What this Trial Is About

Tuberculosis is a leading cause of death among children living with HIV, yet there is limited information about how newer TB prevention treatments affect these children. This research focuses on studying the interactions between dolutegravir, a common HIV medication, and weekly rifapentine/isoniazid (3HP), a short-course treatment for latent TB infection, in children with HIV. The study aims to fill knowledge gaps by examining drug levels and safety in this vulnerable population. Children aged 2 to 11 years will receive their standard HIV treatment including dolutegravir and a weekly dose of rifapentine/isoniazid for 12 weeks as recommended by the World Health Organization. Children under 2 years old will receive standard HIV treatment plus a single dose of rifapentine/isoniazid for study purposes, followed by daily isoniazid for TB prevention. The study involves additional blood samples to measure drug levels and biomarkers, with drug safety and effects monitored throughout the study. Participants will be followed for 48 weeks with blood samples taken at weeks 4, 6, and 7 to measure dolutegravir and rifapentine levels, as well as a biomarker related to liver enzyme activity. Clinical and laboratory assessments will be conducted regularly to check for any side effects or toxicity. The study includes children living with HIV who test negative for active TB and helps researchers understand how these medications work together in children of different ages.

Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention