NCT00001998已完成不适用
Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
Argus Pharmaceuticals2 个研究点 分布在 1 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
- 2
研究概览
简要总结
To define the pharmacokinetic characteristics of Nystatin LF IV (intravenous) in human subjects with AIDS-related complex (ARC) after administration of a single IV dose at each of 4 dose levels.
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
- •Patients must have the following:
- •Positive HIV antibody test.
- •Diagnosis of AIDS-related complex (ARC).
- •CD4+ cell count between 100 and 300 cells/mm
- •Estimated life expectancy of at least 6 months.
- •Normal neurological status.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Active opportunistic infection requiring ongoing therapy except patients being treated topically for oral thrush.
- •Patients with the following are excluded:
- •Active opportunistic infection.
- •Known hypersensitivity to polyene antibiotics.
- •Unwillingness to sign an informed consent or to be in compliance of protocol requirements.
- •Prior Medication:
- •Excluded within 72 hours of study entry:
- •Biologic response modifier agents.
- •Corticosteroids.
- •Cytotoxic chemotherapeutic agents.
- •Potential nephrotoxins.
- •Potential neutropenic agents.
- •Rifampin or rifampin derivatives.
- •Systemic anti-infectives.
- •Phenytoin or barbiturates (inducers of microsomal enzymes).
- •All systemic medications.
- •Prior Treatment:
- •Excluded within 72 hours prior to study entry:
- •Radiation therapy.
- •Active alcohol or drug abuse unless they have been off drugs and/or alcohol for two weeks prior to start of study.
研究者
研究点 (2)
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