PHASE I B/IIA DOSE-FINDING SAFETY AND ACTIVITY STUDY OF AMD11070 (AN ORALLY

AMD11070 的 I B/IIA 期剂量探索安全性和活性研究（口服

• 批准号: 7606430
• 负责人: MITCHELL J GOLDMAN
• 金额: $ 4.57万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606430
• 关键词: Anti-Retroviral Agents; Cardiac; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Evaluation; Funding; Grant; Hour; Immunology; Institution; Label; Laboratories; Monitor; Numbers; Phase; Research; Research Personnel; Resources; Safety; Sample Size; Source; Treatment Protocols; United States National Institutes of Health; Woman; antiretroviral therapy; day; men; treatment duration; virology

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. A5210 is a dose escalating, open-label, safety and activity study of AMD11070 in HIV-infected men and women who may have failed any number of prior antiretroviral regimens or had no prior antiretroviral therapy. Subjects are to be admitted to the general clinical research center (GCRC) for the dosing period; treatment will continue for 10 consecutive days. Thirty-six-hour pharmacokinetic (PK) profiles (intensive 24-hour PK and a trough level at Hour 30-38) will be obtained. Total sample size for this multi-center study is 48 subjects with study duration of 90 days. Subjects will also undergo physical exams, cardiac monitoring, and laboratory safety, virology, and immunology evaluations.

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。 A5210是一项在既往抗逆转录病毒治疗失败或既往未接受过抗逆转录病毒治疗的HIV感染男性和女性中进行的AMD 11070剂量递增、开放标签、安全性和活性研究。 受试者将在给药期间入住一般临床研究中心（GCRC）;治疗将持续10天。将获得36小时药代动力学（PK）曲线（强化24小时PK和第30-38小时的谷浓度）。本多中心研究的总样本量为48例受试者，研究持续时间为90天。受试者还将接受体格检查、心脏监测和实验室安全性、病毒学和免疫学评价。