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

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 Initiated under Protocol v3.0 Initiated under Protocol v4.0
3 to < 6 kg Single PK Curve on 5 mg or 10 mg DTa
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 DTb
20 to <25 kg Single PK Curve on 25 mg FCT Single PK Curve on 30 mg DT or 50 mg FCTb
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
  1. Abbreviations: FCT Film-coated tablets, DT Dispersible tablets, v Version, PK Pharmacokinetic
  2. 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
  3. bPreference given to enrolment of children who completed PK on 25 mg FCT initiated under protocol version 3.0
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