Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children With HIV and TB
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV
- Tuberculosis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Pharmacokinetic evaluation of DTG in children receiving Rifampicin containing TB treatmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 2318 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04746547
- Collaborators
- Centre for the AIDS Programme of Research in South Africa
- Investigators
- Principal Investigator: Moherndran Archary, MBChB, PhD University of KwaZulu
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