NCT00035581终止2 期
A Multi-Center, Randomized, Controlled Study of the Biological Actions of Ampligen as an Adjunct to HAART in HIV Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 7
- 主要终点
- Reduction in HIV-1 Viral Load
研究概览
简要总结
This is an open-label, prospective, randomized, controlled study of the safety and efficacy including clinical, immunologic, and virologic assessments of adding Ampligen to "HAART" in HIV infected patients with CD4 counts >300 and HIV-1 plasma RNA >500 and <30,000 copies/ml (PCR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ampligen
Experimental
Ampligen (polyI-polyC12U) 200-400 mg IV infusions given twice weekly for 24 weeks
干预措施: poly I-poly C12U (Drug)
结局指标
主要结局
Reduction in HIV-1 Viral Load
时间窗: 4, 8, 12, 16, 20 and 24
Evaluate the effects of adding Ampligen (or no Ampligen) to "HAART" in HIV+ patients for evidence of reductions in HIV-1 viral load in plasma using Roche Amplicor assay.
次要结局
未报告次要终点
研究者
研究点 (7)
Loading locations...
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