Overview

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

Status:
Not yet recruiting

Trial end date:
2025-03-31

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Brigham and Women's Hospital

Collaborators:

APIN Public Health Initiatives
University of Cape Town

Treatments:

Rifampin