NCT00002128已完成1 期
Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
研究概览
简要总结
To study the safety, tolerance, and pharmacokinetics of a single dose of bis-POM PMEA (adefovir dipivoxil) when administered by the oral route in patients with HIV infection.
详细描述
Five patients are entered at each of three dose levels of bis-POM PMEA administered orally in a single dose.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •AZT, ddI, or ddC (provided patient has been on a stable regimen for at least 4 weeks prior to study entry).
- •Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone (provided patient has been on a stable regimen for at least 4 weeks prior to study entry).
- •Patients must have:
- •Documented HIV infection or diagnosis of AIDS.
- •Life expectancy of at least 3 months.
- •Prior Medication:
- •Prior AZT, ddI, or ddC.
- •Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Active, serious infections (other than HIV infections) that require parenteral antibiotic therapy.
- •Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- •Gastrointestinal malabsorption syndrome or inability to receive oral medication.
- •Concurrent Medication:
- •Diuretics.
- •Amphotericin B.
- •Aminoglycoside antibiotics.
- •Parenteral antibiotics.
- •Other nephrotoxic agents.
- •Other investigational agents.
- •Non-steroidal anti-inflammatory drugs.
- •Prior Medication:
- •Excluded within 2 weeks prior to study entry:
- •Diuretics.
- •Amphotericin B.
- •Aminoglycoside antibiotics.
- •Parenteral antibiotics.
- •Other nephrotoxic agents.
- •Other investigational agents.
- •Excluded within 3 days prior to study entry:
- •Non-steroidal anti-inflammatory drugs.
- •Aspirin. Active substance abuse (including alcohol or drug abuse).
研究者
研究点 (1)
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