Pharmacokinetics of Efavirenz During Treatment of HIV-1 Infected Subjects With Hepatic Impairment.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Area Under the Plasma Concentration-time Curve Over the Dosing Interval of 24 Hours (AUC[TAU])
研究概览
简要总结
The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable antiretroviral regimens containing EFV, and having selected degrees of hepatic impairment or normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •HIV-1 infection with or without Hepatitis B or C infection
- •Stable antiretroviral regimen containing efavirenz and nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) for at least 1 month
- •Mild, moderate or severe hepatic impairment with hepatic cirrhosis
排除标准
- •Acute flare of hepatitis
- •Positive pregnancy test for a female
- •Significant acute medical illness in past 2 months
- •Use of agents known to significantly affect liver metabolism
- •Change in medications to treat a chronic disease in the past 2 months
研究组 & 干预措施
EFV600mg Participants With Mild Hepatic Impairment
干预措施: efavirenz containing antiretroviral regimen (Drug)
EFV600mg Participants With Moderate Hepatic Impairment
干预措施: efavirenz containing antiretroviral regimen (Drug)
EFV600mg Participants With Severe Hepatic Impairment
干预措施: efavirenz containing antiretroviral regimen (Drug)
EFV600mg Participants With Normal Hepatic Function
干预措施: efavirenz containing antiretroviral regimen (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve Over the Dosing Interval of 24 Hours (AUC[TAU])
时间窗: Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.
The AUC(TAU), from time 0 to the time of the last measurable concentration (t), was calculated by the linear trapezoidal rule.
Maximum Plasma Concentration (Cmax)
时间窗: Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.
Cmax was obtained directly from the concentration-time data.
Minimum Plasma Concentration (Cmin)
时间窗: Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.
Cmin was obtained directly from the concentration-time data.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.
Tmax was obtained directly from the concentration-time data.
次要结局
- Number of Participants Who Experienced AEs Leading to Study Drug Discontinuation(From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).)
- Number of Participants With Marked Abnormalities (MAs) in Hematology Measurements(Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.)
- Number of Participants With Serum Chemistry MAs(Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.)
- Number of Participants With Urinalysis MAs(Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.)
- Number of Participants With Identified Electrocardiogram (ECG) Abnormalities(From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing))
- Number of Participants Who Died or Experienced Other Serious Adverse Events (SAEs)(From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing). Participants were monitored for SAEs up to 30 days after study discharge.)
- Number of Participants Who Experienced AEs(From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).)
- Number of Participants With Clinically Meaningful Vital Signs Measures(From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing))
- Number of Participants With Abnormal Physical Examination Findings at Baseline (Screening and/or Day 1)(From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing))