Evaluating dolutegravir in children with HIV and TB receiving different doses of rifampicin

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 and safety of dolutegravir in HIV/TB coinfected children aged 4 weeks to less than 6 years. It is a prospective, single-arm, open-label study that will recruit 20 children from pediatric HIV clinics in Nigeria, divided into two age cohorts. Participants will receive standard and high doses of rifampicin while undergoing routine clinical monitoring. Blood samples will be collected at various time points to assess drug concentrations and monitor for potential toxicity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• University College Hospital/ University of Ibadan
  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.