Telaprevir Open-Label Study in Co-Infected Patients
2016年8月16日 更新者：Janssen-Cilag International NV
Multicenter, Open-Label, Study of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Human Immunodeficiency Virus/Genotype 1 Chronic Hepatitis C Coinfected Subjects With Severe Fibrosis or Compensated Cirrhosis
The purpose of this study is to collect safety and tolerability data on telaprevir treatment in combination with Peg-IFN-alfa and RBV in patients with HIV/genotype 1 chronic HCV coinfection with severe fibrosis or compensated cirrhosis who are not eligible for enrollment into an ongoing clinical study of telaprevir.
研究概览
详细说明
In this study, all patients will receive open-label (all people involved know the identity of the intervention) telaprevir in addition to Peg IFN-alfa and RBV for treatment of hepatitis C virus (HCV) and protocol permissible treatments for HIV.
Chronic hepatitis C infection causes inflammation of the liver which can potentially cause long-term complications of the current liver disease (fibrosis or cirrhosis).
Therefore it is important the patient is treated for this infection.
Telaprevir is an experimental medication that has been tested for the treatment of hepatitis C infections in several previous studies in more than 2500 patients.
Telaprevir is a member of a new class of drugs being developed for chronic hepatitis C: Direct Acting Antiviral (DAA) agents.
Unlike pegylated interferon (Peg-IFN) and ribavirin (RBV), DAA agents act directly on the hepatitis C virus (HCV) replication cycle.
The aim of the telaprevir treatment is to eradicate the Hepatitis C virus out of the patient's body.
This can be measured by testing the amount of a certain part of this Hepatitis C virus, called the Ribonucleic acid (RNA [HCV RNA]) in their blood.
It is possible that the patient will not respond to the therapy and the levels of HCV RNA in their blood will not decrease or even increase.
Based on these results it might be decided the patient will not benefit from treatment and he/she need to stop the telaprevir only or all medication for their hepatitis C infection.
The doctor will keep them informed about the patient's reaction to the treatment and will take the necessary measurements as prescribed by the study protocol and routine medical practice.
During the study the patient will simultaneously be treated with the therapy that the doctor would normally prescribe for treatment of their chronic hepatitis C infection: "ribavirin (RBV)" and "pegylated interferon alfa (PEG-INF-alfa)".
Telaprevir is always administered in combination with RBV and PEG-IFN-alfa.
In function of the patient's specific HIV status, the doctor has prescribed, or not, a specific treatment that the patient will continue to take during the study.
This treatment could be: (a) efavirenz, tenofovir disoproxil fumarate (TDF), plus either emtricitabine or lamivudine, (b) efavirenz, abacavir, plus either emtricitabine or lamivudine, (c) ritonavir-boosted atazanavir, TDF, plus either emtricitabine or lamivudine, (d) ritonavir-boosted atazanavir, abacavir, plus either emtricitabine or lamivudine, (e) raltegravir, TDF, plus either emtricitabine or lamivudine, (f) raltegravir, abacavir, plus either emtricitabine or lamivudine or (g) etravirine, TDF, plus either emtricitabine or lamivudin, (h) etravirine, abacavir, plus either emtricitabine or lamivudine, (i) rilpivirine, TDF, plus either emtricitabine or lamivudine, (j) rilpivirine, abacavir, plus either emtricitabine or lamivudine, (k) no treatment.
In an interim analysis of a Phase 2a study, human immunodeficiency virus (HIV)-1/HCV genotype 1 coinfected patients currently receiving HIV therapy who had telaprevir added to Peg IFN-alfa-2a and RBV regimen for treatment of their HCV genotype 1 infection had a higher HCV RNA response (undetectable HCV RNA) at Weeks 4 and 12 than those who received only the Peg-IFN-alfa-2a and RBV regimen.
These responses were sustained through Week 24, with 73.7% of patients who had telaprevir added to the Peg-IFN-alfa-2a and RBV regimen and 54.5% of patients who received only the Peg-IFN-alfa-2a and RBV regimen also achieving undetectable HCV RNA at Week 24.
Patients with severe fibrosis or cirrhosis have a lower likelihood of sustained virologic response (SVR) and also have the greatest risk of liver failure, hepatocellular carcinoma (HCC), and death.
Administering telaprevir in this difficult to treat population may reduce the risk of long-term complications associated with HCV in patients with HIV/HCV genotype 1 coinfection.
All patients eligible to enter the study will receive telaprevir (750 or 1,125 mg every 8 hours based on their Highly Active Antiretroviral Therapy (HAART) regimen) during the first 12 weeks of the study in combination with Peg IFN alfa/RBV.
Patients will subsequently be treated with Peg-IFN-alfa/RBV for an additional 36 weeks.
The total duration of Peg-IFN-alfa/RBV will be 48 weeks.
HCV RNA levels should be measured at Weeks 4, 12, 24 and 48.
All patients should have a posttreatment follow-up visit, including measurement of plasma HCV RNA levels, performed 24 weeks after the last administered dose of treatment.
