CLINICAL TRIAL: ACTG A5211: SCH 417690 IN HIV-INFECTED, TREATMENT-EXPERIENCED SU

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。 这是一项关于口服CCR5抑制剂的安全性和有效性的II期随机双盲试验，CCR5抑制剂是一种新型抗逆转录病毒药物。在含有利托那韦的HIV抗逆转录病毒治疗失败的患者中，将添加14天的抑制剂，以评估其抗病毒效力和安全性。将与含有安慰剂、5、10和15毫克剂量的方案进行比较。然后，这些患者将在治疗中添加新的抗逆转录病毒骨干。将进行药代动力学研究。这项研究的“长期”阶段将持续46周。动物数据表明，在较高剂量下，QT延长和癫痫发作是可能的。到目前为止，获得的数据还没有证实这一点在人类身上和使用的剂量。该协议解决了这些可能的毒性问题。还有人担心，抑制使用CCR5的R5病毒将导致选择不使用CCR5受体的CXCR4病毒。这也将受到监控。

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.