NCT05069688 Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
| NCT ID | NCT05069688 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Pediatric HIV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-07-07 |
| Primary Completion | 2026-12 |
Trial Parameters
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Brief 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.
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
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