Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in Kazakhstan
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Tuberculosis, Tuberculosis Infection, Latent, Tuberculosis, Pulmonary, Drug Sensitive. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Research on Evaluating Rifapentine-Based Shorter Regimens for Tuberculosis and Tuberculosis Infection Among People Living With and Without HIV in Programmatic Settings in Kazakhstan (RIFA-REAL)
Overview
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.
Detailed description
Despite World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and European Respiratory Society (ERS) recommendations, uptake of shorter rifapentine-based regimens for DS-TB (2HPMZ/2HPM) and TBI (1HP) remains limited due to concerns about adverse events and lack of real-world implementation evidence.
This study prospectively follows three cohorts over 12 months from treatment initiation. Primary outcomes include favourable treatment outcomes at 12 months (DS-TB cohorts), cumulative incidence and severity of serious adverse events (all cohorts), and key feasibility indicators including recruitment rates, retention, adherence, and treatment completion.
The study was approved by the Local Bioethics Committee of the National Center for Public Health, Ministry of Health of Kazakhstan (Protocol No. 2026-LKB-004-P, 29 April 2026).
Primary outcome measures
- Favourable Treatment Outcome at 12 Months (DS-TB Cohorts) [Time frame: 12 months from treatment initiation]
Secondary outcome measures (2)
- Cumulative Incidence of Serious Adverse Events [Time frame: Up to 4 months]
- Treatment completion rate [Time frame: Up to 4 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Dorman SE, Nahid P, Kurbatova EV, Phillips PPJ, Bryant K, Dooley KE, Engle M, Goldberg SV, Phan HTT, Hakim J, Johnson JL, Lourens M, Martinson NA, Muzanyi G, Narunsky K, Nerette S, Nguyen NV, Pham TH, Pierre S, Purfield AE, Samaneka W, Savic RM, Sanne I, Scott NA, Shenje J, Sizemore E, Vernon A, Waja Z, Weiner M, Swindells S, Chaisson RE; AIDS Clinical Trials Group; Tuberculosis Trials Consortium. PMID 33951360
- Swindells S, Ramchandani R, Gupta A, Benson CA, Leon-Cruz J, Mwelase N, Jean Juste MA, Lama JR, Valencia J, Omoz-Oarhe A, Supparatpinyo K, Masheto G, Mohapi L, da Silva Escada RO, Mawlana S, Banda P, Severe P, Hakim J, Kanyama C, Langat D, Moran L, Andersen J, Fletcher CV, Nuermberger E, Chaisson RE; BRIEF TB/A5279 Study Team. One Month of Rifapentine plus Isoniazid to Prevent HIV-Related Tubercul PMID 30865794
Identifiers
NCT: NCT07668479 · RIFA-REAL-KZ-2026