EUCTR2013-002607-33-FR进行中（未招募）不适用
Pilot study to assess efficacy and safety of Sofosbuvir/Ledipasvir (GS-5885) fixed-dose combination with Ribavirin in NS3/4A protease inhibitor-experienced subjects with HCV genotype 1 infection and HIV co-infection
INSERM-ANRS0 个研究点开始时间: 2015年6月19日最近更新:
适应症
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
- •Adult =18 years
- •Confirmed HIV infection
- •Infection with HCV genotype 1 only, confirmed at screen visit, with a HCV-RNA = 1000 UI/mL at screen visit
- •Treatment-experienced subjects with:
- •- previous virological failure to tritherapy with Peginterferon/Ribavirin and protease inhibitor,
- •- or premature discontinuation of previous tritherapy with Peginterferon/Ribavirin and protease inhibitor due to intolerance to Peginterferon or protease inhibitor
- •Anti-HCV treatment stopped for at least the last 3 months
- •Patients on a stable (for more than 1 month) antiretroviral treatment consisting of an emtricitabine/tenofovir or lamivudine/tenofovir standard of care backbone plus efavirenz or raltegravir or rilpivirine or enfuvirtide.
- •CD4 > 100/mm3 and > 15% at screen visit
- •HIV-RNA < 50cp/ml for more than 3 months at screen visit
- •Any liver fibrosis grade, with the assessment of the presence or not of cirrhosis at screening, cirrhosis being defined as a METAVIR score of F4 on the liver puncture biopsy and/or with hepatic impulse elastometry = 15 kPa:
- •Previous liver biopsy exhibiting cirrhosis lesions (METAVIR F4),
- •and/or significant liver biopsy (cumulative length = 15mm and = 6 portal spaces), within the past 18 months
- •and/or significant and reliable liver stiffness assessment (Fibroscan®) within the past 6 months (at least 10 measures with IQR less than 25% of the mean value and a success rate of at least 80%).
- •Male patients, female patients with child-bearing potential, and their heterosexual partners must use adequate contraception from 1 month before initiation of treatment up to 7 months following the end of treatment for men and to 4 months following the end of treatment for women.
- •Body weight =40 kg and =125 kg
- •Informed and signed consent for the main study and the PK sub-study (for the participating patients)
- •Patients with Health insurance (Sécurité Sociale or Couverture Médicale Universelle)
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Child-Pugh B or C cirrhosis or history of decompensated cirrhosis.
- •Co-infection with Hepatitis B virus (AgHBs +) with HBV DNA > 1000 UI/ml
- •Pregnant or breast-feeding women
- •Transplant recipients
- •Opportunistic infections (stage C), active or occurred within 6 months prior to baseline
- •Evolutive malignancy, including hepatocarcinoma which should be controlled prior to baseline
- •Alcohol or drug consumption which may affect the study participation according to the investigator. Patients included in a programme of substitution with methadone or buprenorphine could be enrolled. The opinion of a consultant in addictology is recommended for patients presenting with current drug use or drug use during the previous year.
- •Patients with a history of non-adherence, who will be at risk of being unable to respect the study follow-up timetable
- •Patients participating in another clinical trial within 30 days prior to inclusion
- •Hb < 10 g/dL (female) or < 11g/dL (male)
- •Platelets < 50 000/mm3
- •Neutrophil count < 750/mm3
- •Renal failure defined as creatinine clearance (MDRD) < 60ml/min
- •Other antiretroviral drugs than those allowed in the study
- •Contra-indications to Sofosbuvir, Ledipasvir, Ribavirin
研究者
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