ODYSSEY (PENTA 20)

ODYSSEY (PENTA 20)

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.