***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE The efficacy of recombinant interleukin-2 ( rIL-2 ) was assessed in HIV-infected patients with advanced immune suppression and a discordant immune response to highly active antiretroviral therapy ( HAART ) . The primary endpoint was median change in CD4 + T-cell counts at the end of treatment as compared to baseline . Secondary endpoints were safety and changes in the various T-cell sub population s. MATERIAL AND METHODS In a prospect i ve cohort study , 19 patients with HIV-RNA < 50 copies/mL and < 200 CD4 + T cells/mm3 without a significant increase in the previous 12 months were scheduled to receive 6 cycles of 4.5 x 10(6 ) IU subcutaneous rIL-2 daily for 5 consecutive days , every 4 weeks . RESULTS Median age was 43 years , and 64 % had a previous AIDS-defining event .  Median nadir and baseline CD4 + cell counts were 36 and 99 cells/mm3 , respectively . Three patients discontinued treatment and one experienced grade 4 side effects . CD4 + T-cell counts increased to 147 cells/mm3 ( range , 24 - 285 ) at 1 month following completion of treatment ( P = 0.002 ) , and 180 cells/mm3 ( range , 38 - 280 ) at 18 months ( P < 0.001 ) . This improvement was associated with a significant decrease in expression rates of the activation markers , HLA-DR and CD38 . CONCLUSION Our results suggest that in patients with advanced HIV-infection showing a blunted immune response to HAART , rIL-2 might increase the pool of CD4 + T-cells by down-regulating the status of immune activation Objectives To assess the immunological and virological effects , safety profile and feasibility of subcutaneous interleukin-2 ( scIL-2 ) therapy in an HIV-infected Thai population . Design Seventy-two patients with baseline CD4 cell count of ⩾ 350 × 106/l and no history of opportunistic infection were r and omized to receive antiretroviral therapy plus scIL-2 ( scIL-2 group ) or antiretroviral therapy alone ( control group ) . scIL-2 was administered at one of three doses for at least 24 weeks . The main measure of treatment efficacy was change in CD4 cell count . Results The time-weighted mean change in CD4 cell count from baseline to week 24 was + 252 × 106/l for the scIL-2 group compared with + 42 × 106/l for the control group ( P < 0.0001 ) . Changes in plasma HIV RNA were not significantly different between the groups over the same time period : there was a 0.83 log10 copies/ml decrease for the scIL-2 group and a 0.70 log copies/ml decrease for the control group ( P = 0.362 ) . Conclusions This study provides the most extensive experience of scIL-2 therapy in HIV-1 infected women and Asians , and demonstrates the immunological efficacy , tolerability and feasability of scIL-2 therapy in this population . Data from this study were instrumental in guiding the selection of the scIL-2 dosing regimen for ongoing phase III trials The safety and activity of outpatient-based continuous intravenous interleukin-2 ( CIV IL-2 ) or a slow-release , polyethylene glycol (PEG)-modified IL-2 were studied in human immunodeficiency virus (HIV)-infected persons with CD4 cell counts between 200 and 500/mm3 . One hundred fifteen patients were r and omized to antiretroviral therapy plus cyclical CIV IL-2 ( n = 27 ) , subcutaneous PEG IL-2 ( n = 58 ) , or no IL-2 ( n = 30 ) . Toxicity withdrawal rates were low ( 4 % for CIV IL-2 and 7 % for PEG IL-2 ) . There were median CD4 cell count increases of 359 and 44 cells/mm3 and a decline of 46 cells/mm3 in the 3 groups , respectively , over 1 year ( P < .0001 for each intergroup comparison ) . CD4 cell count increases were greatest in those with lower HIV RNA load . Delayed-type hypersensitivity scores increased and HLA-DR expression on CD8 cells decreased significantly with IL-2 therapy . HIV RNA levels were unaffected . IL-2 therapy may exp and the existing immune repertoire but not immediately reconstitute lost immune function HIV-1- and cytomegalovirus (CMV)-specific CD4 T-cell-mediated antiviral immunity was evaluated