NCT00530972已完成4 期
Treatment of Patients With Chronic Hepatitis C Co-infected With HIV Relapsers or Non Responders, Previous Exposed to Sub-optimal Therapies: Open, Pilot Trial
Hospital Carlos III, Madrid1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- % of patients with RNA-HCV undetectable
研究概览
简要总结
To determine the efficacy and safety of Peginterferón alfa-2a (40 KD) plus Ribavirin in patients who have relapsed or not responded to a previous suboptimal therapy based in Interferon.
详细描述
An important number of co-infected patients were treated suboptimally in the past with others ineffective therapies interferon-based.
All co-infected patients should be an opportunity of retreatment with actually therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between 18 and 65 years of age
- •Anti-HCV positive
- •Detectable plasma HCV-RNA
- •Relapsers after treatment with interferon o peginterferon +/- ribavirin
- •HIV positive
- •CD4 >/= 200 cell
- •Patients on clinically stable liver disease with:
- •Hgb >/= 12 g/dL in women or 13 g/dL in men
- •Leucocytes >/= 3000 mm3
- •Neutrophil count (ANC) >/= 1500 cells/mm3
- •Platelet count >/= 100.000 cells/mm3
- •Normal prothrombin, bilirubin, albumin, creatinine and uric acid
- •HBsAg negative
- •With antecedents of diabetes or hypertension is necessary an previous ocular exploration
排除标准
- •Women with ongoing pregnancy or breast feeding
- •Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg
- •Hemochromatosis
- •Deficit of alfa-1 antitrypsin
- •Wilson disease
- •Alcoholic liver disease
- •Autoimmune hepatitis
- •Hepatitis by toxin exposures
- •Hepatitis by obesity
- •Hemoglobinopathy (e.g. thalassemia)
- •History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- •Hepatocarcinoma observed in the liver ecography.
- •History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
- •History of a severe seizure disorder or current anticonvulsant use
- •History of significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
- •Diabetes Mellitus
- •History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
- •History or other evidence of chronic pulmonary disease associated with functional limitation
- •Drug use within 6 months of 1st dose and excessive alcohol consumption.
- •Concomitant treatment with ddI
- •Male partners of women who are pregnant
研究组 & 干预措施
Peginterferon alfa-2a plus ribavirin
Experimental
干预措施: Peginterferon alfa-2a plus ribavirin adjusted to body weight (Drug)
结局指标
主要结局
% of patients with RNA-HCV undetectable
时间窗: 24 weeks after end of treatment
次要结局
- % of patients with RNA-HCV undetectable at different moments of the treatment according genotype, viremia, liver fibrosis, number of CD4 cells and previous therapy(At weeks 4, 12, 24 and 48 on treatment)
- Ribavirin levels(At weeks 4, 12, 24 and 48 on treatment)
- Impact of dose reduction peg-interferon and/or ribavirin(At weeks 4, 12, 24 and 48 on treatment)
研究者
研究点 (1)
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