This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor 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).
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