About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Locations
Sponsors and collaborators
Public Union "Kazakhstan Association of Phthisiopulmonologists"
Lead sponsor
The Western-Eastern European Partnership Initiative on HIV, Viral Hepatitis and TB
Collaborator