An open label, randomised, non-inferiority trial of pegylated interferon, ribavirin and telaprevir versus pegylated interferon and ribavirin alone in the response guided treatment of acute hepatitis C genotype 1 virus infection in patients with HIV-1 co-infection - CHAT Study

niversitätsklinikum Bonn0 个研究点目标入组 40 人2013年4月9日

概览

暂无简介。

注册库

who.int

开始日期

2013年4月9日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

Male

发起方

niversitätsklinikum Bonn

•1\. Documented current acute hepatitis C genotype 1 infection with detectable HCV\-RNA (PCR\-assay) with an estimated duration less than 24 weeks as defined below: a. First HCV RNA positive AND b. Prior negative anti\-HCV antibody or HCV RNA test within 6 months OR c. rise of liver transaminases above 2\.5 x ULN within the past 6 months with prior normal transaminases during the year before AND d. exclusion of other causes of acute hepatitis
•2\. Confirmed HIV infection
•3\. Receiving a atazanavir\-, etravirine\-, rilpivirine\-, efavirenz\- or raltegravir\-based ART regimen or able to switch regimen to these agents with an undetectable HIV viral load for at least 3 months, or not receiving ART with no immediate plans to start ART during the first 6 months of study 4\. CD4 T cell count \>200/ìl at screening in patients under ART, CD4 T cell count \>500/ìl at screening in patients without ART
•5\. Patients who are 18 years or older
•6\. Able to give informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 38
•F.1\.3 Elderly (\>\=65 years) yes

•1\. HCV infection with non\-1 genotype
•2\. Acute opportunistic infection requiring treatment
•3\. Malignancy requiring chemotherapy or radiotherapy
•4\. Active HBV infection (HBs Ag \+ with positive hepatitis B DNA unless tenofovir containing ART)
•5\. Known autoimmune disease
•6\. Hepatic failure
•7\. History of ischaemic heart disease or other serious cardiac disease
•8\. Current symptoms of depression, or past history of depression for which the patient is currently taking medication, or history of other serious psychiatric disease
•9\. Haemoglobinopathy or severe anaemia of any cause
•10\. Serious abnormality on screening blood tests including, but not limited to: Hemoglobin \<8g/dl, absolute neutrophil count \<750/mm3, platelets \<50000/mm3, creatinine clearance \<60ml/min