NCT01332955已完成2 期
Pilot Study of PegInterferon-Ribavirin-Telaprevir Efficacy and Tolerability in HIV-HCV Coinfected Patients Who Had Previously Failed a PegInterferon-Ribavirin Regimen. (ANRS HC26 TelapreVIH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Estimation of SVR following a 12 wks treatment by telaprevir combined with a 48 or 72 wks peginterferon-ribavirin treatment, based upon the rapid virological response, and comparison to 20% (which would correspond to a significant therapeutic benefit)
研究概览
简要总结
This phase II, multicentric, national pilot trial is designed to estimate the sustained virological response rate (SVR) following a 12 weeks treatment by telaprevir combined with a 48 or 72 weeks treatment by peginterferon and ribavirin, based upon the rapid virological response (RVR) at week 8 (4 weeks after telaprevir start), and to compare the observed SVR to 20%, a rate determining a significant therapeutic benefit in this population of patients. The primary endpoint will be the SVR defined as undetectable HCV-RNA measured 24 weeks after the end of therapy (EOT).
详细描述
This phase II pilot trial is designed for HIV-1 and HCV genotype 1 coinfected patients who had previously failed a peginterferon-ribavirin regimen.
Intervention Design:
- Induction, Lead-in, phase: day 0 to week 4 PegInterferon alpha-2a, 180 µg subcutaneous injection, once weekly + Ribavirin (weight-based dose) 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d.
- Telaprevir phase: week 4 to week 16 PegInterferon alpha-2a, 180 µg subcutaneous injection, once weekly + Ribavirin (weight-based dose) 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d.
- Telaprevir 750 mg q 8h (or 1125 mg q 8h in association with Efavirenz)
- Maintenance phase: week 16 to week 48 or 72 PegInterferon alpha-2a, 180 µg subcutaneous injection, once weekly + Ribavirin (weight-based dose) 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d.
The duration of the maintenance phase is determined by the RVR at week 8 (4 weeks after Telaprevir start.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent form signed at screening visit at the latest
- •Patient registered with or covered by a social security scheme
- •HIV-1 infection
- •Chronic, genotype 1, hepatitis C with detectable HCV RNA at screening
- •Virological failure following a previous treatment of at least 12 weeks by peginterferon alpha-2a ≥ 135 µg once weekly or peginterferon alpha-2b ≥ 1.0 µg per kg once weekly + ribavirin ≥ 600 mg once daily. Virological failure defined by persistence of a detectable HCV-RNA, with the same genotype than before. Null responder patient, with less than 2 Log10 HCV-RNA decline at week 12 with cirrhosis are excluded from the study. Null responder patients without cirrhosis (equal or below METAVIR F3) are limited to less than 30 % of all patients included
- •No Interferon and/or Ribavirin within past 6 months
- •Stable antiretroviral treatment for over 3 months at screening. Authorized combinations: tenofovir-emtricitabine-boosted atazanavir,tenofovir-emtricitabine-efavirenz,tenofovir-emtricitabine-raltegravir, once Drug-Drug interaction data will be available. Patients with a stable combination of at least 3 of the following drugs: tenofovir, emtricitabine/lamivudine, efavirenz, atazanavir-boosted or not, raltegravir. These patients cannot participate in the pharmacokinetic study
- •CD4 >200/mm3 and >15% at screening
- •Plasma HIV-RNA <50 copies/mL for at least 6 months at screening visit
- •Body weight ≥ 40 kg to equal or below 125 kg
- •Fibrosis stage have to be documented by a significant liver biopsy (cumulative length ≥ 15 mm or ≥ 6 portal spaces), within 3 years. Patients with a previous liver biopsy exhibiting cirrhosis lesions (METAVIR F4) are allowed to enter the study without a new biopsy. The proportion of patients with cirrhosis lesions (METAVIR F4) is limited to 50% of all patients.
- •Male patients, female patients with child-bearing potency and their heterosexual partners must use an adequate contraception from 1 month before initiation of treatment to 7 months following the end of treatment for men and to 4 months following the end of treatment for women. Subjects (or their female partners) must not be pregnant or planning to become pregnant within 2 years after enrolling in the study
排除标准
- •Patient with liver failure (Child B and C) or past history of decompensated cirrhosis
- •Significant oesophageal varices (Stages 2-3) on a gastrointestinal endoscopy within 3 years
- •Detectable AgHBs
- •HIV-2 co-infection
- •Contra-indication to ribavirin or peginterferon
- •Severe pre-existing cardiac or pulmonary disease
- •Untreated dysthyroidism
- •Uncontrolled Type 2 diabetes
- •Optic neuritis past history and retinal condition
- •History of organ transplant
- •Severe hemoglobinopathy
- •Congenital QT prolongation, family history of congenital QT prolongation or sudden unexpected death
- •Contra-indication to telaprevir, hypersensitivity to any component of the drug product
- •Any disease requiring long term, systemic corticotherapy or immunosuppressive therapy during study
- •Alcohol intake that may represent an obstacle for the participation of the subject
- •Substance abuse that may represent an obstacle for the participation of the subject
- •Acute CDC stage C opportunistic infection within the previous 6 months
- •Past history of cancer within the previous 5 years (except skin basal cell carcinoma, Kaposi's disease in stable remission, in situ cervical cancer and in situ anal cancer)
- •Any active malignant disease including hepatocellular carcinoma
- •Patients unable to observe the study procedures
- •Participation to another clinical trial within the previous 30 days
- •Haemoglobin <120 g/L for women and <130 g/L for men
- •Platelets <90 000/mm3
- •Neutrophils <1 500/mm3
- •Renal insufficiency defined by an estimated Glomerular Filtration Rate < 60 mL/mn (MDRD equation)
- •Associated medication susceptible to interfere with the pharmacokinetic parameters of telaprevir and/or antiretroviral associated drugs
研究组 & 干预措施
Telaprevir-pegIFN alfa-2a-ribavirine
Experimental
Single Group Assignment
干预措施: Telaprevir (Drug)
Telaprevir-pegIFN alfa-2a-ribavirine
Experimental
Single Group Assignment
干预措施: pegIFN alfa-2a (Biological)
Telaprevir-pegIFN alfa-2a-ribavirine
Experimental
Single Group Assignment
干预措施: Ribavirin (Drug)
结局指标
主要结局
Estimation of SVR following a 12 wks treatment by telaprevir combined with a 48 or 72 wks peginterferon-ribavirin treatment, based upon the rapid virological response, and comparison to 20% (which would correspond to a significant therapeutic benefit)
时间窗: up to 92 weeks or 116 weeks depending on rapid virologic response
HCV-RNA measured 24 weeks after the end of HCV treatment
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(From week 0 up to 92 weeks or 116 weeks depending on rapid virologic response)
- Estimation of the Sustained Virological Response defined as undetectable HCV-RNA at Week 12 after the end of HCV treatment(at Week 60 or Week 84 depending on rapid virologic response)
研究者
研究点 (1)
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