Children with HIV in Africa – Pharmacokinetics and Acceptability of Simple second-line antiretroviral regimens

Do new second-line antiretroviral drugs/formulations maximise the long-term health gains and optimise second-line treatment in children living with HIV?

What is this study about?

The growing number of children taking antiretroviral therapy (ART), coupled with better 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.

More information and resources from CHAPAS-4.


Type of study

Randomised trial

Contact details

Who is funding the study?

The CHAPAS-4 project is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP), a collaboration between countries in Europe and sub-Saharan Africa supported by the European Union, to improve the health of Africans by doing important research trials [TRIA2015- 1078].

Additional funding support is provided by Janssen Pharmaceutica and Gilead Sciences Inc. MRC CTU at UCL is supported by Medical Research Council core funding.


When is it taking place?

The first participant was recruited in December 2018. Recruitment was completed at the end of January 2023 and analysis is ongoing.

Where is it taking place?

Uganda, Zimbabwe and Zambia.

Who is included?

We aimed to include 1000 HIV children living with HIV failing first-line ART treatments, aged 3-15 years, with a viral load of >400 copies/ml.
At the end of participant recruitment, we had recruited 919 children with a viral load of >1000copies/ml.