Actively Recruiting
Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
Led by Centers for Disease Control and Prevention · Updated on 2026-05-06
3400
Participants Needed
21
Research Sites
543 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Persons with latent tuberculosis infection (LTBI) without active TB disease and at increased risk of progression to TB
- Positive tuberculin skin test (TST) or interferon gamma release assay (IGRA) confirming LTBI
- Close contact with a person with confirmed TB within 2 years prior to enrollment
- Recent M. tuberculosis infection indicated by conversion from negative to positive TST or IGRA within 2 years
- HIV co-infection with CD4+ count above 100 cells/mm3
- Pulmonary fibrosis area of 2 cm2 or more on chest X-ray with no prior TB or LTBI treatment
- Recent immigration within 3 years to a low or moderate TB incidence country with abnormal chest X-ray and no active TB
- Recent immigration within 3 years from countries with high TB incidence and positive IGRA or TST 65 mm
- Refugees or asylum seekers recently immigrated within 3 years from high TB incidence countries with positive IGRA or TST 65 mm
- Individuals with increased TB risk due to medical conditions such as end-stage renal disease
- Individuals currently using immunosuppressive medications including chronic steroids
- Individuals planning to use TNF-alpha inhibitors
- Individuals planning for solid organ or hematologic transplantation
- Willingness to provide informed consent or parental permission and assent
- Pregnant women in second or third trimester meeting stage-specific participation criteria
- Children under 12 years meeting stage-specific participation criteria
You will not qualify if you...
- No documented positive IGRA or TST confirming latent TB infection
- Currently breastfeeding
- Women pregnant in first trimester (less than 14 weeks) or planning pregnancy within 120 days
- Women of childbearing potential refusing adequate contraception or abstinence
- Current culture-positive, clinical, or suspected active TB
- TB resistant to rifamycin in the source case
- Prior treatment with rifamycin or rifamycin plus isoniazid exceeding specified durations within 2 years
- Completed adequate prior treatment for TB or LTBI if HIV-negative
- Allergy or intolerance to rifamycin drugs
- Elevated liver enzymes (ALT or AST) more than 5 times upper limit of normal at screening
- Use of medications contraindicated with study drugs
- Weight less than 25 kg for participants 12 years or older, less than 3 kg for participants under 12 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 21 locations
1
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
Actively Recruiting
2
George Washington University
Washington D.C., District of Columbia, United States, 20001
Actively Recruiting
3
Washington DC VA Medical Center
Washington D.C., District of Columbia, United States, 20001
Actively Recruiting
4
New York Harbor Healthcare System
Manhattan, New York, United States, 10001
Actively Recruiting
5
New York City Bureau of TB Control
New York, New York, United States, 11201
Actively Recruiting
6
San Antonio VA
San Antonio, Texas, United States, 78201
Active, Not Recruiting
7
Seattle King County Health Department
Seattle, Washington, United States, 98101
Actively Recruiting
8
Liverpool Hospital
Sydney, Australia
Actively Recruiting
9
Paramatta Chest
Sydney, Australia
Actively Recruiting
10
Royal Prince Alfred Hospital
Sydney, Australia
Actively Recruiting
11
National Referral University Hospital for Pneumo-physiology
Cotonou, Benin
Active, Not Recruiting
12
Calgary TB Clinic
Calgary, Alberta, Canada, T1Y 6H6
Actively Recruiting
13
Edmonton TB Clinic
Edmonton, Alberta, Canada
Actively Recruiting
14
British Columbia Centre for Disease Control
Vancouver, British Columbia, Canada
Actively Recruiting
15
Toronto Western Hospital
Toronto, Ontario, Canada, M5P 1N5
Actively Recruiting
16
McGill University Health Centre
Montreal, Quebec, Canada, H3A 0G4
Actively Recruiting
17
Les Centres Gheskio (INLR) CRS
Port-au-Prince, Haiti
Actively Recruiting
18
Desmond Tutu TB Center
Stellenbosch, South Africa
Not Yet Recruiting
19
Joint Clinical Research Centre/ Makerere Univ Med Sch
Kampala, Uganda
Actively Recruiting
20
Ho Chin Minh City-District 6 TB Unit
Ho Chi Minh City, Vietnam
Actively Recruiting
21
Ho Chin Minh City-Phoi Viet Resportory Centre
Ho Chi Minh City, Vietnam
Actively Recruiting
Research Team
A
Amber B Robinson, PhD
CONTACT
T
TBTC Research Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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