drugset / Trial / NCT04721795

Treating Tuberculosis With the Lipid Lowering Drug Atorvastatin in Nigeria(ATORvastatin in Pulmonary TUBerculosis)

NCT04721795

RandomizedParallel-groupSingle-blindTreatment

Summary

Tuberculosis (TB) is caused by mycobacterial organism. It is the leading infectious disease cause of death globally, with more than 10 million new cases and over 2 million deaths annually. Developing countries bear the greatest brunt of the disease. The long duration of current treatment is associated with poor compliance, thereby contributing to frequent relapses and to the emergence of drug-resistant TB. In addition, individuals who have been clinically cured may have lung damage, which could be permanent. Therefore, new and more effective therapeutic agents against TB are needed. Emerging evidence has shown that lipid lowering drugs like statins can make the TB bacteria more susceptible to current treatments. This proof-of-concept clinical trial will add the repurposed drug atorvastatin, commonly used to reduce cholesterol levels, to the standard therapies of TB patients in Nigeria. Atorvastatin is a well-tolerated and safe drug, and its addition is expected to accelerate clearance of the TB-causing bacteria without additional side effects. If this research is successful, it could provide evidence for using a common, easily available generic drug to improve treatment of one of the most debilitating infectious diseases.

Timeline

Start
2021-01-19
Primary completion
2022-03-31
Completion
2022-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 30 mg Oral
Subject Atorvastatin Small molecule 40 mg Oral
Comparator Ethambuthol Unknown Oral
Comparator INH Unknown Oral
Comparator Pyrazinamide Small molecule Oral
Comparator Rifampin Small molecule Oral