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.
Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection : the STALWART study / J.A. Tavel, A. Babiker, C. Carey, M. Fisher, L. Fox, D. Gey, G.D. Lopardo, J.C. Lopez, N. Markowitz, D. Munroe, N. Paton, K. Ruxrungtham, B. Standridge, D. Wentworth, N. Wyman, B. Aagaard, L. Borup, J. Grarup, P.-. Jansson, K. Jensen, J. Lundgren, D. Mollerup, S. Reilev, N. Braimah, J. Darbyshire, J. Horton, E. King, N. Smith, F. Van Hooff, D.A. Cooper, D. Courtney-Rodgers, S. Emery, E. Finley, F. Gordin, A. Sanchez, D. Thomas, J. Bebchuk, P. Bollenbeck, E. Denning, A.G. Duchene, L. Fosdick, M. Harrison, E. Krum, G. Larson, J.D. Neaton, R. Nelson, K. Quan, S.-.L. Quan, T. Schultz, G. Thompson, S. Collins, D.H. Haerry, M. Meulbroek, D. Peavy, C. Rappoport, S. Schwarze, M. Valdez, J. Watson, W.H. Belloso, R. Davey, D. Duprez, J.M. Gatell, J. Hoy, A. Lifson, C. Pederson, G. Perez, R. Price, R. Prineas, F. Rhame, J.H. Sampson, J. Worley, J.F. Modlin, V. Beral, R.E. Chaisson, T.R. Fleming, C. Hill, K. Kim, B.E. Murray, B. Pick, M. Seligmann, I. Weller, M.A. Luzar, A. Martinez, V. Costas, J. Eckstrand, S. Brown, S.H. Lupo, M.H. Losso, J. Anderson, J. Chuah, M. Kelly, D. Orth, M.J. Wolff, S. Rusconi, G. Tambussi, A. Horban, F. Antunes, K. Mansinho, J.A.V. Da Conceicao Vera, H. Himmich, P. Chetchotisakd, P. Kantipong, C. Orkin, S. Portsmouth, A. Winston, M.J. Wiselka, G.M. Anstead, R.C. Arduino, M.B. Goetz, K. Hennessey, W. El-Sadr, A.M. Labriola, D.E. Nixon, M.C. Rodriguez-Barradas. - In: PLOS ONE. - ISSN 1932-6203. - 5:2(2010), pp. e9334.1-e9334.9. [10.1371/journal.pone.0009334]
Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection : the STALWART study
S. Rusconi;
2010
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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