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

21. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert 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).

Studietype

Observasjonsmessig

Registrering (Antatt)

350

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Public Union "Kazakhstan Association of Phthisiopulmonologists"

Samarbeidspartnere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. august 2027

Datoer for studieregistrering

Først innsendt

8. mai 2026

Først innsendt som oppfylte QC-kriteriene

21. juni 2026

Først lagt ut (Faktiske)

25. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RIFA-REAL-KZ-2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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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