A Phase II, Open-label Trial, to Evaluate the Safety, Tolerability and Antiviral Activity of TMC125 in Antiretroviral Experienced HIV-1 Infected Children and Adolescents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 主要终点
- The Number of Patients With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.
详细描述
The study design is a single arm treatment (all patients assigned to receive etravirine), open label (patients will know the identity of the treatments they are receiving) safety and antiviral activity of Etravirine (TMC125) in treatment-experienced, HIV infected children and adolescents 6 to 17 years of age. Etravirine is a new drug belonging to the NNRTI (a non-nucleoside reverse transcriptase inhibitor) drug class that slows down the growth of the human immunodeficiency virus (HIV). This drug has been tested for safety and effectiveness in adults, however, there is no data on the drug's long-term safety and antiviral activity in children and adolescents. This study will last for a maximum of 48 weeks. A total of 100 ptients will receive etravirine tablets based on body weight and an investigator selected optimized background regimen (OBR) of at least 2 antiretrovirals (ARVs), consisting of a boosted protease inhibitor (PI) and nucleoside reverse transcriptase inhibitor(s) (NRTI[s]). Use of enfuvirtide is optional. Safety will be monitored throughout the study.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infected
- •Body weight according to age within the 10-90th percentile of CDC growth chart
- •On steady antiretroviral therapy regimen for at least 8 weeks at screening and willing to remain on that regimen until baseline
- •HIV viral load of 1,000 copies/ml or greater at study entry
- •Parent or legal guardian willing to provide informed consent, if necessary
排除标准
- •The Key Exclusion Criteria are: Evidence of resistance to etravirinel Any grade 3 or 4 toxicity (More information available in the protocol)
- •Use of disallowed concomitant therapy (specified in the protocol)
- •Currently active AIDS defining illness (category C)
- •Active hepatitis A, B or C virus infection
- •Any clinically significant diseases or findings that, in the opinion of the investigator, would interfere with the study
- •Receipt of any ARV or non-ARV investigational medication or investigational vaccine within 30 days prior to screening
- •History of clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC125)
研究组 & 干预措施
Etravirine (TMC125)
干预措施: Etravirine (TMC125) (Drug)
Etravirine (TMC125)
干预措施: Optimized background regimen (OBR) (Drug)
结局指标
主要结局
The Number of Patients With Treatment-emergent Adverse Events (TEAEs)
时间窗: 48 weeks
A treatment-emergent adverse event (TEAE) was defined as an event that occurred in the 48-week treatment period during which it emerged (i.e. started or worsened in severity, relation, or other attribute), and not in the subsequent study periods, even if the event continued to be present. Adverse events were graded from 1 to 4 in severity using the Division of Acquired Immunodeficiency Syndrome severity scale (grade 1 being less severe and grade 4 being more severe). ETR=etravirine/TMC125; OBR=optimized background regimen
The Percentage of Patients With Treatment-emergent Adverse Events (TEAEs)
时间窗: 48 weeks
The percentage of patients with a treatment-emergent adverse event (TEAE) (defined as an event that occurred in the 48-week treatment period during which it emerged \[i.e. started or worsened in severity, relation, or other attribute\], and not in the subsequent study periods, even if the event continued to be present\] are provided below. Adverse events were graded from 1 to 4 in severity using the Division of Acquired Immunodeficiency Syndrome severity scale (grade 1 being less severe and grade 4 being more severe). ETR=etravirine/TMC125; OBR=optimized background regimen
次要结局
- Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Area Under the Plasma Concentration-time Curve Over 12 Hours at Steady-state (AUC12h)(Weeks 4-48)
- Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Trough Plasma Concentration (C0h)(Week 48)
- Population Pharmacokinetic (PK) Estimates of Etravirine/TMC125 (ETR): Maximum Plasma Concentration (Cmax)(Week 4)
- Percentage of Patients With Virologic Response at Week 24(Week 24)
- Change From Baseline in Human Immunodeficiency Virus - Type 1 (HIV-1) Ribonucleic Acid (RNA) in Plasma Over Time(Baseline, Week 48)
- The Change From Baseline in CD4 Cell Counts Over Time(Baseline, Week 48)
- The Emergence of Non-nucleoside Reverse Transcriptase Inhibitor Resistance-associated Mutations (NNRTI RAMs) in Patients Classified as Virologic Failures(Baseline and Endpoint (up to Week 48))