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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-002607-33
    Sponsor's Protocol Code Number:ANRSHC31SOFTRIH
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2013-002607-33
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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-infection
    A.4.1Sponsor's protocol code numberANRSHC31SOFTRIH
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorINSERM-ANRS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportINSERM-ANRS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationService de Pharmacologie Clinique – CIC Inserm 0203 - CHU de RENNES
    B.5.2Functional name of contact pointFougerou
    B.5.3 Address:
    B.5.3.1Street Address 2, rue Henri Le Guilloux
    B.5.3.2Town/ cityRennes
    B.5.3.3Post code35033
    B.5.3.4CountryFrance
    B.5.6E-mailClaire.FOUGEROU@chu-rennes.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSOF/LDV/FDC
    D.3.2Product code GS-7977/GS-5885 FDC
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSofosbuvir
    D.3.9.1CAS number 1190307-88-0
    D.3.9.3Other descriptive nameSOFOSBUVIR
    D.3.9.4EV Substance CodeSUB121170
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEDIPASVIR
    D.3.9.1CAS number 1256388-51-8
    D.3.9.2Current sponsor codeGS-5855
    D.3.9.3Other descriptive nameLEDIPASVIR
    D.3.9.4EV Substance CodeSUB120165
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIBAVIRIN
    D.3.9.1CAS number 36791-04-5
    D.3.9.4EV Substance CodeSUB10297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Coinfection with HCV genotype 1 and HIV
    E.1.1.1Medical condition in easily understood language
    Coinfection with HCV genotype 1 and HIV
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy and safety of 24 weeks of a triple oral combination with Sofosbuvir/Ledipasvir fixed-dose combination and Ribavirin in subjects with HCV genotype 1 infection and HIV co-infection, who have previously failed a NS3/4A protease inhibitor plus PEG/RBV regimen or stopped prematurely their treatment for intolerance.
    E.2.2Secondary objectives of the trial
    Safety assessment
    HCV virological assessment
    Describe HCV virological kinetics and response, globally and according to the subtype (1a or 1b)
    Study the prognostic factors associated with SVR
    Assess the emergence of resistance to Sofosbuvir and/or Ledipasvir

    HIV virological assessment
    Hepatic and metabolic evaluation: evaluate the relationship and virological response

    Describe Ribavirin residual concentration one month after its introduction and study its relationship with the variation of hemoglobinemia and virological response kinetics
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic substudy version n°1.0. of 18 december 2013
    Describe Sofosbuvir and Ledipasvir residual concentrations and study their relationship with the virological response kinetics
    Describe pharmacokinetic parameters of antiretroviral (Raltegravir and Tenofovir) and anti-HCV (Sofosbuvir and Ledipasvir) drugs (sub-group study)
    Assess possibles drug-drug interactions between HCV (Sofosbuvir and Ledipasvir) and HIV (Raltegravir and Tenofovir) drugs (sub-group study)
    E.3Principal 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)
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    Sustained virological response, defined by an undetectable plasma HCV RNA 12 weeks post-treatment (SVR12)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks post-treatment
    E.5.2Secondary end point(s)
    Safety
    SVR rate 24 weeks (i.e. W48) after the end of treatment globally and according to the HCV subtype (1a or 1b)
    Measurements of HCV RNA at D0, W1, W2, W4, W8, W12, W16, W20, W24, and 4, 8, 12, 18 and 24 weeks after the end of the treatment (W28, W32, W36, W42 and W48), globally and according to the HCV subtype (1a or 1b)
    HCV resistance mutations to Sofosbuvir and/or Ledipasvir (in case of virological failure)

    Plasma HIV RNA levels at D0, W4, W8, W12, W16, W20, W24, W36 and W48
    CD4 and CD8 cell counts (absolute count, percentage and CD4/CD8 ratio) at D0, W4, W8, W12, W16, W20, W24, W36 and W48

    Hepatic and metabolic assessment
    Biological (Fibrotest®, Fibromètre® or Hepascore ®) and imaging (Fibroscan®) parameters describing the evolution of liver fibrosis between baseline and 24 weeks post-treatment (W48)
    Insulin resistance measured using the HOMA-IR score (measured at D0 and W36)
    Parameters that define metabolic syndrome (waist circumference, blood pressure, fasting glucose, triglyceridemia, HDL-cholesterol) measured at D0 and W36

    In all patients: Ribavirin residual concentration (Cres) at W4
    -In all patients: Sofosbuvir and Ledipasvir residual concentrations at W4, W12 and W24
    In a sub-group of 20 voluntary patients (preferred Anti Retroviral Treatment (ART) for these patients will be RAL+ TDF/FTC):
    PharmacoKinetic (PK) parameters (Cres, Cmax, AUC10, AUC24) of HIV drugs (Raltegravir and Tenofovir) at D0 and W4
    PharmacoKinetic (PK) parameters (Cres, Cmax, AUC10, AUC24) of Sofosbuvir and Ledipasvir at W4.

    Patients’ reported outcomes (PRO) including perceived symptoms reported by the patients (ANRS AC24 perceived symptoms questionnaire), fatigue intensity and quality of life (MOS-SF12) at follow-up visits D0, W8, W24 and W48. PRO will be available from patients’ answers in the self-administered questionnaires.
    Patients’ adherence measured using the Inserm-ANRS self–administered questionnaire at follow-up visits D0, W8, W24 and W36.
    E.5.2.1Timepoint(s) of evaluation of this end point
    through the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned44
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    NONE
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-12
    P. End of Trial
    P.End of Trial StatusOngoing
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