TILT: A randomized controlled trial of interruption of antiretroviral therapy with or without interleukin-2 in HIV-1 infected individuals

Brian Angus, Fiona Lampe, Guiseppe Tambussi, Claudine Duvivier, Christine Katlama, Mike Youle, Ian Williams, Bonaventura Clotet, Martin Fisher, Frank A. Post, Abdul Babiker, Andrew Phillips

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)737-740
Number of pages4
JournalAIDS (London, England)
Volume22
Issue number6
DOIs
Publication statusPublished - Mar 2008

Keywords

  • Immunotherapy
  • Interleukin-2
  • Structured treatment interruption

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

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