HIV-infected children face unique challenges, such as; perinatal transmission of drug resistant HIV virus, limited safety data, impact of ARVs on their grown and development, need for different formulations and doses as they grow, and ease to transition to adult formulations. These issues challenge the development of a single fixed dose combination (FDC).
The UNIVERSAL 1 study aims to assess the short-term pharmacokinetics, safety and efficacy of DTG and FTC/TAF dispersible formulations with specific calculated doses are within the ranges previously reported for adults and children, to allow for universal dosing for a pediatric FDC administered to HIV-infected children, aged 28days to ≤10years, weighing ≥3kg to <25kg.
Expected impact: To have one safe and efficacious FDC first-line ART regimen, that can be used for children across the different WHO weight bands, and ages, and allow for easy transition to adult ART regimens.
