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Table 2 Dolutegravir dosing in odyssey main trial participants by protocol versiong

From: 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

WHO weight-band FDA approvala EMA approvalb ODYSSEY v2.0a ODYSSEY v3.0 ODYSSEY v4.0 ODYSSEY v5.0/v6.0
(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 mgc Feb-2017 20 mg FCTd 20 mg FCTd 25 mg FCT → 25 mg DTf 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 FCTf 50 mg FCT
25 to < 30 kg    25 mg Feb-2017 25 mg FCT 25 mg FCT → 50 mg FCTe 25 mg FCT → 50 mg FCTe 50 mg FCT
30 to < 35 kg 35 mg Jun-2016 35 mg Feb-2017 35 mg FCT 35 mg FCT → 50 mg FCTe 35 mg FCT → 50 mg FCTe 50 mg FCT
35 to < 40 kg 35 mg Jun-2016 35 mg Feb-2017 35 mg FCT 35 mg FCT → 50 mg FCTe 35 mg FCT → 50 mg FCTe 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
  1. Abbreviations: FCT Film-coated tablets, DT Dispersible tablets, v Version
  2. a Approval in ≥12 years in Aug 2013, restriction removed Jun 2016
  3. b Approval in ≥12 years in Jan 2014, ≥6 years in Feb 2017
  4. c 20 mg FCT approved by EMA in children weighing 15 to < 20 kg only
  5. d From May 2017, ≥6 years, in children weighing 15 to < 20 kg only
  6. 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]
  7. 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
  8. g Protocol version 1.0 was not used
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