NCT00782301撤回4 期
A Multicenter, Randomized, Open, Comparative Trial Of Maraviroc Versus Etravirine Each In Combination With Darunavir/Ritonavir And Raltegravir For The Treatment Of Antiretroviral-Experienced HIV-1 Subjects Co-Infected With Hepatitis C And/Or Hepatitis B
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percentage of subjects with Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L through Week 48.
研究概览
简要总结
Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 RNA viral load of ≥1000 copies/mL at the screening visit. Detectable HCV RNA levels or Hepatitis B surface antigen (HBsAg) positive. Previous antiretroviral treatment experience with at least 2 antiretroviral drug classes for ≥3 months.
- •Documented resistance to an NNRTI as well as documented resistance to another antiretroviral agent.
- •CCR5 tropic virus detected by the TrofileTM assay.
排除标准
- •Suspected or documented active, untreated HIV-1 related Opportunistic Infection (OI) or other condition requiring acute therapy at the time of randomization (subjects on a stable (>1 month) secondary OI prophylaxis regimen are eligible for the study; subjects on a primary OI prophylaxis regimen of any duration are also eligible for the study).
- •Prior treatment with darunavir/ritonavir, raltegravir, or another integrase inhibitor, etravirine, maraviroc or another CCR5 inhibitor for more than 14 days at any time.
- •Subjects receiving treatment for chronic Hepatitis or the expected need to initiate HCV treatment within 48 weeks of randomization. (Subjects who were previously treated for Hepatitis C are eligible for the study).
- •AST and/or ALT greater than 5 times the upper limit of normal (ACTG Grade 3).
研究组 & 干预措施
Maraviroc
Active Comparator
干预措施: maraviroc (Drug)
Etravirine
Active Comparator
干预措施: etravirine (Drug)
结局指标
主要结局
Percentage of subjects with Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L through Week 48.
时间窗: 48 weeks
次要结局
- Percentage of HCV treated subjects with Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L through 96.(48 weeks)
- Time to development of Grade 3 and Grade 4 ALT test abnormalities associated with a change from baseline ALT ≥100 IU/L.(96 weeks)
- Percentage of subjects with Hy's law abnormalities through Week 48.(48 weeks)
- Percentage of HCV treated subjects with Hy's law abnormalities through Week 96.(96 weeks)
- Change from baseline in mean Hepatitis C viral load through Week 48(48 weeks)
- Undetectable HCV viral load 24 weeks after stopping HCV treatment.(240 weeks)
- Percentage of subjects with HIV-1 RNA levels <48 copies/mL at Week 48.(48 weeks)
- Change from baseline in CD4+ cell count at Week 48.(48 weeks)
- Change from baseline in mean hepatitis B DNA through Week 48(48 Weeks)
研究者
研究点 (1)
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