title: Interleukin-2 before antiretroviral therapy in patients with HIV infection: a randomized trial (ANRS 119).
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/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 (P = .008). Median changes from baseline in the IL-2 and control arms were +51 and -64 cells/microL, respectively, for CD4 cell count (P < .001) and were +0.02 and +0.04 log(10) copies/mL, respectively, for plasma viral load (P = .93). 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 (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.
  
  
  CONCLUSIONS
  IL-2 increased CD4 cell counts without affecting HIV replication and allowed the initiation of ART to be deferred.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00120185 .
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, France. jean-michel.molina@sls.aphp.fr
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Molina
authors.forename: Yves
authors.initials: Y
authors.lastname: Levy
authors.forename: Isabelle
authors.initials: I
authors.lastname: Fournier
authors.forename: Stephanie
authors.initials: S
authors.lastname: Hamonic
authors.forename: Michèle
authors.initials: M
authors.lastname: Bentata
authors.forename: Genevieve
authors.initials: G
authors.lastname: Beck-Wirth
authors.forename: Marie-Lise
authors.initials: ML
authors.lastname: Gougeon
authors.forename: Alain
authors.initials: A
authors.lastname: Venet
authors.forename: Isabelle
authors.initials: I
authors.lastname: Madelaine
authors.forename: Daniel
authors.initials: D
authors.lastname: Sereni
authors.forename: François
authors.initials: F
authors.lastname: Jeanblanc
authors.forename: Thomas
authors.initials: T
authors.lastname: Boulet
authors.forename: François
authors.initials: F
authors.lastname: Simon
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Aboulker
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D004334:Drug Administration Schedule; D005260:Female; D006678:HIV / Q000187:drug effects; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007376:Interleukin-2 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D014779:Virus Replication / Q000187:drug effects; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D007376:Interleukin-2