SAFETY, TOLERANCE, PK ANTIVIRAL ACTIVITY OF FTC IN PATIENTS WITH HIV

FTC 在 HIV 患者中的安全性、耐受性和 PK 抗病毒活性

• 批准号: 6115501
• 负责人: JAMES S KAHN
• 金额: $ 3.1万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6115501
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; clinical trial phase I; drug resistance; drug screening /evaluation; human subject; human therapy evaluation; lamivudine; nucleoside analog; pharmacokinetics

The aim of a phase I monotherapy study in HIV-infected volunteers is to define and select a dose and schedule according to pharmacokinetics/ dynamics and tolerability. FTC is a nucleoside analogue that structurally resembles 3TC, but has 10-fold greater (in vitro) potency. In patients receiving 3TC alone, a fully resistant viral population develops within 12 weeks. Patients for this study must be 3TC naive.

在HIV感染志愿者中进行的I期单药治疗研究的目的是 根据药代动力学定义和选择剂量和时间表/ 动力学和耐受性。 FTC是一种核苷类似物， 类似于3 TC，但具有10倍的（体外）效力。 患者 单独接受3 TC，完全耐药的病毒群体在12 周 本研究的患者必须是3 TC初治患者。