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.
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.
- 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.