Details

Autor(en) / Beteiligte

• Molina, Jean-Michel
• Levy, Yves
• Fournier, Isabelle
• Hamonic, Stephanie
• Bentata, Michèle
• Beck-Wirth, Genevieve
• Gougeon, Marie-Lise
• Venet, Alain
• Madelaine, Isabelle
• Sereni, Daniel
• Jeanblanc, François
• Boulet, Thomas
• Simon, François

Titel

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

Ist Teil von

• The Journal of infectious diseases, 2009-07, Vol.200 (2), p.206-215

Ort / Verlag

Oxford: The University of Chicago Press

Erscheinungsjahr

2009

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• BackgroundInterleukin (IL)–2 increases CD4 T cell counts when combined with antiretroviral therapy (ART). Whether IL-2 alone can increase CD4 cell counts is unknown MethodsA 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 ResultsThrough 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 ConclusionIL-2 increased CD4 cell counts without affecting HIV replication and allowed the initiation of ART to be deferred Trial registrationClinicalTrials.gov identifier: NCT00120185