Dolutegravir-based ART is superior to NNRTI- and PI-based ART in infants, children and adolescents living with HIV (combined results of the main trial and the ‘under 14kg’ cohort)
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,