Phase 2 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:

• People diagnosed with pulmonary (lung) tuberculosis (TB) who have either never been treated for TB before, or who completed TB treatment more than 2 years ago, with a positive sputum (mucus/phlegm) test result showing a medium or high level of TB bacteria within the last 7 days.
• People whose TB has been confirmed by laboratory testing within the last 7 days to be sensitive (not resistant) to two common TB antibiotics: isoniazid (INH) and rifampicin (RIF).
• People who have had their HIV status confirmed through approved testing, following a documented process for confirming a positive result if applicable.
• People living with HIV who have a CD4+ immune cell count of at least 100 cells/mm³, tested within the last 30 days.
• People living with HIV who are already taking, or plan to start by week 8 of the trial, a dolutegravir-based HIV treatment regimen.
• People aged 18 years or older.
• People whose recent blood test results (within the last 7 days) fall within acceptable ranges for liver enzymes, kidney function, potassium and magnesium levels, white blood cells, red blood cells (haemoglobin), and platelets — and who test negative for hepatitis B and hepatitis C infections.
• Women who could become pregnant must have a negative pregnancy test within 3 days before joining, and must agree to use at least two forms of contraception during the trial and for 12 months after stopping the study medications.
• Women who cannot become pregnant (due to menopause, hysterectomy, removal of both ovaries, or tubal ligation) are eligible without needing to use contraception.
• Women who could become pregnant but do not engage in sexual activity that could lead to pregnancy do not need to use additional contraception.
• Men who engage in sexual activity that could lead to a partner's pregnancy must agree to remain abstinent or use male contraception during the trial and for 90 days after stopping the experimental treatment, and are strongly encouraged to inform partners who could become pregnant to also use effective contraception.
• Men who have had a confirmed successful vasectomy or confirmed absence of sperm for any reason are eligible without needing to use contraception.
• Men with pregnant partners must agree to use condoms during vaginal intercourse for the duration of the trial and for 90 days after stopping the experimental treatment.
• Men must agree not to donate sperm during the trial and for 90 days after stopping the experimental treatment.
• People with a Karnofsky performance score of 60 or above (a measure of general physical functioning) assessed within the last 14 days (confirm with trial site).
• People who have had a chest X-ray within the last 14 days.
• People who have a verifiable home address and are willing to let the study team know if they move during the trial.
• People who are willing and able to give their informed consent to participate.

Who may not be able to join:

• People who have already received more than 7 cumulative days of TB treatment for their current TB episode in the 60 days before joining the trial.
• People who, in the opinion of the treating doctor, currently have TB affecting parts of the body other than the lungs.
• People whose heart rhythm test (ECG) shows a QTcF interval greater than 450 milliseconds within the last 7 days (a measure of heart electrical activity).
• People with a current or past history of heart failure.
• People with a personal or family history of a condition called congenital long QT syndrome (an inherited heart rhythm disorder).
• People with a known and untreated underactive thyroid (hypothyroidism).
• People with a history of, or ongoing, an abnormally slow heart rhythm (bradyarrhythmia).
• People with a history of a serious heart rhythm disorder called torsades de pointes.
• People currently experiencing moderate or severe peripheral neuropathy (nerve damage causing pain, numbness, or weakness, typically in the hands or feet).
• People with other significant health conditions — such as diabetes, liver or kidney disease, blood disorders, or chronic diarrhoea — where, in the opinion of the site doctor, the current health condition is likely to affect treatment or assessment.
• People who are pregnant, breastfeeding, or planning to become pregnant within the next 12 months.
• People who weigh less than 35 kg.
• People who are unable to swallow oral medications.
• People currently taking any medications listed as prohibited by the trial.
• People with a known allergy or sensitivity to any of the investigational study drugs or their ingredients.
• People with active drug or alcohol use or dependence, or a mental health condition (such as major depression) that, in the opinion of the site doctor, could interfere with following the trial requirements.
• People who have taken another experimental drug or vaccine within 30 or more days before joining the trial.

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