NCT00002195已完成3 期
A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination With Retrovir and Epivir Compared to Retrovir and Epivir Alone in Patients With HIV Infection.
Glaxo Wellcome17 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 17
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.
详细描述
This is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141W94, retrovir, and epivir and a double regimen consisting of retrovir and epivir.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •HIV-positive status.
- •Screening viral load >= 10,000 copies/mm3 14 days prior to entry.
- •CD4+ cell counts >= 200 cells/mm3 14 days prior to entry.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Clinical diagnosis of AIDS (CDC 1993 Classification C).
- •Concurrent Medication:
- •Terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens.
- •Patients with the following prior conditions are excluded:
- •Clinically relevant hepatitis in the previous 6 months.
- •Prior Medication:
- •Greater than 4 weeks of any nucleoside antiretroviral therapy.
- •Previous therapy with an HIV protease inhibitor.
- •Cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
- •Immunomodulating agents within 3 months prior to entry.
- •Prior Treatment:
- •Radiotherapy within 4 weeks prior to entry.
- •Risk Behavior:
- •Current alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations.
研究者
研究点 (17)
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