Note that in certain countries, an additional main objective of the study is to provide Early Access to telaprevir in this population.
研究类型
介入性
注册 (实际的)
122
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Perm、俄罗斯联邦
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Saint-Petersburg、俄罗斯联邦
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St Petersburg、俄罗斯联邦
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Toliatti、俄罗斯联邦
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Volgograd、俄罗斯联邦
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Yoshkar - Ola、俄罗斯联邦
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Budapest、匈牙利
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Luxembourg、卢森堡
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Berlin、德国
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Bonn、德国
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Dortmund、德国
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Frankfurt、德国
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Hannover、德国
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Köln、德国
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Stuttgart、德国
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Tübingen、德国
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Antwerpen、比利时
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Brussel、比利时
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Bruxelles、比利时
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Charleroi、比利时
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Gent、比利时
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Leuven、比利时
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Liège、比利时
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Dublin、爱尔兰
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Glasgow、英国
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Liverpool、英国
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London、英国
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Plymouth、英国
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Amadora、葡萄牙
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Lisboa、葡萄牙
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Lisbon、葡萄牙
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Porto、葡萄牙
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria: - Have diagnosis of HIV-1 or HIV-2 infection, or HIV-1 and HIV-2 coinfection for more than 6 months before the screening visit.
- Should have been on a stable permissible HAART regimen for more than 8 weeks before Day 1 without switches.
OR Not on a HAART regimen and not expected to start HIV treatment during the study, ie, have CD4 count of ≥500 cells/mm3 and a HIV-1 and/or HIV-2 viral load ≤50,000 copies/mL at screening - If on stable permissible HAART regimen, have CD4 count ≥200 cells/mm3 or ≥15% and HIV-1 and/or HIV-2 viral load <50 copies/mL for at least 6 months before starting treatment is recommended - Have evidence of HCV infection genotype 1 (molecular assay) - Have a quantifiable plasma HCV RNA Exclusion Criteria: - Is eligible for enrollment into an ongoing clinical study of telaprevir - Is infected or coinfected with HCV of another genotype than genotype 1 - Has a contraindication to the administration of Peg-IFN-alfa or RBV, or medical history or laboratory values that preclude treatment with Peg-IFN-alfa or RBV according to the respective local prescribing information - Have any contraindication to the currently prescribed HAART regimen at screening.
Note: Patients who have a contraindication to a nonprescribed permissible HAART medication are not excluded.
- Positive human leukocyte antigen (HLA)-B5701 genotyping result at screening (or documented result prior to screening) if abacavir is a component of HAART
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：open label telaprevir
Depending on the patient's HAART regimen, 750 or 1125 mg telaprevir every 8 hours for 12 weeks in combination with pegylated interferon alfa and ribavirin for 48 weeks.
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type = exact number, unit = mg, number = 750, form = tablet, route = oral use, every 8 hours for 12 weeks in combination with pegylated interferon alfa (Peg-IFN alfa) and ribavirin (RBV) during 48 weeks for eligible non treated HIV patients and for patients whose highly active antiretroviral therapy (HAART) regimen is the combination of ritonavir-boosted atazanavir, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or the combination of raltegravir, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or etravirine, TDF, plus either emtricitabine or lamivudine, or etravirine, abacavir, plus either emtricitabine or lamivudine, or rilpivirine, TDF, plus either emtricitabine or lamivudine, or rilpivirine, abacavir, plus either emtricitabine or lamivudine.
type = exact number, unit = mg, number = 1125, form = tablet, route = oral use, every 8 hours for 12 weeks in combination with Peg-IFN alfa and RBV during 48 weeks when patient's HAART regimen is the combination of efavirenz, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or etravirine, TDF, plus either emtricitabine or lamivudine, or etravirine, abacavir, plus either emtricitabine or lamivudine, or rilpivirine, TDF, plus either emtricitabine or lamivudine, or rilpivirine, abacavir, plus either emtricitabine or lamivudine.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Treatment-emergent Adverse Events
大体时间：from first use of the medicinal product to 30 days after administration of the last dose of investigational product (telaprevir)
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Protocol-defined adverse events whether serious or non-serious, that occur from the first use of investigational product (telaprevir) to 30 days after administration of the last dose of investigational product (telaprevir) will be part of the analysis.
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from first use of the medicinal product to 30 days after administration of the last dose of investigational product (telaprevir)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年6月1日
初级完成 (实际的)
2014年8月1日
研究完成 (实际的)
2014年8月1日
研究注册日期
首次提交
2011年12月22日
首先提交符合 QC 标准的
2011年12月27日
首次发布 (估计)
2011年12月28日
研究记录更新
最后更新发布 (估计)
2016年8月18日
上次提交的符合 QC 标准的更新
2016年8月16日
最后验证
2016年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CR018787
- VX-950HPC3005 (其他标识符：Janssen-Cilag International NV)
- 2011-003593-85 (EudraCT编号)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.