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

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)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07668479

Acronym

RIFA-REAL

Enrollment

350

Registered

2026-06-25

Start date

2026-07-01

Completion date

2027-08-01

Last updated

2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis, Tuberculosis Infection, Latent, Tuberculosis, Pulmonary, Drug Sensitive

Keywords

rifapentine, 4HPMZ, 1HP, drug-susceptible tuberculosis, TB infection, shorter treatment regimen, operational research, HIV

Brief 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.

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Favourable Treatment Outcome at 12 Months (DS-TB Cohorts)	12 months from treatment initiation	Proportion of patients with drug-susceptible tuberculosis who achieve a favourable treatment outcome, defined as "cured" or "treatment completed" without recurrence, within 12 months of treatment initiation. Compared between 2HPMZ/2HPM and standard 2HRZE/4HR cohorts.

Secondary

Measure	Time frame	Description
Cumulative Incidence of Serious Adverse Events	Up to 4 months	Cumulative incidence rate, timing of onset, severity, and outcomes of all serious adverse events recorded during treatment in the 2HPMZ/2HPM and 1HP cohorts. Treatment duration is up to 4 months for 2HPMZ/2HPM and up to 1 month for 1HP.
Treatment completion rate	Up to 4 months	Percentage of participants who complete the full assigned regimen (2HPMZ/2HPM or 1HP) without premature discontinuation, measured from treatment initiation through the end of the assigned regimen.

Contacts

CONTACTElmira Gurbanova, MD, PhD

elmiragurbanova@gmail.com+37256144656

CONTACTGulnaz Musabekova, MD

gulnazmussabekova@gmail.com+77776814267

Outcome results