跳至主要内容
临床试验/NCT00337701
NCT00337701已完成4 期

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

Hoffmann-La Roche0 个研究点目标入组 326 人开始时间: 2006年6月最近更新:
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
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

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

Experimental

干预措施: enfuvirtide [Fuzeon] (Drug)

2

Experimental

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)

研究者

申办方类型
Industry
责任方
Sponsor

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