RecruitingPhase 1NCT05069688

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

Mind the Gaps: Pharmacokinetic Research to Advance Pediatric HIV/TB Cotreatment and TB Prevention


Sponsor

Brigham and Women's Hospital

Enrollment

20 participants

Start Date

Jul 7, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 4 WeeksMax Age: 5 Years

Plain Language Summary

Simplified for easier understanding

This study examines how dolutegravir — an HIV medication — behaves in the bodies of very young children (aged 4 weeks to under 6 years) who have both HIV and active tuberculosis (TB). The challenge is that rifampicin, a key TB drug, affects how dolutegravir is processed by the body, and this study explores whether a higher rifampicin dose changes this interaction. **You may be eligible if...** - Your child is between 4 weeks and under 6 years old with confirmed HIV infection - Your child has an active TB diagnosis and weighs at least 3 kg - A parent or legal guardian can provide consent **You may NOT be eligible if...** - Your child has severely abnormal lab results (liver enzymes, bilirubin, neutrophil count, platelets, or creatinine) - Your child has suspected TB meningitis or is in acute respiratory distress - Your child is taking other medications that interact with dolutegravir or rifampicin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGrifampicin

Patients will receive standard TB and HIV treatment, however, for two weeks (study weeks 20-21) the dose of rifampicin will be increased from standard-dose to high-dose to assess pharmacokinetics and safety


Locations(1)

University College Hospital/ University of Ibadan

Ibadan, Oyo State, Nigeria

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NCT05069688


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