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    Summary
    EudraCT Number:2014-002284-15
    Sponsor's Protocol Code Number:SSAT058
    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:2015-07-15
    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 number2014-002284-15
    A.3Full title of the trial
    SSAT058: A phase IV, open-label, multi centre pilot study to assess changes in cerebral function parameters in patients without perceived Central Nervous System (CNS) symptoms when switched from tenofovir/emtricitabine/efavirenz (Atripla®) to a fixed dose combination of tenofovir/emtricitabine/rilpivirine (Eviplera®).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess changes in Central Nervous System (CNS) function where no obvious symptoms exist, when switching from Atripla to Eviplera switch in HIV infected patients
    A.3.2Name or abbreviated title of the trial where available
    SSAT058:Atripla to Eviplera switch in patients without CNS symptoms
    A.4.1Sponsor's protocol code numberSSAT058
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSt Stephen's AIDS 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 supportGilead Sciences Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt Stephen's AIDS Trust
    B.5.2Functional name of contact pointJustine Boles
    B.5.3 Address:
    B.5.3.1Street AddressLondon House,
    B.5.3.2Town/ city266 Fulham Rd
    B.5.3.3Post codeSW10 9EL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02033153761
    B.5.5Fax number02030550044
    B.5.6E-mailjustine.boles@chelwest.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 Eviplera
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameEviplera
    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 INNEmtricitabine
    D.3.9.1CAS number 143491-57-0
    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 INNRilpivirine
    D.3.9.1CAS number 500287-72-9
    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 number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtenofovir disoproxil
    D.3.9.1CAS number 202138-50-9
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number245
    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
    HIV
    E.1.1.1Medical condition in easily understood language
    HIV
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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 changes in neuropsychiatric and central nervous system (CNS) parameters in patients without perceived Central Nervous System (CNS) symptoms after 4 weeks of switching from Atripla (TDF/FTC/EFV) to Eviplera (TDF/FTC/RPV).
    E.2.2Secondary objectives of the trial
    • To assess changes in neuropsychiatric and central nervous system (CNS) parameters after 12 and 24 weeks of switching from Atripla (TDF/FTC/EFV) to Eviplera (TDF/FTC/RPV).
    • To assess the proportion of patients with undetectable viral load (by local assay) at weeks 4, 12 and 24 post switch.
    • To assess the proportion of patients with viral load below 400 copies/mL at weeks 4, 12 and 24 post switch.
    • To assess the change in CD4+ count at week 12 and 24 post switch.
    • To assess the proportion of patients with grade 2-4 laboratory adverse events (excluding lipids) and the proportion with grade 2-4 non-CNS adverse events after 4, 12 and 24 weeks of switching from Atripla (TDF/FTC/EFV) to Eviplera (TDF/FTC/RPV).
    • To assess the change in mean fasting cholesterol (total, HDL, LDL and total:HDL ratio) and triglycerides at week 4, 12 and 24 post switch.
    • To assess the change in quality of life at week 4, 12 and 24 post switch.
    • To assess change in neurocognitive function at wee
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    SSAT058 Magnetic Resonance Imaging substudy - To assess change in cerebral MR-measurable imaging modalities at week 24 post switch
    (Within main protocol).
    E.3Principal inclusion criteria
    1. Is male or female aged 18 years or above
    2. Has HIV-1 infection documented in their medical notes
    3. Has signed the Informed Consent Form voluntarily
    4. Is willing to comply with the protocol requirements
    5. Has been on Atripla for at least 12 weeks before enrolment
    6. Has an undetectable HIV-plasma viral load at screening by local assay (single re-test allowed)
    7. Has a CD4 cell count at screening >50 cells/mm3
    8. Has an estimated glomerular filtration rate (MDRD) >50 ml/min.
    9. Has no significant CNS symptoms which may be attributable to EFV.
    10. If female and of childbearing potential, is using effective birth control methods (for example, hormonal contraceptive, condom, abstinence, IUD, as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial. Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential
    11. If a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until follow-up visit
    E.4Principal exclusion criteria
    Patients meeting 1 or more of the following criteria cannot be selected:
    1. Infected with HIV-2
    2. Using any concomitant therapy disallowed as per SPC for the study drugs (e.g proton pump inhibitors )
    3. Has acute viral hepatitis including, but not limited to, A, B, or C
    4. Has chronic hepatitis B and/or C with AST and/or ALT >5 x ULN
    Note: Patients can enter trial with chronic HBV if HBV-DNA undetectable at screen (and no detectable result in last 6 months) and with chronic HCV if not expected to require treatment during the trial period.
