PLACEBO CONTROLLED STUDY OF SAFETY OF PMPA IN HIV+ PATIENTS

PMPA 对 HIV 患者的安全性安慰剂对照研究

• 批准号: 6297550
• 负责人: PATRICIA A BARDITCH-CROVO
• 金额: $ 0.23万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 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/6297550
• 关键词: AIDS; AIDS therapy; HIV infections; adenine analog; antiAIDS agent; clinical research; clinical trial phase I; dosage; drug screening /evaluation; human subject; human therapy evaluation; pharmacokinetics

All subject evaluations have been completed. In this study, PMPA prodrug demonstrated dose-related anti-HIV effect at the end of 28 days of dosing; median log10 decreases in HIV RNA from baseline were 0.32, 0.44, and 1.22. Pharmacokinetic data obtained in this study showed that exposure was dose related and that the serum half life was > 17 hours. Data obtained from this study are being used to choose doses and dosing regimens for the Phase II larger trials that are being designed at the current time

所有科目评估均已完成。在本研究中，PMPA前体药物 在28天结束时表现出剂量相关的抗HIV效应 剂量：HIV RNA较基线下降的中位数log10分别为0.32，0.44， 和1.22。本研究获得的药代动力学数据显示， 暴露与剂量相关，血清半衰期为17小时。 从这项研究中获得的数据被用来选择剂量和剂量 正在设计的第二阶段更大规模试验的方案 当前时间