Biojector 2000 Open-Label Safety Study (BOSS) to Evaluate Signs and Symptoms Associated With a Needle-free Injection Device for Administration of Fuzeon to Patients With HIV-1 Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 326
- 主要终点
- Composite endpoint (pain, induration, nodules/cysts)
研究概览
简要总结
This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (>4 weeks) administration of Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for the next 4 weeks. The anticipated time on study treatment is <3 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
- •adult patients >=16 years of age;
- •current or former Fuzeon user who may benefit from needle-free administration of Fuzeon;
- •naive to use of the B2000 device;
- •positive test results for human immunodeficiency virus infection.
排除标准
- •patients naive to Fuzeon;
- •inability to self-inject Fuzeon, or no reliable caregiver to administer injections;
- •evidence of active, untreated, opportunistic infections.
研究组 & 干预措施
1
干预措施: enfuvirtide [Fuzeon] (Drug)
2
干预措施: enfuvirtide [Fuzeon] (Drug)
结局指标
主要结局
Composite endpoint (pain, induration, nodules/cysts)
时间窗: Throughout study
次要结局
- AEs and ISRs(Throughout study)
