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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Elmira Gurbanova
Principal Investigator
Public Union "Kazakhstan Association of Phthisiopulmonologists"