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Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in Kazakhstan (RIFA-REAL)

21. juni 2026 opdateret af: Elmira Gurbanova, Public Union "Kazakhstan Association of Phthisiopulmonologists"

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Anslået)

350

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adults aged 18 years and older with drug-susceptible tuberculosis or tuberculosis infection, including people living with and without HIV, enrolled at tuberculosis facilities in four regions of Kazakhstan.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.
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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Favourable Treatment Outcome at 12 Months (DS-TB Cohorts)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cumulative Incidence of Serious Adverse Events
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Programmatic operability
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Public Union "Kazakhstan Association of Phthisiopulmonologists"

Samarbejdspartnere

The Western-Eastern European Partnership Initiative on HIV, Viral Hepatitis and TB

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. juni 2026

Først opslået (Faktiske)

25. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RIFA-REAL-KZ-2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

This is an operational research study in a programmatic setting. Individual patient data sharing is not planned at this stage, and protocol does not specify an IPD sharing plan.

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Ingen

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