NCT00002344已完成1 期
Double-Blind Crossover Study Assessing the Dose Proportionality of Azithromycin Tablets in HIV-Infected Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
To assess the dose proportionality of azithromycin concentrations and toleration when delivered in tablet formulation to HIV-infected patients.
The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population.
详细描述
The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population.
Patients are randomized to receive azithromycin at 1 of 2 doses in a two-treatment, two-period, cross-over study. Dosing visits are separated by at least 14-day wash-out periods.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
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 seropositivity.
- •CD4 count <= 500 cells/mm
- •NO active AIDS opportunistic infection.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Other active intercurrent illness.
- •Any condition possibly affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies.
- •Signs or symptoms of severe illness that would preclude study participation.
- •Known allergies to macrolide antibiotics.
- •Patients with the following prior condition are excluded:
- •Clinically important change in baseline status within 4 weeks prior to study entry.
- •Prior Medication:
- •Investigational drugs including treatment IND drugs within 4 weeks prior to study entry.
- •Known drug or alcohol dependence.
研究者
研究点 (1)
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