NCT00002145已完成3 期
Phase III Multicenter, Open-Label, Randomized Trial of Induction Versus Induction Plus Maintenance Foscarnet ( Foscavir ) Therapy for Gastrointestinal CMV Disease
Astra USA29 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 29
研究概览
简要总结
PRIMARY: To compare the frequency of and time to relapse of Cytomegalovirus (CMV) gastrointestinal disease following foscarnet induction therapy only versus induction plus maintenance therapy.
SECONDARY: To determine frequency of and time to recurrence of gastrointestinal symptoms, response rate of pathological lesions, and incidence of nongastrointestinal CMV disease in this patient population.
详细描述
Patients receive intravenous foscarnet either as induction only for 4 weeks or as induction for 4 weeks followed by maintenance for 22 weeks. All patients are followed for 26 weeks or until relapse.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Patients must have:
- •CMV GI disease.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Non-GI CMV disease.
- •Ulcerative colitis, inflammatory bowel disease, or other condition that may interfere with study results.
- •Other GI pathogens.
- •Concurrent Medication:
- •Drugs that may interact with foscarnet.
- •Systemic acyclovir, ganciclovir, or acyclovir prodrug.
- •Drugs known to affect renal function.
- •Prior Medication:
- •Prior foscarnet in extremis.
- •Investigational agents other than 3TC or d4T within 7 days prior to study entry.
研究者
研究点 (29)
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