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RECRUITING
NCT07303699
PHASE2

ATORvastatin in Pulmonary TUBerculosis: a POPulation PharmacoKinetics -PharmacoDynamics Sub-study (ATORTUB popPK-PD)

Sponsor: Obafemi Awolowo University Teaching Hospital

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess pharmacokinetic parameters of atorvastatin at different doses when combined with the standard first line tuberculosis (TB) treatment regimen in adults with drug sensitive pulmonary TB. The pharmacokinetics parameters will be correlated with Pharmcodynamic measures and a PK/PD model that will identify an optimal dosing regimen of atorvastatin that is appropriate for the treatment of pulmonary tuberculosis will be developed.

Official title: Population Pharmacokinetics and Pharmacodynamics of Standard First Line Anti-TB Versus Atorvastatin-Containing Regimens in the Treatment of Pulmonary Tuberculosis: A Sub-study of the ATORTUB Phase 2C Randomized Controlled Trial (ATORTUB popPK-PD Study)

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-01-03

Completion Date

2028-03-30

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

DRUG

Atorvastatin 20 mg

Participants will receive 16weeks of daily oral treatment with 20mg atorvastatin 4AT(20)\]

DRUG

Atorvastatin 40 mg

Participants will receive 16 weeks of daily oral treatment with 40mg atorvastatin 4AT(40)\]

DRUG

Atorvastatin 60 mg

Participants will receive 16weeks of daily oral treatment with 60mg atorvastatin 4AT(60)

DRUG

Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamid (Z) Ethambutol (E)

Participants will receive 8 weeks of daily oral treatment with rifampin, isoniazid, pyrazinamide, ethambutol, followed by 16 weeks of daily treatment with rifampin, isoniazid \[2RHZE/4RH\]

Locations (3)

National Tuberculosis and Leprosy Training Centre, Saye

Zaria, Kaduna State, Nigeria

Federal Teaching Hospital

Katsina, Katsina State, Nigeria

Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Osun state, Nigeria

Ile-Ife, Osun State, Nigeria