A Phase III, Randomized, Open-label, Controlled Trial to Investigate the Efficacy and Safety of UB-421 Monotherapy as Substitution for Stable Antiretroviral Therapy in HIV-1 Infected Adults
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Number of participants without virologic failure
研究概览
简要总结
The purpose of this phase III study is to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound in HIV-1 infected adults undergoing antiretroviral treatment interruption.
详细描述
This is an open-label, Phase III study to evaluate the efficacy, safety and tolerability of UB-421 monotherapy in suppressing viral rebound while replace HAART in virally suppressed HIV-1 infected adults. In this study, approximately 375 subjects on stable HAART treatment will be randomized to receive either continuing HAART treatment alone (Cohort 1) or UB-421 as the monotherapy (Cohort 2) in 1:2 ratio. For Cohort 1, subjects will receive current standard HAART treatment as the active control group. For Cohort 2, UB-421 will be administered to enrolled subjects without HAART treatment in the Cohort 2 during the 26-week treatment period. After treatment period, both cohort 1 and cohort 2 enter 22-week follow-up period.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 sero-positive
- •Aged 20 years or older
- •Were not breastfeeding for women
- •Subjects with a negative serum pregnancy test result at screening visit for women of childbearing potential
- •Subjects agree on using birth control barrier (female or male condom) during the entire study period
- •Subjects sign the informed consent before undergoing any study procedures
排除标准
- •Any active infection except for HIV, and required immediate therapy
- •Any active AIDS-defining illness per Category B and Category C conditions according to the U.S. Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection
- •Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history, and/or physical examination that, in the investigator's opinion, would preclude the subject from participating in this study
- •Life expectancy less than 12 months
- •Any alcohol or illicit drug used, according to the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations
研究组 & 干预措施
Cohort 1
Subjects will receive current standard HAART treatment as the active control group.
干预措施: current standard HAART treatment (Drug)
Cohort 2
Subjects will receive UB-421 without HAART treatment by intravenous infusion at 25 mg/kg bi-weekly. After 26-week treatment period, subjects will enter 22-week follow-up period with current standard HAART treatment.
干预措施: UB-421 (Drug)
Cohort 2
Subjects will receive UB-421 without HAART treatment by intravenous infusion at 25 mg/kg bi-weekly. After 26-week treatment period, subjects will enter 22-week follow-up period with current standard HAART treatment.
干预措施: current standard HAART treatment (Drug)
结局指标
主要结局
Number of participants without virologic failure
时间窗: 24 weeks
次要结局
- Number of participants with treatment-related adverse events(48 weeks)
- Time to virologic failure(26 weeks)
- Peak concentration of UB-421 in Cohort 2(30 weeks)
- Trough concentration of UB-421 in Cohort 2(30 weeks)