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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项针对口服 CCR5 抑制剂（一类新型抗逆转录病毒药物）安全性和有效性的 II 期随机双盲试验。 接受包含利托那韦的 HIV 抗逆转录病毒疗法失败的个体将添加该抑制剂 14 天，以评估其抗病毒效力和安全性。将与含有安慰剂、5、10 和 15 毫克剂量的方案进行比较。 然后，这些人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。 这一“长期”研究阶段将持续 46 周。 动物数据表明，较高剂量可能会导致 QT 间期延长和癫痫发作。 迄今为止获得的数据尚未在人体和使用剂量中证实这一点。 该协议解决了这些可能的毒性。 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。