Coovadia 2010.

Methods	Randomized open label trial
Participants	323 children less than 2 years old previously exposed to NNRTI, median age 20 months (IQR 10‐36) in the control and 19 (IQR 9‐43) months in the switch group. Inclusion criteria: met clinical and immunological criteria for treatment initiation (WHO 2006), exposed to NVP and started on PI‐based regimen; achieved and sustained less than 400 copies/ml for at least 3 months within the first 12 months of treatment Exclusion criteria: children receiving tuberculosis treatment, having abnormalities in ALT greater than grade 2 (grading from Division of AIDS guidelines) and needing acute treatment for opportunistic infections (except TB) or tumours
Interventions	Control: continuous PI based ART Intervention: switch to NVP based ART
Outcomes	Mortality; Any viral load >50 copies/ml; Confirmed viral load >1000 copies/ml; Change in CD4%; Change in weight and height Z scores; Adverse events
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	quote:" Randomization was done in cohort blocks of variable size between 8 and 12. Allocations were generated by the study statistician"
Allocation concealment (selection bias)	Low risk	Quote from trial manuscript: "Allocations were concealed in opaque envelopes opened on site at the time of randomisation"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	None, but outcomes are unlikely to be biased by unmasking
Blinding of outcome assessment (detection bias) All outcomes	Low risk	None, but outcome measurements are unlikely to be biased by unmasking
Incomplete outcome data (attrition bias) All outcomes	Low risk	quote: "Modified intent‐to‐treat analyses were conducted excluding those children (n = 3) missing virologic outcome data" Missing data were reported in detail
Selective reporting (reporting bias)	Low risk	Study protocol available in the public domain, risk of selective reporting is very unlikely
Other bias	Low risk