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

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.

Conditions

• Tuberculosis, Pulmonary
• Tuberculosis

Interventions

DRUG

Atorvastatin with standard anti tuberculosis drugs

Participants will receive oral 30/40mg of atorvastatin daily for 2 months together with oral doses of standard antituberculosis drugs consisting of Rifampicin, INH, Ethambuthol and pyrazinamide for 2months. At the end of 2months, participants will continue with only standard anti tuberculosis drugs, Rifampicin and INH for 4months.Doseage of antituberculosis drugs are dependent on weight

DRUG

Standard anti tuberculosis drugs only

Participants will receive oral doses of standard antituberculosis drugs consisting of Rifampicin, INH, Ethambuthol and pyrazinamide for 2months. At the end of 2months, participants will continue with only standard anti tuberculosis drugs, Rifampicin and INH for 4months.Doseage of antituberculosis drugs are dependent on weight

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust

  collaborator OTHER

• Cures Within Reach

  collaborator OTHER

• Obafemi Awolowo University Teaching Hospital

  lead OTHER

Principal Investigators

• Olanisun P Adewole, MD · Obafemi Awolowo University Teaching Hospitals Complex

• Bolanle A Omotoso, MD · Obafemi Awolowo University Teaching Hospitals Complex

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-19

Primary Completion

2022-03-31

Completion

2022-06-30

Countries

• Nigeria
• United Kingdom

Study Locations