Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children With HIV and TB

Phase 4 Unknown 20 enrolled University of KwaZulu Centre for the AIDS Programme of Research in South Africa · collab

NaSingle-groupOpen-labelTreatment

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

Timeline

Start: 2021-08-19
Primary completion: 2025-07-31
Completion: 2025-07-31

Publications

Naidoo A, Waalewijn H, Naidoo K, Letsoalo M, Cromhout G, Sewnarain L, Mosia NR, Osuala EC, Wiesner L, Wasmann RE, Denti P, Dooley KE, Archary M; ORCHID study team. Pharmacokinetics and safety of dolutegravir in children receiving rifampicin tuberculosis treatment in South Africa (ORCHID): a prospective cohort study. Lancet HIV. 2025 Apr;12(4):e273-e282. doi: 10.1016/S2352-3018(24)00312-6. Epub 2025 Feb 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dolutegravir	Other / unclassified	10 mg	—
Subject	Dolutegravir	Other / unclassified	50 mg	—

Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children With HIV and TB

Summary

Timeline

Publications

Drugs

Indications