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. 2017 May 25;2017(5):CD009818. doi: 10.1002/14651858.CD009818.pub2

Kelleher 1998.

Methods This was a single centred pilot study which was planned as a pilot study of a multi‐centred RCT to be conducted.
Participants 18 participants consecutively enrolled into 3 groups
Inclusion criteria
  • Adults who had asymptomatic HIV infections.

  • CD4 counts between 200 to 500 cells/mm³.

  • Receiving nucleoside analogue ART regimen.


Exclusion criteria: not specified
Interventions Treatment group A (IL‐2 plus ART only)
  • IL‐2 at doses of 12.6 X 106 U/day


as continuous intravenous infusions for 5 days every 8 weeks for 6 cycles
Treatment group B (IL‐2 linked to polyethylene glycol plus ART)
  • Escalating doses of subcutaneous injections of IL‐ 2 on day 1 and 3 of each 8‐week cycle.


Control group
  • ART alone.


Each group had 150 mg of lamivudine twice daily added to their regimen at 30 weeks.
Outcomes
  • CD4 cell counts.

  • Viral loads.

  • Responses to recall antigens.

Notes This was a multicentred trial conducted in Australia.
Duration of follow‐up: 48 weeks
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The trial authors did not describe the method of random sequence generation.
Allocation concealment (selection bias) Unclear risk The trial authors did not describe the method of allocation concealment.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The trial was not blinded. However, the outcomes measures are objective and unlikely to have been influenced by lack of blinding.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The trial was not blinded. However, the outcomes measures are objective and unlikely to have been influenced by lack of blinding.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk The trial excluded less than 15% of the participants.
Selective reporting (reporting bias) Low risk There was no evidence of selective reporting.
Other bias Low risk We did not identify any other potential sources of bias.