A Phase IIa, Open-label, Randomized Trial in Treatment-naive HIV-1-infected Subjects to Determine the Antiviral Activity of 14 Days of Monotherapy With 4 Different Dose Regimens of TMC310911 Coadministered With Ritonavir
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 主要终点
- Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA)
研究概览
简要总结
The purpose of this study is to evaluate the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 4 different dose regimens of TMC310911 co-administered with ritonavir.
详细描述
This is an open-label (all people know the identity of the intervention) and randomized (study medication assigned by chance) study in treatment-naive human immunodeficiency virus type 1 (HIV-1)-infected participants (participants who had not been treated with a therapeutic HIV vaccine within 1 year prior to enrollment and who had never been treated with an antiretroviral [ARV] medication indicated for the treatment of HIV-infection or ARVs for treatment of hepatitis B infection with anti-HIV activity prior to screening). In this study approximately 32 participants will be enrolled and randomly assigned to receive 4 different dose regimens co-administered with ritonavir (8 participants in each dosing regimen). The trial will consist of a screening period (maximum 6 weeks), a treatment period with TMC310911 (2 weeks), and a follow-up period (4 weeks). Safety evaluation will include assessment of adverse events, clinical laboratory tests, vital sign measurements, physical examinations and electrocardiograms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Documented human immunodeficiency virus type 1 (HIV-1) infection for at least 6 months prior to the screening date
- •Participant who has not been treated with a therapeutic HIV vaccine within 1 year prior to enrolment and has never been treated with an antiretroviral (ARV) medication indicated for the treatment of HIV infection or ARVs for treatment of hepatitis B-infection with anti-HIV activity
- •Participant agrees not to start antiretroviral therapy (ART) before the baseline visit
- •Able to comply with the protocol requirements and have good accessible veins
- •HIV-1 plasma viral load at screening visit of above 5,000 HIV-1 Ribonucleic acid copies/mL
- •CD4+ cell count above 200 cells/mm3 at screening
排除标准
- •HIV-2 infected participants and/or participants with any active or chronic hepato-renal disease
- •Life expectancy of less than 6 months
- •Documented acute (primary) HIV-1 infection
- •Pre-existing protease inhibitor (PI) medication resistance
- •Any currently active Acquired Immunodeficiency Syndrome (AIDS) - defining illness
- •Any active clinically significant disease or findings during screening or medical history or physical examination that in the investigator's opinion, would compromise the outcome of the study
- •Any confirmed grade 3 or 4 toxicity according to the Division of AIDS (DAIDS) grading scale at screening
研究组 & 干预措施
TMC310911/rtv 75/100 mg twice daily
TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
干预措施: TMC310911 75 mg twice daily (Drug)
TMC310911/rtv 75/100 mg twice daily
TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
干预措施: Ritonavir 100 mg twice daily (Drug)
TMC310911/rtv 150/100 mg twice daily
TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
干预措施: TMC310911 150 mg twice daily (Drug)
TMC310911/rtv 150/100 mg twice daily
TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
干预措施: Ritonavir 100 mg twice daily (Drug)
TMC310911/rtv 300/100 mg twice daily
TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
干预措施: TMC310911 300 mg twice daily (Drug)
TMC310911/rtv 300/100 mg twice daily
TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
干预措施: Ritonavir 100 mg twice daily (Drug)
TMC310911/rtv 300/100 mg once daily
TMC310911 300 mg + ritonavir 100 mg once daily on Days 1 to 14
干预措施: TMC310911 300 mg once daily (Drug)
TMC310911/rtv 300/100 mg once daily
TMC310911 300 mg + ritonavir 100 mg once daily on Days 1 to 14
干预措施: Ritonavir 100 mg once daily (Drug)
结局指标
主要结局
Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA)
时间窗: Baseline (Day 1), Day 8, Day 15
The antiviral activity of TMC310911 is measured by the change in viral load from baseline in the 14 days of treatment following initiation of treatment with 4 different dosing regimens of TMC310911 coadministered with ritonavir.
次要结局
- Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment Period(14 days)
- Mean Changes From Baseline in CD4+ Cell Count(Baseline (Day 1), Day 8, Day 15)
- Maximum Plasma Concentration (Cmax) of TMC310911(Day 1 and Day 14)
- Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911(Day 1 and Day 14)
- Area Under the Plasma Concentration-time Curve (AUC12) From the Time of Administration of TMC310911 up to 12 Hours After Dosing(Day 1 and Day 14)
- Predose Plasma Concentration (C0h) of TMC310911(Day 2, Day 3, Day 4, Day 6, Day 8, Day 10, Day 12 and Day 14)
- Average Steady-state Plasma Concentration (Css,av) of TMC310911(Day 14)
- Fluctuation Index of TMC310911(Day 14)