A Phase IIa, Open-label, Multiple-Dose Trial to Investigate the Safety and Efficacy of the UB-421 in Asymptomatic HIV-1 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
- 2
- 主要终点
- To evaluate safety and tolerability of multiple intravenous infusions of two dose cohorts of UB-421
研究概览
简要总结
The purpose of this Phase IIa study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule of T-lymphocytes and monocytes, is safe and effective when multiple doses are administered by intravenous infusion to asymptomatic HIV-1 infected adults and to assess pharmacokinetic parameters of the antibody in blood and on cells. The neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1 infection.
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
- •Asymptomatic, treatment-naive, HIV-1 seropositive
- •CD4+ T cell count >350 cells/cubic millimeter
- •HIV-1 viral load >5,000 copies/mL
- •Other inclusion criteria apply
排除标准
- •Active infection requiring immediate therapy (except HIV-1)
- •Previous exposure to monoclonal antibody (including UB-421)
- •Prior participation in any HIV vaccine trial
- •Use of immunomodulating drugs or systemic chemotherapy
- •Other exclusion criteria apply
研究组 & 干预措施
Antibody UB-421 Cohort 1
10 mg/kg BW, 8 weekly doses for 8-week treatment period
干预措施: Antibody UB-421 (Drug)
Antibody UB-421 Cohort 2
25 mg/kg BW, 4 biweekly doses for 8-week treatment period
干预措施: Antibody UB-421 (Drug)
结局指标
主要结局
To evaluate safety and tolerability of multiple intravenous infusions of two dose cohorts of UB-421
时间窗: 16-week study period
Safety evaluations include physical examination, measurement of vital signs, clinical chemistry and hematology tests at each visit (to assess changes from normal range), incidence of adverse event (AE) and serious AE (SAE) of two dose cohorts and are followed for 16 weeks (end of study). Overall treatment tolerability of UB-421 for each cohort is defined as the percentage of the number of actual infusion doses divided by number of actual infusion doses plus number of missed doses of subject(s) who drops out due to drug-related AE(s); calculation follows specific formula.
To evaluate efficacy by measurement of individual maximal viral load reduction and mean maximal viral load reduction of two dose cohorts of UB-421.
时间窗: 16-week study period
Efficacy measurements include virologic responses and determination of the proportion of subjects with viral load \<50 copies/mL or \<200 copies/mL; viral load reduction \>0.5 log10 copies/mL or \>1.0 log10 copies/mL; viral rebound over 0.5 log10 increase in viral load from the nadir value during 8-week treatment period, suggesting presence of study drug resistance mutants. HIV-1 viral load is determined at each blood collection during 16-week study period.
次要结局
- To determine pharmacokinetic parameters of two dose cohorts of UB-421.(16-week study period)
- To determine the anti-UB-421 antibody concentration in serum of two dose cohorts of UB-421(16-week study period)