Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in Kazakhstan (RIFA-REAL)
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)
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.
Обзор исследования
Статус
Подробное описание
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).
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Elmira Gurbanova, MD, PhD
- Номер телефона: +37256144656
- Электронная почта: elmiragurbanova@gmail.com
Учебное резервное копирование контактов
- Имя: Gulnaz Musabekova, MD
- Номер телефона: +77776814267
- Электронная почта: gulnazmussabekova@gmail.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
|---|
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4HPMZ/HPM Cohort (Short DS-TB Regimen)
Patients with drug-susceptible tuberculosis (DS-TB) receiving the 4-month rifapentine-based regimen: 2 months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide (HPMZ) followed by 2 months of isoniazid, rifapentine, and moxifloxacin (HPM), administered under routine programmatic conditions in Kazakhstan.
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HRZE/HR Cohort (Standard DS-TB Regimen)
Patients with drug-susceptible tuberculosis (DS-TB) receiving the standard 6-month regimen: 2 months of isoniazid, rifampicin, pyrazinamide, and ethambutol (HRZE) followed by 4 months of isoniazid and rifampicin (HR), administered under routine programmatic conditions in Kazakhstan.
|
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1HP Cohort (TB Infection Regimen)
Individuals with tuberculosis infection (TBI) receiving the 1-month regimen of daily isoniazid and rifapentine (1HP) under routine programmatic conditions in Kazakhstan.
Includes people living with and without HIV.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Favourable Treatment Outcome at 12 Months (DS-TB Cohorts)
Временное ограничение: 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.
|
12 months from treatment initiation
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Cumulative Incidence of Serious Adverse Events
Временное ограничение: 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.
|
Up to 4 months
|
|
Treatment completion rate
Временное ограничение: 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.
|
Up to 4 months
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Programmatic operability
Временное ограничение: Up to 4 months
|
Descriptive documentation of reasons for treatment non-initiation or premature discontinuation across the 2HPMZ/2HPM and 1HP cohorts, assessed from treatment initiation through the end of the assigned regimen.
|
Up to 4 months
|
Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- 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. Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis. N Engl J Med. 2021 May 6;384(18):1705-1718. doi: 10.1056/NEJMoa2033400.
- 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 Tuberculosis. N Engl J Med. 2019 Mar 14;380(11):1001-1011. doi: 10.1056/NEJMoa1806808.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- RIFA-REAL-KZ-2026
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
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