Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
NCT03474029 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Rifapentine daily for 6 weeks
- DRUG Rifapentine and Isoniazid weekly for 12 weeks
- DRUG Rifampin and Isoniazid daily for 12 weeks
- DRUG Rifampin daily for 16 weeks
Study Locations (16)
Other
- Liverpool Hospital — Sydney
- Paramatta Chest — Sydney
- Royal Prince Alfred Hospital — Sydney
- Desmond Tutu TB Center — Stellenbosch
District of Columbia
- George Washington University — Washington D.C.
- Washington DC VA Medical Center — Washington D.C.
New York
- New York Harbor Healthcare System — Manhattan
- New York City Bureau of TB Control — New York
Alberta
- Calgary TB Clinic — Calgary
- Edmonton TB Clinic — Edmonton
Colorado
- Denver Health and Hospital Authority — Denver
Texas
- San Antonio VA — San Antonio
Washington
- Seattle King County Health Department — Seattle
British Columbia
- British Columbia Centre for Disease Control — Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,400 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03474029
The ClinicalTrials.gov registry entry for NCT03474029 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centers for Disease Control and Prevention, which has 42 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Latent Tuberculosis appearing as the primary indexed condition, and to 4 interventions — of which Rifapentine daily for 6 weeks is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03474029 reports 16 study locations spanning 10 distinct geographic areas — top geographies include Other, District of Columbia, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03474029 about?
NCT03474029 is a clinical study titled "Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI". 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 co...
What is the current status of trial NCT03474029?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 3,400 participants. The study started on 2019-08-01. Estimated completion is 2029-12.
What conditions does trial NCT03474029 study?
This clinical trial studies the following conditions: Latent Tuberculosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03474029?
The interventions under investigation include: Rifapentine daily for 6 weeks (DRUG), Rifapentine and Isoniazid weekly for 12 weeks (DRUG), Rifampin and Isoniazid daily for 12 weeks (DRUG), Rifampin daily for 16 weeks (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03474029?
This trial is sponsored by Centers for Disease Control and Prevention, which has 42 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03474029 being conducted?
This trial has 16 study locations across Colorado, District of Columbia, New York, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.