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    Summary
    EudraCT Number:2012-003581-40
    Sponsor's Protocol Code Number:CRO1992
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-07
    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 ConcernedIreland - HPRA
    A.2EudraCT number2012-003581-40
    A.3Full title of the trial
    A prospective, observational study to examine the effects of ageing on the clinical outcomes of people living with HIV in England and Ireland.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    POPPY Pharmacokinetic and clinical observations in people over fifty
    A prospective, observational study to examine the effects of ageing on the clinical outcomes of people living with HIV in England and Ireland.
    A.3.2Name or abbreviated title of the trial where available
    POPPY Pharmacokinetic and clinical observations in people over fifty
    A.4.1Sponsor's protocol code numberCRO1992
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01737047
    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 SponsorImperial College London
    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 supportBristol-Myers-Squibb
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportGilead Sciences
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportJanssen Pharmaceuticals
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportViiv Healthcare
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College London
    B.5.2Functional name of contact pointDaphne Babalis
    B.5.3 Address:
    B.5.3.1Street AddressImperial Clinial Trials Unit, Stadium House, 68 Wood lane
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW12 7RH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402075943403
    B.5.6E-maild.babalis09@imperial.ac.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 Viread
    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.3.4Pharmaceutical 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 disoproxil fumarate
    D.3.9.1CAS number 202138-50-9
    D.3.9.2Current sponsor codeCRO 1992
    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.3.11 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
    HIV
    E.1.1.1Medical condition in easily understood language
    Patients over the age of 50 with HIV infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10000807
    E.1.2Term Acute 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
    To analyse the incidence and outcomes of intercurrent illnesses (other illnesses occurring or recurring) in older HIV-positive people and their relationship with demographic( for example age, gender, ethnicity employment, housing and relationship status) and clinical factors (for example any details of past or present illnesses and treatments). Also history of illnesses within the family.

    E.2.2Secondary objectives of the trial
    To evaluate associations between antiretroviral drug concentrations and age, and to assess the potential impact of age on drug effectiveness, interactions or side effects becuse of drug combinations and other current illnesses.

    To contribute to the development and implementation of evidence-based recommendations for the clinical monitoring of older HIV-positive patients.
    Our study, by enrolling both younger and older HIV-positive individuals matched with a HIV-negative control group, will be in the unique position to determine the effects of ageing and HIV status on chronic HIV-infection. In addition, results from this study will be well placed to assist in informing about future HIV treatment in older subjects and assisting in the design of future studies for the treatment of age associated illnesses in older HIV positive patients.
    It will also assess the use of healthcare resources and other medication in the older HIV positive group.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: The POPPY St. Mary’s MRI Sub-study V3 04/02/2013
    Aims: To analyse detailed neurocognitive function, lumbar puncture findings and cerebral imaging findings in a cohort of subjects entering the POPPY study. These participants will be attending the St Mary's hospital site. They will include both HIV-ve and +ve participants equal to or greater than the age of 50 years.
    Additional investigations will involve detailed blood tests of thyroid and diabetic function. Blood and stool samples will be stored. Assessment of cardiovascular function including and ECG will take place. Respiratory function test will be performed. MRS scans will be performed at the 1 and 2 year visits. A lumbar puncture will be performed on all subjects at the year 1 visit and for the HIV +ve group at the 2 year visit.
    E.3Principal inclusion criteria
    Older HIV-positive cohort (n=1000):
    • documented HIV infection
    • age >50 years at study entry
    • self defined white or black African ethnicity
    • likely route of HIV acquisition via sexual exposure
    • able to comprehend study patient information leaflet




    Younger HIV-positive cohort (n=500):
    • documented HIV infection
    • age <50 at study entry*
    • self defined white or black African ethnicity
    • likely route of HIV acquisition via sexual exposure
    • able to comprehend study patient information leaflet

    * this group will comprise of at least 150 subjects in each of the following age groups: 20-29, 30-39, 40-49 years. Recruitment will be monitored by the Study Monitoring Team

    HIV-negative cohort (n=500):
    • documented negative HIV test at screening
    • age >50 years at study entry
    • self defined white or black African ethnicity
    • registered with a General Practitioner

    The control groups will be frequency matched to the cases on gender, ethnicity, mode of HIV acquisition and clinic location.
    E.4Principal exclusion criteria
    • in the opinion of the investigator, those unable or unwilling to comply with the requirements of the study
    • life expectancy less than 6 months
    E.5 End points
    E.5.1Primary end point(s)
    Clinical events at baseline (prevalence)
    New clinical events or recurrence.
    Events considered will specifically include deterioration in neurocognitive function, bone pain, fractures, liver disease, kidney disease, myocardial infarction and malignancy. Other more general problems such as hypertension, changes in blood sugar levels, and cholesterol abnormalities will be addressed. Also it is hoped to be able to develop a measure of general frailty in an individual.
    E.5.1.1Timepoint(s) of evaluation of this end point
    These will be visits at baseline, after 1 year and after 2 years. For HIV negaive participants there will only be a telephone visit at year 1. Recruitment is likely to take 12 months.
    E.5.2Secondary end point(s)
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To indicate the increased burden of treating concurrent disease in HIV +ve patients over 50
    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 concerned6
    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 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
    The end of the trial will be the last data capture for the last patient recruited to the POPPY study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days28
    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: 1800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state1900
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 2000
    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)
    As this is observational in nature, normal medical care will continue. Should the DEXA scans indicate that intervention is required then appropriate referral will take place either within a clinic setting or via primary care.
    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 Decision2013-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-13
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