Evaluating Dolutegravir Dosing in Children with HIV and TB
An Open-label, Sequential Non-randomised Pharmacokinetics Study of DTG Plasma Exposure When Given as Twice or Once Daily DTG in the Presence of Rifampicin in Children With HIV and TB Between 20-35kgs in SA
This study is testing if a twice-daily dose of Dolutegravir is safe and effective for children with both HIV and tuberculosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 23 Months to 18 Years |
| Sex | All |
| Sponsor | University of KwaZulu Academic / other |
| Locations | 1 site (Durban, KwaZulu-Natal) |
| Trial ID | NCT04746547 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years with confirmed HIV-1 infection weighing between 20-35 kg who are either ART-naive or experienced and are starting DTG for HIV treatment.
Not a fit: Patients with known allergies to DTG or significant liver function abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize HIV treatment protocols for children co-infected with TB, improving their health outcomes.
How similar studies have performed: Other studies have shown promise in optimizing HIV treatment in co-infected populations, but this specific dosing approach in children is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Durban, KwaZulu-Natal
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.