A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS

Gilead Sciences17 个研究点分布在 2 个国家目标入组 30 人开始时间: 2001年8月31日最近更新: 2005年6月24日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Gilead Sciences
入组人数: 30
试验地点: 17

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for refractory mucocutaneous herpes simplex virus disease in AIDS patients. To determine whether topical HPMPC therapy can induce re-epithelialization and healing of refractory mucocutaneous herpes simplex virus disease in AIDS patients. To evaluate the virologic effects of topical HPMPC therapy on herpes simplex virus shedding from refractory lesions.

详细描述

Patients are randomized to receive topical therapy with placebo (vehicle alone) or HPMPC at either 0.3 or 1.0 percent once daily for 5 days. Patients are assessed to day 15; those with no significant toxicity are eligible to receive open-label topical HPMPC for up to 6 months.

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: 13 Years 至 —（Child, 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

研究者

发起方

Gilead Sciences

申办方类型

Industry

研究点 (17)

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