Interleukin‐2 as an adjunct to antiretroviral therapy for HIV‐positive adults


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Number Trial ID Follow-up duration Dosing regimen for interleukin-2 (IL-2) Comparisons Outcomes ART experienced or naive 1 Abrams 2002 16 months

Dose: 2 doses (4.5 and 7.5 miu)

Route: subcutaneous

Duration: twice daily for 5 days every 8 weeks

ART not specified

Viral load

CD4 cell count

ART experienced 2 Abrams 2009b 7 years

Dose: 4.5 miu

Route: subcutaneous

Duration: twice daily, 6 cycles

ART not specified

Opportunistic infections

Death from any cause

Adverse events

Not specified 3 Abrams 2009a 7 years

Dose: 7.5 miu

Route: subcutaneous

Duration: twice daily, 3 cycles

ART not specified

Opportunistic infections

Death from any cause

Adverse events

Not specified 4 Amendola 2000 28 weeks

Dose: 1 miu

Route: subcutaneous

Duration: daily for 5 days/week every alternate week for 3 months

Indinavir, stavudine, and lamivudine

CD4 cell count

Viral load

ART naive 5 de Boer 2003 12 months

Dose: 12 miu

Route: intravenous

Duration: for 3, 4, or 5 days every 8 weeks for 6 cycles

ART not specified

CD4 cell count

Viral load

Adverse events and serious adverse events

AIDS defining complex

ART experienced 6 Caggiari 2001 12 months

Dose: 6 miu

Route: subcutaneous

Duration: from days 1 to 5 and days 8 to 12 of a 28-day cycle for 6 cycles

2 nucleoside reverse transcriptase inhibitors (NRTIs) or 2 NRTIs and indinavir

CD4 cell count

Viral load

ART naive 7 Carr 1998 12 months

Dose: 1 miu

Route: subcutaneous and intravenous

Duration: Group A: 12 miu daily for 5 days every 8 weeks (27 participants)

Group B: 1 miu per cycle in equal divided doses in day 1 and 3 every 8 weeks (58 participants)

Zidovudine + didanosine + zalcitabine

CD4 cell count

Adverse events

Viral load

Opportunistic infections

ART experienced 8 Davey 2000 48 weeks

Dose: 7.5 miu

Route: subcutaneous

Duration: 6 cycles every 12 hours for 5 days every 8 weeks

ART not specified

CD4 cell count

Viral load

Adverse events

ART experienced 9 Dybul 2002 12 months

Dose: 7.5 miu

Route: subcutaneous

Duration: 3 cycles for 5 days every 8 week

ART not specified

CD4 cell count

Viral load

Not specified 10 Hengge 1998 12 months

Dose: 9.6 miu

Route: subcutaneous

Duration: 5 cycles were given. One cycle was given every 6 weeks over a period of 52 weeks.

Treatment group A : subcutaneous administered daily in cycles consisting of 5 days.

Treatment group B: subcutaneous administered at a dose of 9.6 miu daily whenever CD4 counts dropped to below 1.25 fold of individual’s baseline value

Saquinavir, lamivudine, and zidovudine

CD4 cell count

Viral load

Opportunistic infections

 ART experienced 11 Katlama 2002 24 weeks with outcomes measured at weeks 1, 6, 12, 18, and 24

Dose: 4.5 miu

Route: subcutaneous

Duration: every 6 weeks for 4 cycles, every 12 hours for 5 days

2 nucleoside analogues and one PI

CD4 cell count

Viral load

Adverse events

ART experienced

Not specified 12 Kelleher 1998 48 weeks

Dose: 12 miu

Route: intravenous

Duration: Group A: 12.6 miu as continuous intravenous infusions for 5 days every 8 weeks for 6 cycles. Group B (IL-2 linked to polyethylene glycol plus ART):

subcutaneous injections on days 1 and 3 of each 8-week cycles

ART included nucleoside analogues such as lamivudine

CD4 cell count

Viral load

ART experienced  13 Kovacs 1996 14 months

Dose: 18 miu

Route: intravenous

Duration: daily for 5 days every other month for 6 cycles from month 0 to 10

ART included didanosine, zidovudine, zalcitabine, or stavudine

CD4 cell count

Plasma HIV RNA

Not specified 14 Lalezari 2000 6 months

Dose: 1.2 miu, and then increased by 0.3 miu every 2 weeks for 6 months until a participant experienced grade 2 or greater toxicity.

