A randomised open label two-arm, 96 week trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir based triple antiretroviral therapy (ART) compared to daily dolutegravir/tenofovir based triple ART in virologically suppressed HIV infected adolescents aged 12 to 19 years of age in sub Saharan Africa
Can young people living with HIV safely take weekends off dolutegravir-based HIV treatment?
What is this study about?
The goal of HIV treatment is to make sure the amount of HIV virus in the blood remains very low. This is called having an undetectable viral load. If this goal is achieved and sustained life-long, then people living with HIV 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.
In BREATHER Plus we will compare two different ways of taking HIV medicines that include the HIV medicine dolutegravir. We want to see if a similar proportion of young people in the Short Cycle Therapy group have low HIV virus as in the Continuous Treatment group and whether they find there are other benefits to having two days off treatment each week:
- Short Cycle Therapy: where people taking part will take all their HIV medicines during the week but stop taking them at weekends (either Friday and Saturday or Saturday and Sunday)
- Continuous Treatment: where people taking part will take all their HIV medicines every day without any interruptions
People joining BREATHER Plus will have an equal chance of being randomised to one of the two groups.
Type of study
Who is funding the study?
This project is part of the EDCTP2 Programme supported by the European Union.
The European and Developing Countries Clinical Trials Partnership (EDCTP2) is 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.
When is it taking place?
The trial will take place from June 2022 to 2025.
Where is it taking place?
The trial is taking place in Uganda, Zimbabwe, Kenya and South Africa.
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 aged 12 to 19 years old,
• be diagnosed with HIV-1 infection,
• have undetectable HIV viral load for at least the last year,
• be on combination antiretroviral therapy,
• never have switched HIV medication in the past because of treatment failure.