Actively Recruiting
ATORvastatin in Pulmonary TUBerculosis: a POPulation PharmacoKinetics -PharmacoDynamics Sub-study (ATORTUB popPK-PD)
Led by Obafemi Awolowo University Teaching Hospital · Updated on 2026-01-23
80
Participants Needed
3
Research Sites
116 weeks
Total Duration
On this page
Sponsors
O
Obafemi Awolowo University Teaching Hospital
Lead Sponsor
O
Open Philanthropy
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
ATORvastatin in Pulmonary TUBerculosis: a POPulation PharmacoKinetics -PharmacoDynamics Sub-study (ATORTUB popPK-PD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Positive sputum test for tuberculosis using Gene Xpert or smear microscopy
- No previous anti-TB treatment or less than 2 weeks of prior treatment
- Age 12 years or older
- Have a stable home address accessible for visits
- Agree to participate and provide blood for HIV testing
- Normal lab results within 14 days before screening including ALT ≤3x upper limit, bilirubin ≤2.5x upper limit, creatinine ≤2x upper limit, potassium ≥3.5 meq/L, hemoglobin ≥7.0 g/dL, and platelets ≥100,000/mm3
- Provided informed consent and agree to HIV testing
You will not qualify if you...
- Known or suspected drug-resistant tuberculosis
- HIV infection
- Poor general health requiring immediate treatment
- Significant metabolic or co-morbid diseases including malignancy or cardiovascular disorders
- Known or family history of bleeding disorders
- Renal impairment with serum creatinine clearance ≥1.5x upper limit
- Myositis or creatinine phosphokinase >3x upper limit
- Moribund state
- Tuberculosis meningitis
- Presence of specified non-TB diseases as per protocol
- Diabetes mellitus
- Hypertension
- Currently on anti-TB medication
- Chronic illnesses requiring daily medications
- Psychiatric illness
- Pregnant or breastfeeding
- Current tobacco use in any form
- Alcoholism
- Use of methylxanthine-containing drinks or grapefruit, herbal supplements within 7 days before and during study
- Participation in other therapeutic clinical trials
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
National Tuberculosis and Leprosy Training Centre, Saye
Zaria, Kaduna State, Nigeria
Actively Recruiting
2
Federal Teaching Hospital
Katsina, Katsina State, Nigeria
Actively Recruiting
3
Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife, Osun state, Nigeria
Ile-Ife, Osun State, Nigeria, 2345
Actively Recruiting
Research Team
O
Olanisun O Adewole, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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