Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03474029 · ClinicalTrials.gov registry record · Phase 2
Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
A Phase 2 study of Latent Tuberculosis, sponsored by Centers for Disease Control and Prevention.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 3,400
- Enrollment target
- 16
- Study locations
NCT03474029 is a Phase 2 study of Latent Tuberculosis that is actively recruiting participants, run by Centers for Disease Control and Prevention. The registered enrollment target is 3,400 participants, above the 526-participant average among 5 other Latent Tuberculosis trials with a reported enrollment target (546% higher). The trial reports 16 study locations across 10 states.
The verdict
NCT03474029, a Phase 2 study of Latent Tuberculosis, is actively recruiting participants, sponsored by Centers for Disease Control and Prevention.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 3,400 participants
- Enrollment target
- 16
- Study locations
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?
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, categorized as Phase 2. The registered enrollment target is 3,400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 526-participant average among 5 other Latent Tuberculosis trials with a reported enrollment target (546% higher). The listed sponsor is Centers for Disease Control and Prevention, which has 139 total studies on file at ClinicalTrials.gov.
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.
NCT03474029 reports 16 study locations spanning 10 distinct geographic areas - top geographies include Other, District of Columbia, New York.
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.
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).
Who is sponsoring clinical trial NCT03474029?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
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
Similar trials for Latent Tuberculosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Training Protocol on the Natural History of Tuberculosis
RECRUITING
-
Economic Incentives and vDOT for Latent Tuberculosis Infection
RECRUITING · NA
-
Brief Educational Video for Patients Prescribed LTBI Treatment
ACTIVE NOT RECRUITING · NA
-
One-month Latent Tuberculosis Treatment for Renal Transplant Candidates
ACTIVE NOT RECRUITING · Phase 4
-
Immune Response to Mycobacterium Tuberculosis Infection
COMPLETED
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.