Interleukin-2 before antiretroviral therapy in patients with HIV infection: a randomized trial (ANRS 119)

BACKGROUND: Interleukin (IL)-2 increases CD4 T cell counts when combined with antiretroviral therapy (ART). Whether IL-2 alone can increase CD4 cell counts is unknown. METHODS: A total of 130 adults who had a CD4 cell count of 300-500 cells/microL (and, thus, were not eligible to receive ART) were randomized to receive either intermittent IL-2 therapy or no treatment. The primary end point was a drop in CD4 cell count to <300 cells/microL, initiation of ART, the occurrence of an AIDS-defining event, or death. RESULTS: Through week 96, 35% of the patients in the IL-2 arm and 59% in the control arm reached the primary end point ([Formula: see text]). Median changes from baseline in the IL-2 and control arms were +51 and -64 cells/microL, respectively, for CD4 cell count ([Formula: see text]) and were +0.02 and +0.04 log(10) copies/mL, respectively, for plasma viral load ([Formula: see text]). Among patients with a baseline viral load <4.5 log(10) copies/mL, 64% in the IL-2 arm and 10% in the control arm did not reach the primary end point through week 150 ([Formula: see text]), and the time to ART initiation was deferred by 92 weeks in the IL-2 arm. The incidences of an AIDS-defining event, death, and grade 3 or 4 adverse events were similar between study arms. CONCLUSION: IL-2 increased CD4 cell counts without affecting HIV replication and allowed the initiation of ART to be deferred. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00120185. Copyright © 2009 Infectious Diseases Society of America [ABSTRACT FROM AUTHOR]