An Open Label Study to Investigate the Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Drug Levels in Blood
研究概览
简要总结
This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.
Twenty HIV-1 infected subjects will be recruited, subjects will switch antiretroviral therapy to:
- tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus
- raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.
详细描述
This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.
Twenty HIV-1 infected subjects will be recruited. Eligible subjects will currently be receiving stable antiretroviral therapy with undetectable plasma HIV RNA and have no evidence of previous HIV- resistance mutations on genotypic resistance testing.
At baseline, subjects will switch antiretroviral therapy to:
- tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus
- raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.
Follow up over 6 months, subjects will attend on days 14, 90 and 180 for follow up visits that will include standard safety parameters. Assessment of cardiac biomarkers at baseline and on days 90 and 180 and assessment of neurocognitive function at screening, baseline and on day 180 will also be undertaken.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infected males or females
- •60 years of age or greater*
- •signed informed consent
- •willing to switch therapy as per study protocol
- •no previous exposure to raltegravir or HIV-1 integrase inhibitors
- •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 with no antiretroviral drug switches for at least 3 months
- •no previous clinically-significant resistance documented on HIV-1 genotypic resistance
- •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 with spermicide) 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 * 50% of total enrolled cohort will be 65 years of age or over. Subsequent to 10 subjects aged between 60 and 64 recruited, only subjects aged 65 or over will be eligible.
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
研究组 & 干预措施
Tenofovir/Emtricitabine and Raltegravir
Single arm study
tenofovir/emtricitabine 245/200 mg once daily and raltegravir 400 mg twice daily
干预措施: Raltegravir (Drug)
Tenofovir/Emtricitabine and Raltegravir
Single arm study
tenofovir/emtricitabine 245/200 mg once daily and raltegravir 400 mg twice daily
干预措施: Tenofovir (Drug)
Tenofovir/Emtricitabine and Raltegravir
Single arm study
tenofovir/emtricitabine 245/200 mg once daily and raltegravir 400 mg twice daily
干预措施: Emtricitabine (Drug)
结局指标
主要结局
Drug Levels in Blood
时间窗: Day 28
rategravir concentration
Changes in Haematology, Biochemistry and Virology Tests
时间窗: 6 months
full blood count, electrolytes and blood lipids will be measured at all visits to assess for changes through out the study. HIV viral load will also be measured to assess the efficacy of the medication at controlling the virus
次要结局
- Cerebral Function; Changes in Global Cognitive Z-score(6 months)
- Cardiovascular Disease Markers(6 months)