NCT01327547已完成4 期
A Multicenter, Randomized, Blinded, Placebo-controlled Study To Evaluate The Safety Of Maraviroc In Combination With Other Antiretroviral Agents In Hiv-1-infected Subjects Co-infected With Hepatitis C And/or Hepatitis B Virus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 48
- 主要终点
- Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48
研究概览
简要总结
To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV coinfected with HCV and/or HBV.
- •Undetectable HIV-1 RNA for at least 3 months prior to the screening visit
- •Treatment with current antiretroviral therapy (3-6 drugs excluding low-dose ritonavir) for at least 5 months.
排除标准
- •Currently receiving maraviroc.
- •Active opportunistic infections.
- •ALT and/or AST >5x upper limit of normal.
- •Direct bilirubin >1.5x upper limit of normal.
- •Severe or decompensated liver disease.
- •Liver disease unrelated to viral hepatitis infection.
研究组 & 干预措施
1.0
Experimental
干预措施: Maraviroc (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48
时间窗: 48 weeks
Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as \>5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or \>3.5x baseline for participants whose baseline ALT \>ULN, up to and including Week 48 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.
次要结局
- Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144(Week 48, 96 and 144)
- Time to Development of Grade 3 and Grade 4 ALT Abnormalities(144 weeks)
- Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48, 96 and 144(Week 48, 96 and 144)
- Mean Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48, 96 and 144(48, 96 and 144 weeks)
- Mean Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48, 96 and 144(48, 96 and 144 weeks)
- Absolute Fibrosis Score (Ishak) in Liver Biopsy Samples at Baseline and at Week 144(Baseline and Week 144)
- Exposure-response Relationship Between Change From Baseline in Liver Fibrosis Biomarkers Versus MVC Cavg at Week 48(Week 48)
- Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L(144 weeks)
- Number of Participants With Hy's Law Abnormalities Through Week 144(144 weeks)
- Mean Change From Baseline in CD38 Expression on CD4 and CD8 Cells at Weeks 48, 96 and 144(48, 96 and 144 weeks)
- Mean Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48, 96 and 144.(48, 96 and 144 weeks)
- Mean Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48, 96 and 144(48, 96 and 144 weeks)
- Mean Change From Baseline in Markers of Immune Activation: D Dimer - Week 48, 96 and 144(48, 96 and 144 weeks)
- Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Through Week 144(Week 96 and 144)
- Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 144 Associated With a Change From Baseline ALT >100 IU/L(144 weeks)
- Mean Change From Baseline in Log10 Plasma Hepatitis C Virus (HCV) RNA at Week 48, 96 and 144(48, 96 and 144 weeks)
- Change From Baseline in Fibrosis Score (Ishak) in Liver Biopsy Samples at Week 144(Week 144)
- Summary of Estimated Maraviroc PK Parameters(Week 48)
- Mean Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48, 96 and 144(48, 96 and 144 weeks)
- Percentage of Participants Who Were Hospitalized Due to Hepatic Disease Through Week 144(144 Weeks)
研究者
研究点 (48)
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