Pharmacokinetics and Safety of Twice Daily Dolutegravir with Standard and High-Dose Rifampicin in Children Aged 4 Weeks to Under 6 Years with HIV and Tuberculosis

What this Trial Is About

Researchers are studying the safety and drug levels of dolutegravir given twice daily in children aged 4 weeks to under 6 years who have both HIV and tuberculosis TB. The study focuses on how dolutegravir works when taken with standard and higher doses of rifampicin, a TB medicine, since current rifampicin doses may be too low for children. This research aims to better understand treatment effects and improve outcomes in this vulnerable group. Children in this study will receive HIV and TB treatments according to current care standards. For weeks 20 and 21, the dose of rifampicin will be increased to a higher level to observe how it affects dolutegravir levels and safety. Blood samples will be collected during weeks 20, 22, and 30 to measure drug concentrations and assess biomarkers related to drug processing in the body. Participants will be monitored through clinical and laboratory tests over a 48-week period. Blood samples will be taken multiple times to assess drug levels and a specific biomarker to understand drug effects better. Safety will be closely followed, especially during the higher rifampicin dose period. The main outcomes include measuring dolutegravir exposure during standard and high-dose rifampicin and monitoring for any serious adverse events by week 48.

Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin