NCT00002115已完成1 期
A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of PMEA ( adefovir ) when administered daily by intravenous (IV) and/or subcutaneous (SC) injection in patients with advanced HIV disease.
详细描述
Patients receive a single IV or SC dose of PMEA daily for 4 weeks. A maximum tolerated dose will be defined for these regimens.
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:
- •Other antiretroviral therapy IF on a stable dose for at least 4 weeks prior to study entry.
- •Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable prophylactic regimen for at least 4 weeks prior to study entry.
- •Patients must have:
- •HIV seropositivity.
- •Elevated p24 antigen (> 40 pg/ml).
- •Mean CD4 count <= 100 cells/mm
- •Life expectancy of at least 3 months.
- •Prior Medication:
- •Other prior antiretroviral therapy.
- •Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Inadequate venous access.
- •Active serious infection (other than HIV infection) requiring parenteral antibiotic therapy.
- •Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- •Psychiatric disturbance or illness that may affect compliance.
- •Malignancy other than Kaposi's sarcoma.
- •Concurrent Medication:
- •Investigational agents other than stavudine (d4T).
- •Interferon-alpha.
- •Ganciclovir.
- •Foscarnet.
- •Diuretics.
- •Amphotericin B.
- •Aminoglycoside antibiotics.
- •Other nephrotoxic agents.
- •Acyclovir at doses >= 2 g/day.
- •Prior Medication:
- •Excluded within 2 weeks prior to study entry:
- •Investigational agents other than stavudine (d4T).
- •Interferon-alpha.
- •Ganciclovir.
- •Foscarnet.
- •Diuretics.
- •Amphotericin B.
- •Aminoglycoside antibiotics.
- •Other nephrotoxic agents.
- •Excluded within 4 weeks prior to study entry:
- •Systemic therapy for Kaposi's sarcoma. Substance abuse.
研究者
研究点 (1)
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