PRO 140 2103: A Phase 2a, Randomized Study of PRO 140 by Subcutaneous Injection in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 7
- 主要终点
- Maximum change in viral load following initiation of different dosing regimens of PRO140
研究概览
简要总结
PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female adult subjects infected with CCR5-tropic HIV-1.
详细描述
Protocol PRO 140 2103 is a multicenter, randomized parallel group study, conducted in approximately 40 male and female adult subjects (n=10/treatment group) infected with CCR5-tropic HIV-1. Subjects will be randomized into one of four treatment groups. Blood samples for drug concentrations, PD variables, and efficacy variables will be obtained over a 59-day period following initiation of dosing. Safety will be monitored throughout the course of the study.
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
- 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
- •Males and females, age ≥18 years
- •Has not taken any antiretroviral therapy (ART) within 12 weeks of the early screening visit
- •Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
- •CD4+ lymphocyte cell count ≥500 cells/mm3 and no documented count less than or equal to 250 cells/mm3
- •Exclusive CCR5-tropic virus as determined by as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
- •Clinically normal resting 12-lead ECG at screening visit
- •Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit. Within hours prior to receiving the first dose of study drug, women of reproductive potential must have a negative urine pregnancy test. Male and female subjects must agree not to participate in a conception process and agree to use one barrier method of contraception plus one other highly reliable contraceptive method from the early screening visit through three weeks after the last administered subcutaneous dose of PRO 140.
排除标准
- •CXCR4-tropic virus, dual/mixed tropic (R5X4) virus as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
- •Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
- •Diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A or a new diagnosis of hepatitis B or C within 24 weeks of dosing)
- •Chronic hepatitis
- •Prior use of any entry, attachment, CCR5 coreceptor, or fusion inhibitor, including PRO 140, experimental or approved
- •Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.
研究组 & 干预措施
Treatment Arm 4
PRO 140: one SC dose, 700 mg (day 1) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
干预措施: PRO 140 (Biological)
Treatment Arm 3
PRO 140: one SC loading dose, 700 mg (day 1), followed by one single SC dose 350 mg (day 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
干预措施: PRO 140 (Biological)
Treatment Arm 2
PRO 140: one SC loading dose, 700 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
干预措施: PRO 140 (Biological)
Treatment Arm 1
PRO 140: one SC dose, 350 mg (day 1), followed by two single SC doses, 350 mg each (days 8 and 15) Intervention: Drug: PRO 140 (humanized monoclonal antibody to CCR5)
干预措施: PRO 140 (Biological)
结局指标
主要结局
Maximum change in viral load following initiation of different dosing regimens of PRO140
时间窗: 59 days
Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL
次要结局
未报告次要终点