participants are enrolled and randomly assigned to one of the two study arms: experimental 6wP or control. The comparator (control) arm's treatment regimens include 12 weeks of once-weekly isoniazid (INH) and rifapentine (3HP), 12 weeks of daily INH and rifampin (3HR), and 16 weeks of daily rifampin (4R). A total of 560 participants per arm (1,120 total) for the evaluation of safety and 1,700 participants per arm (3,400 total) for the evaluation of effectiveness will be enrolled, given treatment as per randomization assignment, and followed for 24 months from the date of enrollment. After completion of data collection, statistical analyses will be conducted to compare proportions of drug discontinuation due to adverse drug reaction (ADR) and proportions of newly diagnosed tuberculosis between 6wP and control arm.
Study identification
- NCT ID
- NCT03474029
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 3,400 participants
Conditions and interventions
Conditions
Interventions
- Rifampin and Isoniazid daily for 12 weeks Drug
- Rifampin daily for 16 weeks Drug
- Rifapentine and Isoniazid weekly for 12 weeks Drug
- Rifapentine daily for 6 weeks Drug
Drug
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2019
- Primary completion
- Dec 30, 2029
- Completion
- Dec 30, 2029
- Last update posted
- May 5, 2026
2019 – 2029
United States locations
- U.S. sites
- 7
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | Recruiting |
| George Washington University | Washington D.C. | District of Columbia | 20001 | Recruiting |
| Washington DC VA Medical Center | Washington D.C. | District of Columbia | 20001 | Recruiting |
| New York Harbor Healthcare System | Manhattan | New York | 10001 | Recruiting |
| New York City Bureau of TB Control | New York | New York | 11201 | Recruiting |
| San Antonio VA | San Antonio | Texas | 78201 | Active, not recruiting |
| Seattle King County Health Department | Seattle | Washington | 98101 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
Recently updated Latent Tuberculosis trials
Other public records listing Latent Tuberculosis. Sorted by last update posted; newest first. Not a recommendation.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03474029, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2026 · Synced Aug 15, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03474029 live on ClinicalTrials.gov.