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

RecruitingPhase 1Ages 4 Weeks - 5 YearsAllBrigham and Women's Hospital
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • rifampicin
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Where

1 site
University College Hospital/ University of Ibadan
Ibadan, Nigeria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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