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Clinical effect of interleukin-2 (IL-2) immuno-adjuvant treatment in HIV+ advanced naïve patients

Purpose of the study

The risk of opportunistic infections and inefficient immune reconstitution in advanced naive HIV+ patients starting HAART are critical issues in the management of HIV infection. We studied the effects of IL-2 adjuvant therapy in favoring a rapid CD4 cell rescue, shortening the time frame at highest risk of HIV-related clinical events in patients with severe immune impairment.


After 2 weeks of HAART, 73 HAART-naive patients with baseline CD4 cells <200/μL were randomized to receive IL-2+HAART (n = 33) or to continue ongoing HAART (n = 40). Three cycles of IL-2 were administered (one cycle: 3 × 106 IU QD sc at days 1–5 and 8–12), for an overall duration of 3 months. Patients were followed-up over 18 months. Patients failing to show a sustained CD4 recovery of >30% from baseline after 6 months (IL-2 non-responders, IL-2NR) received three further IL-2 cycles.

Summary of results

At baseline, IL-2 and HAART-control patients were comparable in terms of median CD4 counts (61/μL and 48/μL, respectively, p = 0.23) and prevalence of patients with AIDS-defining conditions (HAART-controls: 27; IL-2 patients: 15, p = 0.1). Rapid HIV-RNA decrease with no rebounds was observed in both IL-2 and HAART-patients. Major results are shown in Table 1. Compared to HAART-controls, IL-2 resulted in a more significant and rapid CD4 rescue after 3 months (p = 0.01). However, response to IL-2 was not equally persistent among patients: IL-2R displayed a higher and more sustained CD4 recovery up to month 18 respect to IL-2NR (p = 0.01) and controls (p = 0.04). Three additional cycles in IL-2NR did not result in any further significant CD4 recovery. During study period, AIDS-defining events were diagnosed in six (15%) HAART-controls and in one (3%) IL-2+HAART patient (p = 0.06).

Table 1


In advanced naïve patients, IL-2 adjuvant therapy is efficacious in inducing a rapid and significant CD4 reconstitution, in most cases sustained up to 18 months. The finding of a reduced prevalence of patients developing AIDS-defining conditions suggests a possible efficacy in functional immune enhancement which may translate into earlier clinical benefit.

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Tincati, C., Cesari, M., Meroni, L. et al. Clinical effect of interleukin-2 (IL-2) immuno-adjuvant treatment in HIV+ advanced naïve patients. JIAS 11 (Suppl 1), P1 (2008).

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