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    Summary
    EudraCT Number:2012-002205-22
    Sponsor's Protocol Code Number:SSAT047
    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:2012-08-03
    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 number2012-002205-22
    A.3Full title of the trial
    A phase III, open-label, multi centre pilot study to assess the feasibility of switching, individuals receiving Atripla or Kivexa plus Efavarinz with continuing Central Nervous System (CNS) toxicity, 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
    Efavirenz to Rilpivirine FDC Switch Study
    A.3.2Name or abbreviated title of the trial where available
    SSAT 047: Efavirenz to Rilpivirine FDC Switch Study
    A.4.1Sponsor's protocol code numberSSAT047
    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 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 organisationChelsea & Westminster NHS Trust
    B.5.2Functional name of contact pointMark Nelson
    B.5.3 Address:
    B.5.3.1Street AddressChelsea and Westminster Hospital
    B.5.3.2Town/ city369 Fulham Road
    B.5.3.3Post codeSW10 9NH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0208 746 5610
    B.5.5Fax number0208 846 8537
    B.5.6E-mailmark.nelson@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 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 nameEviplera (tenofovir/emtricitabine/rilpivirine)
    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 INNTenofovir
    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 number245
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEmtricitabine
    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 number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRilpivirine
    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 number25
    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] - 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 investigate whether switching individuals who have central nervous system (CNS) side effects from taking efavirenz-containing treatment (as Atripla or Kivexa plus efavarinz) to Eviplera resolves the CNS side effects after 12 weeks.
    E.2.2Secondary objectives of the trial
    - To investigate whether switching individuals who have central nervous system (CNS) side effects from taking efavirenz-containing treatment to Eviplera resolves the CNS side effects after 24 weeks.
    - To investigate the impact of switching to Eviplera from an efavirenz-containing treatment on quality of sleep over 24 weeks
    - To investigate the change in CD4 count in individuals switching to Eviplera from an efavirenz-containing treatment over 24 weeks
    - To investigate continued virus suppression in individuals switching to Eviplera from an efavirenz-containing treatment over 24 weeks
    - To investigate changes in fasting lipids- cholesterol and triglycerides- in individuals switching to Eviplera from an efavirenz-containing treatment over 24 weeks
    - To investigate the safety of switching to Eviplera from an efavirenz-containing treatment over 24 weeks
    - To investigate the impact of switching to Eviplera from an efavirenz-containing treatment on drug adherence over 24 weeks
    - To
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetic substudy
    E.3Principal inclusion criteria
    - Is male or female aged 18 years or above
    - Has HIV-1 infection documented in their medical notes
    - Has signed the Informed Consent Form voluntarily
    - Is willing to comply with the protocol requirements
    - Has been on Atripla for at least 12 weeks OR Kivexa plus efavirenz
    - Has an HIV-plasma viral load at screening <50 copies/mL (single re-test allowed)
    - Has a CD4 cell count at screening >50 cells/mm3
    - Estimated glomerular filtration rate (MDRD) >50 ml/min.
    - Has symptomatic CNS related toxicity associated with EFV
    - If female and of childbearing potential, is using effective birth control methods (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
    - 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
    - Infected with HIV-2
    - Using any concomitant therapy disallowed as per SPC for the study drugs (note acid-reducing agents and interaction with rilpivirine)
    - Has acute viral hepatitis including, but not limited to, A, B, or C
    - Has chronic hepatitis B and/or C with AST and/or ALT >5 x ULN
    Note: Subjects 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.
    - Any investigational drug within 30 days prior to the trial drug administration
    - Has received rilpivirine in the past
    - Any clinical evidence of baseline resistance mutations
    - Known allergy to lactose monohydrate, sunset yellow aluminium lake (E110), and patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
    - Severe hepatic impairment
    - Moderate or severe renal impairment (creatinine clearance < 50ml/min)
    - If female, she is pregnant or breastfeeding
    - 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).
    - Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the trial.
    E.5 End points
    E.5.1Primary end point(s)
    The rate of neuropsychiatric and central nervous system (CNS) toxicity (as measured by a questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale) after 12 weeks of tenofovir/emtricitabine/rilpivirine therapy as measured by:
    - Proportion of subjects with grade 2-4 events
    - Sum total of all grades of CNS adverse events
    - Median number of grade 2-4 CNS adverse events
    Baseline results will be compared with after 12 weeks on tenofovir/emtricitabine/rilpivirine FDC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    - The rate of neuropsychiatric and central nervous system (CNS) toxicity (as measured by a questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale) after 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine therapy:
    o Proportion of subjects with grade 2-4 events
    o Sum total of all grades of CNS adverse events
    o Median number of grade 2-4 CNS adverse events
    Baseline results will be compared with 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine FDC.
    - Change in sleep from baseline compared with after 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine therapy as determined by the Pittsburgh Sleep Score
    - Change in CD4 cell count and % from baseline compared with after 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine therapy
    - Proportion of subjects maintaining viral suppression to <400 and <50 and <5 copies/ml after 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine therapy
    - Change from baseline in median fasting cholesterol (total, HDL, LDL and total:HDL ratio) and triglycerides after switching from Atripla to tenofovir/emtricitabine/rilpivirine for 4, 12 and 24 weeks
    - Proportion of patients with grade 2-4 laboratory parameters (excluding lipids) after 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine compared with baseline and proportion of patients with grade 2-4 non-CNS adverse events after 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine compared with baseline
    - Change from baseline in adherence after 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine as measured by the adherence questionnaire: Medication Adherence Self-Report Inventory (M-MASRI)
    - Change from baseline in quality of life after 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine as measured by the EuroQOL questionnaire
    - Change from baseline of CNS toxicity as measured by Hospital Anxiety and Depression (HADS) score (baseline vs week 12 and week 24 of tenofovir/emtricitabine/rilpivirine)
    - Change from baseline in NC function after 4, 12 and 24 weeks of tenofovir/emtricitabine/rilpivirine therapy as determined by computerised NC assessment and Instrumental Activities of Daily Life (IADL) questionnaire (week 12 IADL only)
    - Efavirenz plasma concentration decay and rilpivirine plasma concentrations after the switch from Atripla
    - Association between genetic polymorphisms in drug disposition genes and drug exposure
    E.5.2.1Timepoint(s) of evaluation of this end point
    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 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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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
    Subjects who have not switched to Eviplera
    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 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
    Last subject last visit
    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 months0
    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 months0
    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: 40
    F.1.3Elderly (>=65 years) Yes
    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, the patient will be prescribed enough antiretroviral treatment until their next follow-up with their regular clinic doctor. This may be a different combination depending on discussion with their regular clinic doctor and clinic policy/national guidelines. This will be discussed with the patient at the beginning of the study.
    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 Decision2012-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-11
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