NCT00002346已完成1 期
A Phase I/II Study of Safety, Tolerance, Pharmacokinetics, and Anti-HIV Activity of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) and Placebo 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
- 36
- 试验地点
- 1
研究概览
简要总结
To study the safety, tolerance, single and multiple dose pharmacokinetics, and anti-HIV activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to HIV-infected patients.
详细描述
Patients are randomized to receive bis-POM PMEA at one of three fixed dose levels or placebo daily for 2 weeks. At each dose level, nine patients receive bis-POM PMEA and three patients receive placebo.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
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:
- •Prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone, provided a stable regimen has been maintained for at least 4 weeks prior to study entry.
- •Patients must have:
- •HIV seropositivity.
- •CD4 count >= 100 cells/mm
- •p24 antigen (immune-complex dissociated) >= 50 pg/ml.
- •Life expectancy of at least 6 months.
- •Prior Medication:
- •Prior prophylaxis with 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 infection (other than HIV infection) requiring parenteral antibiotic therapy.
- •Malignancy other than cutaneous Kaposi's sarcoma.
- •Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- •Gastrointestinal malabsorption syndrome.
- •Inability to take oral medication.
- •Concurrent Medication:
- •Any parenteral antibiotic therapy.
- •Diuretics.
- •Amphotericin B.
- •Didanosine (ddI).
- •Fluconazole.
- •Foscarnet.
- •Ganciclovir.
- •Interferon-alpha.
- •Interferon-beta.
- •Isoniazid.
- •Aminoglycoside antibiotics.
- •Ketoconazole (topical allowed).
- •Itraconazole.
- •Rifabutin.
- •Rifampin.
- •Stavudine (d4T).
- •Zalcitabine (ddC).
- •Zidovudine (AZT).
- •Lamivudine (3TC).
- •Any investigational agents (except with sponsor approval).
- •Systemic therapy for Kaposi's sarcoma.
- •Patients with the following prior condition are excluded:
- •History of lactose intolerance.
- •Prior Medication:
- •Excluded within 2 weeks prior to study entry:
- •Any parenteral antibiotic therapy.
- •Diuretics.
- •Amphotericin B.
- •Didanosine (ddI).
- •Fluconazole.
- •Foscarnet.
- •Ganciclovir.
- •Interferon-alpha.
- •Interferon-beta.
- •Isoniazid.
- •Aminoglycoside antibiotics.
- •Ketoconazole (topical allowed).
- •Itraconazole.
- •Rifabutin.
- •Rifampin.
- •Stavudine (d4T).
- •Zalcitabine (ddC).
- 另有 5 项未显示
研究者
研究点 (1)
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