A Single Arm Open Label Phase 2 Trial of Anti-CD4 Antibody UB-421 in Combination With Optimized Background Antiretroviral Therapy in Patients With Multi-Drug Resistant HIV-1 Infection
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of participants with =0.5 log10 reduction in HIV-1 plasma viremia
研究概览
简要总结
Background:
People with HIV usually take a combination of 2 or more anti-HIV drugs daily to help manage their infection. Sometimes, however, HIV becomes resistant to these drugs, and the infection cannot be treated. Untreated HIV infection can make people more vulnerable to other infections as well as some cancers. Better treatments are needed for people with drug-resistant HIV.
Objective:
To see if a study drug (UB-421) is effective in people with drug-resistant HIV.
Eligibility:
People aged 18 years and older with HIV that is resistant to anti-HIV drugs.
Design:
Participants will be in the study for 35 weeks.
Participants will have separate screening and baseline visits within 2 months of each other. They will have a physical exam with blood and urine tests both times. On the second visit, they will undergo apheresis: Blood will be drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in the other arm.
Participants will begin receiving the study drug 1 week after their baseline visit. UB-421 is given through a tube attached to a needle placed in a vein in the arm. They will return for UB-421 treatments every week for 26 weeks. Each visit will take 3 to 6 hours.
Participants will have 2 follow-up visits 4 and 8 weeks after their last treatment with UB-421. Apheresis will be repeated at 1 of these visits.
详细描述
Study Description:
This is a Phase 2 single arm study to evaluate the efficacy and safety of UB-421 in conjunction with an existing failing antiretroviral therapy (ART) for 2 weeks followed by optimized background therapy (OBT) in conjunction with UB-421 for 24 weeks.
Objectives:
Primary Objectives:
To assess the antiviral activity of UB-421 in reducing human immunodeficiency virus type 1 (HIV-1) plasma viremia during the 2-week functional monotherapy treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
10 adults (>18 years of age) with human immunodeficiency virus (HIV) who demonstrate evidence of HIV-1 replication despite ongoing ART with documented genotypic and/or phenotypic resistance to multiple classes of HIV drugs (3 classes or more)
干预措施: UB-421 (Biological)
结局指标
主要结局
Number of participants with =0.5 log10 reduction in HIV-1 plasma viremia
时间窗: baseline (Day 7) to Day 21
Number of participants with =0.5 log10 reduction in HIV-1 plasma viremia from baseline (Day 7) to Day 21.
The number of grade 2 or higher adverse events (AEs)
时间窗: treatment phase
The number of occurrence of grade 2 or higher adverse events (AEs), including serious adverse events (SAEs), which are probably or definitely related to UB-421.
次要结局
- Number of participants achieving HIV-1 RNA <200 copies/mL(Baseline (Day 7) through EOT)
- Measured levels of anti-UB-421 antibodies(Baseline (Day 7) through EOT)
- Number of participants achieving HIV-1 plasma viremia <40 copies/mL(Baseline (Day 7) through EOT)
- Measured levels of serum UB-421 concentration(Baseline (Day 7) through EOT)
- Mean change in CD4+ and CD8+ T cell counts(Baseline (Day 7) through EOT)