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

Losso 2000.

Methods Study design was a prospective open‐labelled RCT
Participants There were a total of 73 participants
Inclusion criteria
  • HIV participants who had been on ART For greater than or equal to 7 days.

  • Not pregnant with a Karnofsky performance score ≥ 80.

  • Were over 18 years of age.

  • Had a most recent CD4 cel count of > 350 cells/mm³.


Exclusion criteria
  • History of or presence of AIDS defining illness.

  • History of malignancy requiring systemic use of corticosteroids or immuno modulators within the prior 5 years.

  • Autoimmune/inflammatory disease like Crohns disease.

Interventions
  • Treatment group: subcutaneous IL‐2 given at escalating doses of 1.5 miu, 4.5 miu, 7.5 miu with ART given twice daily for 5 consecutive days every 8 weeks plus ART.

  • Control group: ART alone.

Outcomes
  • Proportion of participants with viral load ≤ 500 copies/mL.

  • Mean change in CD4 cell count.

  • Mean change in viral load.

Notes This was a multi‐centred trial conducted in 6 clinical centres in Buenos Aires, Argentina.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The trial used a stratified block randomization method, using blocks of 24 stratified according to ART history (naive or experienced) and clinical centres.
Allocation concealment (selection bias) Low risk The trial used a centralized method of randomization.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk The trial was not blinded. However, the outcome 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 outcome 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% (2 out of 73 participants) from the analysis. There was no differential loss to follow‐up.
Selective reporting (reporting bias) Low risk There was no evidence of selective reporting.
Other bias High risk There was more monitoring in the treatment group compared to the control group.