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

临床试验：ACTG A5211：SCH 417690 在 HIV 感染者、接受过治疗的 SU 中进行

• 批准号: 7718421
• 负责人: JUDITH Ann ABERG
• 金额: $ 0.96万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718421
• 关键词: AIDS clinical trial group; Address; Anti-Retroviral Agents; Antiviral Agents; CCR5 gene; CXCR4 gene; Chemokine (C-C Motif) Receptor 5; Class; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Data; Dose; Double-Blind Method; Drug Kinetics; Funding; Grant; HIV; Human; Individual; Institution; Monitor; Pharmaceutical Preparations; Phase; Placebos; Protocols documentation; Randomized; Research; Research Personnel; Resources; Ritonavir; Safety; Seizures; Source; Toxic effect; Treatment Protocols; United States National Institutes of Health; Vertebral column; Virus; Week; animal data; day; experience; inhibitor/antagonist

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.

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项II期随机双盲试验，旨在评估口服CCR 5抑制剂（一种新型抗逆转录病毒药物）的安全性和有效性。 在一个失败的艾滋病毒抗逆转录病毒方案含有利托那韦的个人将有抑制剂添加14天，以评估其抗病毒效力和安全性。将与包含安慰剂、5、10和15 mg剂量的方案进行比较。 然后，这些人将有一个新的抗逆转录病毒骨干添加到治疗。将进行药代动力学研究。 该研究的“长期”阶段将持续46周。 动物数据表明，在较高剂量下可能出现QT间期延长和癫痫发作。 迄今为止获得的数据尚未证实在人类和所用剂量中的这一点。 方案讨论了这些可能的毒性。 人们还担心，抑制使用CCR 5的R5病毒将导致选择不使用CCR 5受体的CXCR 4病毒。这也将受到监测。