NCT01272258撤回2 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Observed Systemic, Long-Acting, Anti-HIV Treatment With a Monoclonal Anti CCR5 Antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-Infected Injection Drug Users With Viral Rebound and Documented Poor Adherence to the Previous Antiretroviral Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Specific measure that will be used to determine the effect of the interventions: Percentage of subjects without virologic failure at week 24.
研究概览
简要总结
PRO 140 2102 is a phase 2b, national, multicenter, randomized, double-blind, placebo-controlled study in order to evaluate the safety and efficacy of PRO 140 (anti-CCR5 monoclonal antibody) administered subcutaneously as an adjunct to a new, optimized, oral antiretroviral regimen in HIV-infected injection drug users with viral rebound and documented poor adherence to the previous antiretroviral regimen.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only R5 virus
- •HIV-1 RNA > 1,000 copies/mL but < 100,000 copies/mL
- •CD4+ lymphocyte counts > 100 cells/μL
- •Non-prescription recreational drug use within the previous 6 months
排除标准
- •Females who are pregnant (positive blood test), lactating, or breastfeeding, or who plan to become pregnant during the study
- •Prior use of any CCR5 entry inhibitors
- •History of any acquired immune deficiency syndrome (AIDS)-defining illness
研究组 & 干预措施
Arm 1
Experimental
PRO 140
干预措施: PRO 140 (Drug)
Arm 2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Specific measure that will be used to determine the effect of the interventions: Percentage of subjects without virologic failure at week 24.
时间窗: 24 Weeks
Percentage of subjects without virologic failure at week 24.
次要结局
未报告次要终点
研究者
研究点 (1)
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