A Randomised, Double Blind, Placebo-controlled, Multicenter Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8
研究概览
简要总结
A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability of UK-453,061 in asymptomatic HIV infected subjects.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Asymptomatic HIV-1 infected male and patients aged 18-55 years inclusive.
- •Patients with virus not containing NNRTI resistant mutations as determined by the VircoGEN virtual phenotyping essay.
排除标准
- •Patients with a CD4 count less than 250 cells/mm
- •Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for whom there is evidence of recent seroconversion.
- •Patients with an HIV viral load less than 5000 copies/ml using RT-PCR(Roche Amplicor v1.5).
研究组 & 干预措施
Stage 1
干预措施: UK-453,061 (Drug)
Stage 2
干预措施: UK-453,061 (Drug)
结局指标
主要结局
Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8
时间窗: Baseline, Day 8
Change from baseline in log 10-transformed plasma viral load(Human Immunodeficiency Virus-1 Ribonucleic Acid\[HIV-1 RNA\]) levels(log10 copies/milliliter\[copies/mL\])reported.Viral load determined using reverse transcriptase-polymerase chain reaction(RT-PCR) assay with standard lower limit of detection(LLOD) 400 copies/mL.For samples with reading less than (\<)400 copies/mL,assay repeated using ultra sensitive method with LLOD of 50 copies/mL.Values below limit of quantification(LOQ) 50 copies/mL set to 50 copies/mL.Baseline was mean of three pre-dose values taken at screening,randomization,Day 1.
次要结局
- Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load(Day 8 up to Follow-up (Day 38 to 40 [31 to 33 days post-last dose]))