NCT02184351已完成3 期
A Prospective Randomized, Blinded Parallel Group Study of Clotrimazole Troches vs. Mycelex® Troches (10 mg Troche Five Times a Day for 14 Days) in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 187
- 主要终点
- Percent of patients that have a clinical response assessed by symptoms and physical examination
研究概览
简要总结
The objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where this condition has been diagnosed by clinical examination and confirmed by fungal culture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
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
- •Documented HIV positive status
- •Clinical examination of oropharynx is consistent with diagnosis of oral Candidiasis (such as creamy, white, curdlike patches or erythematous lesions on mucosal surfaces)
- •Findings on direct microscopic examination (Gram Stain or potassium hydroxide smear) consistent with Candida species or positive fungal culture for Candida species, with culture obtained in the 2 days preceding initiation of therapy with the study drug
- •Male or female patients ≥ 18 years
- •For women of childbearing potential: negative blood or urine pregnancy test and agreement to use adequate contraception (investigator's discretion) while on study drug
- •Mental status allows comprehension of instructions for troche administration
- •Written informed consent
排除标准
- •Sings of symptoms suggestive of esophageal Candidiasis (such as dysphagia or odynophagia) unless the results of an endoscopic evaluation of the esophagus are negative
- •Presence of perioral lesions only
- •Use of other antifungal agents within 5 days of enrollment to the study
- •Pregnant or lactating women
- •History of hypersensitivity to imidazole or azole compounds
- •Patient unwilling or unable to be followed at the study center for the duration of the study (3 weeks)
- •Patients has received an investigational drug in the last 30 days
- •Treatment with another investigational drug is planned within the next 3 weeks
研究组 & 干预措施
Roxanes's clotrimazole troches
Experimental
干预措施: Roxanes's clotrimazole troches (Drug)
Mycelex® troches
Active Comparator
干预措施: Mycelex® troches (Drug)
结局指标
主要结局
Percent of patients that have a clinical response assessed by symptoms and physical examination
时间窗: Day 21
次要结局
- Incidence of negative fungal cultures of the oropharynx for Candida species(after 14 days of treatment)
- Clinical response by symptom assessment and physical examination(after 7 and 14 days of treatment)
- Assessment of compliance with Treatment by troche Count and Patient interview(after 7 and 14 days of treatment)
研究者
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