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Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in Kazakhstan

Not Yet RecruitingN/A

Sponsor: Public Union "Kazakhstan Association of Phthisiopulmonologists"

Conditions: Tuberculosis, Tuberculosis Infection, Latent, Tuberculosis, Pulmonary, Drug Sensitive

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Study type: OBSERVATIONAL

Eligibility criteria

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