NCT00002271已完成不适用
An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
适应症
相关药物
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 3'-deoxy-3'-fluorothymidine (FLT), in a liquid formulation, after single doses in asymptomatic HIV-infected patients and to assess the safety and tolerance of the single oral doses of FLT.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Exclusion Criteria
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Oral candida infection documented by morphology or by response to antifungal therapy within 2 months prior to study entry.
- •Temperature > 37.8 degrees Centigrade.
- •Malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
- •Significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial.
- •Concurrent Medication:
- •Patients with the following are excluded:
- •Significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial.
- •Unwilling to sign informed consent.
- •Intolerant to zidovudine (AZT).
- •Oral hairy leukoplakia at any time prior to study entry.
- •Prior Medication:
- •Excluded within 7 days of study entry:
- •Antiretroviral drugs.
- •Immunomodulators.
- •Excluded within 30 days of study entry:
- •Any investigational drugs.
- •Patients have the following:
- •HIV seropositivity by licensed ELISA test, confirmed by Western Blot analysis.
- •No symptoms as defined by:
- •Normal neurological exam.
- •Absence of the following:
- •Unintentional weight loss of greater than 10 pounds or more than 10 percent of usual body weight within 2 months prior to study entry.
- •Unexplained temperature > 37.8 C on more than 5 consecutive days or on more than 10 days in any 30 day period in the one month prior to expected study entry.
- •Unexplained diarrhea defined by = or > 3 liquid stools per day persisting > 7 days within 2 months prior to expected study entry.
排除标准
- 未提供
研究者
研究点 (1)
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