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

RecruitingPhase 1

Sponsor: Brigham and Women's Hospital

Conditions: Pediatric HIV Infection, Tuberculosis Infection

Interventions: rifampicin

Countries: Nigeria

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.

Eligibility overview

Sex: ALL

Age: 4 Weeks to 5 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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
* Receipt of a medication that has drug-drug interactions with dolutegravir or rifampicin

Locations (1)

Ibadan, Oyo State, Nigeria