NCT00495677已完成2 期
A Randomised, Double-Blind, Placebo-Controlled, Multicentre Study In Asymptomatic Hiv-Infected Patients To Investigate The Pharmacodynamics, Pharmacokinetics, Safety And Toleration Of PF-00232798
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11
研究概览
简要总结
To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral doses of PF 00232798 in HIV-positive patient volunteers.
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 (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 patients between the ages of 18 and 55 years inclusive.
- •Patients with CCR5 tropic virus as determined by the Monogram PhenoSense Entry assay.
排除标准
- •Patients who have received any experimental drug within the past four months (prior to the first dosing day of the study) or who have previously received another CCR5 antagonist.
- •Patients with evidence of decompensated liver disease.
研究组 & 干预措施
PF-00232798 40 mg
Active Comparator
干预措施: PF-00232798 (Drug)
PF-00232798 300 mg
Active Comparator
干预措施: PF-00232798 (Drug)
PF-00232798 400 mg
Active Comparator
干预措施: PF-00232798 (Drug)
PF-00232798 5 mg
Active Comparator
干预措施: PF-00232798 (Drug)
PF-00232798 20 mg
Active Comparator
干预措施: PF-00232798 (Drug)
PF-00232798 150 mg
Active Comparator
干预措施: PF-00232798 (Drug)
结局指标
主要结局
Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11
时间窗: Baseline, Day 11
Viral load was determined using the Roche COBAS Taqman HIV-1 assay with a lower limit of detection of 40 copies per milliliter (copies/mL). Samples with an initial reading of less than 1,000,000 copies/mL were diluted into range and re-assayed.
次要结局
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)(0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10)
- Maximum Observed Plasma Concentration (Cmax)(0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning)
- Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load(Day 1 up to Day 25)
研究者
研究点 (1)
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