PHASE I/II MULTIPLE DOSE STUDY OF ZINTEVIR IN HIV-1 PATIENTS

Zintevir 在 HIV-1 患者中的 I/II 期多剂量研究

• 批准号: 6114030
• 负责人: MICHAEL F GIORDANO
• 金额: $ 7.95万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 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/6114030
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; clinical trials; drug screening /evaluation; enzyme inhibitors; human immunodeficiency virus 1; human subject; human therapy evaluation; integrase; pharmacokinetics

The objective of this study is to determine the safety, pharmacokinetic profile, immunologic and virologic activity of Zintevir, an anti-HIV integrase inhibitor. Integrase inserts the genetic material of HIV into the host cell upon infection. This study will determine the activity of Zintevir to inhibit the enzyme integrase. Progress report and summary of findings: This continues as a dose escalation study to determine the maximally tolerated dose and active dose (anti-HIV). No antiviral effect yet demonstrated.

本研究的目的是确定抗HIV整合酶抑制剂Zintevir的安全性、药代动力学特征、免疫学和病毒学活性。 整合酶在感染时将HIV的遗传物质插入宿主细胞。本研究将确定Zintevir抑制酶整合酶的活性。进展报告和结果总结：这是一项剂量递增研究，以确定最大耐受剂量和活性剂量（抗HIV）。 尚未证实抗病毒作用。