by assessing the frequency of interleukin 2 (IL-2)- and interferon gamma (IFN-gamma)-secreting cells following antigen-specific stimulation in blood and lymph node . HIV-1-infected subjects with progressive disease at early stage of infection with no previous history of antiretroviral therapy ( ART ) , subjects with nonprogressive disease , and HIV-negative subjects were studied . On the basis of the ability to secrete IL-2 and IFN-gamma , 3 functionally distinct population s of CD4 T cells were identified : ( 1 ) IL-2-secreting cells ; ( 2 ) IL-2/IFN-gamma-secreting cells ; and ( 3 ) IFN-gamma-secreting cells . CMV-specific CD4 T cells were almost equally distributed within the 3 functionally distinct cell population s in the 3 study groups as well as HIV-1-specific CD4 T cells in subjects with nonprogressive disease . However , a skewing toward IFN-gamma-secreting cells ( 70 % of HIV-1-specific CD4 T cells ) was observed in subjects with progressive disease , and IL-2- and IL-2/IFN-gamma-secreting cells were almost absent . The frequencies of IL-2- and of IL-2/IFN-gamma-secreting HIV-1-specific CD4 T cells were negatively correlated with the levels of viremia . Interestingly , prolonged ART was able to correct the skewed representation of different population s of HIV-1-specific CD4 T cells but was associated with only a partial recovery of IL-2-secreting cells . These results indicate that the composition of the pool of functionally distinct virus-specific CD4 T cells is important for virus control CONTEXT While interleukin 2 ( IL-2 ) is capable of inducing a marked expansion of the CD4 T-lymphocyte pool , limited data exist on whether IL-2 treatment can add significantly to the immunologic and virologic effects of potent antiretroviral therapy ( ART ) . OBJECTIVE To determine the rate and magnitude of CD4 cell recovery and viral suppression when using a combination therapy of IL-2 and ART compared with ART alone . DESIGN AND SETTING R and omized , controlled multicenter trial conducted from April 1996 through April 1998 at 8 clinical sites in the United States . PATIENTS Eighty-two adult out patients who were infected with human immunodeficiency virus ( HIV ) and had baseline CD4 cell counts of 200 x 10(6)/L to 500 x 10(6)/L and baseline RNA levels of fewer than 10,000 copies/mL were r and omized ; 78 completed the study . INTERVENTIONS Thirty-nine patients were r and omly assigned to receive a combination therapy of subcutaneous IL-2 ( administered in 5-day courses every 8 weeks at a starting dosage of 7.5 mIU twice per day ) and ART ; 43 were to receive ART therapy alone . MAIN OUTCOME MEASURES  Interleukin 2 safety and differential effects on CD4 cell counts , CD4 cell percentages , and plasma HIV RNA levels . RESULTS The mean ( SD ) percentage increase in CD4 cell counts at 1 year for patients who received IL-2 was 112 % ( 113 % ) compared with 18 % ( 35 % ) in recipients of ART alone ( P<.001 ) . Both groups had mean ( SD ) increases in CD4 cell percentage : from 20.4 % ( 6.3 % ) to 32.3 % ( 12.4 % ) for the combination therapy group compared with 20.4 % ( 5.1 % ) to 23.0 % ( 7.2 % ) for recipients of ART alone ( P<.001 ) . Using a sensitive viral RNA assay , mean viral load changes were -0.28 and 0.09 log(10 ) copies for IL-2 recipients and control patients , respectively ( P=.03 ) . Twenty ( 67 % ) of 30 evaluable patients receiving IL-2 achieved final viral loads of fewer than 50 copies/mL compared with 13 ( 36 % ) of 36 control patients ( P=.02 ) . Toxic effects were common among patients who received IL-2 and were managed with antipyretics , hydration , rest , and dosage reduction as needed . CONCLUSIONS Intermittent therapy with IL-2 and ART produced a substantially greater increase in CD4 cells and was associated with a larger decrease in viral load than ART alone . Clinical end-point trials will be necessary to determine whether the enhanced viral suppression and CD4 cell increases associated with IL-2 therapy will translate into improved clinical outcomes . JAMA . 