Evaluating drug levels in children with HIV receiving TB prevention treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the pharmacokinetics of dolutegravir and rifapentine in children living with HIV who are receiving treatment for latent tuberculosis infection. It is a prospective, open-label study that will assess drug concentrations in two age groups: children aged 2-11 years receiving standard treatment and children under 2 years receiving a single dose of rifapentine. The study aims to fill knowledge gaps regarding TB prevention strategies in this vulnerable population. Participants will be recruited from pediatric HIV clinics in Nigeria, and the study will involve intensive blood sampling to monitor drug levels and safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• University College Hospital
  Ibadan, Oyo State, Nigeria Recruiting

Study contacts

• Principal investigator: Holly Rawizza, MD, MPH — Brigham and Women's Hospital
• Study coordinator: Holly Rawizza, MD, MPH
• Email: hrawizza@bwh.harvard.edu
• Phone: 617-432-4686

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.