Amendola 2000.

Methods	Open‐label RCT
Participants	22 HIV‐infected adults (12 males and 10 females) Inclusion criteria HIV‐infected adults > 18 years of age. Asymptomatic. CD4 cell count > 400 to 600 cells/mm³. Viral load > 5000 copies/mL. Exclusion criteria Prior exposure to antiretrovirals, immunomodulators, corticosteroids. Hepatitis B and C infection. Patients with autoimmune disease.
Interventions	The participants were enrolled in 3 randomized groups. Six participants (group 1) were treated with ART (Indinavir 2400 mg/day; stavudine 60 ± 80 mg/day; lamivudine 300 mg/day). Eight participants (group 2) were treated with ART and IL‐2 (aldesleukin, 1000 000 U/day ) subcutaneously, 5 days/week at alternative weeks). Eight participants (group 3) received granulocyte colony‐stimulating factor (G‐CSF; filgrastim, 5 mg/kg per day, for 5 consecutive days) to stimulate hematopoietic progenitor cell mobilization before starting ART and rIL‐2. All participants were treated with ART for 1 month before receiving differentiated therapies (ART; ART 1rIL‐2; (G‐CSF) ART 1rIL‐2) for an additional 12/24 weeks.
Outcomes	CD4 cell count. Viral load. Level of peripheral mononuclear blood cell apoptosis. Expression of CD45RA and CD62L T naive cells and memory cells.
Notes	The trial was conducted in Italy. Duration of follow‐up: 24 weeks. Outcomes were analysed at baseline, 12, and 24 weeks.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The trial authors did not describe whether this was done or not.
Allocation concealment (selection bias)	Unclear risk	The trial authors did not describe whether this was done or not.
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 study 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	Unclear risk	We do not have enough information from the trial to make a judgement.
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.