Study to assess efficacy and safety of Sofosbuvir/Ledipasvir (GS-5885) fixed-dose combination with Ribavirin in treatment experienced subjects with HCV genotype 1 infection and HIV co-infectio

• Conditions: Coinfection with HCV genotype 1 and HIV; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-002607-33-FR
• Lead Sponsor: INSERM-ANRS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-19
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified