NCT00002057已完成不适用
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC
Bristol-Myers Squibb2 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 determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (group III or IV, CDC classification).
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Systemic or oral antibiotics.
- •Experimental drugs (IND drugs) which are targeted specifically against the AIDS (group IV CDC classification) virus or stimulate the immune system.
- •Patients with the following conditions are included:
- •AIDS or AIDS related complex (ARC) (HIV infection Group 3 or 4, CDC classification) who have had culture-proven oral candidiasis clinically cured within 7 days of study entry and are likely to be compliant for the 20 weeks of nystatin pastille prophylaxis.
- •Able to follow instructions regarding the use of a pastille.
- •Patients entering part II of this study (randomized double-blind) must have been clinically cured of oral candidiasis within 1 - 7 days of entry into this randomized study.
- •Oral lesions such as Kaposi's sarcoma, herpes zoster, and herpes simplex can be enrolled.
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Systemic candidiasis.
- •Hypersensitivity to nystatin.
- •Suspected or proven candidal esophagitis.
- •Patients with the following are excluded:
- •Systemic candidiasis.
- •Projected survival of less than 6 months.
- •Unable to maintain a pastille in the buccal cavity for approximately 20 minutes twice a day.
- •Hypersensitivity to nystatin.
- •Suspected or proven candidal esophagitis.
研究者
研究点 (2)
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