Journal article
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
JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, v 66(4), pp 399-406
01 Aug 2014
PMID: 24815851
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Background: 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.
Methods: 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 mu g/kg of palifermin on 3 consecutive days.
Results: 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(3)] and the 20-mu g/kg dose [11 (2, 32) cells/mm(3)], the 40-mu g/kg dose [12 (-2, 25) cells/mm(3)], or the 60-mu g/kg dose arm [8 (-13, 35) cells/mm(3)] of palifermin. No significant changes were observed in thymus size or in the number of naive T cells or recent thymic emigrants.
Conclusions: 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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Details
- Title
- 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
- Creators
- Jeffrey M. Jacobson - Drexel UniversityHongying Wang - Harvard UniversityRebeka Bordi - Gene Therapy LaboratoryLu Zheng - Harvard UniversityBarry H. Gross - Rush UniversityAlan L. Landay - Rush UniversityJohn Spritzler - Harvard UniversityJean-Pierre Routy - McGill UniversityConstance Benson - University of California San DiegoJudith Aberg - Icahn School of Medicine at Mount SinaiPablo Tebas - University of PennsylvaniaDavid W. Haas - Vanderbilt UniversityJennifer Tiu - AACTG Operations CenterKristine Coughlin - Frontier Science & Technology Research FoundationLynette Purdue - National Cancer InstituteRafick-Pierre Sekaly - Gene Therapy LaboratoryAIDS Clinical Trials Grp ACTG
- Publication Details
- JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, v 66(4), pp 399-406
- Publisher
- Lippincott Williams & Wilkins
- Number of pages
- 8
- Grant note
- 5UM1AI069470-07 / Columbia University HPT CRS ACTG CTU A1 069424 / Harbor-UCLA ACTG CTU UL1TR000124 / NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Advancing Translational Sciences (NCATS) AI069434 / University of Washington AIDS CRS ACTG CTU UM1 AI069424 / UCLA CARE ACTG CTU AI69501 / MetroHealth Medical Center ACTG CTU P30Al050409 / Emory Center for AIDS Research (CFAR) 1U01AI69467 / Hospital of the University of Pennsylvania CRS ACTG CTU UL1 TR000040 / CTSA; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Advancing Translational Sciences (NCATS) U01AI069511-02 / AIDS Care, CRS ACTG CTU AI069495 / Washington University CRS ACTG CTU U01 AI069474 / Ohio State University Medical Center ACTG CTU AI069428 / University of Southern California CRS ACTG CTU UM1AI069532 / New York University/NYC HHC at Bellevue Hospital Center ACTG CTU AI69432 / ACTG CTU 5UM1-AI069484-07 / Duke University Medical Center CRS ACTG CTU (ACTSI)-UL1TR000454 / National Center for Advancing Translational Sciences for the National Institutes of Health AI69501 / Case CRS ACTG CTU AI-069439 / Vanderbilt University ACTG CTU U01AI069511-02 / University of Rochester CRS ACTG CTU UL1RR025747 / NATIONAL CENTER FOR RESEARCH RESOURCES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Research Resources (NCRR) UL1 RR024160 / CRC; Australian Government; Department of Industry, Innovation and Science; Cooperative Research Centres (CRC) Programme 1U01Al069418-01 / Emory University HIV/AIDS Clinical Trials Unit ACTG CTU RR 025747 / UNC Clinical Trials Research Center of the Clinical and Translational Science Award U01A1069447 / Institute of Human Virology Baltimore Treatment CRS ACTG CTU AI050410 / UNC Center for AIDS Research Grant 5UO1A1069472 / Boston Medical Center ACTG CRS ACTG CTU UM1AI069511 / NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Allergy & Infectious Diseases (NIAID) 5-U01 AI069423-03 / UNC AIDS Clinical Trials Unit ACTG CTU 5 UM1 AI069477 / University of Miami AIDS CRS ACTG CTU UL1TR000124 / CTSI P30 AI 045008 / Center for AIDS Research (CFAR)
- Resource Type
- Journal article
- Language
- English
- Web of Science ID
- WOS:000339012300014
- Scopus ID
- 2-s2.0-84903772644
- Other Identifier
- 991019335320304721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Immunology
- Infectious Diseases