A Randomized, Open-Label, Phase III, International Study of Subcutaneous Recombinant IL-2 (Proleukin®) in Patients With HIV-1 Infection and CD4+ Cell Counts ≥ 300/mm3: Evaluation of Subcutaneous Proleukin® in a Randomized International Trial (ESPRIT). EudraCT number: 2004-000702-46.
A total of 4150 study participants were enrolled in the ESPRIT study from 255 sites in 25 countries around the world. The Copenhagen region has enrolled 982 participants from 43 sites in 9 countries.
In November 2008 follow-up of all study participants was finalised, and all sites were officially closed in May/June 2009.
Clarifying whether administration of IL-2 provides clinical protection in HIV-infected populations started more than a decade ago and an enormous number of professionals have worked on answering this research question ever since.
The important findings from the ESPRIT study has been shared with all investigators after the unblinding of the study and the study results have been published in the New England Journal of Medicine, 15 October 2009.
Please refer to “publications” for the complete list of publications.
The ESPRIT Trial
The ESPRIT trial compared the effects of subcutaneous recombinant interleukin-2 (SC rIL-2) and no SC rIL-2 on disease progression and death over a 5 year follow-up period. Patients was HIV-1 positive with an absolute CD4+ count of above 300/mm3 receiving combination antiretroviral treatment.
CHIP was one of four regional trial centers. The Copenhagen Regional Center was responsible for centers in Denmark, Norway, Sweden, Germany, Spain, Portugal, Belgium, Poland and Austria (875 patients were projected to be enrolled from these countries). ESPRIT was an international collaboration between 23 countries world-wide.
Dr. James Neaton (USA) served as principal investigator, and the Executive Committee consisted of: Dr. Donald Abrams (USA), Dr. David Cooper (Australia), Dr. Janet Darbyshire (UK), Dr. William Duncan (USA), Dr. Sean Emery (Australia), Dr. Clifford Lane (USA) and Dr. Jens D. Lundgren (Denmark).
A five year grant was awarded by the US National Institutes of Health. The first patient was enrolled in USA on 13 March 2000 and the randomisation was closed with the enrollment of patient no. 4150 on 31 May 2003.
For details about the trial go to the
INSIGHT website. For a complete list of INSIGHT publications also see the
INSIGHT website.
The EudraCT number for ESPRIT is 2004-000702-46.
For additional information about or help in using the EudraCT number please contact CHIP.