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Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention

RecruitingPhase 1Ages 4 Weeks - 11 YearsAllBrigham and Women's Hospital
NCT06281834 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention/latent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population.

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📋 Eligibility rules (as published)
Inclusion Criteria: * (1) ART-naïve or ART-experienced HIV-infected children 4 weeks to \<12 years of age; * (2) no evidence of active TB based on an appropriate clinical evaluation; * (3) negative TB diagnostic test if performed (other than tuberculin skin testing); * (4) weight of at least 4 kilograms; and * (5) consent of the parent or legal guardian and assent of the child (if ≥7 years of age). Exclusion Criteria: * (1) Baseline labs with evidence of ≥grade 3 abnormalities: alanine aminotransferase (ALT), total bilirubin, absolute neutrophil count (ANC), platelets, creatinine; * (2) presenting with acute respiratory distress or decompensation, or any clinical syndrome which could suggest undiagnosed TB or other opportunistic infection; or * (3) receipt of a medication that has drug-drug interactions with DTG or RPT.
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What it tests

  • Rifapentine
  • Dolutegravir
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Where

1 site
University College Hospital
Ibadan, Nigeria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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