A Phase II, Open-label, Multiple-dose Trial to Investigate the Safety and Efficacy of UB-421 Monotherapy in Substitution for Stable Antiretroviral Therapy in HIV Infected Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The purpose of this phase II study is to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression.
详细描述
This is an open-label, Phase II study to evaluate the safety, tolerability and efficacy of two multi-dose regimens of UB-421 monotherapy in replacement of HAART in HIV-1 infected adults with virological suppression. In this study, approximately 29 subjects will be enrolled to receive one of the two UB-421 regimens as the monotherapy in replacement of HARRT treatment. Subjects assigned to Cohort 1 will receive UB-421 infusion at 10 mg/kg weekly for 8 weeks; subjects assigned to Cohort 2 will receive UB-421 infusion at 25 mg/kg bi-weekly for 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Have received HAART treatment
- •CD4+ T cell count ≧ 350 cells/mm3
- •HIV-1 plasma RNA level remains below the limit of
- •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 documented CD4+ T cell count < 200 cells/mm3 within the past 12 weeks before screening visit
- •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
- •Any vaccination within 8 weeks prior to the first dose of study drug
- •Any immunomodulating therapy (including interferon and steroid) or systemic chemotherapy within 12 weeks prior to the first dose of study drug
- •Any illicit intravenous drugs within 12 weeks prior to the first dose of study drug
- •Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations
- •More than one change of HAART regimen because of virologic failure
研究组 & 干预措施
cohort 1
Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly
干预措施: UB-421 (Drug)
cohort 2
Subjects will receive 8 doses of the UB-421 by intravenous infusion at 25 mg/kg weekly
干预措施: UB-421 (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: 17 weeks for cohort 1, 25 weeks for cohort 2
次要结局
- Peak concentration of UB-421(8 weeks for cohort 1, 15 weeks for cohort 2)
- Trough concentration of UB-421(8 weeks for cohort 1, 15 weeks for cohort 2)