Long-Acting Treatment in Adolescents (LATA): A randomised, open-label, two-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 12-19, do long-acting injectable medicines work 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, whether taking these long-acting injectable medicines works just as well as taking oral HIV medicines every day.
Participants will be allocated between two groups:
- Long-Acting Injectable Group: participants will be given long-acting injectables, called cabotegravir (CAB) and rilpivirine (RPV), every 8 weeks for at least 96 weeks.
- Continuous Oral Treatment Group: participants 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 (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 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; Janssen-Cilag, a pharmaceutical company that makes one of the long-acting injectable medicines; and ViiV Healthcare, another pharmaceutical company which makes the other injectable medicine. ViiV Healthcare 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?
LATA enrolled its first participant in June 2023 and recruitment is ongoing.
Where is it taking place?
Kenya, South Africa, Uganda and Zimbabwe.
Who is included?
We want to recruit 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 12-19 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.