ODYSSEY clinical trial design: a randomised global study to evaluate the efficacy and safety of dolutegravir-based antiretroviral therapy in HIV-positive children, with nested pharmacokinetic sub-studies to evaluate pragmatic WHO-weight-band based dolutegravir dosing

Table 4 Dolutegravir dosing in odyssey pk sub-study participants by protocol version

WHO weight-band	Initiated under Protocol v3.0	Initiated under Protocol v4.0
3 to < 6 kg	–	Single PK Curve on 5 mg or 10 mg DT^a
6 to < 10 kg	–	Single PK Curve on 15 mg DT
10 to < 14 kg	–	Single PK Curve on 20 mg DT
14 to < 20 kg	Single PK Curve on 25 mg FCT	Single PK Curve on 25 mg DT^b
20 to <25 kg	Single PK Curve on 25 mg FCT	Single PK Curve on 30 mg DT or 50 mg FCT^b
25 to < 30 kg	Cross-over PK with one curve on 25 mg FCT and second curve on 50 mg FCT	–
30 to < 35 kg	Cross-over PK with one curve on 35 mg FCT and second curve on 50 mg FCT	–
35 to < 40 kg	Cross-over PK with one curve on 35 mg FCT and second curve on 50 mg FCT	–
≥40 kg	–	–

Abbreviations: FCT Film-coated tablets, DT Dispersible tablets, v Version, PK Pharmacokinetic
^aDTG dose for infants 3- < 6 kg is dependent on age initially. Infants < 6 months of age receive DTG 5 mg QD while infants ≥6 months of age receive DTG 10 mg QD, both as dispersible tablets
^bPreference given to enrolment of children who completed PK on 25 mg FCT initiated under protocol version 3.0

ISSN: 1471-2334