title: TILT: a randomized controlled trial of interruption of antiretroviral therapy with or without interleukin-2 in HIV-1 infected individuals.
abstract: OBJECTIVE
  We aimed to see if structured treatment interruption (STI) could be supported safely with the use of two cycles of IL-2 (4.5 MIU q12h subcutaneously 5 days) before STI to prolong the time before therapy restarted.
  
  
  METHODS
  Subjects were randomly allocated to either A - continuous ART; B - continue for 9 weeks, then STI; restart with the same ART when the CD4 count falls below 200 cells; or C - two cycles of IL-2, 8 weeks apart, while still on ART; at week 9 stop ART and use a new cycle of IL-2 alone whenever the CD4 count falls < 300 cells. Patients were followed until week 105.
  
  
  RESULTS
  86 mostly white middle aged homosexual men with a baseline median CD4 count of 754 cells/ml (range 240-1400) and a nadir CD4 count of 268 cells/ml (range 62-822) enrolled. By 96 weeks there was a 66% probability of having restarted ART in arm B compared with 34% in arm C (p = 0.002; log rank test). New drugs were used in 60% in arm A, 57% in arm B and 45% in arm C. 4 subjects had a dose modification in the first cycle due to toxicity with 2 interrupting. There were 39 SAEs with 21 in arm C. There were no deaths.
  
  
  CONCLUSIONS
  The primary aim of the trial was to gain experience in using IL-2. IL-2 delayed restarting drugs and fewer new drugs were used.
authors: Nuffield Department of Medicine, John Radcliffe Hospital, Oxford, UK. brian.angus@ndm.ox.ac.uk
authors: Brian
authors: B
authors: Angus
authors: Fiona
authors: F
authors: Lampe
authors: Guiseppe
authors: G
authors: Tambussi
authors: Claudine
authors: C
authors: Duvivier
authors: Christine
authors: C
authors: Katlama
authors: Mike
authors: M
authors: Youle
authors: Ian
authors: I
authors: Williams
authors: Bonaventura
authors: B
authors: Clotet
authors: Martin
authors: M
authors: Fisher
authors: Frank A
authors: FA
authors: Post
authors: Abdul
authors: A
authors: Babiker
authors: Andrew
authors: A
authors: Phillips
mesh_terms: D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D018791:CD4 Lymphocyte Count; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D015497:HIV-1; D006716:Homosexuality; D006801:Humans; D007376:Interleukin-2 / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D019562:Viral Load
chemical_list: D044966:Anti-Retroviral Agents; D007376:Interleukin-2