title: Comparison between subcutaneous and intravenous interleukin-2 treatment in HIV disease.
abstract: OBJECTIVE
  Therapy of HIV-infection using intravenous interleukin-2 (IL-2) is known to be effective in terms of increasing CD4-counts but is associated with significant side-effects and hospitalization. However, the combination with protease-inhibitor therapy has not been tested yet. The aim of the present study was to investigate the safety and efficacy of intravenous vs. subcutaneous IL-2 regimes using 9 Mio I.U. of IL-2, in combination with protease-inhibitor therapy.
  
  
  METHODS
  All patients were treated with a combination of two reverse transcriptase inhibitors and a protease-inhibitor prior to IL-2 administration for at least 6 weeks. Ten patients were assigned to the intravenous IL-2 group (group A). 10 to the subcutaneous group (group B).
  
  
  RESULTS
  In both treatment groups, CD4 count significantly increased shortly after the end of therapy (group A: 223% over baseline [day 7]; group B: 264% over baseline [day 7]). During the follow-up CD4 counts slowly decreased thereafter but remained above baseline 3 months following IL-2 treatment. The CD8 lymphocytes showed a similar but less pronounced pattern with a maximum at day 7 (group A: 116% over baseline, group B: 158% over baseline) and reached baseline earlier in the follow-up-period. Altogether the CD4/CD8-ratio was elevated through long periods on follow-up. Throughout follow-up, there were no apparent changes in viral load during IL-2 therapy in either groups. IL-2 therapy was administered for a mean time of 4.2+/-0.1 days in the intravenous group and of 4.8+/-0.1 days in the subcutaneous group until therapy was terminated at day 5 or due to side-effects. Only 1/10 patients completed the 5-day course of intravenous therapy in contrast to 6/10 in the subcutaneous group.
  
  
  CONCLUSIONS
  Subcutaneous interleukin-2 using 9 Mio IU day(-1) in combination with protease-inhibitors showed equal efficacy as intravenous therapy and was associated with less side-effects.
authors.affiliation: Department of Medicine, University of Essen, Germany.
authors.forename: O
authors.initials: O
authors.lastname: Witzke
authors.forename: T
authors.initials: T
authors.lastname: Winterhagen
authors.forename: W
authors.initials: W
authors.lastname: Reinhardt
authors.forename: U
authors.initials: U
authors.lastname: Heemann
authors.forename: H
authors.initials: H
authors.lastname: Grosse-Wilde
authors.forename: E
authors.initials: E
authors.lastname: Kreuzfelder
authors.forename: M
authors.initials: M
authors.lastname: Roggendorf
authors.forename: T
authors.initials: T
authors.lastname: Philipp
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000627:therapeutic use; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D007376:Interleukin-2 / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D007376:Interleukin-2