NCT03882177

StAT-TB (Statin Adjunctive Therapy for TB): A Phase 2b Dose-finding Study of Pravastatin in Adults With Tuberculosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of pravastatin adjunctive therapy when combined with the standard tuberculosis (TB) treatment regimen in adults with TB.

Detailed description

This study will assess the safety, tolerability, and pharmacokinetics of pravastatin adjunctive therapy when combined with the standard TB treatment regimen in adults with drug-sensitive TB. The pharmacokinetic data for pravastatin will be used to choose a dose to be studied as adjunctive TB treatment in subsequent trials. This study is a dose-escalation trial, and participants will be sequentially enrolled into four study arms. Participants will receive standard anti-TB therapy (Rifafour) and pravastatin daily for 14 days. Pravastatin will be given alone on Day 1, and pravastatin + Rifafour will be given on Days 2-15. Total study duration for participants will be 30 days, during which time participants will attend several study visits. Study visits may include sputum specimen collection, blood and urine collection, lung function testing, and pharmacokinetic assessments. All study participants will be referred appropriately to continue standard TB treatment at study completion.

Conditions

• Tuberculosis
• Pulmonary Tuberculosis

Interventions

Type	Name	Description
DRUG	Pravastatin	Tablets, administered orally
DRUG	Rifafour	Fixed-dose combination (isoniazid, rifampin, pyrazinamide, and ethambutol) tablets, administered orally
DIETARY_SUPPLEMENT	Vitamin B6	Administered orally.

Timeline

• Start date: 2020-02-21
• Primary completion: 2022-05-12
• Completion: 2022-12-31
• First posted: 2019-03-20
• Last updated: 2023-09-18
• Results posted: 2023-09-18

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated drug study