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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