Shortened Regimen for Drug-susceptible TB in Children

Inclusion Criteria23

• Parent or guardian is willing and able to provide written informed consent for potential participant's study participation; in addition, when applicable per Ethics Committee/Institutional Review Board (EC/IRB) policies and procedures, potential participant is willing and able to provide assent for study participation.
• At Entry, age of less than 10 years.
• At Entry, weight 3 kilograms (kg) or greater.
• At Entry, diagnosed with TB disease, defined as:
• Pulmonary (including pleural effusion) and/or lymph node (extra-thoracic and/or intra-thoracic) TB with or without bacteriologic confirmation;
• Clinician has decided to treat with standard first-line drug-susceptible TB regimen.
• Known HIV status or HIV testing in progress based on meeting testing requirements.
• Has normal, Grade 1 or 2 test results for all of the following done at or within 14 days of Entry (including the most recent):
• Alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal;
• Total bilirubin less than or equal to 2.5 times the upper limit of normal;
• Potassium level of 3.0 milliequivalent/L or greater;
• Hemoglobin level of 7.0 g/dL or greater;
• Platelet count of 100,000/mm3 or greater;
• Estimated glomerular filtration rate (eGFR; bedside Schwartz formula) 60 mL/min/1.73m2 or higher.
• For children living with HIV:
• On antiretroviral therapy (ART) at Entry: Must be on, or able to be switched to a dolutegravir-based regimen at or prior to Entry;
• Not on ART at Entry: Planned initiation of dolutegravir before or at study Week 4.
• For participants who have reached menarche or who are engaging in sexual activity (self-reported): negative serum or urine pregnancy test within 7 days of Entry.
• For participants who are engaging in sexual activity that could lead to pregnancy (self-reported): agrees to practice at least one non-hormonal method of contraception or abstain from heterosexual intercourse during study drug treatment and for 30 days after stopping study medications. Non-hormonal methods include:
• Male or female condoms
• Diaphragm or cervical cap (with spermicide, if available)
• Non-hormonal intrauterine device (IUD) or intrauterine system (IUS)
• At Entry, intends to remain in the catchment area of the study site for the duration of study follow-up or willingness to be followed up beyond the catchment area if/when applicable, as determined by the site investigator based on participant/parent/guardian report.