NCT00232908已完成4 期
An Open-label Study of a HAART (Highly Active Antiretroviral Therapy) Regimen Containing Subcutaneous Injection of Fuzeon on Quality of Life in Clinically Stable, Treatment-experienced Patients With HIV-1 Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 361
- 主要终点
- QoL (MOS-HIV)\n
研究概览
简要总结
This study will evaluate patient quality of life and tolerability of a HAART (highly active antiretroviral therapy) regimen containing twice-daily subcutaneous injections of Fuzeon in clinically stable, treatment-experienced patients with HIV-1 infection. All patients will use a 31-gauge thin-walled 8mm needle to administer Fuzeon. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults or adolescents at least 16 years of age;
- •HIV-1 infection;
- •clinically stable, treatment-experienced;
- •evidence of HIV-1 replication despite ongoing antiretroviral therapy;
- •CD4 + count greater than 50 cells/mm3.
排除标准
- •previous use of Fuzeon and/or T-1249;
- •active, untreated opportunistic infection;
- •inability to self-inject, unless a reliable caregiver is available to inject.
研究组 & 干预措施
1
Experimental
干预措施: ARV regimen (Drug)
1
Experimental
干预措施: enfuvirtide [Fuzeon] (Drug)
结局指标
主要结局
QoL (MOS-HIV)\n
时间窗: Baseline and Week 12
次要结局
- Change from baseline in HIV-RNA(Week 12)
- Change from baseline in CD4 count(Week 12)
研究者
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