EUCTR2012-003984-23-ES进行中（未招募）不适用
A phase III open label study to evaluate safety and efficacy of Boceprevir-response guided therapy in controlled HIV patients with chronic hepatitis C genotype 1 infection who failed previously to Peginterferon /ribavirin. - BOC-HIV
Fundació Clínic per a la Recerca Biomèdica0 个研究点开始时间: 2013年2月4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
- •The subject must meet ALL criteria listed below for entry
- •1. For inclusion in the study, subjects must have a qualifying regimen defined as peginterferon alfa-2a plus ribavirin or peginterferon alfa-2b plus ribavirin for a minimum of 12 weeks. If a subject has received more than one such regimen, the most recent regimen is considered the qualifying regimen.
- •2. Subject must have previously documented CHC genotype 1 infection. Subjects with other or mixed genotypes are not eligible. The HCV-RNA result at the screening visit must confirm genotype 1 infection and be ?10,000 IU/mL.
- •3. Subject must have a liver biopsy with histology consistent with CHC and no other etiology and/or Fibroscan assessment. In case of:
- •a. No cirrhosis. Biopsies and/or Fibroscan must be within 18 months of screening visit.
- •b. Cirrhosis. No specific length of time would be requested.
- •4. All patients with cirrhosis must have an ultrasound 6 month within of screening visit.
- •5. Patients must be on stable antiretroviral therapy including a CD4 cell count of more than 100 per mm3 and a HIV plasmatic viral load undetectable (it is < 50 copies/mL) for more than 6 months. Antiretroviral therapy must be Raltegravir-based (al least during the last 3 months).
- •6. Subject must be ?18 years of age.
- •7. HIV treatment should not contain EFV, NVP, ETV, ddI, d4T, AZT, or HIV protease inhibitors.
- •8. Subject must weight between 40 kg and 125 kg.
- •9. Subject and subject?s partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug.
- •10. Subjects must be willing to give written informed consent and by investigator opinion could follow the protocol visit design.
- •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 128
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects known to be coinfected with hepatitis B virus (HBsAg positive).
- •2. Patients chronically infected with HCV genotype other than 1
- •3. CD4 cell count < 100 cel/mm3.
- •4. Plasma HIV RNA more than 50 copies/mL
- •5. Platelet count less than 80.000 /mm3
- •6. Subjects who required discontinuation of previous interferon or ribavirin regimen for a severe adverse event considered by the investigator to be possibly or probably related to ribavirin and/or interferon.
- •7. Treatment with ribavirin within 90 days and any interferon-alpha within 1 month of Screening.
- •8. Treatment for hepatitis C with any investigational medication. Prior treatments with herbal remedies with known hepatotoxicity are exclusionary.
- •9. Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.
- •10. History of hemoglobinopathy (e.g., thalassemia) or any other cause of or tendency to hemolysis.
- •11.. Evidence of decompensate liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
- •12. Diabetic and/or hypertensive subjects with clinically significant ocular examination findings.
- •13. Unstable or untreated pre-existing psychiatric condition.
- •14. Any known pre-existing medical condition that could interfere with the subject?s participation in and completion of the study.
- •15. Any current evidence of substance abuse of alcohol or other drugs.
- •16.Subjects receiving Opiod Agonist substitution therapy but not enrolled in an opiate substitution maintenance progam.
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