ODYSSEY (Once daily DTG-based ART in young people vs standard therapy)
Research type
Research Study
Full title
A randomised trial of dolutegravir (DTG)-based antiretroviral therapy vs. standard of care (SOC) in children with HIV infection starting first-line or switching to second-line ART
IRAS ID
179128
Contact name
Anna Parker
Contact email
Sponsor organisation
PENTA Foundation
Eudract number
2014-002632-14
ISRCTN Number
ISRCTN91737921
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 2 months, 4 days
Research summary
HIV is treated with a combination of anti-HIV drugs. Dolutegravir (DTG) is a new medication which has recently been approved to treat adults living with HIV. It was shown to be strong, with low toxicity (fewer or no side effects) and only needs to be taken once a day.
The ODYSSEY trial will evaluate whether DTG is as good at treating HIV in children as the drugs that would currently be prescribed for these children. Participants will be allocated a particular treatment group at random (like tossing a coin) and will receive either DTG plus 2 other anti-HIV drugs or a standard combination of 3 anti-HIV drugs (which varies depending on where they live).The aim of ODYSSEY is to evaluate whether DTG-based therapy in children provides good control of the HIV virus with fewer side effects.
The trial will involve 700 children and young people from Europe, Africa, North and South America and Asia. It will include both children who are starting anti-HIV treatment for the first time (ODYSSEY A), and those who need to change treatment because the combination of anti-HIV drugs they are taking is no longer working (OYSSEY B).
Children in the trial will be enrolled over 96 weeks and all will be followed until the last recruited participant reaches week 96.
The trial will compare how well the new treatment manages to keep HIV levels very low in the blood and to prevent HIV-related illnesses and deaths, compared to standard treatment. It will also compare levels of side-effects, how well children’s immune systems respond, changes in lipid levels (such as blood cholesterol), and development of resistance by the HIV to the treatment.
Lay summary of study results: ODYSSEY is a clinical trial (also called a study) that looked at current HIV medicine compared to Dolutegravir, also called DTG. DTG is a new medicine, it’s for children and adults so as you grow up, you can keep taking it.
This study wanted to see if DTG improved the health of children and meant there was less chance their medicine would stop working. This summary is just about ODYSSEY; other studies may have different findings.
More than 700 children from 29 clinics took part from Uganda, South Africa, Zimbabwe, Thailand, UK, Germany, Spain and Portugal.
The children were from 3-18 years old and weighed at least 14kg. There was a separate group who weighed under 14kg. All children were checked up on for nearly 2 years.They were randomly split into 2 groups - one group started taking DTG and the other started taking the usual HIV medicine given to children and young people in that country. This was done to see if DTG was better than other medicines at keeping HIV very low, improving children’s health and stopping children from getting really ill. This study also looked at the side-effects children were having.
The study showed an improvement in the health of children on DTG compared to those on the usual treatment.
For the children on DTG, it was less likely to stop working than those children on other treatment. This meant DTG kept working as it was meant to.
The children grew better – they got taller and weighed slightly more two years after starting DTG compared to those not taking DTG. They had better blood fat results. This might mean their chance of getting sick with heart problems when they are adults is lower.
Only 1 in 7 children taking DTG did not do well on their medicine, compared to 1 in 5 in the group that didn’t take DTG.
Younger children who weighed less than 14 kg also did better taking DTG.
Sometimes people get something called ‘Psychiatric side effects’. These are things like feeling anxious, having sleep problems, feeling moody and sad and feeling like ‘life is not worth living’. Only a few children in both the groups had these side-effects.
This study has been very successful. Because of ODYSSEY, the World Health Organisation (WHO) now says that DTG should be the first medicine given to children living with HIV.
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/1120
Date of REC Opinion
19 Aug 2015
REC opinion
Further Information Favourable Opinion