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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPublic Union "Kazakhstan Association of Phthisiopulmonologists"

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

350 Participants
are grouped into 3 trial groups

Locations

This trial has no locations

Sponsors and collaborators

Public Union "Kazakhstan Association of Phthisiopulmonologists"

Lead sponsor

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

Collaborator