AIDS 347: IL-6 Blockade in Treated HIV Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Grade 2 or Greater AEs
研究概览
简要总结
The study is a phase I/II, double-blind, placebo-controlled, randomized cross-over clinical trial of tocilizumab (TCZ) or placebo in HIV-infected subjects receiving antiretroviral therapy with suppressed viral replication and CD4+ T cell count ≥350 and ≤1,000 cells/mm3)
详细描述
DESIGN The study is a phase I/II, double-blind, placebo-controlled, randomized cross-over clinical trial of tocilizumab (TCZ) or placebo in HIV-infected subjects receiving antiretroviral therapy with suppressed viral replication and CD4+ T cell count ≥350 and ≤1,000 cells/mm3)
DURATION 40 weeks during cross-over treatment periods total per subject.
SAMPLE SIZE 30 subjects with complete data up to week 30. Up to 36 subjects may be enrolled in order to achieve an estimated final sample size of 30 participants with complete data up to week 30.
POPULATION HIV-infected male and female subjects from 18 through 60 years of age receiving combination antiretroviral therapy (ART) without changes in the 24 weeks prior to enrollment (changes for reasons other than virologic failure allowed up to 8 weeks prior to enrollment), with a suppressed plasma HIV RNA (<200 copies/mL, one blip up to <1,000 copies/mL permitted) for at least 96 weeks and a CD4+ T-cell count ≥350 and ≤1,000 cells/mm3 at the time of study enrollment.
REGIMEN Subjects will be randomized 1:1 to one of the following arms:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A: TCZ, then placebo
ARM A: TCZ, 4 mg/Kg by IV infusion over 60 minutes (not to exceed 400 mg) once at study entry, followed by TCZ, 8 mg/Kg by IV infusion over 60 minutes (not to exceed 800 mg) at weeks 4 and 8, and THEN placebo by IV infusion at weeks 20, 24, and 28.
干预措施: tocilizumab (Drug)
Arm A: TCZ, then placebo
ARM A: TCZ, 4 mg/Kg by IV infusion over 60 minutes (not to exceed 400 mg) once at study entry, followed by TCZ, 8 mg/Kg by IV infusion over 60 minutes (not to exceed 800 mg) at weeks 4 and 8, and THEN placebo by IV infusion at weeks 20, 24, and 28.
干预措施: Placebo (Drug)
Arm B: Placebo, then TCZ
ARM B: Placebo by IV infusion at study entry followed by placebo by IV infusion at weeks 4 and 8, and THEN TCZ, 4 mg/Kg (not to exceed 400 mg) by IV infusion over 60 minutes once at week 20, followed by TCZ, 8 mg/Kg (not to exceed 800 mg) by IV infusion over 60 minutes at weeks 24 and 28.
干预措施: tocilizumab (Drug)
Arm B: Placebo, then TCZ
ARM B: Placebo by IV infusion at study entry followed by placebo by IV infusion at weeks 4 and 8, and THEN TCZ, 4 mg/Kg (not to exceed 400 mg) by IV infusion over 60 minutes once at week 20, followed by TCZ, 8 mg/Kg (not to exceed 800 mg) by IV infusion over 60 minutes at weeks 24 and 28.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Grade 2 or Greater AEs
时间窗: 30 weeks
The number and percentage of participants experiencing at least one grade ≥2 clinical or laboratory adverse event related to study treatment during each period (0 to 10 weeks for Period 1 or 20 to 30 weeks for Period 2).
次要结局
- Serum C-reactive Protein Change Between Beginning and End of Treatment Period(study entry - 10 weeks; 20 weeks - 30 weeks)
- Change in Proportion of Central Memory T Cells Expressing Ki67 Between Beginning and End of Treatment Period(study entry - 10 weeks; 20 weeks - 30 weeks)