Volume 11 Supplement 1
Clinical effect of interleukin-2 (IL-2) immuno-adjuvant treatment in HIV+ advanced naïve patients
© Tincati et al; licensee BioMed Central Ltd. 2008
Published: 10 November 2008
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
Median CD4/μL change from BL (T3 mths)
Median CD4/μL change from BL (T6 mths)
Median CD4/μL change from BL (T18 mths)
IL-2+HAART patients (n = 33)
IL-2R (n = 23/33)
IL-2 NR (n = 10/33)
HAART controls (n = 40)
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.
This article is published under license to BioMed Central Ltd.