NCT00002002已完成不适用
A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome
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
- 1
研究概览
简要总结
The primary objective of the study is to evaluate the effectiveness of l-leucovorin in preventing toxicity from high dose trimethoprim / sulfamethoxazole (TMP / SMX) used as a therapy for Pneumocystis carinii pneumonia (PCP) in patients with AIDS.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have the following:
- •Diagnosis of PCP.
- •Fit the CDC definition of AIDS.
- •Be receiving intravenous or oral trimethoprim / sulfamethoxazole (Bactrim, Septra) in doses of = or > 15mg/kg/day of the trimethoprim component.
- •Be receiving = or < 48 hours of trimethoprim / sulfamethoxazole (TMP / SMX) prior to randomization.
- •Must sign informed consent in accordance with FDA guidelines.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Cannot take oral medications.
- •Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.
- •Concurrent Medication:
- •Continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.
- •Patients with the following are excluded:
- •Cannot take oral medications.
- •Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.
- •Prior Medication:
- •> 48 hours of trimethoprim / sulfamethoxazole prior to randomization.
研究者
研究点 (1)
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