NCT00002074已完成不适用
Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
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
- 39
研究概览
简要总结
To compare the safety and effectiveness of fluconazole and amphotericin B as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.
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
- •Concurrent Medication:
- •Antivirals such as zidovudine.
- •Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).
- •Pfizer must be notified if the patient is receiving ganciclovir (DHPG) at entry.
- •Concurrent Treatment:
- •Radiation therapy for mucocutaneous Kaposi's sarcoma.
- •Patients must be oriented to person, place, and time, and able to give written informed consent.
- •Patients must have had an acute episode of cryptococcal meningitis that was documented by recovery and identification of Cryptococcus neoformans from lumbar cerebrospinal fluid (CSF) culture within 6 months prior to entry.
- •Minimum total dose of 15 mg/kg of amphotericin B must have been given (either alone or in combination with flucytosine) during primary therapy.
- •Patients need not be receiving amphotericin B at the time of randomization but must begin study maintenance therapy within 6 weeks of completion of primary amphotericin B therapy. Patients may receive maintenance amphotericin B during the period between completion of primary therapy and study entry.
- •Prior Medication:
- •Antivirals such as zidovudine (AZT).
- •Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
- •History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
- •Moderate or severe liver disease.
- •Concurrent Medication:
- •Ketoconazole.
- •Fluconazole.
- •Itraconazole.
- •Miconazole.
- •Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis.
- •Intrathecal amphotericin B.
- •Coumarin-type anticoagulants.
- •Oral hypoglycemics.
- •Barbiturates.
- •Phenytoin.
- •Immunostimulants.
- •Investigational drugs or approved (licensed) drugs for investigational indications.
- •Concurrent Treatment:
- •Lymphocyte replacement.
- •Patients with the following are excluded:
- •Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
- •History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
- •Moderate or severe liver disease.
- •Inability to take oral medications reliably.
- •Prior Medication:
- •Ketoconazole.
- •Fluconazole.
- •Itraconazole.
- •Miconazole.
- •Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis.
- •Intrathecal amphotericin B.
- •Coumarin-type anticoagulants.
- •Oral hypoglycemics.
- •Barbiturates.
- •Phenytoin.
- •Immunostimulants.
- •Investigational drugs or approved (licensed) drugs for investigational indications.
- •Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
- •Prior Treatment:
- •Lymphocyte replacement.
研究者
研究点 (39)
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