The virologic, immunologic, and clinical effects of interleukin 2 with potent antiretroviral therapy in patients with moderately advanced human immunodeficiency virus infection. A randomized controlled clinical trial - AIDS clinical trials group 328

Ronald Mitsuyasu, Rebecca Gelman, Deborah Weng Cherng, Alan Landay, John Fahey, Richard Reichman, Alejo Erice, R. Pat Bucy, J. Michael Kilby, Michael M. Lederman, Carol D. Hamilton, Juan Lertora, Becky L. White, Pablo Tebas, Anne Marie Duliege, Richard B Pollard

Research output: Contribution to journalArticle

31 Scopus citations

Abstract

Background: Interleukin 2 (IL-2) administration increases CD4 counts in persons with higher counts. This study investigated persons with moderately advanced human immunodeficiency virus infection receiving highly active antiretroviral therapy (HAART). Methods: Two hundred four patients with CD4 T-cell counts from 50/μL to 350/μL who were treatment naive or had been treated only with reverse transcriptase inhibitors began a specified protease inhibitor HAART regimen. Virologic responders (≤5000 copies/mL) at 12 weeks were randomized to open-label continuous-infusion IL-2 (IV IL-2), subcutaneous IL-2 (SC IL-2), or HAART alone. Thirty were not randomized and 15 enrolled in a substudy, leaving 159 for analysis. Subjects continued HAART alone for 72 weeks (n=52) or with IV IL-2 (n=53) or SC IL-2 (n=54) for 5 days every 8 weeks. The IV IL-2 subjects could switch to SC IL-2 if their CD4 T-cell count increased by 100/μL or by 25%. Results: Patients receiving IV or SC IL-2 had greater increases in CD4 cell counts. At week 84, median increases were 459/μL, 312/μL, and 102/μL. Increases of greater than 50% at week 60 (primary end point) were achieved in 39 patients (81%) and 32 (67%) in the IV and SC IL-2 arms, respectively, compared with 13 (29%) in the HAART arm (P<.001 for both). Treatment with IL-2 did not increase plasma human immunodeficiency virus RNA levels. There were fewer new AIDS-defining events in the IV (P=.006) and SC (P=.03) IL-2 groups than in the HAART group (0, 1, and 7, respectively). Drug-related adverse events were more frequent with IL-2 treatment. Conclusion: Addition of IL-2 to HAART can significantly expand CD4 T-cell counts in moderately advanced human immunodeficiency virus infection, without loss of virologic control.

Original languageEnglish (US)
Pages (from-to)597-605
Number of pages9
JournalArchives of Internal Medicine
Volume167
Issue number6
DOIs
StatePublished - Mar 26 2007

ASJC Scopus subject areas

  • Internal Medicine

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