Phase 3 Tuberculosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have read and signed a consent form before any screening, and you are willing to have an HIV test
• You are between 18 and 65 years old and weigh between 50 kg (110 lbs) and 90 kg (198 lbs)
• Your TB treatment worked well and your sputum (mucus) test came back negative at week 16 of treatment
• You have completed a full 24-week (6-month) course of standard TB treatment
• You have been officially declared "cured" of TB by the South African TB Control Program
• If you are HIV-positive: you have been on HIV treatment (antiretroviral therapy) for at least 12 weeks and your HIV viral load is undetectable within the last 30 days
• If you are HIV-positive: your immune cell count (CD4) is above 350 cells/µL within the last 30 days
• Your liver enzyme levels (AST and ALT) are within an acceptable range based on a blood test taken within the last 30 days
• Your kidney function level (creatinine) is within an acceptable range based on a recent blood test
• Your haemoglobin (a measure of healthy red blood cells) is above a minimum level
• Your platelet count (cells that help blood clot) is above a minimum level
• Your creatinine kinase level (a muscle-related marker) is within an acceptable range
• You are able and willing to come back for follow-up visits
• You are willing to have biological samples, including DNA, stored for research
• You are willing to use a reliable method of contraception consistently throughout the trial

Who may not be able to join:

• You are currently suffering from an acute (sudden or short-term) illness
• You currently have a fever above 38°C (100.4°F)
• You are currently taking, have taken in the last 3 months, or are likely to need cholesterol-lowering medication (such as statins)
• You have a known allergy or medical reason to avoid the study drug or any statin medications
• You have drug-resistant TB
• Your TB has spread outside the lungs, including to the lining around the lungs (confirm with trial site)
• You are pregnant or planning to become pregnant in the next 6 months
• You are unable to swallow and take oral (by mouth) medications
• You have diabetes, as determined by specific blood sugar test results or by currently using any diabetes medication, including traditional medicines
• You have a long-term illness or complication that could affect your safety or the trial results, such as a known chronic inflammatory condition (for example, rheumatoid arthritis or sarcoidosis)
• You have used immune-suppressing medications (such as steroids or certain biologic drugs) within the past 2 weeks
• You have taken part in another clinical drug trial within the past 3 months
• You have issues with alcohol or substance use that might make it difficult to take medications regularly during the trial
• Your doctor feels this study is not appropriate for you for any reason

Important: Always verify eligibility with the trial site directly before applying.