ANRS HC20 Pilot Study, Multicenter, Assessing the Effectiveness of an Optimized Anti HCV (360μg/Week Induction of PegIFN-alpha2a + 18mg/kg/j of RBV for 6 Months and Then Depending on the Virological Response to S12, Elongation up S72 to the Dual Anti HCV, With Accompanying Measures) on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Study the proportion of patients co-infected HIV-HCV, non-responders to treatment for HCV (genotype 1 and 4), with a sustained virological response (6 months after stopping treatment (W72 or W96)) at a re-optimized treatment of hepatitis C.
研究概览
简要总结
The purpose of this study is to assess the effectiveness of an optimized anti HCV treatment (360μg per week of PegIFN-alpha2a + 18mg/kg/j of Ribavirin for 6 months.
详细描述
In patients HIV infected, the success rate do not exceed 20% in genotype 1 or 4 patients. In case of treatment failure , patients are rarely re-treated, and liver fibrosis progresses rapidly. The new molecules are not yet available for patients co-infected with HIV, and patients having already undergone a first treatment will likely be among the last to be included in trials evaluating the effectiveness of these treatments.
However, recent studies show that it is possible to propose a new treatment "optimized" to these patients in the hope to obtain better success rate. Provide antiretroviral treatment, use of high doses of Peg-interferon and ribavrine, and supporting patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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 over 18 years
- •Weight 85 kg below the pre-inclusion visit.
- •Documented HIV infection (HIV positive)
- •HCV infection documented by a positive PCR
- •HCV Genotype 1 or 4
- •Compensated liver disease (Child-Pugh below/equal to 6)
- •Lymphocytes CD4 above 200/mm3
- •Patient not answering a treatment for hepatitis C.
- •Patient not covered by dual by Peg-IFN + riba for at least three months (wash out)
排除标准
- •Co-infection with HBV (HBsAg positive)
- •Neutropenia below 1000/mm3
- •Thrombocytopenia below 90000/mm3 or thrombocytosis over 500 000/mm
- •Hemoglobin below 11 g / dL (men and women)
- •Arguments radiological (ultrasound, CT or MRI) of hepatocellular carcinoma cell
- •Antiretroviral containing didanosine (ddI) and stavudine (d4T) and zidovudine (AZT) and abacavir (ABC).
研究组 & 干预措施
PegIFN- alpha 2a + RBV
干预措施: Peg-interféron alpha 2a + ribavirin (Drug)
结局指标
主要结局
Study the proportion of patients co-infected HIV-HCV, non-responders to treatment for HCV (genotype 1 and 4), with a sustained virological response (6 months after stopping treatment (W72 or W96)) at a re-optimized treatment of hepatitis C.
时间窗: W72 or W96 (depending of the end of treatment)
次要结局
- Analyze rapid virological response (W4) and early (W12).(W4 and W12)