Children with HIV in Africa – Pharmacokinetics and Acceptability of Simple second-line antiretroviral regimens.
Do new second-line antiretroviral (ART) drugs/formulations maximise the long-term health gains and optimise second-line treatment in HIV-infected children?
What is this study about?
The growing number of children taking ART, coupled with increased detection of ART treatment failure, has increased the number of children needing to switch from their first-line ART treatment to second-line treatment. This raises the question of whether current second-line treatment for children failing first-line treatment is optimal in terms of maximising children’s health gains and minimising toxicity from the treatment long-term. The current WHO-recommended second-line ART for children failing standard first-line treatment is not ideal, as it is based on a fixed dose combination drug which needs to be taken as whole pills, mini-pill pellets or unpalatable liquid, and also interacts with anti-tuberculosis (TB) drugs. Many children suffering from HIV also develop TB, strengthening the need to investigate new second-line ART treatments.
CHAPAS-4 also aims to evaluate the pharmacokinetics and acceptability of the second-line ART treatments. Pharmacokinetic studies will investigate what happens to the drug in the children’s bodies and will investigate the optimum dosing schedule for second-line treatment. Acceptability questionnaires will investigate whether the children find the CHAPAS-4 second-line treatment medicines easier to take than their first-line treatment.
Type of study
Who is funding the study?
The European and Developing Countries Clinical Trial Partnership (EDCTP).
When is it taking place?
First participant recruited December 2018. Recruitment due to finish mid-2022.
Where is it taking place?
Uganda, Zimbabwe and Zambia
Who is included?
1000 HIV infected children aged 3-15 years, with a viral load of >400 copies/ml, and failing first-line ART treatments will be included in CHAPAS-4.