Abstract
ODYSSEY
- Internationalmulti-centre,randomised96-weeknon- inferiority trial
- WeaimedtocompareefficacyandsafetyofDTG-basedART with standard-of-care in children and adolescents starting first-line ART (ODYSSEY A) or second-line (ODYSSEY B)
Main trial enrolled children≥14kg
- Aim to enrol ≥700 children: 310 ODYSSEY A, 390 ODYSSEY B
- Powered for efficacy (total population and A&B separately)
- Once enrolment in the main trial was completed, the trial was opened for ‘under 14kg cohort’
‘Under 14kg’ cohort
- Aim to enrol ≥20 children in each of the three lower WHO weight bands: 3-<6kg, 6-<10kg and 10-<14kg
- To confirm efficacy, safety and the most practical dosing
- Proportions of first- and second-line not pre-specified
- Children in DTG arm did intensive PK