NCT00002316已完成1 期
Phase I Study to Evaluate the Safety and Tolerance of RMP-7 Administered With Amphotericin B to Patients With HIV Infection and Cryptococcal Meningitis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 11
研究概览
简要总结
To evaluate the safety of escalating doses of RMP-7 administered in persons with HIV infection and cryptococcal meningitis and to determine the MTD of the drug. To evaluate the pharmacokinetics, including cerebrospinal fluid (CSF) penetration, of amphotericin B when administered with RMP-7.
详细描述
Patients receive intravenous RMP-7 added to conventional therapy with intravenous amphotericin B (with or without flucytosine). Treatment continues for 14 days, with follow-up visits 4 and 12 weeks later.
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:
- •Up to 1 mg/kg amphotericin B for the current episode of cryptococcal meningitis.
- •Patients must have:
- •HIV infection.
- •Acute cryptococcal meningitis.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Cardiovascular disorders including congestive heart failure, uncontrolled hypertension (seated diastolic blood pressure > 95 mm Hg), or symptomatic ischemic heart disease (angina).
- •Orthostatic hypotension, defined as a decrease in systolic blood pressure of >= 20 mm Hg upon standing.
- •Other CNS disease (e.g., other intracranial infections) that may interfere with assessment of response.
- •Opening CSF pressure >= 350 mm or papilledema. (For patients with recurrent disease, evidence of mass effect on either MRI or CT excludes.)
- •Any concurrent disease that would preclude participation in the study.
- •Patients with the following prior conditions are excluded:
- •History of any bleeding disorder.
- •History of active renal or hepatic disease.
- •Myocardial infarction within the previous 3 months.
- •Stroke within the previous 3 months.
研究者
研究点 (11)
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