Odyssey

is a pragmatic strategy trial
evaluating the efficacy and safety of once daily dolutegravir-based antiretroviral therapy compared with standard of care in children and adolescents starting first- or second-line antiretroviral therapy in resource-limited and well-resourced settings.

Odyssey

is a pragmatic strategy trial
evaluating the efficacy and safety of once daily dolutegravir-based antiretroviral therapy compared with standard of care in children and adolescents starting first- or second-line antiretroviral therapy in resource-limited and well-resourced settings.
Dolutegravir

Dolutegravir (DTG)

is a new drug which offers the potential to be highly effective, safe and simple when used as part of first- or second-line antiretroviral therapy regimens. Following adult Phase II/III trials, DTG needs evaluation to determine its place as first-line and second-line therapy in adolescent and paediatric HIV treatment.
Background

Background

DTG-based treatment with two NRTIs offers a potent regimen, with advantages of low toxicity, and the potential for once daily dosing. The rapid virological response observed following initiation of DTG-based antiretroviral therapy will be highly relevant for children with very high viral loads, which are commonly observed in younger children.

Study Treatment

Dolutegravir has high potency at a low milligram dose. Therefore, it could be particularly attractive for young children in both well-resourced and resource-limited settings, who have limited options and may be more likely to be infected with resistant viruses through mother-to-child transmission. A DTG-based first-line regimen is likely to be better tolerated and logistically advantageous for antiretroviral programmes currently using liquid LPV/r (recommended for young children), as well as needing to be dosed once rather than twice daily. Besides that, DTG can be used as part of a second-line regimen in children failing first-line PI-based therapy. Despite the presence of viral rebound for long periods, the NRTI backbone remains relatively protected in the presence of a boosted PI.
Clinical Sites

Clinical Sites

Countries

Countries

Patients Enrolled

Patients Enrolled

Governance

 

The Sponsor of the trial is PENTA Foundation, who delegates trial management activities to the following Clinical Trials Units:

Penta-ID Foundation
MCR-UCL
Inserm
PHPT