Odyssey trial’s COVID-19 response and CROI update
Results from the Odyssey trial will be presented at this year’s Conference on Retroviruses and Opportunistic Infections in Boston, USA.
Data from ODYSSEY are used by ViiV Healthcare to file FDA and EMA submissions for the first-ever dispersible formulation of dolutegravir for children living with HIV
Using data from the ongoing P1093 and the ODYSSEY (PENTA20) study, ViiV Healthcare has filed submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir (DTG) for children living with HIV. If approved, this new formulation of dolutegravir...
ODYSSEY has reached a major milestone by completing the recruitment of participants to the main trial. A big thank you to all the sites and everyone else for their hard work and continuous effort put into making the study a success.
ODYSSEY presented at ‘Annual Conference of the International Society for Clinical Biostatistics’ in Leuven, Belgium
We are pleased to report that a presentation from the ODYSSEY team at MRC CTU at UCL was well received at the 40th Annual Conference of the International Society for Clinical Biostatistics in Leuven, Belgium (14 – 18 July 2019). Rebecca Turner delivered the talk as part of the Bayesian clinical trials session on Tuesday morning (16 July).
We are delighted to report that a late breaker oral presentation on the key PK substudy nested within the ODYSSEY trial was accepted and presented at the 10th IAS Conference on HIV Science (IAS 2019) on 21-24 July, 2019.
Adult doses of an antiviral drug could offer a practical and accessible option for children weighing 20-25kg living with HIV. The results of the pharmacokinetic sub-study (measuring levels of drug in the blood to check if doses are correct), part of the ODYSSEY trial, were presented at the Conference on Retroviruses and Opportunistic Infections, in Seattle, Washington.
We are pleased to announce that recruitment to the main trial has now completed. We have recruited slightly more than the total target of 700 participants: 312 recruited into ODYSSEY A (naïve to HIV treatment) and 396 into ODYSSEY B (starting second line HIV treatment). A huge thank you to all involved in achieving this milestone!
Recruitment of children 3-<14kg has commenced at sites taking part in the pharmacokinetic substudy, and will continue until 60 children 3-<14kg have been recruited.
ODYSSEY B, which compares dolutegravir versus standard-of-care drugs in HIV-infected children who are starting second-line treatment, has completed recruitment ahead of target. 395 children have enrolled, mostly in Africa. Enrollment into ODYSSEY A for children starting treatment for the first time continues.
With more than 350 patients randomized into the trial, ODYSSEY has reached 50% of its recruitment target. Congratulations to the ODYSSEY team!