Multicenter, Rising, Multiple-Dose, Placebo-Controlled, Dose-Response Study to Evaluate the Safety, Tolerability, and Anti-Viral Activity of 4 Weeks of Treatment With 200-800 Mg Fozivudine Tidoxil in Patients With HIV-1 Infection (MF4314).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
To identify doses of fozivudine tidoxil that are well tolerated and produce measurable antiviral activity.
To identify the adverse event profile that defines the maximum tolerated dose. To characterize the single- and multiple-dose pharmacokinetics of fozivudine and its metabolites.
To correlate the adverse event profile and antiviral activity of fozivudine with pharmacokinetic parameters.
详细描述
In this double-blind, dose-escalating study, patients receive fozivudine tidoxil at one of 5 dosage levels for 4 weeks and are randomized with respect to once- or twice-daily administration (cohorts 2 vs. 3 and 4 vs. 5). Within each cohort, 10 patients are randomized to the study drug and 2 to the placebo. At least 9 of the 12 patients enrolled in Cohort 1 must complete the entire 4-week course before Cohorts 2 and 3 are enrolled. At least 18 of these 24 patients must complete 2 weeks of the 4-week course before Cohorts 4 and 5 are enrolled.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供