A Randomized, Double-blind, Placebo-controlled Phase 3 Trial With UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection

United BioPharma0 个研究点目标入组 50 人开始时间: 2023年12月1日最近更新: 2023年4月24日

适应症

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 50
主要终点: Change in HIV-1 RNA viral load between 2 arms

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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 seropositive
•Have a history of at least 6 months on antiretroviral treatment
•Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening

排除标准

•Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST > 4 x upper limit of normal (ULN)
•Females who are pregnant
•Any vaccination within 2 weeks prior to the Screening
•Any prior exposure to UB-421

结局指标

主要结局

Change in HIV-1 RNA viral load between 2 arms

时间窗: 14 Days

次要结局

未报告次要终点

研究者

发起方

United BioPharma

申办方类型

Industry

责任方

Sponsor

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