Odyssey

Objectives

The Odyssey Trial primary objective is to assess the difference in virological or clinical failure by 96 weeks between children receiving a dolutegravir-based regimen and those on standard of care.

Odyssey

Objectives
Odyssey Trial primary objective of the study is to assess the difference in virological or clinical failure by 96 weeks between children receiving a DTG-based regimen and those on standard of care.
Objectives of the study

Secondary efficacy outcomes which will be compared between children receiving dolutegravir and those receiving standard of care include:

  • difference in proportion with clinical or virological failure at 48 weeks
  • time to any new or recurrent AIDS defining event or severe WHO 3 events
  • proportion of children with viral load less than 50 and less than 400 copies/ml at 48 and 96 weeks
  • rate of clinical events (WHO 4, severe WHO 3 and death)
  • change in CD4 count and percentage and CD4/CD8 ratio from baseline to weeks 48 and 96
  • proportion developing new resistance mutations.

 

 

Secondary safety outcomes which will be compared between children receiving DTG and those receiving standard of care include:

  • change in lipid profile at 48 and 96 weeks
  • incidence of serious adverse events
  • incidence of new clinical and laboratory grade 3 and 4 adverse events.

Quality of life, adherence to treatment and acceptability of treatment will also be compared between treatment groups.