Pharmacokinetics of Pediatric Aluvia® (Lopinavir /Ritonavir 100/25 mg) and Generic Lopinavir/Ritonavir Tablet Formulation (200/50 mg) in Clinically and Virologically Stable HIV-1 Infected Thai Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- AUC, Cmin, Cmax of LPV/r between Aluvia and generic
研究概览
简要总结
The purpose of this study is to study the pharmacokinetics profiles of generic lopinavir/ritonavir and Pediatric Aluvia® at reduced dose by assessing safety, tolerability and efficacy.
详细描述
This is a prospective, 2 arms, randomized intensive PK study with cross over design. This design will provide us optimal information to answer our research question. First and most important, we can assess the PK when lopinavir/r is used in a dose reduced form. By randomizing the patients to either Abbott's pediatric Aluvia dose reduction or India generic LPV/r dose reduction will allow us to assess the differences in AE severity and frequency. Using the standard abbott product as a control our study will provide important information about the bioavailability of the generic product. Although it's not an original BE design we must be able to make preliminary comparisons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Signed informed consent
- •Evidence of HIV infection (confirmed positive ELISA and/or documented history of measurable HIV RNA)
- •Age> 18 years
- •Have been on standard dose of any PI containing regimen for at least 4 weeks prior to study entry
- •Currently having no AIDS defining illness
- •Plasma HIV RNA < 50 copies/mL for at least 24 weeks
- •Willing to adhere to the protocol requirements
排除标准
- •Any history of taking CYP450 inhibitors or inducers, or any gastric acid-reducing drugs within 14 days of enrollment in the study
- •Current pregnancy or lactating
- •Active opportunistic infection
- •ALT/ AST more than 2x upper limit
- •creatinine more than 1.5 time the upper limit
- •Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion
- •History of sensitivity/idiosyncrasy to the drug or chemically related compounds or pharmaceutical excipients which may be employed in the study.
- •Active drug abuse
研究组 & 干预措施
1
First Generic LPV/r 200/50 mg BID, then cross over to Pediatric Aluvia 200/50 mg BID
干预措施: Generic LPV/r and Aluvia (pharmacokinetics) (Drug)
2
First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID
干预措施: Aluvia and Generic LPV/r (pharmacokinetics) (Drug)
结局指标
主要结局
AUC, Cmin, Cmax of LPV/r between Aluvia and generic
时间窗: week 2
AUC, Cmin, Cmax of LPV/r between Aluvia and generic
次要结局
未报告次要终点