NCT00002293已完成不适用
Nystatin Pastille for the Prophylaxis of Oral Candidiasis in Patients With AIDS or AIDS Related Syndromes
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 prophylaxis of oral candidiasis in patients with AIDS or AIDS related syndromes (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:
- •Experimental drugs (IND drugs) which are targeted specifically against the AIDS virus or which stimulate the immune system.
- •Systemic or oral antibiotics.
- •Patients must have AIDS or AIDS-related syndromes (HIV infection:
- •Group III or IV, CDC classification) and not have been treated for oral candidiasis during the past year.
- •Patients can be entered into the study who have:
- •Other oral lesions due to Kaposi's sarcoma, herpes zoster, and herpes simplex.
- •A positive or negative oral culture for Candida.
- •Must be able to follow instructions regarding the use of a pastille.
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Oral lesions diagnostic of oral candidiasis or systemic candidiasis.
- •Suspected or proven candidal esophagitis.
- •Patients with the following are excluded:
- •Oral lesions diagnostic of oral candidiasis or systemic candidiasis.
- •Receiving any effective antifungal agent orally or intravenously within 72 hours of study entry.
- •Not expected to survive for at least 6 months.
- •Unable to voluntarily maintain a pastille in the buccal cavity for approximately 20 minutes twice a day.
- •Known hypersensitivity to nystatin.
- •Suspected or proven candidal esophagitis.
- •Prior Medication:
- •Excluded within 72 hours of study entry:
- •Any oral or intravenous antifungal agent.
研究者
研究点 (2)
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