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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: APIN Public Health Initiatives; University of Cape Town
• Treatments: Rifampin

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