NCT00002133已完成不适用
An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Janssen, LP
- 试验地点
- 18
研究概览
简要总结
To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.
详细描述
Patients receive itraconazole oral solution twice daily. Per 08/15/94 amendment, patients with complete resolution of oropharyngeal candidiasis lesions upon completion of treatment are eligible for maintenance treatment on protocol FDA 236C. Patients who decline maintenance are followed for 6 weeks. Patients who relapse during follow-up are re-treated for 14-28 days; if lesions clear, patients may enter the maintenance protocol.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •HIV antibody seropositivity or diagnosis of AIDS.
- •Confirmed oropharyngeal candidiasis.
- •Failed fluconazole treatment within the past 14 days.
- •Life expectancy of at least 3 months.
- •NO symptoms of esophageal candidiasis (e.g., dysphagia) unless endoscopic exam of esophagus was performed and fungal esophagitis was not present.
- •NO prior disseminated candidiasis.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Underlying clinical condition that precludes study completion or places the patient at significant risk.
- •Considered unreliable about following physician's directives.
- •Concurrent Medication:
- •Investigational drugs (approved expanded access drugs are permitted).
- •Rifampin.
- •Rifabutin.
- •Phenobarbital.
- •Phenytoin.
- •Carbamazepine.
- •Terfenadine.
- •Astemizole.
- •Patients with the following prior conditions are excluded:
- •History of hypersensitivity to imidazole or azole compounds.
- •Clinical evidence of significant hepatic disease within the past 2 months.
- •Prior Medication:
- •Investigational drugs within 1 month prior to study entry (approved expanded access drugs are permitted).
研究者
研究点 (18)
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