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Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: The STALWART study

  • Author(s): Tavel, JA
  • Babiker, A
  • Carey, C
  • Fisher, M
  • Fox, L
  • Gey, D
  • Lopardo, GD
  • Lopez, JC
  • Markowitz, N
  • Munroe, D
  • Paton, N
  • Ruxrungtham, K
  • Standridge, B
  • Wentworth, D
  • Wyman, N
  • Aagaard, B
  • Borup, L
  • Grarup, J
  • Jansson, PO
  • Jensen, K
  • Lundgren, J
  • Mollerup, D
  • Reilev, S
  • Braimah, N
  • Darbyshire, J
  • Horton, J
  • King, E
  • Smith, N
  • Van Hooff, F
  • Cooper, DA
  • Courtney-Rodgers, D
  • Emery, S
  • Finley, E
  • Gordin, F
  • Sánchez, A
  • Thomas, D
  • Bebchuk, J
  • Bollenbeck, P
  • Denning, E
  • DuChene, AG
  • Fosdick, L
  • Harrison, M
  • Krum, E
  • Larson, G
  • Neaton, JD
  • Nelson, R
  • Quan, K
  • Quan, SFL
  • Schultz, T
  • Thompson, G
  • Collins, S
  • Haerry, DH
  • Meulbroek, M
  • Peavy, D
  • Rappoport, C
  • Schwarze, S
  • Valdez, M
  • Watson, J
  • Belloso, WH
  • Davey, R
  • Duprez, D
  • Gatell, JM
  • Hoy, J
  • Lifson, A
  • Pederson, C
  • Perez, G
  • Price, R
  • Prineas, R
  • Rhame, F
  • Sampson, JH
  • Worley, J
  • Modlin, JF
  • Beral, V
  • Chaisson, RE
  • Fleming, TR
  • Hill, C
  • Kim, KM
  • Murray, BE
  • Pick, B
  • Seligmann, M
  • Weller, I
  • Luzar, MA
  • Martinez, A
  • Costas, V
  • et al.
Abstract

Background: The Study of Aldesleukin with and without antiretroviral therapy (STALWART) evaluated whether intermittent interleukin-2 (IL-2) alone or with antiretroviral therapy (ART) around IL-2 cycles increased CD4+ counts compared to no therapy. Methodology: Participants not on continuous ART with ≥300 CD4+ cells/mm3 were randomized to: no treatment; IL-2 for 5 consecutive days every 8 weeks for 3 cycles; or the same IL-2 regimen with 10 days of ART administered around each IL-2 cycle. CD4 + counts, HIV RNA, and HIV progression events were collected monthly. Principal Findings: A total of 267 participants were randomized. At week 32, the mean CD4+ count was 134 cells greater in the IL-2 alone group (p<0.001), and 133 cells greater in the IL-2 plus ART group (p<0.001) compared to the no therapy group. Twelve participants in the IL-2 groups compared to 1 participant in the group assigned to no therapy experienced an opportunistic event or died (HR 5.84, CI: 0.59 to 43.57; p = 0.009). Conclusions: IL-2 alone or with peri-cycle HAART increases CD4+ counts but was associated with a greater number of opportunistic events or deaths compared to no therapy. These results call into question the immunoprotective significance of IL-2-induced CD4+ cells. Trial Registration: ClinicalTrials.gov NCT00110812.

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