NCT00002076已完成不适用
Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 试验地点
- 5
研究概览
简要总结
To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in AIDS patients. Both newly diagnosed and relapsed patients are eligible.
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
- •Concurrent Medication:
- •Antiviral therapy such as zidovudine.
- •Prophylaxis for Pneumocystis carinii pneumonia.
- •Aerosolized pentamidine.
- •Concurrent Treatment:
- •Radiation therapy for mucocutaneous Kaposi's sarcoma.
- •Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
- •No prior systemic antifungal therapy for cryptococcosis.
- •Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.
- •Prior Medication:
- •Antiviral therapy such as zidovudine.
- •Prophylaxis for Pneumocystis carinii pneumonia.
- •Aerosolized pentamidine.
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
- •History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
- •Moderate or severe liver disease defined by specified lab values.
- •Patients who are unable to take oral medication.
- •Unlikely to survive more than 2 weeks.
- •Renal impairment.
- •Concurrent Medication:
- •Coumarin-type anticoagulants.
- •Oral hypoglycemics.
- •Barbiturates.
- •Phenytoin.
- •Immunostimulants.
- •Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.
- •Excluded within 4 weeks of study entry:
- •Greater than 1 mg/kg/wk amphotericin B.
- •Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
- •Concurrent Treatment:
- •Lymphocyte replacement.
- •Patients with the following are excluded:
- •Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
- •History of allergy to or intolerance of imidazoles or azoles.
- •Moderate or severe liver disease defined by specified lab values.
- •Patients who are unable to take oral medication.
- •Life expectancy of < 2 weeks.
- •Any condition that may impair absorption of oral medication.
- •Prior Medication:
- •Coumarin-type anticoagulants.
- •Oral hypoglycemics.
- •Barbiturates.
- •Phenytoin.
- •Immunostimulants.
- •Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.
- •Excluded within 4 weeks of study entry:
- •Greater than 1 mg/kg/wk amphotericin B.
- •Prior Treatment:
- •Lymphocyte replacement.
研究者
研究点 (5)
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