Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age4-5
SponsorBrigham and Women's Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- rifampicin
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
APIN Public Health Initiatives
Collaborator
University of Cape Town
Collaborator
Source ClinicalTrials.gov