Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in Kazakhstan (NCT07668479) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in Kazakhstan
350 participantsStarted 2026-07-01
Plain-language summary
RIFA-REAL is a prospective observational longitudinal study evaluating the safety, feasibility, and effectiveness of rifapentine-based shorter treatment regimens for drug-susceptible tuberculosis (DS-TB) and tuberculosis infection (TBI) under routine programmatic conditions in Kazakhstan.
The study enrolls three cohorts: patients with DS-TB receiving the 4-month isoniazid-rifapentine-moxifloxacin-pyrazinamide regimen (2HPMZ/2HPM), patients with DS-TB receiving the standard 6-month isoniazid-rifampicin-pyrazinamide-ethambutol regimen (2HRZE/4HR), and individuals with TBI receiving the 1-month rifapentine-isoniazid regimen (1HP). Participants include people living with and without HIV.
The study is conducted across four regions of Kazakhstan and is funded through the Western-Eastern European Partnership Initiative on HIV, Viral Hepatitis and TB (WEEPI) grant. Findings will inform national TB policy and contribute to global evidence on programmatic implementation of rifapentine-based regimens.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
FOR DS-TB COHORTS (2HPMZ/2HPM and 2HRZE/4HR):
* Age 18 years or older
* Bacteriologically confirmed drug-susceptible pulmonary tuberculosis
* Newly diagnosed, not previously treated (or treated less than 1 month)
* Willing and able to provide written informed consent
* Residing in one of the four pilot regions of Kazakhstan
FOR TBI COHORT (1HP):
* Age 18 years or older
* Diagnosed with tuberculosis infection
* No evidence of active tuberculosis disease
* Willing and able to provide written informed consent
* Residing in one of the four pilot regions of Kazakhstan
Exclusion Criteria:
FOR DS-TB COHORTS:
* Confirmed or suspected drug-resistant tuberculosis (rifampicin-resistant tuberculosis (RR-TB) or multidrug-resistant tuberculosis (MDR-TB))
* Extrapulmonary tuberculosis as the sole manifestation
* Pregnancy or breastfeeding at time of enrollment
* Severe hepatic impairment (alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \>3x upper limit of normal)
* Known hypersensitivity to rifapentine, isoniazid, moxifloxacin, or pyrazinamide
* corrected QT interval (QTc) interval \>500 ms on baseline electrocardiogram (ECG)
* Currently receiving medications with significant interactions contraindicated with study regimens
FOR TBI COHORT:
* Active tuberculosis disease
* Previous treatment for TB or TBI within the past 2 years
* Pregnancy at time of enrollment
* Severe hepatic impairment
* Known hypersensitivity to rifapentine or isoniazid
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Favourable Treatment Outcome at 12 Months (DS-TB Cohorts)
Timeframe: 12 months from treatment initiation
Trial details
NCT IDNCT07668479
SponsorPublic Union "Kazakhstan Association of Phthisiopulmonologists"