Prendergast 2008 (a).

Methods	Pilot randomised controlled trial
Participants	Age: 63 HIV infected infants from birth Inclusion criteria: born in one of the study hospitals and had confirmed intrauterine/intrapartum HIV infection and caregivers gave consent for enrolment. Exclusion criteria: gestational age less than 37 weeks, birth weight less than 2 kg, evidence of other congenital infections or severe abnormalities.
Interventions	Arm A: deferred ART, according to WHO 2003 guidelines Arm B: immediate ART given for 1 year, then stopped Arm C: immediate ART given with up to three structured treatment interruptions to 18 months of age, then stopped.
Outcomes	Mortality; morbidity; virological suppression; change in CD4%
Notes	Data regarding stopping or interrupting strategy not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated sequence by trial statistician
Allocation concealment (selection bias)	Low risk	Quote from correspondence: " Opaque envelope at study sites were used for concealment allocation"
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	Unclear risk	No loss to follow up was reported.
Selective reporting (reporting bias)	Low risk	Major outcomes to address efficacy and safety of antiretroviral therapy were all reported, therefore risk of bias is unlikely.
Other bias	High risk	The trial was a feasibility study and was not designed or powered to assess difference in mortality between the two arms.