NCT04746547

Pharmacokinetics of Twice or Once Daily DTG (50mg) 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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of KwaZulu · Academic / Other
• Sex: All
• Age: 23 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

Stage 1 proposed study will provide evidence to support the use of twice-daily dose 50mg DTG in children (20-35kgs) co-treated with RIF. Note: An amendment has been added to include children from 3kgs and a dose of 10mg dispersible DTG

Detailed description

This is a single centre, open-label, non-randomised, prospective study evaluating the steady-state pharmacokinetics of twice-daily dose DTG administered during concurrent RIF treatment and assessing safety and tolerance in HIV-TB co-infected children weighing 20 to 35 kg. DTG will be administered as a twice-daily dose 50mg tablet formulation both before starting and after completion of the standard six-month RIF-based anti-TB treatment. The NRTI background and anti-TB drugs will be prescribed following the national weight band dosing guidelines. Those initially diagnosed with TB are likely to be sicker, and the recommendation is to start anti-TB treatment first and follow with ART two weeks later.

Conditions

• Tuberculosis
• Hiv

Interventions

Type	Name	Description
DRUG	Dolutegravir 50 MG	Twice daily dolutegravir with rifampicin containing TB treatment
DRUG	Dolutegravir 10 MG	Twice daily dolutegravir with rifampicin containing TB treatment

Timeline

• Start date: 2021-08-19
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2021-02-09
• Last updated: 2024-02-01

Locations

1 site across 1 country: South Africa