Randomized, Controlled, Open Label, Pilot Study to Evaluate Fosamprenavir Activity on Genotype 1 Hepatitis C Virus (HCV) Infection Evolution in Human Immunodeficiency Virus (HIV) Co-infected Subjects With Antiretroviral Treatment Including Fosamprenavir
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- HCV Viral load and changes in HCV protease gene
研究概览
简要总结
This study examines the impact of fosamprenavir as part of an ART on virological, immunological and clinical parameters of genotype 1 HCV infection in HIV co-infected subjects. Fosamprenavir could have a direct or immune-mediated activity against HCV. If this is shown to be true, changes in HCV viral load or biological characteristics could be demonstrated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 yo
- •HIV/HCV co-infected patients with HCV detectable viremia in 2 determinations separated at least by 6 months.
- •HCV genotype 1
- •Currently receiving ART including 2NRTI+1 PI/r (excluding FPV) or 1 NNRTI, without changes in the last 6 months
- •HIV RNA < 50 copies/mL for the last 6 months
排除标准
- •Previous anti HCV treatment
- •Foreseeable HCV treatment in the next 12 months
- •Acute HCV infection
- •Active opportunistic infection
- •HIV with FPV resistance mutations
- •Current or previous treatment with FPV
- •Chronic hepatitis B
- •Current alcohol consumption greater than 20 g per day
研究组 & 干预措施
HAART inlcuding Fos APV/r
ART with 3 drugs including 2 NRTIs plus ritonavir boosted fosamprenavir
干预措施: Fosamprenavir (Drug)
结局指标
主要结局
HCV Viral load and changes in HCV protease gene
时间窗: 48 weeks
Undetectable HCV viral load. It will be considered that one patient achieves this endpoint if he/she has an undetectable HCV viral load (\<30 copies/mL) at any time during the study. If a patient shows undetectable HCV viral load and afterwards shows a detectable load, it will be considered that this patient achieved this endpoint. Changes in the HCV protease gen. Any change from baseline in the protease catalytic domain, analysed by population sequencing of the catalytic domain of the HCV protease.
次要结局
未报告次要终点