Open Multicentre, Phase IV Study to Evaluate Efficacy and Safety of Pegylated Interferon Alpha-2a (40 KD) Plus Ribavirin for Chronic Hepatitis C With Normal Transaminases in Human Immunodeficiency Virus-infected Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 18
- 主要终点
- % patients with RNA-HCV negative
研究概览
简要总结
In the current practice patients with normal levels of ALT were not treated. However, a percentage of patients will present an advanced grade of fibrosis and cirrhosis.
Another reason to treat is the similar response to the treatment than elevated ALT patients published recently in mono-infected patients.
The investigators have not data concerning the evolution and response to the treatment in co-infected patients with normal ALT.
In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it assumes a behavior similar between mono and co-infected patients and the results are different.
In the case of normal ALT the investigators do not know if the natural history in co-infected patients is similar than the mono-infected patients, and also the response of the treatment.
This study prospective and controls is the answer of this question. The main hypothesis is if the response of treatment in co-infected patients is not inferior than mono-infected patients.
The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning genotype, gender and hospital.
详细描述
The treatment of co-infected patients with normal ALT would be very important because the evolution of cirrhosis in this patients is quicker and frequently than mono-infected patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Hepatitis C co infected with stable HIV-1 and normal ALT (CASE) or elevated levels of ALT (CONTROL)
- •CD4 > 200 cel/mL
- •Stable anti-retroviral treatment for HIV during at least, the 6 previous months to the inclusion
- •Negative contraception test
- •Informed consent signed
排除标准
- •Pregnancy
- •Any previous treatment for CHC
- •Any experimental treatment in the 6 previous weeks to the inclusion
- •Cirrhosis grade B or C (Child-Pugh)
- •Treatment with colony-stimulating factors, didanosine or zidovudine, immunomodulator therapy, isoniazid, rifampicin, ...
- •Hepatic cancer
- •Neutrophils < 1500 cel/mL, Platelets < 70000 cel/mL, Hemoglobin < 11 g/dL (men) or < 12 g/dL (women) previous to inclusion
- •Severe psychiatric illness background
- •Serum creatinin > 1,5 times the upper normal limit
- •Background of Pulmonary or Cardiovascular disease
研究组 & 干预措施
1
Peginterferon alfa-2a + ribavirin in normal ALT
干预措施: Peginterferon alfa-2a + ribavirin in normal ALT (Drug)
2
peginterferon alfa-2a + ribavirin in elevated ALT
干预措施: Peginterferon alfa-2a + ribavirin in elevated ALT (Drug)
结局指标
主要结局
% patients with RNA-HCV negative
时间窗: 24 weeks after treatment
次要结局
未报告次要终点
研究者
Miguel Santin
Dr
Hospital Universitari de Bellvitge