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    Summary
    EudraCT Number:2014-004819-37
    Sponsor's Protocol Code Number:APART_2014
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-08-02
    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 number2014-004819-37
    A.3Full title of the trial
    A multi-centre, prospective, randomised trial of short course alendronate therapy or placebo combined with vitamin D and calcium to prevent loss of bone mineral density in antiretroviral-naïve, HIV-1 infected subjects initiating antiretroviral therapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Alendronate for Prevention of antiretroviral therapy-associated bone loss.
    A.3.2Name or abbreviated title of the trial where available
    Alendronate for Prevention of ART-associated bone loss (APART study)
    A.4.1Sponsor's protocol code numberAPART_2014
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02322099
    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 SponsorUniversity College Dublin
    B.1.3.4CountryIreland
    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 supportHealth Research Board (HRB)
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College Dublin
    B.5.2Functional name of contact pointHIV Molecular Research Group
    B.5.3 Address:
    B.5.3.1Street AddressCatherine McAuley Education and Research Centre, 21 Nelson Street
    B.5.3.2Town/ cityDublin
    B.5.3.3Post codeD7
    B.5.3.4CountryIreland
    B.5.4Telephone number+353 1 7164550
    B.5.5Fax number+353 1 716
    B.5.6E-mailtara.mcginty@ucd.ie
    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 Fostolin
    D.2.1.1.2Name of the Marketing Authorisation holderACTAVIS GROUP PTC ehf
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameFostolin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Human immunodeficiency virus (HIV) infection
    E.1.1.1Medical condition in easily understood language
    HIV 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 20.1
    E.1.2Level PT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In antiretroviral-naïve, HIV1-infected adults, to compare the effect of a short (14 week) course of oral alendronate 70mg weekly versus placebo combined with calcium and vitamin D, initiated 2 weeks prior to start of antiretroviral therapy (ART) for HIV1 infection on ART-induced bone mineral density (BMD) loss over 48 weeks of follow-up post ART initiation.
    E.2.2Secondary objectives of the trial
    To explore the effect of alendronate on bone turnover in HIV-1 infected subjects initiating ART.
    To determine which factors, such as choice of ART, impacts the protective effect of alendronate in preventing BMD loss.
    To investigate relationships between ART-induced changes in immune function, inflammation, bone metabolism and BMD.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Immunological sub-study (included in the main study protocol Version 1.0, 23rd January 2015).
    Objective: to explore how changes in T/B cells subset with ART relate to changes in BMD and turnover.
    Stored PBMC samples will be analysed using polychromatic flow cytometry to evaluate T/B cells and monocyte biomarkers, including markers of immune activation, senescence and cytokine expression, and BTMs will be measured on stored serum samples.

    Two analyses will be performed, one at week 14 (week 12 post-ART initiation), when the greatest increases in markers of bone resorption (CTX) are expected, and another at week 50 (week 48 post-ART initiation), when re-establishment of bone remodeling equilibrium is expected to occur.
    E.3Principal inclusion criteria
    • male>25 years old or female>30 years old
    • HIV-1 antibody positive (no CD4 or HIV RNA criteria)
    • antiretroviral therapy naïve (Not having had suppressive ART in the previous 12 months to enrollment)
    • be presumed to have achieved peak bone mass
    • eligible for initiation of antiretroviral therapy in the opinion of the investigator
    • able to provide written informed consent
    E.4Principal exclusion criteria
    - • subjects unable to comply with the study protocol or unable to stand/sit upright for at least 30 minutes
    • history of osteoporosis (defined as hip, femoral neck or spine T score of <-2.5 in men over age >50 or in post-menopausal women)
    • history of fragility fracture or previous femoral fracture
    • chronic renal failure (estimated GFR<60mls/min/1.73m2)
    • hypocalcaemia (corrected calcium<2.2mmol/L) or hypercalcaemia (>2.6mmol/L) at screening
    • history of Paget’s disease or known primary hyperparathyroidism
    • previous treatment with or allergy (including hypersensitivity) to bisphosphonates
    • recent history (past 12 months) of peptic or duodenal ulcers or oesophagitis, aspiration or any other upper-gastrointestinal problem or oesophageal disease that in the opinion of the investigator precludes the use of alendronate
    • history of dental disease, periodontal disease, poor oral hygiene (as judged in the opinion of the investigator) or recent invasive dental procedures (within the past 3 months) comprising dental extraction and dental prosthetic
    • current therapy with prescribed calcium or vitamin D preparations (other than over-the-counter multivitamin preparations)
    • current therapy with aspirin or other regularly prescribed non-steroidal anti-inflammatory drugs
    • recent significant steroid exposure defined as continual or cumulative use of >5mg prednisolone daily or equivalent for ≥ three months, as per EACS guidelines
    • for female subjects: pregnancy or breastfeeding at screening, planning future pregnancies or unwilling to take measures to avoid pregnancy for the duration of the study
    • where in the investigator’s opinion, there is a necessity to initiate ART within the pre-ART study window period
    • hepatitis B (sAg positive) or hepatitis C (Ab and RNA positive) co-infection
    • any active illness (including AIDS-defining illness) which in the opinion of the investigator precludes participation in the study.
    • subjects concurrently enrolled in another clinical trial of an investigational medical product
    E.5 End points
    E.5.1Primary end point(s)
    Between-group difference in percentage change in total hip BMD from baseline to week 50 among subjects who received at least one dose of study medication.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and week 50
    E.5.2Secondary end point(s)
    Between-group differences in percentage change in lumbar spine, femoral neck BMD and body composition to week 50.
    Between-group differences in percentage change in total hip, lumbar spine and femoral neck BMD to weeks 14 and 26.
    Between-group differences in percentage change in bone turnover markers to weeks 26 and 50.
    Between-group differences in percentage change in 25(OH)D, PTH and calcium to week 50.
    Between-group differences in ART-induced changes immune function, BMD and bone turnover to week 14 and 50.
    Between-group differences in measures of safety.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, week 14, week 26 and week 50
    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 Yes
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 months7
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years2
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    HIV positive subjects
    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 80
    F.4.2.2In the whole clinical trial 80
    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)
    Ongoing specialist care will be provided within the site for chronic HIV infection
    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 Decision2017-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-09-07
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