Goals and objectives
The goals of UNIVERSAL are:
- To develop two complementary antiretroviral fixed-dose combinations for infants and children newly diagnosed with HIV initiating antiretroviral therapy, and for children failing first-line therapy who need to switch to a new treatment regimen.
- To monitor the long-term efficacy and safety of other paediatric ART formulations as they enter the market across Africa.
The objectives of UNIVERSAL are:
- To use available adult and paediatric pharmacokinetic data to model fixed-dose combinations and determine optimal drug ratios and unit dose to cover all paediatric weight bands, as defined by WHO
- Based on modelling results, engage and team-up with the pharmaceutical industry to develop two child appropriate fixed-dose combinations of HIV drugs
- Using clinical trial products, evaluate the pharmacokinetics and short-term safety and efficacy of the newly developed formulations
- To monitor these priority drugs’ long-term safety and efficacy through extended follow-up of existing large-scale African paediatric HIV trials
- Incorporate strong capacity building through the involvement of various clinical trial sites in Africa.
Through UNIVERSAL we are contributing to:
- Improve health and reduce mortality and morbidity in children living with HIV in sub-Saharan Africa, thereby contributing to realise the UN Sustainable Development Goal 3 – to “ensure healthy lives and promote well-being for all at all ages”
- Reduce the main treatment gaps for children living with HIV and accelerate harmonization of treatments with adults
- Improve HIV disease management and prevention through evidence-based changes in national programmes, clinical practice in low and middle-income countries and global paediatric HIV guidelines
- Improve the capacity of African partners to conduct clinical trials that can lead to regulatory approval and long-term safety studies.