An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 753
- 试验地点
- 25
- 主要终点
- Number of Participants With Any Adverse Event (AE): Interim Analysis
研究概览
简要总结
GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.
详细描述
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age according to local requirements).
- •Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or PRO30017 or have participated in APV30001 or other studies as deemed appropriate by the project team.
排除标准
- •Permanent discontinuation of GW433908 in a previous study due to intolerance.
- •An active CDC Class C Event.
- •Any condition which, in the opinion of the investigator, would preclude a subject from participation.
结局指标
主要结局
Number of Participants With Any Adverse Event (AE): Interim Analysis
时间窗: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Number of Participants With Any Adverse Event (AE): Final Analysis
时间窗: Post January 2006; for up to 241 weeks
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
时间窗: Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
时间窗: Weeks 120, 180, 204, 216, and 432
Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216
时间窗: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216
blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168
时间窗: Baseline (Day 1) and Weeks 48, 96, 132, and 168
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432
时间窗: Weeks 120, 180, 204, 216, and 432
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
时间窗: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
时间窗: Baseline (Day 1) and Weeks 48, 96, 132, and 168
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
时间窗: Weeks 120, 180, 204, 216, and 432
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.
次要结局
- Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)(Baseline and Weeks 48, 120, 180, and 216)
- Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)(Baseline and Weeks 12, 24, 48, 60, 96, and 132)
- Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)(Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432)
- Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis(Baseline and Weeks 48, 120, 168, 180, 204, and 216)
- Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis(Baseline and Weeks 24, 48, 96, 132, and 168)
- Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216(Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216)
- Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168(Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168)
- Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432(Weeks 180, 240, 300, 360, 420, and 432)
- Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline(Baseline (Day 1) up to 31 January 2006 (up to Week 264))
- Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions(Baseline (Day 1) up to 31 January 2006 (up to Week 264))
- Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions(Baseline (Day 1) up to 31 January 2006 (up to Week 264))