Pharmacokinetics and Safety of DolutegravIr in Neonate

Summary

A Phase I/II, open-label, single arm, two-stage trial to evaluate the single and multi-dose PK and safety of DTG in HIV-exposed neonates on ARV prophylaxis. HIV-exposed term neonates born mothers with HIV on DTG-based antiretroviral therapy with a birth weight ≥2000 g who are on ARV postnatal prophylaxis will be enrolled.

Timeline

Start

2022-09-12

Primary completion

2024-06-30

Completion

2024-12-31

Publications

• Bekker A, Salvadori N, Rabie H, du Toit S, Than-In-At K, Groenewald M, Barnabas S, Ganger L, Luangcharoenkul T, Pingkarawat S, Capparelli EV, Owen A, Cressey R, Fry S, Le Roux G, Tawon Y, Kaewmalee J, Phitak T, Lallemant M, Cotton MF, Cressey TR. Safety and pharmacokinetics of dolutegravir dispersible tablets and oral films in term neonates exposed to HIV in South Africa (PETITE-DTG study): an open-label, randomised, phase 1/2 trial. Lancet HIV. 2025 Nov;12(11):e753-e762. doi: 10.1016/S2352-3018(25)00239-5. Epub 2025 Oct 8.
• Cressey TR, Salvadori N, Rabie H, du Toit S, Than-In-At K, Groenewald M, Capparelli E, Owen A, Cressey R, Lallemant M, Cotton MF, Bekker A. Single Doses of Pediatric Dolutegravir Dispersible Tablets in Neonates Support Multidosing: PETITE-Dolutegravir Study. J Acquir Immune Defic Syndr. 2025 Jun 1;99(2):195-201. doi: 10.1097/QAI.0000000000003652.

Drugs

Indications