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. |