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Interleukin-2 before Antiretroviral Therapy in Patients with HIV Infection: A Randomized Trial (ANRS 119)

Jean-Michel Molina, Yves Levy, Isabelle Fournier, Stephanie Hamonic, Michèle Bentata, Genevieve Beck-Wirth, Marie-Lise Gougeon, Alain Venet, Isabelle Madelaine, Daniel Sereni, François Jeanblanc, Thomas Boulet, François Simon and Jean-Pierre Aboulker
The Journal of Infectious Diseases
Vol. 200, No. 2 (Jul. 15, 2009), pp. 206-215
Published by: Oxford University Press
Stable URL: http://www.jstor.org/stable/40254985
Page Count: 10
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Interleukin-2 before Antiretroviral Therapy in Patients with HIV Infection: A Randomized Trial (ANRS 119)
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Abstract

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/µL (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/µL, 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 (P = .008). Median changes from baseline in the IL-2 and control arms were +51 and –64 cells/µL, respectively, for CD4 cell count (P<. 001) and were +0.02 and +0.04 log₁₀ copies/mL, respectively, for plasma viral load (P = .93). Among patients with a baseline viral load <4.5 log₁₀ copies/mL, 64% in the IL-2 arm and 10% in the control arm did not reach the primary end point through week 150 (P< .001), 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.

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