Actively Recruiting
Atorvastatin-containing Treatment Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase IIC/III Clinical Trial
Led by Obafemi Awolowo University Teaching Hospital · Updated on 2025-09-25
440
Participants Needed
8
Research Sites
26 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
Tuberculosis (TB) is a serious infectious disease caused by Mycobacterium tuberculosis, leading to millions of cases and deaths worldwide, particularly in developing countries like Nigeria. TB mainly affects the lungs and is worsened by HIV infection, making it a top cause of death globally. The trial investigates atorvastatin, a cholesterol-lowering drug, to see if it can improve TB treatment by reducing bacteria and lung damage, building on promising earlier studies that showed atorvastatin was safe and may enhance TB therapy outcomes. The trial is a phase IIC, multicenter, randomized, open-label study comparing four treatment groups: three different daily doses of atorvastatin (20mg, 40mg, 60mg) given for 16 weeks along with standard 6-month anti-TB therapy, and a control group receiving standard therapy alone. Patients are randomly assigned to one of these groups and followed closely for 12 months after starting treatment. The study aims to evaluate safety, the speed at which TB bacteria clear from sputum, improvement in chest X-rays, and lung function. Participants aged 12 to 65 with active pulmonary TB will undergo screening including medical history, HIV and diabetes testing, sputum cultures, blood tests, lung function, and pregnancy tests for women. During the study, sputum samples, blood tests, chest X-rays, and lung function will be monitored regularly. Researchers will track side effects and measure outcomes like TB disease-free survival and symptom improvement at 6 and 12 months. The long follow-up period allows for detailed assessment of treatment effects and safety.
CONDITIONS
Brief Title
ATORvastatin in Pulmonary TUBerculosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected pulmonary tuberculosis with positive sputum smear or positive Xpert MTB/RIF test showing medium or high bacterial load without rifampicin resistance
- No previous tuberculosis treatment (treatment naive)
- Age 12 years or older
- Verifiable and accessible residence with willingness to inform study team of address changes during study
- Documented HIV infection status
- Documented blood sugar level or diabetes status
- For HIV-positive participants, CD4 T cell count ≥ 100 cells/mm3 within 30 days prior to screening
- Laboratory tests within 14 days prior to screening meeting specified limits for liver, kidney functions, blood counts, and electrolytes
- Negative pregnancy test for women of childbearing potential within 7 days prior to screening
- Written informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Unable to take oral medications
- Already receiving tuberculosis treatment
- Body weight less than 40.0 kg
- Known allergy or intolerance to study medications
- Tuberculosis resistant to rifampin, isoniazid, pyrazinamide, or ethambutol at enrollment
- Significant metabolic or comorbid conditions such as malignancy or cardiovascular diseases (heart failure, coronary heart disease, arrhythmia)
- Known or family history of bleeding disorders
- Renal impairment with creatinine clearance > 1.5 times upper limit of normal
- Myositis or creatinine phosphokinase levels > 3 times upper limit of normal
- Other medical conditions that make participation unsafe or unsuitable by investigator judgment
- Late exclusions include failure to grow M. tuberculosis in sputum cultures or detection of drug-resistant TB after enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive daily oral atorvastatin (20mg, 40mg, or 60mg) for 16 weeks combined with a 24-week standard anti-tuberculosis drug regimen, or standard anti-tuberculosis treatment alone for 24 weeks.
Visits at weeks 0 (baseline), 2, 4, 6, 8, 10, 12, 16, 22, and 24 post randomization
Duration - Up to 12 months post randomization
Participants are monitored for safety, lung function, chest x-ray improvement, and tuberculosis disease-free survival after treatment completion.
Visits at months 8, 10, and 12 post randomization
Trial Site Locations
Total: 8 locations
1
National Tuberculosis Reference Laboratory
Zaria, Kaduna State, Nigeria
Actively Recruiting
2
Federal Teaching Hospital
Katsina, Katsina State, Nigeria
Actively Recruiting
3
Federal Medical Center
Keffi, Nasarawa State, Nigeria
Actively Recruiting
4
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, Osun State, Nigeria
Actively Recruiting
5
Bowen University Teaching Hospital
Iwo, Osun State, Nigeria, 2345
Actively Recruiting
6
University College Hospital
Ibadan, Oyo State, Nigeria
Actively Recruiting
7
Usman Danfodio University
Sokoto, Sokoto State, Nigeria
Actively Recruiting
8
University of Abuja Teaching Hospital
Gwagwalada, Nigeria
Actively Recruiting
Research Team
O
Olanisun O Adewole, MD
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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