NCT00002181已完成不适用
Open-Label Study of Cidofovir Gel for Acyclovir-Unresponsive Mucocutaneous Herpes Simplex Disease in Patients With AIDS.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 15
研究概览
简要总结
The purpose of this study is to see if cidofovir gel (Forvade) is safe and effective in treating herpes simplex in patients with AIDS who do not respond to acyclovir.
详细描述
Patients receive open-label treatment with cidofovir gel.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must have:
- •AIDS diagnosis per CDC criteria.
- •At least partially external mucocutaneous HSV infection confirmed by culture of current outbreak.
- •Current HSV outbreak that is unresponsive to >= 10-day course of acyclovir at 1-4 gm/day po or 15 mg/kg/day IV or in vitro resistance of HSV isolate to acyclovir demonstrated within 60 days of study.
- •Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Evidence of cervical intraepithelial neoplasia class III (CIN III) on Pap smear (Pap smear required within 6 months of starting study drug).
- •Concurrent Medication:
- •Acyclovir, valacyclovir, famciclovir, ganciclovir, foscarnet, topical trifluride, cidofovir injection or other systemic or topical drugs with anti-herpes activity.
- •>= 10 day course acyclovir at 1-4 gm/day po or 15mg/kg/day IV (not required if there is confirmed in vitro resistance to acyclovir).
研究者
研究点 (15)
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