• AIDS Res. Hum. Retroviruses · Jun 2002

    Randomized Controlled Trial Clinical Trial

    Effect of etanercept (Enbrel) on interleukin 6, tumor necrosis factor alpha, and markers of immune activation in HIV-infected subjects receiving interleukin 2.

    • Beverly E Sha, Hernan Valdez, Rebecca S Gelman, Alan L Landay, Jan Agosti, Ronald Mitsuyasu, Richard B Pollard, Donna Mildvan, Ann Namkung, Debra M Ogata-Arakaki, Lawrence Fox, Scharla Estep, Alejo Erice, Patrick Kilgo, Robert E Walker, Lynne Bancroft, and Michael M Lederman.
    • Section of Infectious Diseases, Department of Medicine, Rush Medical College, Chicago, Illinois 60612-3833, USA. bsha@rush.edu
    • AIDS Res. Hum. Retroviruses. 2002 Jun 10;18(9):661-5.

    AbstractThe effect of etanercept, a soluble p75 tumor necrosis factor (TNF) receptor:Fc fusion protein (Enbrel; Immunex, Seattle, WA) on plasma cytokines was evaluated in 11 HIV-infected subjects receiving highly active antiretroviral therapy (HAART) for 28 weeks with or without subcutaneous or intravenous recombinant human interleukin 2 (rhIL-2). Plasma IL-6 and C-reactive protein (CRP) levels increased after rhIL-2 treatment. Etanercept pretreatment attenuated these increases. Median plasma IL-6 levels were 20.29 pg/ml 4 days after rhIL-2 and 7.87 pg/ml 4 days after etanercept and rhIL-2 (p = 0.22); median CRP levels were 78.73 and 46.16 microg/ml, respectively (p = 0.03). An effect on TNF bioactivity could not be assessed as all measurements were below limits of detection. No significant changes were seen in temperature or plasma levels of IL-4, IL-10, IL-12, interferon gamma, or HIV-1 RNA levels. All subjects had undetectable or low-level HIV-1 RNA levels before etanercept dosing. One subject died; however, her death was thought to be unrelated to etanercept. Pretreatment with etanercept may blunt activation of IL-6 and CRP expression induced by rhIL-2. The safety and utility of etanercept in HIV-infected persons should be explored further.

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