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

Stellbrink 2002.

Methods Prospective RCT
Participants There were 56 participants.
Inclusion criteria
  • Asymptomatic HIV participants.

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

  • plasma viral load> 400 copies/mL.

  • Had seroconverted 12 months prior to entry.

  • Aged between 18 to 70 years.


Exclusion criteria
  • History of AIDS defining illness (Castro 1992).

  • Malignancy needing treatment within the last 5 years.

  • Medical condition corticosteroids.

Interventions
  • Treatment group (27): ART plus recombinant subcutaneous IL‐2 at 9 MU (megaunits) once daily (with an option to switch to 4.5 MU twice daily) for 5 consecutive day

  • Control group (29): ART alone consisting of stavudine 30 to 40 mg twice daily, and lamivudine 150 mg twice daily, nelfinavir 750 mg 3 times daily, and saquinavir 600 mg 3 times daily.

Outcomes
  • Change in CD4 count

  • Change in plasma viral levels

Notes This was an open label RCT conducted in Germany. Mean follow‐up duration ranged from 582 ‐ 601 days.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The trial authors did not report the method of sequence generation.
Allocation concealment (selection bias) Unclear risk The trial authors did not report the method of allocation concealment.
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 authors performed analysis was ITT and there were no losses to follow‐up.
Selective reporting (reporting bias) Low risk There was no evidence of selective reporting.
Other bias Low risk There was no evidence of other potential sources of bias.