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 2 Dolutegravir dosing in odyssey main trial participants by protocol version^g

WHO weight-band	FDA approval^a		EMA approval^b		ODYSSEY v2.0^a	ODYSSEY v3.0	ODYSSEY v4.0	ODYSSEY v5.0/v6.0
WHO weight-band	FDA approval^a		EMA approval^b		*(Sep 2016 onwards)*	*(Mar 2017 onwards)*	*(May 2018 onwards)*	*(May 2019/Feb 2020 onwards)*
3 to < 6 kg					–	–	–	–
6 to < 10 kg					–	–	–	–
10 to < 14 kg					–	–	–	–
14 to < 20 kg			20 mg^c	Feb-2017	20 mg FCT^d	20 mg FCT^d	25 mg FCT → 25 mg DT^f	25 mg DT
20 to <25 kg			25 mg	Feb-2017	25 mg FCT	25 mg FCT	25 mg FCT → 30 mg DT or 50 mg FCT^f	50 mg FCT
25 to < 30 kg			25 mg	Feb-2017	25 mg FCT	25 mg FCT → 50 mg FCT^e	25 mg FCT → 50 mg FCT^e	50 mg FCT
30 to < 35 kg	35 mg	Jun-2016	35 mg	Feb-2017	35 mg FCT	35 mg FCT → 50 mg FCT^e	35 mg FCT → 50 mg FCT^e	50 mg FCT
35 to < 40 kg	35 mg	Jun-2016	35 mg	Feb-2017	35 mg FCT	35 mg FCT → 50 mg FCT^e	35 mg FCT → 50 mg FCT^e	50 mg FCT
≥40 kg	50 mg	Aug-2013	50 mg	Jan-2014	50 mg FCT	50 mg FCT	50 mg FCT	50 mg FCT

Abbreviations: FCT Film-coated tablets, DT Dispersible tablets, v Version
^a Approval in ≥12 years in Aug 2013, restriction removed Jun 2016
^b Approval in ≥12 years in Jan 2014, ≥6 years in Feb 2017
^c 20 mg FCT approved by EMA in children weighing 15 to < 20 kg only
^d From May 2017, ≥6 years, in children weighing 15 to < 20 kg only
^e From 1st of Apr 2018, after ethics notification, sites following protocol version 3.0 and above were recommended to increase the DTG dose of children 25 to < 40 kg to 50 mg FCT QD at their next scheduled study visit based on the results of the weight-band pharmacokinetic sub-study [23]
^f Protocol version 4.0 also allowed for the adjustment of weight-band dose based on findings from the ongoing weight-band pharmacokinetic sub-study with ethics notification
^g Protocol version 1.0 was not used

ISSN: 1471-2334