NCT00144248已完成4 期
A Pharmacokinetic Study to Assess Nevirapine Levels in HIV-infected Patients With Impaired Hepatic Function
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 8
- 主要终点
- The primary endpoints are the degree of hepatic impairment, steady state nevirapine clearance, and the increase in estimated clearance when trough is supplemented by plasma levels measured one, two and four hours after nevirapine administration
研究概览
简要总结
The objective of this study was to evaluate the steady-state clearance of nevirapine among HIV-1 positive patients with hepatic fibrosis, and to examine whether the degree of hepatic impairment influences clearance.
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
- 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
- •Male or female subjects >=18 years of age with HIV-1 infection and chronic liver disease as reflected by a documented biopsy with hepatic fibrosis present.
- •a. Participants must be receiving nevirapine 200 mg twice daily as part of a stable ARV regimen for a minimum of 6 weeks prior to trough level sample collection.
- •b. Participants receiving nevirapine 400 mg once daily as part of a stable ARV regimen for a minimum of 6 weeks, who are willing to switch to nevirapi0 mg twice daily for a minimum of 14 days prior to trough collection.
- •Participants must have uoxylin and Eosin (H and E) stained slide and one trichrome stained pathology slide available at the time of enrollment. There is no time restriction on liver biopsy slides that pathologically confirm the presence of cirrhosis. The presence of cirrhosis must be documented on the liver biopsy report.
- •Current (within the past 4 weeks) HIV antiviral therapy with other NNRTI's.
- •Concurrent use (within the past 7 days) of any of the following:
- •Systemic azole antifungal agents (fluconazole, itraconazole, ketoconazole, etc.)
- •Clarithromycin
- •St John's Wort
- •Inability to provide a blood sample.
- •Patients who have evidence for hepatic or other encephalopathy above Grade 1
- •Patients with renal failure who require dialysis.
- •Pregnant and/or breast feeding women..
排除标准
- 未提供
结局指标
主要结局
The primary endpoints are the degree of hepatic impairment, steady state nevirapine clearance, and the increase in estimated clearance when trough is supplemented by plasma levels measured one, two and four hours after nevirapine administration
时间窗: Up to 4 hours
次要结局
- Plasma levels of nevirapine metabolites of all patients and Child-Pugh scores among patients with cirrhosis.(Up to 14 hours)
研究者
研究点 (8)
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