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. Enrolment into ODYSSEY A for children starting treatment for the first time continues.
In addition a pharmacokinetic (PK) substudy within ODYSSEY has been completed which will help to define simple dosing of dolutegravir in African children; data will be shared with WHO and is being requested by the FDA. Further PK work is planned.
A big thanks to all members of the ODYSSEY team (current and past) and participating sites in Germany, Portugal, South Africa, Spain, Thailand, Uganda, UK and Zimbabwe.
ODYSSEY is a multi-centre, randomised clinical trial to assess the efficacy and toxicity of Dolutegravir plus 2 NRTI versus standard of care among HIV positive children and adolescents. PENTA is sponsor of this study, with 700 patients to be enrolled in 30 sites in Europe, the US, Latin America, Africa and Asia.