NCT00461266撤回4 期
A Randomized, Open Label Study to Determine the Immunological Benefits of Adding Fuzeon to an Antiretroviral Regimen in HIV-infected Fuzeon-naïve Patients With Sustained HIV Viral Suppression
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Mean change in CD4 cell count from baseline
研究概览
简要总结
This 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count <250 cells/mm3 and an HIV RNA viral load <400 copies/mL. Eligible patients will be randomized to receive Fuzeon 90mg bid sc in addition to their current antiretroviral therapy, or to continue their current antiretroviral therapy alone. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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
- •adult patients, >=18 years of age;
- •documented chronic HIV infection;
- •currently receiving a stable antiretroviral regimen;
- •CD4 cell count <250 cells/mm3;
- •HIV RNA viral load <400 copies/mL for >12 months.
排除标准
- •prior exposure to Fuzeon;
- •prior non-adherence to antiretroviral treatment regimens;
- •active opportunistic infection;
- •currently taking, or anticipated to take during the study, any immunomodulator.
研究组 & 干预措施
1
Experimental
干预措施: enfuvirtide [Fuzeon] (Drug)
1
Experimental
干预措施: Antiretroviral therapy (Drug)
2
Active Comparator
干预措施: Antiretroviral therapy (Drug)
结局指标
主要结局
Mean change in CD4 cell count from baseline
时间窗: Week 24
次要结局
- Change in HIV RNA from baseline(Week 24)
- Change in HIV RNA and CD4 cell count(Weeks 24-48)
- Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs.(Throughout study)
研究者
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