Table 3. Primary and secondary outcome measures.

Primary outcome measure
▪The proportion of participants with confirmed virological rebound*, defined as 2 consecutive plasma HIV-RNA ≥50 copies/mL at any time up to the 96-week assessment.
Secondary outcome measures
Efficacy
▪Proportion of participants with HIV-RNA ≥50 copies/mL at 48 and 96 weeks using the modified Food and Drug Administration (FDA) snapshot algorithm ▪The proportion of participants with HIV-RNA ≥1000 copies/mL (confirmed) by week 96 ▪The number and type of HIV mutations at confirmed virological rebound** ▪HIV-RNA <50 copies/mL and no switch to second-line ART for treatment failure at 24, 48, 72 and 96 weeks
Safety
▪Change in toxicity profile including change in metabolic parameters (lipids, glycosylated haemoglobin (HbA1c), phosphate), renal function (estimated Glomerular Filtration Rate (eGFR) from baseline to 96 weeks; change in anthropometric measures from baseline to 48 and 96 weeks ▪Time to any new or recurrent WHO stage 3 or WHO stage 4 event or death ▪Incidence of serious, grade 3, 4 and 5, and treatment-modifying (of any grade) adverse events ▪The proportion of participants with any change from baseline ART regimen
Patient Reported Outcomes
▪Adherence, acceptability, wellbeing and neuropsychiatric toxicities and neuropsychiatric problems (e.g. depression, anxiety and sleep disturbance) ▪Healthcare resource utilisation (as a sub-study outcome) ▪Health-related quality-of-life (as a sub-study outcome

Abbreviations: HIV RNA = human immunodeficiency virus ribonucleic acid; WHO = World Health Organization; ART = antiretroviral therapy; FDA = Food and Drug Administration; HbA1c = glycosylated haemoglobin; eGFR = estimated glomerular filtration rate. virological rebound is defined as two consecutive HIV-RNA ≥50 copies/mL.

^*virological rebound is defined as two consecutive HIV-RNA ≥50 copies /mL.

^**As obtaining resistance data is challenging when viral loads are very low, resistance testing may need to be restricted to samples with a higher VL where the chances of being able to sequence are greater; this will also be dependent on available technologies for testing.