NCT00002139已完成1 期
Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of 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
- 试验地点
- 1
研究概览
简要总结
To compare the uptake of azithromycin in white cells relative to plasma concentrations in HIV-infected patients.
详细描述
Patients are randomized to receive azithromycin orally or intravenously, with crossover to the alternate treatment after a 21-day wash-out period.
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
- •Concurrent Medication:
- •Antiretroviral agents, provided regimen has been stable for at least 1 month.
- •Patients must have:
- •HIV infection.
- •CD4 count <= 200 cells/mm
- •No active opportunistic infection (pending discussion with Pfizer Clinician).
- •Prior Medication:
- •Prior antiretroviral agents.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Active intercurrent illness (pending discussion with the Pfizer Clinician).
- •Allergies to macrolide antibiotics.
- •Signs and symptoms of severe illness that would preclude treatment.
- •Patients with the following prior conditions are excluded:
- •History of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- •Clinically important change in baseline status within 4 weeks prior to study entry.
- •Condition affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies) 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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