Get to know the UNIVERSAL project: Relative Bioavailability study (PK sub-study)

March 8, 2023

Welcome to the “Get to know the UNIVERSAL project” series! Here we will introduce you to the various work packages and facets that make up the UNIVERSAL project.

The UNIVERSAL-Relative Bioavailability (RBA) sub-study will inform the UNIVERSAL 1 trial which aims to identify the right dose and drug ratio to treat HIV in children. One of the tablets to be developed within UNIVERSAL contains dolutegravir, tenofovir alafenamide fumarate and emtricitabine (DTG and F/TAF). In the RBA sub-study, DTG and F/TAF are safely administered both separately and in combination to healthy volunteers. This way, we can determine whether the medicines influence each other’s levels in the body when taken at the same time.


1. Why was this included in the UNIVERSAL project?

DTG and F/TAF potentially interfere with each other in the body when taken simultaneously. To investigate whether this is the case for the special tablet developed for children, and what happens in the body when the drugs are taken together, this pharmacokinetic study will be conducted so we gain more knowledge about whether sufficient doses are given to the children living with HIV within Work Package 3.


2. What are PK studies and why are they important?

Pharmacokinetic studies are studies on what the body does with a drug. Basically, they assess how much of a drug that is taken is available to do its work in the body. These studies are important because they help us to understand how drugs behave in the body and if we know how drugs behave in the body, we can make treatments safer and more effective.


3. What impact could this sub-study have on children living with HIV?

By conducting this study, we can determine whether the medicines influence each other when taken at the same time as paediatric tablet. By determining this, we can make the treatment of children living with HIV safer and more effective, which impacts the health and wellbeing of these children.