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J Acquir Immune Defic Syndr. 2014 Aug 1;66(4):399-406. doi: 10.1097/QAI.0000000000000195.

A randomized controlled trial of palifermin (recombinant human keratinocyte growth factor) for the treatment of inadequate CD4+ T-lymphocyte recovery in patients with HIV-1 infection on antiretroviral therapy.

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*Division of Infectious Diseases and HIV Medicine, Drexel University College of Medicine, Philadelphia, PA; †AIDS Clinical Trials Group, Statistical and Data Analysis Center, Harvard University School of Public Health, Boston, MA; ‡Vaccine and Gene Therapy Institute, Port Saint Lucie, FL; §Department of Radiology, University of Michigan School of Medicine, Ann Arbor, MI; ‖Department of Immunology/Microbiology, Rush University School of Medicine, Chicago, IL; ¶Division of Hematology and Chronic Viral Illness Service, McGill University Health Centre, Montreal, CA; #Division of Infectious Diseases, Department of Medicine, University of California, San Diego, School of Medicine, San Diego, CA; **Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY; ††Division of Infectious Diseases, Department of Medicine, University of Pennsylvania, Philadelphia, PA; ‡‡Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN; §§Social and Scienti\x{fb01}c Systems, Inc., Silver Springs, MD; ‖‖Frontier Sciences, Buffalo, NY; and ¶¶Division of AIDS, NIAID, Bethesda, MD.



Poor CD4 lymphocyte recovery on antiretroviral therapy (ART) is associated with reduced function of the thymus. Palifermin (keratinocyte growth factor), by providing support to the thymic epithelium, promotes lymphopoiesis in animal models of bone marrow transplantation and graft-versus-host disease.


In AIDS Clinical Trials Group A5212, a randomized, double-blind, placebo-controlled study, 99 HIV-infected patients on ART with plasma HIV-1 RNA levels ≤200 copies per milliliter for ≥6 months and CD4 lymphocyte counts <200 cells per cubic milliliter were randomized 1:1:1:1 to receive once daily intravenous administration of placebo or 20, 40, or 60 μg/kg of palifermin on 3 consecutive days.


The median change in the CD4 T-cell count from baseline to week 12 was not significantly different between the placebo arm [15 (-16, 23) cells/mm] and the 20-μg/kg dose [11 (2, 32) cells/mm], the 40-μg/kg dose [12 (-2, 25) cells/mm], or the 60-μg/kg dose arm [8 (-13, 35) cells/mm] of palifermin. No significant changes were observed in thymus size or in the number of naive T cells or recent thymic emigrants.


Palifermin in the doses studied was not effective in improving thymic function and did not raise CD4 lymphocyte counts in HIV-infected patients with low CD4 cell counts despite virologically effective ART.

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