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