A PHASE I, DOSE-RISING STUDY OF AMD11070 IN HIV-SERONEGATIVE MEN, A5191

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。AMD 11070是一种研究性CXCR 4抑制剂，具有体外抗HIV活性。ACTG 5191是一项评价AMD 11070的安全性和药代动力学（血液中的药物浓度）的开放标签研究。将招募健康HIV阴性志愿者，并给予单次或多次AMD 11070，以确定无显著副作用的最大剂量，并确定每次给药的血药浓度。其他组将与食物一起服用AMD 11070，以确定这是否影响药物的吸收。最后一组将与另一种可能影响身体代谢AMD 11070的HIV药物（利托那韦）一起服用。利托那韦常用于治疗HIV，可能会影响AMD 11070的代谢。因此，在HIV感染受试者同时使用这两种药物之前，确定其药代动力学非常重要。将通过临床（包括心电图或心脏描记）和实验室评价密切监测受试者。

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. AMD11070 is an investigational CXCR4 inhibitor with activity against HIV in vitro. ACTG 5191 is an open-label study to evaluate the safety and pharmacokinetics (drug levels in the blood) of AMD11070. Healthy HIV-negative volunteers will be enrolled and administered single or multiple doses of AMD11070 to determine the maximum dose without significant side effects, and to ascertain the blood levels with each dose. Additional groups will take AMD11070 with food to determine if this has an affect on the absorption of the drug. A final group will take the drug with another HIV medication (Ritonavir) that may affect how the body metabolizes AMD11070. Ritonavir is commonly used in the treatment of HIV and will likely affect the metabolism of AMD11070. Thus, it is important to determine the pharmacokinetics prior to administration of these two drugs concomitantly to HIV infected subjects. Subjects will be monitored closely by clinical (including electrocardiograms or heart tracings) and laboratory evaluations.