Actively Recruiting
ATORvastatin in Pulmonary TUBerculosis
Led by Obafemi Awolowo University Teaching Hospital · Updated on 2025-09-25
440
Participants Needed
8
Research Sites
143 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 caused by mycobacterial organism. It is the leading infectious disease cause of death globally. According to recent estimates from the World Health Organization (WHO), over 10 million new cases and 1.6 million deaths from TB occurred in 2021. The vast majority of TB cases and TB deaths are in developing countries. Nigeria has the highest TB burden in Africa with a high number of undetected TB cases as well. The spread of HIV has fueled the TB epidemic, and TB is the leading cause of death among patients infected with HIV and has assumed the lead position as the number one infectious disease cause of death globally. Even though the COVID-19 was associated with a huge mortality, TB contributed significantly to death and one of the single predictors of death among COVID-19 infected individuals. TB predominantly affects young adults in their most productive years of life and has substantial impact on economic development. Emerging evidence has shown that lipid lowering drugs like statins can make the TB bacteria more susceptible to current treatment regimen. The ATORTUB group recently completed Phase II A and Phase IIB studies to assess the safety, tolerability and efficacy of atorvastatin when administered with the current standard of care. The investigators demonstrated that atorvastatin is well tolerated, save, and has beneficial microbiological and radiological impacts in tuberculosis, thus, warrants further studies. This phase IIC trial sets out to evaluate the safety and efficacy of different doses of atorvastatin containing regimen, determine rate of decline of viable sputum bacilli, the time to stable sputum conversion, improvement in chest ray severity scores and lung function parameters post randomization in the different treatment arms. The phase II C is a Selection Trial with Extended follow-up STEP and has been devised as a pilot phase III where patients are studied for longer period (12months post randomization) than the usual phase IIB. Thus, providing additional data that will justify a successful phase III trial.
CONDITIONS
Official Title
ATORvastatin in Pulmonary TUBerculosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected pulmonary tuberculosis with at least one sputum positive for acid-fast bacilli or M. tuberculosis by Xpert MTB/RIF with medium or high result and no rifampicin resistance detected
- Treatment naive for tuberculosis
- Age 12 years or older
- Has a verifiable and accessible residence and agrees to inform study team of address changes
- Documented HIV infection status
- Documented blood sugar level or diabetes status
- For HIV-positive, CD4 T cell count of 100 cells/mm3 or greater within 30 days prior to screening
- Laboratory tests within 14 days prior to screening showing ALT 3x upper limit normal, bilirubin 2.5x upper limit, creatinine 2x upper limit, potassium 3.5 meq/L, hemoglobin 7.0 g/dL, platelet count 100,000/mm3
- For women of childbearing potential, a negative pregnancy test within 7 days prior to screening
- Written informed consent
You will not qualify if you...
- Pregnant or breastfeeding
- Unable to take oral medications
- Currently on tuberculosis treatment
- Weight less than 40.0 kg
- Known allergy or intolerance to study medications
- Known resistance of M. tuberculosis to rifampin, isoniazid, pyrazinamide, or ethambutol
- Significant metabolic or comorbid diseases including cancer or cardiovascular disorders
- Known or family history of bleeding disorders
- Renal impairment with creatinine clearance >1.5 times upper limit normal
- Myositis or creatinine phosphokinase >3 times upper limit normal
- Other medical conditions judged by investigator to make participation unsafe
- Late exclusions: lack of M. tuberculosis growth in sputum cultures or detection of drug resistance after enrollment
AI-Screening
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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
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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