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The STALWART Study

Protocol title:
A randomised, open-label, international study of subcutaneous recombinant interleukin-2 (rIL-2, Aldesleukin) with and without concomitant antiretroviral therapy in patients with HIV-1 infection and CD4+ cell counts > 300/mm3: study of Aldesleukin with and without antiretroviral therapy (ESPRIT 002: STALWART). EudraCT number: 2005-001490-95

The Copenhagen Regional Centre (CHIP) was one of four regional trial centres in STALWART and CHIP was responsible for coordinating study activities at sites in Poland, Portugal and Spain.

Status
Active follow-up of STALWART study participants ended on 28 February 2009 based on the findings in the ESPRIT and SILCAAT studies. These studies showed that IL-2 produces a rise in CD4+ cell counts but that these higher CD4+ cell counts do not protect patients from opportunistic infections or death. Therefore all further IL-2 treatment in STALWART was cancelled.

However, the STALWART protocol team and the INSIGHT Executive Committee have developed a plan for extended follow-up of STALWART study participants.

The purpose of the extended follow-up of STALWART participants was to continue un-blinded safety assessments in groups that received IL-2 compared to the group that did not receive IL-2, which means that there was no intervention but only collection of routine data until 28 February 2011.

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