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Table 3 Primary and secondary outcome measures in odyssey

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

Primary Efficacy Outcome
Difference in proportion with clinical or virological failure by 96 weeks, defined as the first occurrence of any of the following components:
1. Insufficient virological response defined as <1 log10 drop at week 24 (or viral load ≥50c/mL at week 24 in a participant with viral load < 500c/mL at baseline) and switch to second/third line antiretroviral therapy for treatment failure
2. Virological failure (defined as a viral load of greater than or equal to 400 copies/mL at or after week 36 confirmed by the next visit)
3. New or recurrent AIDS defining event (WHO 4) or severe WHO 3 event, confirmed by the Endpoint Review Committee (see Appendix)
4. All-cause death
Secondary efficacy outcomes
Difference in proportion with clinical or virological failure (as defined above) by 48 weeks
Time to any new or recurrent AIDS defining event (WHO 4) or severe WHO 3 events, confirmed by the Endpoint Review Committee
Proportion of children with Viral Load < 50 c/ml at 48 and 96 weeks
Proportion of children with Viral Load < 400 c/ml at 48 and 96 weeks
Rate of HIV-associated events (WHO 4 and severe WHO 3) and death over 96 weeks
Change in CD4 count and percentage and CD4/CD8 ratio from baseline to weeks 48 and 96
Proportion developing new resistance mutations
Secondary safety outcomes
Change in total cholesterol, triglycerides and lipid fractions (high-density lipoproteins, low-density lipoproteins) from baseline to weeks 48 and 96 (change in total cholesterol from baseline to week 96 will be used to formally assess superiority of dolutegravir-based regimen vs. standard-of-care)
Incidence of serious adverse events
Incidence of new clinical and laboratory grade 3 and 4 adverse events
Incidence of adverse events (of any grade) leading to treatment modification
Other secondary outcomes
Quality of life
Adherence and acceptability
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