ODYSSEY

is a pragmatic strategy trial

ODYSSEY is evaluating the efficacy and safety of a once daily dose of dolutegravir-based antiretroviral therapy compared with the current standard HIV treatment in children and adolescents with HIV. ODYSSEY is taking place in in Germany, Spain, South Africa, Portugal, Thailand, Uganda, UK and Zimbabwe.

ODYSSEY

is a pragmatic strategy trial
evaluating the efficacy and safety of once daily dolutegravir-based antiretroviral therapy compared with standard of care in children and adolescents starting first- or second-line antiretroviral therapy in resource-limited and well-resourced settings.
Dolutegravir

Dolutegravir (DTG)

DTG is a new medicine being used to treat adults with HIV. In adults it has been shown to be effective and safe, with few side effects, and it only needs to be taken once a day. Sometimes a medicine works differently in growing children than in adults, so we need to check how it works in children as well. DTG could be an excellent option for children if the study finds it works as well as it does in adults. ODYSSEY will see how children and adolescents taking DTG as part of their anti-HIV medicines compare to others taking different anti-HIV medicines.

Background

Study treatment

DTG is a strong medicine at a low dose, which means smaller tablets are needed. It is available as dispersible tablets, which means they can be dissolved in water. Therefore, it could be particularly attractive for young children, who cannot swallow large tablets and have limited treatment options. DTG-based regimens are likely to be better tolerated than liquid LPV/r, currently recommended for young children, which tastes unpleasant. DTG has the advantage of only requiring a single daily dose, rather than twice daily. It is also easier for treatment programmes to procure since it is used in adults in many countries.

Study Impact

ODYSSEY is already having an impact in HIV treatment options. Data collected in ODYSSEY has led to the successful approval of ViiV Healthcare’s submission to the U.S. Food and Drug Administration (FDA) of the adult formulation for children weighing ≥20kg and Dolutegravir dispersible tablets for children of 4 weeks of age and older. This is a significant milestone on which further work can be built towards timely access to optimal antiretroviral therapies (ART) for children living with HIV around the world.

Clinical Sites

Clinical Sites

Countries

Countries

Patients Enrolled

Patients Enrolled

Governance

 

The Sponsor of the trial is Penta Foundation, who delegates trial management activities to the following Clinical Trials Units:

Penta-ID Foundation
MCR-UCL
Inserm
PHPT