CLINICAL TRIAL: TREATMENT OF INADEQUATE CD4+ LYMPHOCYTE RECOVERY

临床试验：CD4 淋巴细胞恢复不足的治疗

• 批准号: 7718664
• 负责人: Michael F. Para
• 金额: $ 1.05万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718664
• 关键词: Bolus Infusion; CD4 Lymphocyte Count; CD4 Positive T Lymphocytes; Cell Count; Clinical Treatment; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Daily; Dose; Double-Blind Method; Funding; Grant; Growth; Growth Factor; Human; Institution; Liquid substance; Lymphocyte; Phase; Placebos; Powder dose form; Randomized; Recombinants; Recovery; Research; Research Design; Research Personnel; Resources; Source; United States National Institutes of Health; Upper arm; Viral Load result; cell growth; day; keratinocyte growth factor; pill

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. A5212 is a double blind, phase II study designed to evaluate whether palifermin (recombinant human keratinocyte growth factor [rHuKGF]) is effective at increasing CD4+ lymphocyte counts through enhanced thymopoiesis in HIV-1-infected subjects with suppressed viral loads but inadequate CD4+ T cell counts. At entry, subjects will be randomized to one of four treatment arms to receive either placebo or one of three dose levels of palifermin intravenously (IV) bolus daily for 3 days. This study will look at whether one type of growth factor, palifermin (rHuKGF), a substance that promotes growth and especially cell growth, can safely increase your CD4+ cell count. This will be done by comparing three different doses of palifermin to placebo (an inactive pill, liquid, or powder that has no treatment value).

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 A5212是一项双盲，II期研究，旨在评估环糖蛋白（重组人角质形成细胞生长因子[RHUKGF]）是否有效地通过抑制病毒载荷但不足的CD4+ T细胞计数的HIV-1感染受试者中的胸腺胸腺素来增加CD4+淋巴细胞计数。进入时，受试者将被随机分为四个治疗臂之一，以静脉注射（IV）的三种剂量环蛋白或三个剂量水平的持续3天。这项研究将研究一种生长因子（RhukGF）的一种类型的生长因子（一种促进生长，尤其是细胞生长的物质）是否可以安全地增加您的CD4+细胞计数。 这将通过将三种不同剂量的califermin与安慰剂（一种没有治疗价值的无活性药物，液体或粉末）进行比较来完成。