Route: subcutaneous

Duration: once daily for 2 weeks

ART not specified

CD4 cell count

Viral load

Adverse events

 ART experienced 15 Levy 1999 14 months

Dose: 12 miu and 3 miu

Route: 12 miu intravenous and 3 miu subcutaneous

intravenously (12 miu/day, N = 22) or subcutaneously (3 miu/m² twice daily, N = 24) for 5 days, or 2 miu/m² intravenous bolus, N = 22) administered every 2 months from week 2 to week 50 (7 cycles).

Zidovudine (600 mg/day) plus didanosine (400 mg/day)

CD4 cell count

Viral load

Adverse events

ART naive 16 Levy 2003 18 months

Dose: 5 miu

Route: subcutaneous

Duration: twice daily for a 5 day cycle given every 4 weeks for the first 3 cycles and then subsequently every 8 weeks for the next 7 cycles

ART included lamivudine (300 mg/day), stavudine (60 to 80mg/day) and indinavir (2400 mg/day)

CD4 cell counts

Viral load

AIDS defining events

ART naive or naive to PIs alone 17 Losso 2000 24 weeks

Dose: escalating doses of 1.5 miu, 4.5 miu, 7.5 miu

Route: subcutaneous

Duration: twice daily for 5 consecutive days every 8 weeks

ART not specified

CD4 cell counts .

Viral load

Both naive and experienced participants were included in the study. 18 Marchetti 2002 48 weeks

Dose: 3 miu

Route: subcutaneous

Duration: administered as a single subcutaneous injection at days 1 to 5 and 8 to 12 of a 4-week cycle, for a total of 3 cycles

ART was either 2 nucleoside reverse transcriptase inhibitor
and one PI or at least one non nucleoside reverse transcriptase inhibitor

CD4 cell count

Viral load

Adverse events

ART experienced 19 Marchetti 2004 48 weeks

Dose: 3 miu

Route: subcutaneous

Duration: administered at day 1 to 5 and 8 to 12 for 10 weeks

ART not specified CD4 cell count ART experienced 20 Mitsuyasu 2007 84 weeks

Dose: Group A 9 miu and Group B 7.5miu

Route: intravenous and subcutaneous

Duration: Group A: intravenous infusions 5 days every 8 weeks.

Group B: subcutaneous injections 7.5 miu twice daily for 5 days every 8 weeks

Received ART alone, 2 nucleosides and a PI

CD4 cell count

Viral load

Not specified  21 Ruxrungtham 2000 24 weeks

Dose: Group A 1.5 miu, Group B 4.5 miu, and Group C 7.5 miu

Route: subcutaneous

Duration: twice daily for 5 days, every 8 weeks for three cycles 8-weekly

ART not specified

CD4 cell count

Viral load

 ART experienced 22 Stellbrink 2002 601 days

Dose: 9 miu

Route: subcutaneous

Duration: once daily (with an option to switch to 4.5 miu twice daily) for 5 consecutive days per cycle administered at 6-weekly intervals

ART 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.

CD4 cell count

Viral load

ART naive 23 Tambussi 2001 12 months

Dose: 3 regimens of IL-2

Route: intravenous and subcutaneous

Duration:differed by group see details below

Group A: 12 miu by continuous intravenous infusion followed by subcutaneous 7.5 miu twice a day for 5 days every 8 weeks for the remaining 4 cycles.

Group B: subcutaneous 7.5 miu twice a day for 5 days every 8 weeks for 6 cycles.

Group C: subcutaneous 3 miu twice a day every 4 weeks

2 NRTIs and saquinavir

CD4 cell count

Viral load

ART experienced 24 Tavel 2003 12 months

Dose: 7.5 miu

Route: subcutaneous

Duration: Group A: 7.5 miu twice daily for 5 days versus placebo plus ART.

Group B: 7.5 miu twice a day for 5 days

Nucleosides analogue reverse transcriptase inhibitor and either a non-nucleosides analogue reverse transcriptase inhibitor or PI

CD4 cell count

Viral load

ART experienced 25 Vogler 2004 24 weeks

Dose: 1 miu

Route: subcutaneous

Duration: once daily

2 nucleoside reverse transcriptase inhibitors

CD4 cell count

Viral load

ART experienced