Palumbo 2010.

Methods	Phase II randomised clinical trial
Participants	123 children less than 36 months old Age:> 6 months to < 36 months (up to but not including the 3rd birthday) Inclusion criteria: If either the mother or the child had received NVP; subsequently amended to require specifically that the child had received nevirapine. Had to have diagnosis or AIDS by 60 days from birth and be formula fed from birth. Treatment eligible as defined by the WHO paediatric algorithm. HIV‐1 RNA >5,000 copies/mL within 60 days prior to study entry/randomisation Exclusion criteria: TB treatment or not met inclusion criteria
Interventions	NVP‐based vs LPV/r‐based first line antiretroviral therapy
Outcomes	Treatment failure (virological failure or discontinuation for any cause included death); virological failure; change in CD4%; change in weight and height z scores; adverse events.
Notes	Enrollment was terminated early on the recommendation of the data and safety monitoring board.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from the protocol: "dynamic permuted block system [stratified (<12months>)] "
Allocation concealment (selection bias)	Low risk	Quote from correspondence: "The Subject Registration and Randomization System provides a web‐based interface that leads site personnel through the checklist. If the subject satisfies the entry criteria, the system stores the subject's information in the central database and assigns a treatment based on a permuted block algorithm"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	None (from correspondence), but outcomes are unlikely to be biased by unmasking
Blinding of outcome assessment (detection bias) All outcomes	Low risk	None (from correspondence), but outcome measurements are unlikely to be biased by unmasking
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT was performed and attrition bias is unlikely
Selective reporting (reporting bias)	Low risk	Protocol available, selective outcome reporting is unlikely
Other bias	Unclear risk	Early termination of the study: "Enrollment in this cohort was terminated early on the recommendation of the data and safety monitoring board."