NCT00002294已完成不适用
Double Blind Placebo Controlled Study of Fluconazole (UK-49,858) for Maintenance Treatment 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
- 5
研究概览
简要总结
To compare the safety and effectiveness of fluconazole with that of placebo 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
- 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
- •Concurrent Medication:
- •Antiviral therapy (e.g., zidovudine).
- •Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).
- •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 from lumbar cerebrospinal fluid (CSF) culture within 4 months of study entry.
- •Adequate therapy will consist of 6 - 16 weeks of treatment with amphotericin B alone, amphotericin B + oral flucytosine, or a period of the combination followed by amphotericin alone. Adequate regimens will include:
- •A minimum total amphotericin B dose of 2 grams as monotherapy.
- •6 weeks of flucytosine at 150 mg/kg/day (or levels of 20 to 100 mcg/ml demonstrated) plus amphotericin B at an average daily dose of at least 0.3 mg/kg/day or to a total dose of 1 gram.
- •After a shorter period of the combination amphotericin/flucytosine therapy, an additional Y grams of amphotericin B monotherapy will make therapy adequate where Y = 2 gm-(X weeks combination therapy / 3 weeks).
- •For example, a patient who received 3 weeks of combination followed by amphotericin alone would need an additional 2 gm - 3 weeks/3 weeks = 1 gm of amphotericin B.
- •Patients need not be receiving amphotericin B at the time of randomization but must begin study maintenance therapy within 3 weeks of cessation of primary amphotericin B therapy.
- •Prior Medication:
- •Antiviral therapy (e.g., 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:
- •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 defined by specific lab values.
- •Inability to take oral medications reliably.
- •Prior Medication:
- •Intrathecal amphotericin B.
- •Coumarin-type anticoagulants.
- •Oral hypoglycemics.
- •Barbiturates.
- •Phenytoin.
- •Immunostimulants.
- •Investigational drugs or approved (licensed) drugs for investigational indications.
- •Prior Treatment:
- •Lymphocyte replacement.
研究者
研究点 (5)
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