A Phase 1 Pharmacokinetic Study to Assess the Steady State Pharmacokinetic Profile and Short Term Safety of Maraviroc Dosed With Darunavir/Ritonavir All Once Daily, With and Without Nucleoside Analogues, in HIV-1 Infected Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- The Ratio of the Maximum Plasma Concentration of Maraviroc Between 20 and 10 Day
研究概览
简要总结
This is a phase I, open label, prospective, two phase pharmacokinetic study. Subjects currently attending for HIV care at St. Mary's Hospital, London will be eligible.
详细描述
The study will describe the steady state pharmacokinetic parameters and short term safety of maraviroc/darunavir/ritonavir dosed at 150/800/100 mg once daily with and without tenofovir/emtricitabine 245/200 mg once daily in HIV-1 infected subjects.
Fifteen HIV-1 infected subjects will be recruited. Eligible subjects will currently be receiving antiretroviral therapy comprising:
- tenofovir/emtricitabine 245/200 mg daily plus
- darunavir/ritonavir 800/100 mg daily
On day 1, subjects will modify their current antiretroviral therapy to the following:
- tenofovir/emtricitabine 245/200 mg daily plus
- darunavir/ritonavir 800/100 mg daily plus
- maraviroc 150 mg daily On day 10 subjects will undergo an intensive pharmacokinetic visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infected males or females
- •signed informed consent
- •plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the last 3 months
- •currently receiving an antiretroviral regimen comprising of: tenofovir 245 mg daily,emtricitabine 200 mg daily, darunavir 800 mg daily and ritonavir 100 mg daily
- •no previous protease inhibitor resistance documented on HIV-1 genotypic resistance testing if an HIV resistance test available
- •Between 18 to 65 years of age, inclusive
- •subjects in good health upon medical history, physical exam, and laboratory testing
- •BMI above or equal to 18 and below 32
- •Female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must practice contraception as follows from screening until 8 weeks after completion of the study:
- •barrier contraceptives (condom OR diaphragm PLUS spermicide) or oral, implant or injectable hormonal contraceptive PLUS a barrier contraceptive or
- •IUD /IUS PLUS a barrier contraceptive
- •Female subjects of childbearing potential must have a negative urine pregnancy test.
- •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 no serologic evidence of active HBV infection evidenced by negative hepatitis B surface antigen and no serologic evidence of hepatitis C virus infection evidenced by a negative HCV antibody at screening.
- •Have 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
- •CCR5 tropic HIV virus based on a genotypic tropism assay from either a stored plasma sample where available or fresh plasma
排除标准
- •current alcohol abuse or drug dependence
- •positive urine drug of abuse screening
- •pregnancy
- •active opportunistic infection or significant co-morbidities
- •current disallowed concomitant medication
研究组 & 干预措施
Truvada, Darunavir/r and Maraviroc
Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada
干预措施: Maraviroc (Drug)
Truvada, Darunavir/r and Maraviroc
Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada
干预措施: Truvada (Drug)
Truvada, Darunavir/r and Maraviroc
Participants will be taking Truvada, Darunavir/r before entering the study. On day 1 they will add maraviroc then on day 11 they will stop the Truvada
干预措施: Darunavir (Drug)
结局指标
主要结局
The Ratio of the Maximum Plasma Concentration of Maraviroc Between 20 and 10 Day
时间窗: 10 day, 20 days
On day 10 of the study the maximum concentractions of maraviroc will be measured . On day 20 of the study the maximum plasma concentractions maraviroc will be measured .
次要结局
- Number of Participants With Changes in Haematology and Biochemistry Laboratory Tests(35 days)