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

NCT07303699 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Pulmonary Tuberculosis (TB)

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 \[2RHZE/4RH\]

Sponsors & Collaborators

  • Open Philanthropy

    collaborator OTHER

  • Obafemi Awolowo University

    collaborator OTHER

  • Obafemi Awolowo University Teaching Hospital

    lead OTHER

Principal Investigators

  • Olanisun O Adewole, MD · Obafemi Awolowo University / Teaching Hospital, Ile Ife, Nigeria

  • Bolanle A Omotoso, MD · Obafemi Awolowo University /Teaching Hospital, Ile- Ife, Osun State, Nigeria

  • Olanisun O Adewole, MD · Obafemi Awolowo University /Teaching Hospital, Ile- Ife, Osun State, Nigeria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-03
Primary Completion
2027-03-30
Completion
2028-03-30

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07303699 on ClinicalTrials.gov