Clinical Research Directory
Browse clinical research sites, groups, and studies.
Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
Sponsor: Brigham and Women's Hospital
Summary
Tuberculosis (TB) is the leading cause of death among children with HIV, yet insufficient data are available on the pharmacokinetics of newer HIV/TB cotreatment strategies in children. Current WHO-recommended rifampicin dosages result in low concentrations in most children, and high-dose rifampicin may improve outcomes and shorten treatment duration. Yet the impact of high-dose rifampicin on dolutegravir exposures has not been examined in children. This study aims to evaluate the safety and pharmacokinetics of dolutegravir twice daily among HIV/TB coinfected children receiving standard-dose and high-dose rifampicin.
Official title: Mind the Gaps: Pharmacokinetic Research to Advance Pediatric HIV/TB Cotreatment and TB Prevention
Key Details
Gender
All
Age Range
4 Weeks - 5 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-07-07
Completion Date
2026-12
Last Updated
2025-12-02
Healthy Volunteers
No
Interventions
rifampicin
Patients will receive standard TB and HIV treatment, however, for two weeks (study weeks 20-21) the dose of rifampicin will be increased from standard-dose to high-dose to assess pharmacokinetics and safety
Locations (1)
University College Hospital/ University of Ibadan
Ibadan, Oyo State, Nigeria