2000;284:183 - BACKGROUND Used in combination with antiretroviral therapy , subcutaneous recombinant interleukin-2 raises CD4 + cell counts more than does antiretroviral therapy alone . The clinical implication of these increases is not known . METHODS We conducted two trials : the Subcutaneous Recombinant , Human Interleukin-2 in HIV-Infected Patients with Low CD4 + Counts under Active Antiretroviral Therapy ( SILCAAT ) study and the Evaluation of Subcutaneous Proleukin in a R and omized International Trial ( ESPRIT ) . In each , patients infected with the human immunodeficiency virus ( HIV ) who had CD4 + cell counts of either 50 to 299 per cubic millimeter ( SILCAAT ) or 300 or more per cubic millimeter ( ESPRIT ) were r and omly assigned to receive interleukin-2 plus antiretroviral therapy or antiretroviral therapy alone . The interleukin-2 regimen consisted of cycles of 5 consecutive days each , administered at 8-week intervals . The SILCAAT study involved six cycles and a dose of 4.5 million IU of interleukin-2 twice daily ; ESPRIT involved three cycles and a dose of 7.5 million IU twice daily . Additional cycles were recommended to maintain the CD4 + cell count above predefined target levels . The primary end point of both studies was opportunistic disease or death from any cause . RESULTS In the SILCAAT study , 1695 patients ( 849 receiving interleukin-2 plus antiretroviral therapy and 846 receiving antiretroviral therapy alone ) who had a median CD4 + cell count of 202 cells per cubic millimeter were enrolled ; in ESPRIT , 4111 patients ( 2071 receiving interleukin-2 plus antiretroviral therapy and 2040 receiving antiretroviral therapy alone ) who had a median CD4 + cell count of 457 cells per cubic millimeter were enrolled . Over a median follow-up period of 7 to 8 years , the CD4 + cell count was higher in the interleukin-2 group than in the group receiving antiretroviral therapy alone -- by 53 and 159 cells per cubic millimeter , on average , in the SILCAAT study and ESPRIT , respectively . Hazard ratios for opportunistic disease or death from any cause with interleukin-2 plus antiretroviral therapy ( vs. antiretroviral therapy alone ) were 0.91 ( 95 % confidence interval [ CI ] , 0.70 to 1.18 ; P=0.47 ) in the SILCAAT study and 0.94 ( 95 % CI , 0.75 to 1.16 ; P=0.55 ) in ESPRIT . The hazard ratios for death from any cause and for grade 4 clinical events were 1.06 ( P=0.73 ) and 1.10 ( P=0.35 ) , respectively , in the SILCAAT study and 0.90 ( P=0.42 ) and 1.23 ( P=0.003 ) , respectively , in ESPRIT . CONCLUSIONS Despite a substantial and sustained increase in the CD4 + cell count , as compared with antiretroviral therapy alone , interleukin-2 plus antiretroviral therapy yielded no clinical benefit in either study . ( Clinical Trials.gov numbers , NCT00004978 [ ESPRIT ] and NCT00013611 [ SILCAAT study ] . BACKGROUND Interleukin 2 ( IL-2 ) administration increases CD4 counts in persons with higher counts . This study investigated persons with moderately advanced human immunodeficiency virus infection receiving highly active antiretroviral therapy ( HAART ) . METHODS Two hundred four patients with CD4 T-cell counts from 50/microL to 350/microL who were treatment naive or had been treated only with reverse transcriptase inhibitors began a specified protease inhibitor HAART regimen . Virologic responders ( < or = 5000 copies/mL ) at 12 weeks were r and omized to open-label continuous-infusion IL-2 ( IV IL-2 ) , subcutaneous IL-2 ( SC IL-2 ) , or HAART alone .  Thirty were not r and omized and 1 
    Output:
    
Authors ' conclusions There is high certainty evidence that IL‐2 in combination with ART increases the CD4 cell count  in HIV‐positive adults .
However , IL‐2 does not confer any significant benefit in mortality , there is probably no difference in the incidence of opportunistic infections , and there is probably an increase in grade 3 or 4 adverse effects .
Our findings do not support the use of IL‐2 as an adjunct to ART in HIV‐positive adults .