NCT00002125已完成4 期
A Multicenter Study of Oral Versus Intravenous Hydration in AIDS Patients With CMV Retinitis Treated With Foscavir (Foscarnet Sodium)
Astra USA21 个研究点 分布在 1 个国家目标入组 112 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
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 21
研究概览
简要总结
To assess the relative efficacy of oral versus intravenous hydration during foscarnet sodium (Foscavir) induction therapy, as determined by changes in creatinine clearance. To estimate the timing and volume of oral fluid hydration required to establish a diuresis before and during intravenous Foscavir therapy. To assess the general tolerance of two hydration regimens by the adverse event profile associated with each.
详细描述
Patients are randomized to receive oral hydration versus intravenous hydration therapy during concomitant intermittent intravenous Foscavir therapy for treatment of cytomegalovirus (CMV) retinitis. Treatment continues during 2 or 3 weeks of induction Foscavir therapy.
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:
- •Documented HIV infection.
- •Recent diagnosis of CMV retinitis, by ophthalmoscopic appearance, that requires induction therapy.
- •No corneal, lens, or vitreous opacification that precludes examination of the fundi.
- •No evidence of other end organ CMV infection.
- •No evidence of tuberculous, diabetic, or hypertensive retinopathy.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Clinically significant cardiac, pulmonary, neurologic, gastrointestinal or renal impairment that would prevent adequate voluntary oral hydration (e.g., intubation, coma, status post-gastrectomy, colon resection, gastrointestinal tumors, malabsorption, chronic diarrhea) OR with which hydration would be hazardous (e.g., congestive heart failure).
- •Known allergy to foscarnet or related compounds.
- •Considered noncompliant or unreliable for study participation.
- •Concurrent Medication:
- •Any investigational drug.
- •Potentially nephrotoxic drugs (e.g., amphotericin B, aminoglycosides, cisplatin).
- •Prior Medication:
- •Any investigational drug within 28 days prior to study entry.
- •Potentially nephrotoxic drugs (e.g., amphotericin B, aminoglycosides, cisplatin) within 7 days prior to study entry.
研究者
研究点 (21)
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