EUCTR2016-001125-13-FR进行中（未招募）1 期
Pilot study - Short duration therapy of acute hepatitis C genotypes 1 or 4 in HIV-infected patients: efficacy and tolerability of grazoprevir 100mg/elbasvir 50mg during 8 weeks - SAHIV
IMEA (Institut de Médecine et d’Epidémiologie Appliquée)–Fondation Léon M’Ba0 个研究点目标入组 50 人开始时间: 2017年6月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
入选标准
- •1. Adult =18 years
- •2. A recent acute HCV infection or reinfection (see definition below) occurred within 6 months prior screening:
- •An acute HCV infection is defined by:
- •a. HCV RNA was detectable within 6 months after a negative HCV RNA or HCV serology test.
- •b. Detectable HCV RNA and an acute clinical hepatitis occurred within 5 months prior to the screening visit.
- •Clinical Hepatitis is defined by:
- •- ALT = 250 IU/L with normal ALT within the preceding 8 months,
- •- ALT = 500 IU/L with either no measured ALT or with abnormal ALT within the preceding 8 months.
- •HCV reinfection is defined by:
- •a. Documented de novo infection after prior clearance after treatment or spontaneously,
- •- After-treatment clearance is defined by one negative HCV RNA = 6 months after end of treatment.
- •- Spontaneous clearance is defined by two negative HCV RNA a minimum of 6 months apart.
- •b. Documented infection with a new viral strain, confirmed by phylogenetic or genotypic analysis.
- •3. Infection with HCV genotype 1 or 4 (confirmed at screening visit or by using a previous biological test performed 1 to 4 weeks before D0)
- •4. Plasma HCV-RNA = 1000 UI/mL (confirmed at screening visit or by using a previous biological test performed 1 to 4 weeks before D0)
- •5. Confirmed HIV infection
- •6. Without HIV treatment or with an acceptable stable HIV treatment for at least two weeks (See section 8.3 of the protocol)
- •7. Body weight =40 kg and =125 kg
- •8. Female patients with child-bearing potential and their heterosexual partners must use adequate contraception from the date of screening until 30 days after administration of the last dose of study drug. Male participants must agree to consistently and correctly use a condom, while their female partner must use adequate contraception from the date of screening until 30 days after administration of the last dose of study drug
- •9. Informed and signed consent
- •10. 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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Current condition
- •1. Opportunistic infections (stage C), active or occurred within 6 months prior to baseline.
- •2. Primary HIV infection.
- •3. Co-infection with Hepatitis B virus (AgHBs +) without appropriate treatment (TDF or TAF) for at least 2 weeks.
- •4. Confirmed cirrhosis (before acute HCV diagnosis).
- •5. Any other causes of acute hepatitis.
- •6. Pregnant or breast-feeding women.
- •7. Transplant recipients.
- •8. Evolutive malignancy.
- •9. Patients with a history of non-adherence, who will be at risk of being unable to respect the study follow-up timetable.
- •10. Patients participating in another clinical trial (with an experimental treatment) or within an exclusion period of a previous clinical trial at screening.
- •11. Patients under legal gardianship or incarcerated.
- •Biological criteria
- •12. Hb < 10 g/dL (female) or < 11g/dL (male).
- •13. Platelets < 50 000/mm3.
- •14. Neutrophil count < 750/mm3.
- •Criteria related to study drugs
- •15. Other antiretroviral drugs than those allowed in the study (please refer to section 8.3 of the protocol).
- •16. Contra-indications to Grazoprevir and/or Elbasvir or to any of the excipients listed in the summary of the product characteristics.
- •17. Contra-indicated treatment likely to interfere with the study drugs as listed in the summary of the product characteristics.
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