A randomised trial of dolutegravir-based antiretroviral therapy vs. standard of care in children with HIV infection starting first-line or switching to second-line antiretroviral therapy.
Is a new combination of anti-HIV medicines including dolutegravir as good as current standard HIV treatment in children?
What is this study about?
Dolutegravir is a new drug that offers the potential to be highly effective, safe and simple when used as part of first- or second-line antiretroviral regimens. Following adult Phase II/III trials, dolutegravir needs evaluation to determine its place as first-line and second-line therapy in treating children with HIV.
DTG has high potency at a low milligram dose. This means it could be particularly attractive for young children, who have limited options and may be more likely to be infected with resistant viruses through mother-to-child transmission (MTCT). A DTG-based first-line regimen is likely to be better tolerated and have logistical advantages for ART programmes currently using liquid LPV/r (recommended for young children). DTG can be used as part of a second-line regimen in children failing first-line PI-based therapy; despite the presence of viral rebound for long periods, the NRTI backbone remains relatively protected in the presence of a boosted PI
ODYSSEY is a pragmatic strategy trial evaluating the efficacy and safety of dolutegravir-based antiretroviral therapy compared with standard of care in children starting first- or second-line antiretroviral therapy in resource-limited and well-resourced settings.
The primary objective of the study is to assess the difference in virological or clinical failure by 96 weeks between children receiving a DTG-based regimen and those on standard of care.
Type of study
Who is funding the study?
This study is funded by ViiV Healthcare and the sponsor is Penta Foundation.
When is it taking place?
The study started recruitment in September 2016 and is due to finish in mid-2020.
Where is it taking place?
ODYSSEY is a global trial with participating centres in the UK, Germany, South Africa, Thailand, Uganda, USA, Zimbabwe, Uganda, France, Argentina, Brazil, Portugal, and Spain.
Who is included?
700 HIV-1 infected children aged <18 years starting first-line or second-line antiretroviral therapy.