ODYSSEY

About the trial

Is a new combination of anti-HIV medicines including Dolutegravir as effective as current standard HIV treatment in children?

Odyssey

Objectives
Odyssey Trial 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.
Objectives of the study

Previous evidence in adults shows that DTG-based treatment with two other HIV drugs that work in different ways offers a potent regimen to tackle HIV, with advantages of few side-effects, and the potential for once daily dosing. In adults the amount of virus is quickly reduced once DTG-based treatment is started. This could be very relevant for children who often have very high viral loads.

The primary objective of the ODYSSEY trial is to assess the difference in proportion of children whose virus starts increasing or whose HIV disease gets worse by 96 weeks, comparing those who receive a DTG-based regimen and those on standard treatment.

  • This study is open to children and adolescents who meet the following main criteria:

    • Children ≥28 days and <18 years weighing ≥3kg with confirmed HIV-1 infection
    • Girls who have reached menses must have a negative pregnancy test at screening and randomisation and be willing to adhere to effective methods of contraception if sexually active
    • Parents/carers and children, where applicable, give informed consent and are willing to adhere to a minimum of 96 weeks’ follow-up

     

The trial started recruitment in September 2016 and is due to report results in early 2021.

Developing medicines for children almost always lags behind adults.

This short film is about ODYSSEY’s research into the development of dispersible dolutegravir tablets for children living with HIV.

The medicine is already standard treatment for adults and the new dispersible tablets are easy for children to take, with smaller doses and less susceptibility to resistance than previous drug regimes.