Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in Kazakhstan

NCT07668479 | Not Yet Recruiting

• 1 other identifier: RIFA-REAL-KZ-2026
• Study Type: observational
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tuberculosis; Tuberculosis Infection, Latent; Tuberculosis, Pulmonary, Drug Sensitive

Keywords

rifapentine; 4HPMZ; 1HP; drug-susceptible tuberculosis; TB infection; shorter treatment regimen; operational research; HIV

Outcome Measures

Primary Outcomes (1)

• Favourable Treatment Outcome at 12 Months (DS-TB Cohorts)

  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

Secondary Outcomes (2)

• Cumulative Incidence of Serious Adverse Events

  Up to 4 months

• Treatment completion rate

  Up to 4 months

Other Outcomes (1)

• Programmatic operability

  Up to 4 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Public Union "Kazakhstan Association of Phthisiopulmonologists": lead
• The Western-Eastern European Partnership Initiative on HIV, Viral Hepatitis and TB: collaborator

Related Publications (2)

• 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.

  PMID: 33951360 BACKGROUND

• 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.

  PMID: 30865794 BACKGROUND

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Central Study Contacts

Elmira Gurbanova, MD, PhD

CONTACT

+37256144656; elmiragurbanova@gmail.com

Gulnaz Musabekova, MD

CONTACT

+77776814267; gulnazmussabekova@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share