A randomised trial of dolutegravir (DGT)-based antiretroviral therapy vs. standard of care (SOC) in children with HIV infection starting first-line or switching to second-line ART
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.
This study includes a pharmacokinetics substudy in children 2 to 6 years of age, and results will be used to support regulatory submission for marketing of Dolutegravir in this population.
Penta and the ODYSSEY study have received a financial contribution from ViiV Healthcare U.K. (ViiV). ViiV does not have any operational or executive control over the study. Additionally, ViiV does not have or exercise any editorial control over the publication or generation of results from the ODYSSEY study (if any). Sole responsibility for the ODYSSEY study, including handling, management, publications and/or reported outcomes, lies with PENTA and its affiliates.