NCT00002161已完成不适用
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3
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试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 27
研究概览
简要总结
To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.
详细描述
Patients are randomized to receive either adefovir dipivoxil or placebo daily for 24 weeks, after which all patients will receive open-label drug for an additional 24 weeks. Study drug is administered in combination with a current antiretroviral regimen for the entire 48 weeks. Patients are followed every 4 weeks during the first 24 weeks of study, then every 8 weeks during the last 24 weeks.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •HIV infection with HIV RNA titer >= 2500 copies/ml (2.5 KEq/ml) plasma.
- •CD4 count >= 200 cells/mm
- •No new AIDS-defining event within the past 2 months.
- •Life expectancy at least 1 year.
- •Consent of parent or guardian if less than 18 years old.
- •Tolerated antiretroviral therapy for the past 2 months.
- •Kaposi's sarcoma is permitted provided patient has not received systemic therapy within the past month.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Active, serious infections other than HIV that require parenteral antibiotic or antiviral therapy.
- •Gastrointestinal malabsorption syndrome or chronic nausea or vomiting that would preclude oral medication.
- •Malignancy other than Kaposi's sarcoma or basal cell carcinoma.
- •Concurrent Medication:
- •Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
- •Isoniazid.
- •Rifampin.
- •Investigational agents (unless approved by sponsor).
- •Systemic chemotherapeutic agents.
- •Prior Medication:
- •Parenteral antibiotic or antiviral therapy for another active, serious infection within the past 2 weeks.
- •Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons within the past month.
- •Systemic therapy for KS within the past month.
- •Antiretroviral regimen other than study drug.
- •Antiretroviral therapy for at least the past 2 months. Current alcohol or substance abuse that would interfere with compliance.
研究者
研究点 (27)
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