NCT07668479Not yet recruiting

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

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)

Source: ClinicalTrials.gov · Last updated 25 Jun 2026

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Study type: Observational
Enrollment: 350 (estimated)
First submitted: 8 May 2026
Start date: 1 Jul 2026
Primary completion date: Jun 2027
Lead sponsor: Public Union "Kazakhstan Association of Phthisiopulmonologists"
Diseases: Tuberculosis, HIV
NCT number: NCT07668479

What you commit to

Study type: Observational
Planned participants: 350
From 1 Jul 2026 to the primary completion date, Jun 2027
No sites listed in no country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Currently receiving medications with significant interactions contraindicated with study regimens
- FOR TBI COHORT:
Previous treatment for TB or TBI within the past 2 years

Other illness

Confirmed or suspected drug-resistant tuberculosis (rifampicin-resistant tuberculosis (RR-TB) or multidrug-resistant tuberculosis (MDR-TB))
Extrapulmonary tuberculosis as the sole manifestation
Known hypersensitivity to rifapentine, isoniazid, moxifloxacin, or pyrazinamide
Active tuberculosis disease
Severe hepatic impairment
Known hypersensitivity to rifapentine or isoniazid

Lab values

Severe hepatic impairment (alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \>3x upper limit of normal)
corrected QT interval (QTc) interval \>500 ms on baseline electrocardiogram (ECG)

Other

FOR DS-TB COHORTS:
Pregnancy or breastfeeding at time of enrollment
Pregnancy at time of enrollment

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.