EUCTR2005-002452-17-ES进行中（未招募）不适用
Pilot, open, multicenter, phase IV Clinical Trial to evaluate safety and efficacy in treatment with peginterferon alfa-2a plus ribavirin in VIH patients with advanced immunosupression and chronic hepatopathy secondary to hepatitis C virus. - Treatment with PEG-IFN alfa 2a plus RBV in VIH patients with advanced immunosupression & hepatopathy
Hospital Universitario de Valme0 个研究点开始时间: 2005年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •>18 years CD4+ levels between 50-250 mm3 during at least 48 weeks before the beginning of the study Indetectable VC during 48 weeks before the beginning the study Pregnancy test negative in urine during 24 h. before the first dose Acceptance of written informed consent - BEFORE TREATMENT Chronic hepatitis serologic evidence with anti-HCV antibodies test Chronic hepatopathy consisting in a biopsy HIV-1 serologic evidence
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Virologic failure or clinic events of AIDS 48 weeks before treatment Pregnant or in lactation women/couples Decompensated cirrhosis patients Treated with any experimental pharmaco Treated with D4T/DDI Positive test for immunoglobulines Other hepatic diseases associated Blood alterations-analitical alterations Evidence of hepatocarcinome or conditions of decompensated hepatic disease Severe psichiatric disease, immunologic disease history, chronic disease with functional limitation, significative cardiac disease history, thyroide related history, neoplasy (with treatment or sistemic immunomodulator) Concomitant medication with rifampicine, pirazinamide, isoniazide Drug use or excesive alcohol
研究者
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