ACTG A5211: SCH 417690 IN HIV-INFECTED, TREATMENT-EXPERIENCED SUBJECTS

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项口服CCR5抑制剂（一种新型抗逆转录病毒药物）的安全性和有效性的II期随机双盲试验。在含有利托那韦的HIV抗逆转录病毒治疗方案中失败的个体将添加这种抑制剂14天，以评估其抗病毒效力和安全性。将与含有安慰剂、5毫克、10毫克和15毫克剂量的方案进行比较。然后，这些个体将在治疗中加入新的抗逆转录病毒主干。将进行药代动力学研究。这个“长期”研究阶段将持续46周。动物实验数据表明，高剂量可能导致QT间期延长和癫痫发作。迄今获得的数据尚未证实这一点，也未证实所使用的剂量。该方案涉及这些可能的毒性。也有人担心抑制使用CCR5的R5病毒会导致选择不使用CCR5受体的CXCR4病毒。这也将受到监测。

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. This is a phase II randomized double-blind trial of the safety and efficacy of an orally-administered CCR5 inhibitor, a new class of antiretroviral drugs. Individuals on a failing HIV antiretroviral regimen containing ritonavir will have the inhibitor added for 14 days to assess its antiviral potency and safety. Comparisons will be made with regimens containing placebo, 5, 10, and 15 mg doses. The individuals will then have a new antiretroviral backbone added to the therapy. Pharmacokinetics will be done. This "long-term" phase of the study will continue for 46 weeks. Animal data suggests that prolonged QT and seizures are possible at higher doses. Data obtained thus far have not substantiated this in humans and the doses used. The protocol addresses these possible toxicities. There is also concern that inhibiting R5 viruses that use CCR5 will result in the selection of CXCR4 viruses that don't use the CCR5 receptor. This will also be monitored.