NCT01902615已完成不适用
Multicenter, Observational, Retrospective Study to Assess the Therapeutic Effectiveness of a Strategy of Induction With Enfuvirtide Within an Optimized Regimen of Antiretroviral Drugs (ARV) in Patients Infected With HIV-1 in Routine Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml
研究概览
简要总结
This multicenter, retrospective, observational study will evaluate the therapeutic effectiveness of a strategy of induction with Fuzeon (enfuvirtide) within an optimized regimen of antiretroviral drugs in patients with HIV-1 infection in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patients, >/= 18 years of age
- •HIV-1+ infection
- •Patients with a viral load > 50 copies/ml who have received induction treatment with Fuzeon in combination with antiretroviral treatment
- •Naïve for Fuzeon at initiation of induction treatment
- •Antiretroviral treatment of at least 12 months duration
排除标准
- •Patients who did not receive Fuzeon treatment
结局指标
主要结局
Response rate: Proportion of patients with reduction of viral load to < 50 copies/ml
时间窗: approximately 24 months
次要结局
- Duration of treatment with Fuzeon(approximately 24 months)
- Time to undetectability, defined as time from initiation of treatment to first observation of viral load < 50 copies/ml(approximately 24 months)
- Safety: Incidence of adverse events(approximately 24 months)
- Treatment regimen: Antiretroviral drugs used(approximately 24 months)
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