Open Label, Nonrandomized Clinical Trial of Safety and Tolerability of Enfuviritide (Fuzeon®, HIV Fusion Inhibitor) in Patients With Advanced HIV1 Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events
研究概览
简要总结
This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and the target sample size is 9 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
- •Adult or adolescent patients greater than (>)16 years of age
- •HIV-1 infection
- •CD4 count less than (<)350/cubic millimeters (mm^3)
- •HIV RNA viral load >10,000 copies per milliliter (copies/mL) while on highly active antiretroviral therapy (HAART)
- •Documented resistance, treatment-limiting toxicity, and/or >=6 months' prior experience with each of 3 currently available classes of antiretroviral drugs.
排除标准
- •Women who are pregnant or breastfeeding;
- •Patients unable to self-inject;
- •Active, untreated opportunistic infection.
研究组 & 干预措施
Enfuvirtide
Participants will receive 180 milligrams (mg) of enfuvirtide adminstered twice daily as subcutaneous injections
干预措施: enfuvirtide (Drug)
结局指标
主要结局
Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events
时间窗: Up to 102 weeks
Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections
时间窗: Up to 102 weeks
Percentage of participants who discontinue enfuvirtide due to adverse events\n
时间窗: Up to 102 weeks
次要结局
- Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR(Up to 102 weeks)
- Percentage os participants reporting serious adverse events on the first day of study dosing and up to 28 days after discontinuiation of the study drug(Up to 28 days after discontinuation of enfuvirtide)