NCT00643643已完成2 期
A Randomised, Double Blind, Placebo-Controlled, Multicentre Study Of UK-427,857 25mg O.D. , 50mg B.I.D., 100mg B.I.D And 300mg B.I.D. In Asymptomatic HIV Infected Patients To Investigate Pharmacodynamics, Pharmacokinetics, Safety And Toleration.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change from baseline in viral load
研究概览
简要总结
To investigate the relationship between the pharmacokinetics and pharmacodynamics of UK-427,857 and its antiviral effects in patients with human immunodeficiency virus (HIV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Male with HIV or surgically sterilized female with HIV showing no symptoms of HIV
- •Weight between 50 and 90kg and within the permitted range for their height
排除标准
- •Exclusion criteria:
- •Subjects with a CD4 count less than 250cells/mm3 or HIV viral load of less than 5000 copies/mL
- •Subjects with acquired immune deficiency syndrome (AIDS) or a previous AIDS diagnosis
- •Subjects whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion
- •Subjects who have taken anti-retroviral drugs in the eight weeks prior to the study screening visit
研究组 & 干预措施
A
Experimental
干预措施: Maraviroc (UK-427,857) (Drug)
B
Experimental
干预措施: Maraviroc (UK-427,857) (Drug)
C
Experimental
干预措施: Maraviroc (UK-427,857) (Drug)
D
Experimental
干预措施: Maraviroc (UK-427,857) (Drug)
E
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in viral load
时间窗: Day 11
Pharmacokinetic profile of UK-427,857
时间窗: Days 1 and 10
Receptor saturation
时间窗: Days 1, 5, 10, 11, 13, 15, 19, 40
次要结局
- 12-lead electrocardiography(Days 1-11 and Day 40)
- Time course of viral load from baseline to follow-up(Days 1-15 and Days 19, 22, 25, 40)
- Time to rebound of viral load(Days 1-15 and Days 19, 22, 25, 40)
- The relationship of change in viral load (from baseline to day 11) versus average (Days 1-11) and trough (Day 10) plasma concentrations(Days 1-11)
- The relationship of change in viral load (from baseline to day 11) versus mean receptor saturation (Day 10)(Days 1-11)
- The relationship of change from baseline in viral load versus baseline virus susceptibility (IC 50 and IC 90)(Days 1-11)
- Adverse events(Days 1-40)
- Laboratory safety testing(Days 1, 3, 7, 11, 15, 40)
- Physical examination(Days 1, 11, 40)
- Supine and standing blood pressure and pulse rate(Days 1-11 and Day 40)
研究者
研究点 (1)
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