Evaluating Dolutegravir Dosing in Children with HIV and TB

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 (DTG) administered twice daily in children aged 20-35 kg who are co-infected with HIV and tuberculosis (TB). It is a single-center, open-label, non-randomized, prospective study that aims to assess the safety and tolerance of DTG during concurrent rifampicin treatment. The study will also include children as young as 3 kg receiving a dispersible formulation of DTG. Participants will be monitored for their response to the medication before and after completing a standard six-month TB treatment regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Children \<18 years with confirmed HIV-1 infection weighing 20-35kg ART-naive or experienced, with plans to use DTG for HIV treatment
* Diagnosis of TB disease with clinician initiating rifampicin-containing first-line therapy
* Parents/legal guardians/caregivers and children give informed written consent (or assent, where applicable) to be in the study
* Girls who have reached menses must have a negative pregnancy test at screening and be willing to adhere to two effective methods of contraception (barrier and a non-barrier form of contraception during the study, starting at least 14 days prior to enrolment) if sexually active. The parents/caregivers will be counselled together with the child if the child tests positive in order to reduce any social harm which may arise.

Exclusion Criteria:

* History or presence of known allergy or contraindications to DTG
* Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), OR ALT ≥3xULN and bilirubin ≥2xULN
* Severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones)
* Pregnancy or breastfeeding
* A concurrent illness that could influence drug PK, i.e. severe diarrhoea, vomiting, renal or liver disease
* Treatment with concomitant medications known to have interactions with DTG
* Participants that are eligible for the study but refuse to give consent and/or assent

Where it's running

• King Edward VIII Hospital
  Durban, KwaZulu-Natal, South Africa Recruiting

Study contacts

• Principal investigator: Moherndran Archary, MBChB, PhD — University of KwaZulu
• Study coordinator: Moherndran Archary, MBChB, PhD
• Email: archary@ukzn.ac.za
• Phone: +27312604318

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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.