A Phase 2a, Randomized, Double-blind, Placebo Controlled Study of PRO 140 by Subcutaneous Administration in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).
研究概览
简要总结
The purpose of this study is:
- To assess the antiviral activity of PRO 140
- To assess the safety and tolerability of PRO 140
- To generate additional PK, PD and safety data of PRO 140
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
- Triple (Participant, Care Provider, Investigator)
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 & females, age ≥ 18 years (or minimum adult age as determined by local regulatory authorities)
- •Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
- •CD4+ lymphocyte cell count ≥ 300 cells/mm3 and no documented count < or = 250 cells/mm3
- •Has not taken any antiretroviral therapy (ART) w/in 12 wks of Early Screening Visit
- •Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit
- •Clinically normal or "not clinically significant (NCS)" resting electrocardiogram
- •Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit & a negative urine pregnancy test w/in 72 hrs prior to first dose of study medication, & be non-lactating. Male & female subjects must agree not to participate in a conception process from Early Screening Visit through Day 59.
排除标准
- •CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ Assay.
- •Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant during the study.
- •History of active hepatitis within the previous 24 wks
- •Prior use of any entry, attachment, CCR5 co-receptor 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
Arm 4
PBO for three single SC doses: Days 1, 8 and 15
干预措施: Placebo Comparator (Drug)
Arm 1
PRO 140 for three single SC doses: Days 1, 8, and 15
干预措施: PRO 140 (humanized monoclonal antibody to CCR5) (Drug)
Arm 2
PRO 140 for three single SC doses: Days 1, 8 and 15
干预措施: PRO 140 (humanized monoclonal antibody to CCR5) (Drug)
Arm 3
PRO 140 for two single SC doses: Days 1 and 15 plus one SC dose of PBO at Day 8
干预措施: PRO 140 (humanized monoclonal antibody to CCR5) (Drug)
结局指标
主要结局
Maximum Change in Viral Load Following Initiation of Treatment (Viral Load is Defined as HIV-1 Copies/mL and Expressed as log10 Copies/mL).
时间窗: 59 days
The primary end point was the maximum change from baseline in viral load following initiation of treatment, defined as HIV-1 copies/mL, measured by the Roche Amplicor HIV-1 Monitor UltraSensitive™ Test (lower limit of detection \[LLD\] = 48 copies/mL).
次要结局
未报告次要终点