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.
연구 개요
상태
상세 설명
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).
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Elmira Gurbanova, MD, PhD
- 전화번호: +37256144656
- 이메일: elmiragurbanova@gmail.com
연구 연락처 백업
- 이름: Gulnaz Musabekova, MD
- 전화번호: +77776814267
- 이메일: gulnazmussabekova@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Favourable Treatment Outcome at 12 Months (DS-TB Cohorts)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cumulative Incidence of Serious Adverse Events
기간: 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.
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Up to 4 months
|
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Treatment completion rate
기간: Up to 4 months
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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.
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Up to 4 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Programmatic operability
기간: Up to 4 months
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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.
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Up to 4 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RIFA-REAL-KZ-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
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