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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorObafemi Awolowo University Teaching Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Sputum specimen positive for tubercle bacilli on Gene Xpert or direct smear microscopy

Either no previous anti-TB chemotherapy, or less than 2 weeks of previous chemotherapy

Aged 12years and above

A firm home address that is readily accessible for visiting

Disqualifiers

Participants known or suspected of having any form of drug resistance TB.

Patients co infected with HIV

Those with poor general condition where no delay in treatment can be tolerated

Evidence of clinically significant metabolic or co morbid medical conditions ; malignancy; or other diseases like history of or current cardiovascular disorder such as heart failure, coronary heart disease, arrhythmia.

Trial design

Treatments tested in this trial

  • Atorvastatin 20 mg
  • Atorvastatin 40 mg
  • Atorvastatin 60 mg
  • Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamid (Z) Ethambutol (E)

Treatment groups

80 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Obafemi Awolowo University Teaching Hospital

Lead sponsor

Open Philanthropy

Collaborator

Obafemi Awolowo University

Collaborator