NCT00002200已完成不适用
A 1592U89 Open-Label Protocol for Adult Patients With HIV-1 Infection.
Glaxo Wellcome2 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give 1592U89 to HIV-positive adults. This study also examines the influence previous anti-HIV treatment has on the effectiveness of 1592U89.
详细描述
Patients receive open-label 1592U89 administered orally in combination with at least one other antiretroviral agent that the patient has not previously received.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Concurrent Medication:
- •Erythropoietin, G-CSF and GM-CSF.
- •Patients must have:
- •CD4+ cell count < 100 cells/mm
- •HIV-1 RNA > 30,000 copies/ml.
- •Signed, informed consent from parent or legal guardian for patient under 18 years of age.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Renal failure requiring dialysis.
- •Hepatic failure evident by grade 3/4 hyperbilirubinemia and AST 5 times the upper limit of normal.
- •Documented hypersensitivity to 1592U
- •Serious medical conditions, such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, that would compromise the safety of the patient.
- •Participation in or ability to participate in an enrolling study of 1592U
- •At least 2 nucleoside reverse transcriptase inhibitors (NRTI) and one protease inhibitor (or intolerance to one protease inhibitor and one NRTI due to trying at least 2 different regimens with at least one protease inhibitor).
- •Alcohol or illicit drug use that may interfere with the patient's compliance.
研究者
研究点 (2)
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