RecruitingPhase 2Phase 3NCT04147286

Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion

Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion in HIV-infected and HIV-uninfected Adults Measured by FDG-PET/CT


Sponsor

University of Cape Town

Enrollment

220 participants

Start Date

Jul 14, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a proof-of-concept phase IIB, double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of 40 mg atorvastatin to reduce persistent lung inflammation after successful TB treatment completion in HIV-infected and HIV-uninfected adults measured by PET/CT.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a cholesterol-lowering drug called atorvastatin (a common statin) can reduce ongoing inflammation in the lungs and body after a patient has finished tuberculosis treatment. Even after TB is cured, some patients experience lasting inflammation that can damage the lungs. Researchers want to see if a statin can help. **You may be eligible if...** - You are between 18 and 65 years old and weigh between 50–90 kg - You have completed a full 24-week standard course of TB treatment and are considered cured - Your TB sputum culture was negative at week 16 of treatment - If you have HIV: you must be on antiretroviral therapy for at least 12 weeks, have a suppressed viral load, and a CD4 count above 350 - Your liver enzymes (AST and ALT) are within normal range **You may NOT be eligible if...** - You are currently on or recently completed TB treatment (must have finished the full course) - Your liver function tests are significantly elevated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtorvastatin 40mg

12 weeks of 40 mg atorvastatin therapy per os

DRUGPlacebo oral tablet

Identical placebo


Locations(1)

General Medicine & Global Health, Cape Heart Institute, Faculty of Health Sciences, University of Cape Town

Observatory, WC, South Africa

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NCT04147286


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