A Phase I Pharmacokinetic Study to Assess the Cerebrospinal-fluid (CSF) Exposure of Rilpivirine in HIV-infected Subjects Switching From TDF/FTC/Nevirapine to TDF/FTC/Rilpivirine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- CSF:Plasma Ratio of Rilpivirine Levels
研究概览
简要总结
This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of the study the participants will attend clinic where they will have blood collected followed by a lumbar puncture where cerebrospinal fluid will be collected to measure drug concentration. The participants will then restart their original regime with nevirapine.
详细描述
To investigate the following parameters in HIV-infected patients switching antiretroviral therapy from TDF/FTC/nevirapine to TDF/FTC/rilpivirine for 60 days:
- CSF exposure and CSF : plasma ratio of rilpivirine
- Safety and tolerability of switching antiretroviral therapy from TDF/FTC/nevirapine to TDF/FTC/rilpivirine
- Changes in cerebral metabolites measured via 1-H MRS after switching antiretroviral therapy to TDF/FTC/rilpivirine
- Seminal fluid exposure of rilpivirine
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infected males subjects
- •signed informed consent
- •willing to switch therapy as per study protocol
- •no previous exposure to rilpivirine
- •plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the last 3 months
- •currently receiving a stable antiretroviral regimen comprising of TDF/FTC with nevirapine with nevirapine dosed either 200 mg twice daily or 400 mg once daily with no antiretroviral drug switches for at least 3 months
- •no clinically-significant resistance documented on any prior HIV-1 genotypic resistance testing
- •subjects in good health upon medical history, physical exam, and laboratory testing
- •BMI above or equal to 18 and below 32
- •Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom and diaphragm) during heterosexual intercourse, from screening through completion of the study.
- •Have local screening laboratory results (haematology and chemistry that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance
- •No contraindications to having a lumbar puncture examination found on MRI of the brain
排除标准
- •current alcohol abuse or drug dependence
- •positive urine drug of abuse screening
- •active opportunistic infection or significant co-morbidities
- •current disallowed concomitant medication (as listed in section 4.1.3)
- •contraindication to MR examination or lumbar puncture examination
- •recent head injury (in last 30 days) or chronic ongoing neurological diseases
研究组 & 干预措施
Rilpivirine and Truvada
TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
干预措施: Rilpivirine (Drug)
结局指标
主要结局
CSF:Plasma Ratio of Rilpivirine Levels
时间窗: Day 60
The levels of rilpivirine will be measured in the cerebral spinal fluid and plasma after 60 days of exposure
次要结局
- Number of Subjects With HIV Viral Load Above 50 Copies Per mL(Day 3,14, 28, 60, 80-100)