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

Recruiting now · Phase 1

Conditions studied: Pediatric HIV Infection, Tuberculosis Infection

In brief

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.

Key facts

Study ID

NCT05069688

Run by

Brigham and Women's Hospital

People needed

20

Starts

2023-07-07

Expected to finish

2026-12-31

Last updated by the study team

2026-07-30

Who can join

Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University College Hospital/ University of Ibadan — Ibadan, Oyo State, Nigeria (enrolling)

Full record on ClinicalTrials.gov

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