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    Summary
    EudraCT Number:2011-005581-37
    Sponsor's Protocol Code Number:5946
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-21
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-005581-37
    A.3Full title of the trial
    Efficacy of Switch to Lopinavir/Ritonavir in Improving Cognitive function in Efavirenz treated patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Switching to Lopinavir/Ritonavir (Kaletra) in Improving Cognitive function in patients treated with Efavirenz (EFV) (SLICE Study)
    A.3.2Name or abbreviated title of the trial where available
    SLICE Study
    A.4.1Sponsor's protocol code number5946
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN73411795
    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 SponsorThe Newcastle upon Tyne Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportAbbVie Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Newcastle upon Tyne Hospitals NHS Foundation Trust
    B.5.2Functional name of contact pointDr Ashley Price
    B.5.3 Address:
    B.5.3.1Street AddressElliot Building, Royal Victoria Infirmary, Queen Victoria Road
    B.5.3.2Town/ cityNewcastle upon Tyne
    B.5.3.3Post codeNE1 4LP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01912823854
    B.5.6E-maildavid.price@nuth.nhs.uk
    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 Yes
    D.2.1.1.1Trade name Kaletra
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameKaletra
    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 INNLopinavir
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRitonavir
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cognitive function and sleep pattern in HIV-1 patients
    E.1.1.1Medical condition in easily understood language
    HIV-1 infection
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021425
    E.1.2Term Immune system disorder
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore whether chronic Efavirenz therapy is associated with mild cognitive impairment, and if it is improved by switch to Kaletra after 10 weeks.
    E.2.2Secondary objectives of the trial
    1) To explore whether switch from Efavirenz to Kaletra® results in improvement in cerebral metabolites

    2) To explore whether switch from Efavirenz to Kaletra® results in improvement in sleep quality

    3) To assess recruitment and withdrawal rates and to provide relevant parameter estimates to inform future studies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Documented HIV-1 RNA viral load (VL) measurement of <50 copies/ml within the 4 months preceding study entry and no VL exceeding 200c/ml within 1 year prior to study entry. This constraint is to remove any CNS effects of active viral replication at baseline, and / or potential change in level of viral replication during the study period

    • On HAART (at least 3 anti-retroviral drugs from at least 2 classes) for at least 12 months prior to study entry

    • On Efavirenz (EFV, Sustiva) for at least 6 months prior to study entry. This constraint is to remove acute neuropsychiatric effects of EFV which are typically clinically apparent in the first 4-6 weeks of therapy

    • Patient has provided written informed consent for participation in the study prior to any study specific procedures

    • Age 18 to 65 years inclusive
    E.4Principal exclusion criteria
    • Use of Kaletra or any other HIV protease inhibitor within 6 months of study entry

    • Current self-reported (within last 3 months) recreational drug use

    • Current self-reported weekly alcohol consumption exceeding 35 units / week

    • Known contra-indication to MRI scanning

    • Known hypersensitivity to Kaletra, or to ritonavir in pharmacokinetic boosting doses (100 or 200mg Ritonavir daily)

    • Currently (within 6 weeks of study entry) receiving interferon therapy for treatment of chronic viral hepatitis, or expected to commence such treatment with the next 4 months

    • Severe renal or hepatic impairment

    • Pregnancy, or women planning to become pregnant within next 6 months

    • breastfeeding

    • Use of other investigational study drugs within 30 days prior to study entry (defined as date of randomisation into study)

    • Patients on drugs that will interact with Efavirenz and should not be co-administered including: Terfenadine, Astemizole, Cisapride, Midazolam, Triazolam, Pimozide, Bepridil, or ergot alkaloids (for example, Ergotamine, Dihydroergotamine, Ergonovine and Methylergonovine) because competition for CYP3A4 by Efavirenz could result in inhibition of metabolism and create the potential for serious and/or life-threatening undesirable effects (for example, cardiac arrhythmias, prolonged sedation or respiratory depression), herbal preparations containing St. John's wort (Hypericum perforatum).

    • Patients on drugs that will interact with Kaletra and should not be co-administered including: Terfenadine, Astemizole, Cisapride, Midazolam, Triazolam, Pimozide, Alfuzosin, Amiodarone, Fusidic Acid, Dihydroergotamine, Ergonovine, Ergotamine, Methylergonovine, Lovastatin, Simvastatin Sildenafil, Vardenafil, herbal preparations containing St. John's wort (Hypericum perforatum), Rivaroxaban.

    • Previous participation in this study
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is change from baseline of CogState neurocognitive score in HIV-1 patients 10 weeks following switch from EFV to Kaletra.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome measure (change in neurocognitive function) will be measured at week 10 of treatment.
    E.5.2Secondary end point(s)
    1. Change from baseline of cerebral metabolites as assessed by MRS in HIV-1 patients 10 weeks following switch from EFV to Kaletra.

    2. Change from baseline in resting-state and attentional processing task-based fMRI in HIV-1 patients 10 weeks following switch from EFV to Kaletra

    3. Change from baseline of sleep quality in HIV-1 patients 10 weeks following switch from EFV to Kaletra.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary outcome measure of change in MRS and fMRI will be measured at study week 13. The secondary outcome measure of change in sleep will be measured by diary completion from weeks 13-15, and questionnaire at study week 13.
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.2.3.1Comparator description
    Baseline measurements prior to switch from EFV. Not a comparator.
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 30
    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)
    Study CI or Co-Investigators will ensure, at the time of the final study visit that participants have a sufficient supply of HARRT treatment to last until their next routine appointment. If additional Kaletra is required beyond that dispensed within the study 12 weeks pack, this will be prescribed according to local standard hospital procedures.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Department of Pharmacology, University of Liverpool
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-31
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