THISTLE - The HIV-HCV Silibinin Trial
关键词
抽象
日期
最后验证: | 08/31/2013 |
首次提交: | 03/07/2013 |
提交的预估入学人数: | 03/18/2013 |
首次发布: | 03/21/2013 |
上次提交的更新: | 03/03/2015 |
最近更新发布: | 03/04/2015 |
实际学习开始日期: | 03/31/2013 |
预计主要完成日期: | 03/31/2014 |
预计完成日期: | 11/30/2014 |
状况或疾病
干预/治疗
Drug: Intravenous Silibinin (iSIL)
相
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion criteria: - Age greater or equal 18 years - HIV-HCV co-infection - HCV Genotype 1 infection - At least one liver biopsy since diagnosis of HCV-infection - Fibrosis score METAVIR = 2 documented by biopsy OR a stiffness greater or equal 7.0 kPa documented by fibroscan during the previous 12 months. - Documented previous null-response or partial-response to SOC Exclusion criteria: - Contraindications to the study drug under study, e.g. known hypersensitivity or allergy to any ingredient of the study drug - Patients in need of ART with HIV virological failure (= 400 copies/ml) in the last 3 months |
结果
主要结果指标
1. Frequency of adverse events during iSIL treatment. [Day 15 (after 14days of treatment)]
2. Kinetics of the decline in HCV-RNA after 2 weeks of iSIL treatment (difference in IU/ml from day 1 to day 15). [Day 15]
次要成果指标
1. Drug levels of iSIL and its influence on the drug-level of co-administrated ART. [Day 15]
2. Proportion of patients with HIV virological failure, i.e. confirmed viremia >50cp/ml. [Day 15]