NCT00001994已完成不适用
A Pilot Study of 566C80 for the Salvage Treatment of Toxoplasmic Encephalitis in Patients Infected With the Human Immunodeficiency Virus (HIV) Who Have Failed or Are Intolerant of Pyrimethamine-Sulfadiazine
Glaxo Wellcome37 个研究点 分布在 2 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 37
研究概览
简要总结
To evaluate the safety and tolerance of atovaquone (566C80) in AIDS patients with central nervous system (CNS) toxoplasmosis. To evaluate the efficacy of 566C80 in the acute treatment and suppression of CNS toxoplasmosis in AIDS patients who fail or who cannot tolerate conventional therapy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 the following:
- •Presumptive diagnosis of AIDS.
- •Cerebral toxoplasmosis.
- •Expected survival of at least four weeks without therapy.
- •Willing and able to give informed consent.
- •Prior Medication:
- •Pyrimethamine-sulfonamide.
- •Clindamycin-sulfonamide.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Significant emotional disorder or psychosis.
- •Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
- •Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:
- •Ensure Plus) or pulverized form through a nasogastric tube.
- •Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
- •Concurrent Medication:
- •Drugs with potential anti-toxoplasmosis activity including sulfone, sulfonamide, trimethoprim, pyrimethamine and clindamycin during the acute therapy phase of the trial.
- •First three weeks of treatment:
- •Retrovir (zidovudine) or any investigational agent including antiretroviral agents (eg:
- •ddI,ddC).
- •Patients with the following are excluded:
- •Significant emotional disorder or psychosis.
- •Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
- •Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:
- •Ensure Plus) or pulverized form through a nasogastric tube.
- •Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
- •Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
研究者
研究点 (37)
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