NCT00634959已完成2 期
An Investigation Into The Effects Of Food And Dose Regimen On Viral Load Response In HIV Infected Patients On Short-Term Monotherapy With UK-427,857 (Maraviroc)
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
- 37
- 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 effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Asymptomatic HIV-1 infected male and female patients
- •Weight between 50 and 100kg and within the permitted range for their height
- •Patients with virus that targets CCR5 receptor
排除标准
- •Patients with a CD4 count <250 cells/mm3 or HIV viral load <5000 copies/mL
- •Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion
- •Patients with acquired immunodeficiency syndrome (AIDS) or a previous AIDS diagnosis
- •Patients who are taking or have taken antiretroviral drugs in the eight weeks prior to the study screening visit
研究组 & 干预措施
1
Experimental
干预措施: Maraviroc (UK-427,857) (Drug)
2
Experimental
干预措施: Maraviroc (UK-427,857) (Drug)
3
Experimental
干预措施: Maraviroc (UK-427,857) (Drug)
4
Experimental
干预措施: Maraviroc (UK-427,857) (Drug)
5
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
UK-427,857 pharmacokinetics
时间窗: Days 1-11
次要结局
- Physical examination(Days 1, 11, 40)
- 12-lead ECG(Days 1-11 and Day 40)
- Relationship of change in viral load (baseline to Day 11) versus mean receptor saturation (Day 10)(Days 1-11)
- Time course of viral load from baseline to follow-up(Days 1-13 and Days 15, 19, 22, 25, 40)
- CCR5 receptor saturation(Days 1, 5, 10, 11, 13, 15, 19, 40)
- Adverse events(Days 1-40)
- Relationship of change in viral load (baseline to Day 11) versus baseline susceptibility (IC50 and IC90)(Days 1-11)
- Laboratory safety(Days 1, 3, 7, 11, 15, 40)
- Relationship of change in viral load (baseline to Day 11) versus average and trough plasma concentrations (Day 10)(Days 1-11)
- Supine/standing blood pressure and pulse rate(Days 1-11 and Day 40)
- Time to rebound of viral load(Days 1-13 and Days 15, 19, 22, 25, 40)
研究者
研究点 (1)
Loading locations...
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