CLINICAL TRIAL: TREATMENT OF INADEQUATE CD4+ LYMPHOCYTE RECOVERY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 A5212是一项双盲II期研究，旨在评估palifermin(重组人角质细胞生长因子[rHuKGF])是否有效地通过增强HIV-1感染者的胸腺生成来增加CD4+T细胞计数，这些患者的病毒载量受到抑制，但CD4+T细胞计数不足。在进入试验时，受试者将被随机分到四个治疗组中的一个，接受安慰剂或三个剂量水平的帕利福明静脉注射(IV)中的一个，连续3天。这项研究将着眼于一种生长因子，palifermin(RHuKGF)，一种促进生长，特别是细胞生长的物质，是否可以安全地增加你的CD4+细胞数量。这将通过比较三种不同剂量的帕利福明和安慰剂(一种没有治疗价值的非活性药丸、液体或粉末)来实现。

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).