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)

The purpose of this study was to compare the effects of subcutaneous (SC) recombinant interleukin-2 (rIL-2) administered with and without concomitant pericycle highly active antiretroviral therapy (HAART) to no therapy in patients with HIV-1 infection and CD4+ T lymphocyte count >300 cells/mm3. Pericycle HAART was given only for a few days before, during and after each 5-day IL-2 cycle.

figure 2. STALWART Study randomisation

The hypothesis being tested was that intervention at an early stage of HIV infection with intermittent rIL-2 therapy either alone or with pericycle HAART can maintain or increase CD4+ T cell counts as compared to controls that receive neither antiretroviral therapy nor rIL-2.

The Copenhagen Regional Centre (CHIP) was one of four regional trial centres in STALWART. CHIP was responsible for sites in Poland, Portugal and Spain. A total of 267 participants was included in STALWART and followed until 28 February 2009 when data collection ended. An extended follow-up of STALWART participants took place until 28 February 2011 to continue unblinded safety assessments in groups that received IL-2 compared to the group that did not.

There are no substudies in STALWART. 

For further information please contact CHIP.

The EudraCT number for STALWART is 2005-001490-95

For additional information about or help in using the EudraCT number please contact CHIP.