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Table 5 Clinical assessments undertaken and frequency of testing

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

Clinical Assessment Frequency of Assessment
History and clinical assessment including height, weight (and adjustment of drug doses accordingly) and mid upper arm circumference, change in HIV disease stage, clinical events and presence of adverse events. Every study visit
Tanner scale (children aged 8 or over) Baseline, then every 24 weeks and at the end of study visit
Lipodystrophy assessment including at selected sites bioelectrical impedance analysis. Baseline, then every 48 weeks and at the end of study visit
HIV-1 RNA viral load Every study visit as per local practice. In ODYSSEY B viral load must be measured at screening unless the viral load has been done within 4 weeks prior to screening. Stored plasma samples will be used to examined viral load for study visits where viral load is not routinely done.
T cell lymphocyte subsets including CD4 and CD8 percentage and absolute, total lymphocyte count Baseline, 4, 12, 24, then 24-weekly until week 96 and at the end of study visit
Biochemistry including creatinine, bilirubin, alanine aminotransferase (ALT), and optionally aspartate aminotransferase (AST) Baseline, 4, 24, then 24-weekly until week 96 and at the end of study visit
Haematology including haemoglobin, mean corpuscular volume (MCV), white blood cell count, lymphocytes, neutrophils, and platelets Baseline, 4, 24, then 24-weekly until week 96 and at the end of study visit
Lipids/glucose including fasted triglycerides, cholesterol (total, high-density lipoproteins, low-density lipoproteins), and glucose Baseline, 48, 96 weeks, then every 48 weeks and at the end of study visit
Bone profile including calcium, phosphate, alkaline phosphatase Optional for all sites at baseline, 48, 96 weeks, then every 48 weeks and at the end of study visit
Urine dipstick for protein and glucose Baseline, 48, 96 weeks then every 48 weeks and at the end of study visit
Quality of Life questionnaire Baseline, 12, 24, 48, 96 weeks then every 48 weeks and at the end of study visit
Pregnancy test (for all females of childbearing potential) This was originally at baseline and then every 24 weeks but following the pregnancy alert in DTG in May 2018 this was updated to every study visit (see Section entitled ‘Pregnancy Alert’)
Plasma storage for retrospective HIV-1 RNA viral load, resistance testing where not routinely available locally and sub-study assays Every visit
Peripheral blood mononuclear cell storage at selected sites for immunology/virology sub-study At selected sites for baseline, 12, 48, and 96 weeks
Adherence questionnaire Every visit
Acceptability, sleep & mood questionnairea Baseline, 4, 12, 24, 48, 72, 96 weeks, then every 24 weeks and at the end of study visit. Also acceptability should be completed if treatment failure has occurred or the antiretroviral therapy regimen changed.
  1. a Sleep and mood questions including from protocol version 3.0 onwards
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