    5. Any investigational drug within 30 days prior to the trial drug administration
    6. Has ever received rilpivirine in the past
    7. Any clinical evidence of baseline resistance mutations, prior to commencing antiretroviral therapy.
    8. Known allergy to lactose monohydrate, sunset yellow aluminium lake (E110), and patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
    9. Severe hepatic impairment (defined as Child-Pugh-Turcotte (CPT) Score C).
    10. If female, she is pregnant or breastfeeding
    11. Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed).
    12. Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the trial.
    13. If participating in the MR Imaging substudy, any contraindications to magnetic resonance scanning according to local radiology guidelines (to be assessed by MR Spectroscopy Imaging Department)
    E.5 End points
    E.5.1Primary end point(s)
    Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 4 weeks compared to baseline as measured by:
    o The proportion of patients experiencing grade 2-4 neuropsychiatric and CNS toxicity (as defined by the ACTG adverse event scale and collected by CNS questionnaire.
    o The median number of grade 2-4 neuropsychiatric and CNS toxicity (as defined by the ACTG adverse event scale and collected by CNS questionnaire
    o The median CNS score (derived from the sum of toxicity of all grades collected in the CNS questionnaire).
    o Change in sleep score using the Pittsburgh Sleep Questionnaire.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks
    E.5.2Secondary end point(s)
    • Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 12 and 24 weeks compared to baseline as measured by:
    o The proportion of patients experiencing grade 2-4 neuropsychiatric and CNS toxicity (any and for each individual toxicity) (as defined by the ACTG adverse event scale and collected by CNS questionnaire).
    o The median number of grade 2-4 neuropsychiatric and CNS toxicity (as defined by the ACTG adverse event scale and collected by CNS questionnaire).
    o The median CNS score (derived from the sum of toxicity of all grades collected in the CNS questionnaire).
    o Change in sleep score using the Pittsburgh Sleep Questionnaire.
    • Change in neuropsychiatric and CNS parameters as measured by the change in the Hospital Anxiety and Depression Scale (HADS) at 4, 12 and 24 weeks as compared with baseline.
    • Proportion of patients with undetectable viral load (by local assay) at weeks 4, 12 and 24.
    • Proportion of patients with viral load below 400 copies/mL at weeks 4, 12 and 24.
    • Change in CD4+ count at week 12 and 24 compared to baseline.
    • Proportion of patients with grade 2-4 laboratory adverse events (excluding lipids) and proportion of patients with grade 2-4 non-CNS adverse events at 4, 12 and 24 weeks compared with baseline.
    • Change in mean fasting cholesterol (total, HDL, LDL and total:HDL ratio) and triglycerides after 4, 12 and 24 weeks compared with baseline.
    • Change in quality of life (as assessed by EQ-5D questionnaire) at 4, 12 and 24 weeks compared with baseline.
    • Change in neurocognitive function as determined by computerised neurocognitive assessment and Instrumental Activities of Daily Life (IADL) questionnaire (no computerised cognitive testing at week 12) at 4, 12 and 24 weeks compared with baseline.
    • Change in adherence as measured by the adherence questionnaire: Medication Adherence Self-Report Inventory (M-MASRI) at 12 and 24 weeks compared with baseline.
    • Change in cerebral MR-measurable imaging modalities at 24 weeks compared with baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4, 12 and 24 weeks
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.3 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 concerned4
    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 No
    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 months11
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days31
    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: 40
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    When the research study stops, participants will be prescribed enough antiretroviral treatment until the next follow-up with their regular clinic doctor. They may decide to continue taking Eviplera®, or switch back to Atripla® or switch to an alternative depending on discussion with the regular clinic doctor and clinic policy/national guidelines.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-10
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