NCT00089492已完成2 期
A Phase II Open-label, Randomized, Active-controlled Study Comparing the Efficacy and Safety of Once Daily Enfuvirtide Dosing Versus the Currently Recommended Twice Daily Dosing in HIV-1 Infected Treatment-experienced Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Viral load.\n\n
研究概览
简要总结
This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. 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
- Randomized
- 干预模型
- Parallel
- 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
- •HIV-1 infected adults or adolescents >=16 years of age;
- •HIV-1 RNA >=5000 copies/mL;
- •prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors).
排除标准
- •history of prior use of Fuzeon or T-1249;
- •female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study;
- •current severe illness;
- •currently taking drugs affecting the immune system, HIV vaccine, or investigational agents for any conditions other than HIV/AIDS.
研究组 & 干预措施
2
Active Comparator
干预措施: Optimized Background ARVs (Drug)
1
Experimental
干预措施: Optimized Background ARVs (Drug)
1
Experimental
干预措施: enfuvirtide [Fuzeon] (Drug)
2
Active Comparator
干预措施: enfuvirtide [Fuzeon] (Drug)
结局指标
主要结局
Viral load.\n\n
时间窗: Week 48
次要结局
- CD4 lymphocyte count.(Week 48)
- AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n(Throughout study)
研究者
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