NCT00002341已完成不适用
An Open-Label Extension Study of Maintenance Therapy in HIV-Positive Subjects With Fluconazole-Refractory Oropharyngeal Candidiasis Who Have Responded to Itraconazole Oral Solution
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
- 1
研究概览
简要总结
To provide maintenance treatment with itraconazole solution for patients who were clinical responders in the ITR-USA-94 protocol, even if they subsequently relapsed.
详细描述
Patients who responded to therapy on protocol FDA 236B receive maintenance with itraconazole oral solution for up to 6 months.
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:
- •Met criteria for clinical response on protocol FDA 236B with no residual visible lesion of oropharyngeal candidiasis upon completion of that study OR had initial response on protocol FDA 236B with subsequent relapse and retreatment with itraconazole solution or other therapies.
- •Life expectancy of at least 3 months.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Underlying clinical condition that would preclude completion of study or place subject at significant risk.
- •Judged unreliable with respect to physician's directives.
- •Concurrent Medication:
- •Rifampin.
- •Rifabutin.
- •Phenobarbital.
- •Phenytoin.
- •Carbamazepine.
- •Terfenadine.
- •Astemizole.
- •Systemic antifungals.
- •Patients with the following prior conditions are excluded:
- •Previously documented disseminated candidiasis.
- •Previous clinically significant adverse event during treatment with itraconazole oral solution, unless clearly attributable to an intercurrent illness or condition.
- •History of significant hepatic abnormalities or clinical evidence of significant hepatic disease within 2 months prior to study entry.
- •Prior Medication:
- •Any investigational drug (other than itraconazole solution) within 1 month prior to study entry.
研究者
研究点 (1)
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