Tests dolutegravir levels in young children with HIV and tuberculosis
Tests how dolutegravir is processed when given with standard or high-dose rifampicin in young children.
Plain-language title generated from the registry record
Registry title: Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
Key facts
- Where
- Ibadan, NigeriaSee the site
- Phase
- Phase 1
Where in Nigeria
- University College Hospital/ University of IbadanIbadan, NigeriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Brigham and Women's Hospital
- Trial code
- NCT05069688
- Record updated
- 30 July 2026
- Original description
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.Read full original descriptionShow less
Mind the Gaps: Pharmacokinetic Research to Advance Pediatric HIV/TB Cotreatment and TB Prevention
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.
Inclusion: ART-naïve or ART-experienced HIV-infected children between 4 weeks and <6 years of age; Active TB diagnosis; Weight of at least 3 kilograms; Consent of the parent or legal guardian.
Exclusion: Receipt of a medication that has drug-drug interactions with dolutegravir or rifampicin; Baseline labs with evidence of ≥grade 3 abnormalities: ALT, total bilirubin, absolute neutrophil count (ANC), platelets, or creatinine; Suspected TB meningitis or presenting with acute respiratory distress or decompensation.