A Phase II Multi-center, Randomized, Blind, Placebo-controlled Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With Human Immunodeficiency Virus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- CD4/CD8 ratio changes compared with baseline
研究概览
简要总结
This study is a phase II, multicenter, randomized, blind, placebo-controlled to evaluate the safety, tolerance, efficacy of ASC22 injection in combination with anti-retroviral therapy to treat subjects living with human immunodeficiency virus type 1.
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
- Single (Participant)
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
- •Age ≥18 and ≤ 60 years old at screening.
- •Treated with anti-retroviral medicine continuously for at least 12 months within 6 months of diagnosis of HIV-1 infection.
- •Treated with anti-retroviral medicine continuously, contain integrase inhibitor, for at least months before screening.
- •CD4+ Cell count ≥300 cells/μL and CD4+/ CD8+ratio ≤ 0.9 at screening.
- •Weight ≥ 50 kg at screening.
排除标准
- •Known allergy to the drug or excipients used in this trial.
- •HIV-associated opportunistic infections in the past 5 years.
- •Co-sensors of HBV, HCV, syphilis, etc.
- •With bleeding disorders or on anticoagulant therapy.
研究组 & 干预措施
ASC22 1mg/kg
ASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks
干预措施: ASC22 1mg/kg (Drug)
ASC22 1mg/kg
ASC22 Injection of 1mg/kg and anti-retroviral therapy for 12 weeks
干预措施: Antiretroviral Therapy (Drug)
ASC22 2.5mg/kg
ASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks
干预措施: ASC22 2.5mg/kg (Drug)
ASC22 2.5mg/kg
ASC22 Injection of 2.5mg/kg and anti-retroviral therapy for 12 weeks
干预措施: Antiretroviral Therapy (Drug)
Placebo
0.9% Saline and anti-retroviral therapy for 12 weeks
干预措施: Antiretroviral Therapy (Drug)
Placebo
0.9% Saline and anti-retroviral therapy for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
CD4/CD8 ratio changes compared with baseline
时间窗: Week 4\Week 8\Week 12
次要结局
- HIV-DNA copy changes compared with baselnie(Week 12)
- IL-2 concentration changes compared with baseline(Week 4\Week 8\Week 12)
- CD4+ count changes compared with baseline(Week 12)
- CD8+ count changes compared with baseline(Week 12)
- HLA-DR number changes compared with baseline(Week 12)
- CD38 count changes compared with baseline(Week 12)