The Pharmacokinetics of Atazanavir / Ritonavir 200/100 OD Versus 300/100 mg OD in Combination With 2 NRTIs in HIV Pre-treated Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- the pharmacokinetics of atazanavir/ritonavir (ATV/RTV) 200/100 mg once daily in a sample of 22 patients experiencing virological success
研究概览
简要总结
Several studies from HIV-NAT have demonstrated high nevirapine, indinavir, saquinavir and lopinavir/r levels when compared to Caucasian patients. Until now, the pharmacokinetics of atazanavir have not been explored in a Thai population. We postulate that ATV levels, as with other PIs, are higher in Thai people. Therefore, the level of ATV in ATV/RTV 300/100 OD may be higher than the acceptable range and could be associated with ATV related toxicity.
详细描述
We are interested in once daily ATV/RTV 200/100 mg OD because of the convenience, reduction in ATV doses which may improve adherence while reducing toxicity and cost. There are limited prospective studies evaluating pharmacokinetic and long term efficacy and safety of atazanavir/ritonavir once daily dose in combination of NRTIs in HIV-1 pretreated patients. We believe that the PK parameters of ATV/RTV given at 200/100mg daily in Thai patients will be equivalent to the ATV/RTV 300/100mg once daily dosing in Caucasian patients when combined with 2NRTIs, and that the once daily regimen will have better safety, tolerability profile, and cost saving while maintaining good CD4 and VL outcome. If, the pharmacokinetic profile of ATV/RTV 200/100 mg OD + 2NRTIs is in acceptable range or comparable with standard dose of ATV/RTV 300/100 mg OD, long term efficacy will be explored later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Adults HIV patients currently using ATV/RTV 300/100 mg OD plus 2 NRTIs
- •HIV RNA < 50 copies/ml
排除标准
- •Inability to understand the nature and extent of the study and the procedures required.
- •ALT/ AST more than 5x upper limit
- •Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
- •Use of concomitant medication that may interfere with the pharmacokinetics of atazanavir, and ritonavir
- •History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
- •Active drug abuse or heavy alcoholic drinking
- •History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
- •Active drug abuse or heavy alcoholic drinking
研究组 & 干预措施
1
ATV/r 300/100 mg
干预措施: Atazanavir (Drug)
2
ATV/r 200/100 mg OD
干预措施: Atazanavir (Drug)
结局指标
主要结局
the pharmacokinetics of atazanavir/ritonavir (ATV/RTV) 200/100 mg once daily in a sample of 22 patients experiencing virological success
时间窗: 1 year
次要结局
- short term safety, tolerability and efficacy data in these PK participating patients(4 weeks)
- The pharmacokinetic and pharmacodynamic between these patients and data from Thai cohort treated with ATV/RTV 300/100 mg OD(4 weeks)