ATORvastatin in Pulmonary TUBerculosis: a POPulation PharmacoKinetics -PharmacoDynamics Sub-study (ATORTUB popPK-PD)
Recruiting
Phase 2
Interventional Study
Pulmonary Tuberculosis (TB)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- Obafemi Awolowo University Teaching Hospital · Other
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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 appropria…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
* Agreement to…
Contacts