Long-Acting Treatment in Adolescents (LATA): A randomised open-label 2-arm 96 week trial in virologically suppressed HIV-1-positive adolescents aged 12-19 years of age in Sub-Saharan Africa
For young people, aged 12 to 19, do long-acting injectable medicines works just as well as taking tablet HIV medicines?
What is this study about?
The goal of HIV treatment is to make sure that the quantity of HIV virus in the blood remains very low; this is called having an undetectable viral load. If this goal is achieved and sustained people with HIV infection can live a healthy life, with a normal life expectancy. However, it is challenging to take medication every single day, for life. This may be an even bigger challenge for teenagers living with HIV. There is now a new way of taking HIV medicines, in the form of two injections, called long-acting injectables, given every 8 weeks in the clinic. In LATA, we will investigate in young people living with HIV, aged 12-19 years of age, whether taking these long-acting injectable medicines works just as well as taking oral HIV medicines every day. This is what happens depending on which group participants are allocated to:
- Long-Acting Injectable Group: In this group, long-acting injectables called cabotegravir (CAB) and rilpivirine (RPV) will be given every 8 weeks for at least 96 weeks.
- Continuous Oral Treatment Group: this group will continue to take their HIV medicines every day by mouth. To join the trial, some participants might have to change some of their oral medications, as the combination being used in LATA is TLD. TLD is dolutegravir and tenofovir, plus either lamivudine or emtricitabine, as a single tablet taken once a day.
The aim of the LATA trial is to find out whether taking long-acting injectable medicines every 8 weeks is as effective and safe as taking tablet HIV medicines every day and has quality of life benefits to adolescents living with HIV. If we show this to be the case, then it is hoped that HIV guidelines will change to recommend long-acting injectables as another option for HIV treatment for adolescents.
Who is funding the study?
The trial has two funders. First, the European Union (EDCTP) a collaboration of European countries with countries in Africa, to improve the health of Africans by doing important research trials. Second Janssen-Cilag, one of the pharmaceutical companies that make the long-acting injectable medicines. Another pharmaceutical company called ViiV Healthcare makes the other injectable medicines and they are donating the medicines to LATA free of charge.
'This project is part of the EDCTP2 Programme supported by the European Union'
When is it taking place?
July 2022 onwards.
Where is it taking place?
Kenya, South Africa, Uganda and Zimbabwe.
Who is included?
We want 460 young people living with HIV from Kenya, South Africa, Uganda and Zimbabwe to be part of this trial. People taking part need to: • be 12 to 19 years old • be HIV-1-positive • have undetectable HIV viral load for at least the last year • be on combination antiretroviral therapy • have never switched HIV medication in the past because of treatment failure