title: Interleukin-2 accelerates CD4 cell reconstitution in HIV-infected patients with severe immunosuppression despite highly active antiretroviral therapy: the ILSTIM study--ANRS 082.
abstract: BACKGROUND
  Despite effective highly active antiretroviral therapy (HAART), some patients infected with HIV have persistently low CD4 cell counts with risk of HIV disease progression. The addition of interleukin-2, a cytokine that stimulates CD4 T lymphocyte helper cells, may benefit patients with discordant responses.
  
  
  METHODS
  A total of 72 HIV-infected patients with CD4 cell counts of 25-200 x 10(6) cells/l (median 145) and plasma HIV RNA < 1000 copies/ml were randomized in a multicentre study to receive open-label 4.5 x 10(6) IU interleukin-2 subcutaneously twice daily for 5 days every 6 weeks plus their ongoing HAART or were maintained on HAART alone (control group). After 24 weeks, all patients received interleukin-2 therapy plus HAART up to week 80. Primary end-point was the CD4 T cell area under the curve minus baseline up to week 24.
  
  
  RESULTS
  After four cycles of interleukin-2, in an intent-to-treat analysis, the respective median CD4 cell area under the curve minus baseline values were +51 and +11 cells in the interleukin-2 (n = 34) and the control group (n = 36) (P < 0.0001). The percentage of patients in the two groups with CD4 cell counts > 200 x 10(6) cells/l was 81% and 33%, respectively (P < 0.0001). At week 80, the median CD4 cell counts in the two groups were 380 and 270 x 10(6) cells/l, respectively. Interleukin-2 treatment was reasonably well tolerated and did not result in sustained increases in plasma HIV RNA levels.
  
  
  CONCLUSIONS
  Administration of interleukin-2 produces significant and sustained increase in CD4 cell counts in HAART-treated patients with persistent CD4 cell counts < 200 x 10(6) cells/l.
authors.affiliation: Service for Infectious and Tropical Diseases, Paris, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Katlama
authors.forename: Guislaine
authors.initials: G
authors.lastname: Carcelain
authors.forename: Claudine
authors.initials: C
authors.lastname: Duvivier
authors.forename: Cécile
authors.initials: C
authors.lastname: Chouquet
authors.forename: Roland
authors.initials: R
authors.lastname: Tubiana
authors.forename: Marcio
authors.initials: M
authors.lastname: De Sa
authors.forename: Liliane
authors.initials: L
authors.lastname: Zagury
authors.forename: Vincent
authors.initials: V
authors.lastname: Calvez
authors.forename: Brigitte
authors.initials: B
authors.lastname: Autran
authors.forename: D
authors.initials: D
authors.lastname: Costagliola
mesh_terms: D000328:Adult; D000368:Aged; D023241:Antiretroviral Therapy, Highly Active; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology*; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology* / Q000821:virology; D015497:HIV-1 / Q000502:physiology; D006801:Humans; D016867:Immunocompromised Host; D016130:Immunophenotyping; D007279:Injections, Subcutaneous; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D007376:Interleukin-2