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

Jorge A. Tavel, Abdel Babiker, Cate Carey, Martin Fisher, Lawrence Fox, Daniela Gey, Gustavo D. Lopardo, Juan Carlos Lopez, Norman Markowitz, David Munroe, Nick Paton, Kiat Ruxrungtham, Barbara Standridge, Deborah Wentworth, Nicole Wyman, Bitten Aagaard, Liselotte Borup, Jesper Grarup, Per Olof Jansson, Karoline JensenJens Lundgren, David Mollerup, Søren Reilev, Nafisah Braimah, Janet Darbyshire, Jessica Horton, Eleanor King, Nicki Smith, Fionna Van Hooff, David A. Cooper, David Courtney-Rodgers, Sean Emery, Elizabeth Finley, Fred Gordin, Adriana Sánchez, Doug Thomas, Judith Bebchuk, Patty Bollenbeck, Eileen Denning, Alain G. DuChene, Lisa Fosdick, Merrie Harrison, Eric Krum, Gregg Larson, James D. Neaton, Ray Nelson, Kien Quan, Siu Fun L. Quan, Terri Schultz, Greg Thompson, Simon Collins, David Hans Haerry, Michael Meulbroek, Dwight Peavy, Claire Rappoport, Siegfried Schwarze, Mirta Valdez, Jo Watson, Waldo H. Belloso, Rick Davey, Daniel Duprez, Jose Maria Gatell, Jenny Hoy, Alan Lifson, Court Pederson, George Perez, Richard Price, Ronald Prineas, Frank Rhame, James H. Sampson, John Worley, John F. Modlin, Valerie Beral, Richard E. Chaisson, Thomas R. Fleming, Catherine Hill, Kyung Mann Kim, Barbara E. Murray, Billy Pick, Maxime Seligmann, Ian Weller, Mary Anne Luzar, Ana Martinez, Vanita Costas, Julie Eckstrand, Shawn Brown, Sergio H. Lupo, Marcelo H. Losso, Jonathan Anderson, John Chuah, Mark Kelly, David Orth, Marcelo J. Wolff, Stefano Rusconi, Giuseppe Tambussi, Andrzej Horban, Francisco Antunes, Kamal Mansinho, Jose Alfredo Viegas Da Conceicao Vera, Hakima Himmich, Ploenchan Chetchotisakd, Pacharee Kantipong, Chloe Orkin, Simon Portsmouth, Alan Winston, Martin J. Wiselka, Gregory M. Anstead, Roberto C. Arduino, Matthew B. Goetz, Karen Hennessey, Wafaa El-Sadr, Ann M. Labriola, Daniel E. Nixon, Maria C. Rodriguez-Barradas

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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.

Original languageEnglish
Article numbere9334
JournalPLoS ONE
Volume5
Issue number2
DOIs
Publication statusPublished - 23 Feb 2010

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