NCT00162149已完成1 期
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Nevirapine on the Pharmacokinetics of Atazanavir in HIV-Infected Individuals
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2005年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Steady state pharmacokinetics of atazanavir/ritonavir 300/100mg & 400/100mg each co-administered w/ nevirapine 200mg twice-daily w/ 2 to 3 nucleoside reverse transcriptase inhibitors relative to that of a second cohort of subj.
研究概览
简要总结
Open-Label, multiple-dose, drug interaction study to assess the effect of nevirapine on the pharmacokinetics of atazanavir in HIV-infected individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •signed informed consent form
- •For Cohort 1, HIV-infected subjects receiving nevirapine 200 mg twice-daily and 2 to 3 NRTIs for at least 6 weeks
- •For Cohort 2, HIV-infected subjects receiving atazanavir 300 mg and ritonavir 100 mg once-daily and 2 to 3 NRTIs for at least 6 weeks
- •Have had 2 measurements of plasma HIV RNA of <400 copies/mL. The first test being 6 to 16 weeks prior and the second being within 3 weeks prior to Day 1
- •Have CD4 cell count >=200 cells/mm3
- •Body Mass Index of 18 to 35 kg/m
- •Men and women, ages 18 to 55.
排除标准
- •Women who are pregnant or breastfeeding
- •Presence of a newly diagnosed HIV-related opportunistic infection or CD4 cell count <200 cell/mm3 within the previous 6 months.
- •Any significant acute or chronic medical illness, unless stable or controlled by a non-prohibited medication.
- •History of virologic failure on an antiretroviral regimen.
研究组 & 干预措施
A1
No Intervention
干预措施: Nevirapine (Drug)
A2
Experimental
干预措施: Nevirapine + Atazanavir/Ritonavir (Drug)
A3
Experimental
干预措施: Nevirapine + Atazanavir/Ritonavir (Drug)
B1
No Intervention
干预措施: Atazanavir + Ritonavir (Drug)
结局指标
主要结局
Steady state pharmacokinetics of atazanavir/ritonavir 300/100mg & 400/100mg each co-administered w/ nevirapine 200mg twice-daily w/ 2 to 3 nucleoside reverse transcriptase inhibitors relative to that of a second cohort of subj.
次要结局
- Steady state PK of 2 atazanavir/ritonavir&nevirapine regimens relative to historic data of atazanavir 400mg in HIV-inf subj;Safety & tolerability of co-admin of atazanavir,ritonavir,&nevirapine in the presence of 2to3 nucleoside rev. transcriptase inhibi
研究者
研究点 (1)
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