NCT00002260已完成不适用
An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
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试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
To characterize the pharmacokinetics of orally administered FLT (in a liquid formulation) after single doses in both the fed and fasting states; to assess the effect of food on the oral bioavailability of FLT
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Positive ELISA test confirmed by Western blot analysis.
- •Asymptomatic.
- •Willing to sign an informed consent.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.
- •Oral hairy leukoplakia at any time prior to entry.
- •Temperature > 37.8 C.
- •Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
- •Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.
- •Unwilling to sign an informed consent.
- •Zidovudine induced hematological toxicity.
- •Prior Medication:
- •Therapy with antiretroviral drugs or immunomodulators within seven days before entry.
- •Therapy with any investigational drug during the preceding 30 days.
- •Patients may not have:
- •Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.
- •Oral hairy leukoplakia at any time prior to entry.
- •Temperature > 37.8 C.
- •Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
- •Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.
- •Unwilling to sign an informed consent.
- •Zidovudine induced hematological toxicity.
研究者
研究点 (1)
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