NCT00002431已完成不适用
A Multi-Center Trial to Evaluate the Safety and Effectiveness of Peridex Dosed Twice or Three Times Daily for Preventing or Delaying the Occurrence of Lesions Due to Oral Candidiasis in HIV-Positive Individuals
Procter and Gamble10 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
- 10
研究概览
简要总结
To evaluate the safety and effectiveness of Peridex (an oral rinse containing chlorhexidine gluconate) for preventing the occurrence of clinically-evident microbiologically-documented oral candidiasis in HIV-positive patients, who are at risk of the disease based on previous history of candidiasis.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 13 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior Medication:
- •Allowed within 6 months of study entry:
- •Treatment for oral candidiasis.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Either history of esophageal candidiasis or current mucocutaneous candidiasis (angular cheilitis).
- •Allergies to chlorhexidine.
- •Gross periodontal neglect or need for periodontal treatment within the past two weeks.
- •Concurrent Medication:
- •Systemic or oral topical mucocutaneous antifungal therapy.
- •Systemic or oral topical corticosteroids.
- •Antibiotics.
- •Mouth rinses other than the study drug.
- •Concurrent Treatment:
- •Dental prophylaxis.
- •Patients with the following are excluded:
- •Complete dentures, full partial dentures, removable dentures which fit poorly, or any prosthetic appliances which cannot be cleaned with sodium hypochlorite.
- •Allergies to chlorhexidine.
- •Sensitivity/intolerance to alcohol.
- •Anterior composite/acrylic restorations with poor marginal adaption.
- •Gross periodontal neglect or periodontal treatment within the past two weeks.
- •Inability to comply with the study protocol based on the investigator's discretion.
- •Prior Medication:
- •Excluded within 7 days of study entry:
- •Systemic or oral topical mucocutaneous antifungal therapy.
- •Antibiotics.
- •Daily use of mouth rinses.
- •Excluded within 1 month of study entry:
- •Systemic or oral topical corticosteroids.
- •Prior Treatment:
- •Excluded within 2 weeks of starting study drug:
- •Dental prophylaxis or periodontal treatment.
- •Patients must be:
- •HIV positive.
- •Previously experienced at least one episode of clinically diagnosed oral candidiasis but currently free of clinical signs of oral candidiasis.
- •Willing to sign informed consent.
- •Willing to complete a medical history.
研究者
研究点 (10)
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