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    Summary
    EudraCT Number:2012-003778-16
    Sponsor's Protocol Code Number:J005
    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:2013-04-05
    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 number2012-003778-16
    A.3Full title of the trial
    A phase IV study to determine the oral and genital tract concentration of Maraviroc required for ex vivo protection from HIV-1 using Maraviroc 300mg stat
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The dose and genital tract concentration of Maraviroc needed for protection from HIV infection
    A.3.2Name or abbreviated title of the trial where available
    Pharmacokinetic and pharmacodynamic study investigating the role of Maraviroc 300mg in protection fr
    A.4.1Sponsor's protocol code numberJ005
    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 SponsorGuy's & St. Thomas' 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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy's & St. Thomas' NHS Foundation Trust
    B.5.2Functional name of contact pointDr Julie Fox
    B.5.3 Address:
    B.5.3.1Street AddressHarrison Wing, 2nd Floor Lambeth Wing, St. Thomas' Hospital
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 7EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4402071882643
    B.5.5Fax number4402071882646
    B.5.6E-mailjulie.fox@gstt.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 Celsentri
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare UK 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 INNMaraviroc
    D.3.9.1CAS number 376348-65-1
    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 number300
    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
    HIV
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine concentration of Maraviroc in directly aspirated fluid and tissue from the genital tract and rectal compartments at different time periods following a single oral administration of Maraviroc 300mg in HIV-1-negative healthy volunteers

    E.2.2Secondary objectives of the trial
    To determine the level of Maraviroc required in the plasma, vagina, rectum and urethra for 100% ex-vivo protection from HIV-1

    To determine the safety and tolerability of Maraviroc 300mg in HIV-1 negative individuals administered in a single dose

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The ability to understand and sign a written informed consent form prior to participation in any screening procedures and must be willing to comply with all trial requirements.
    2. Male or non-pregnant, non-lactating females
    3. Age between 18 to 50 years, inclusive.
    4. Body Mass Index (BMI) of 16 to 35 kg/m2, inclusive.
    5. Negative antibody/antigen combined test for HIV-1 and HIV-2.
    6. Absence of any significant health problems (in the opinion of the investigator) on the basis of the screening procedures; including medical history, physical examination, vital signs.
    7. Willing to consent to their personal details being entered on to The Overvolunteering Prevention Scheme (TOPS) database.
    8. Women participating in sexual intercourse that could result in pregnancy must use an adequate form of contraception throughout the study and for two weeks after the study. This includes intrauterine device, condoms, anatomical sterility in self or partner . Oral hormonal methods and implant contraceptives are allowed but only in combination with the additional protection of a barrier method.
    9. Female participants may not use any vaginal products or objects or have vaginal sex for 48 hours before and after the collection of vaginal fluid and vaginal biopsies. This list includes tampons, female condoms, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method),douches, lubricants, vibrators/dildos, and drying agents.
    10. Males participating in sexual intercourse that could result in pregnancy must use condoms during the duration of the study.
    11. Men cannot use anal products or objects including but not exclusive to douches, lubricants and vibrators/dildos, butt plugs or urethral sounds or have receptive anal intercourse for 48 hours before and after the collection of rectal fluid and rectal biopsies.
    E.4Principal exclusion criteria
    1. Any significant acute or chronic medical illness as determined by the investigator..
    2. Evidence of organ dysfunction or any clinically significant deviation from normal
    in physical examination, vital signs or clinical laboratory determinations.
    3. Positive blood screen for syphilis, hepatitis B (HBs Ag) and/or C antibodies.
    4. Positive blood screen for HIV-1 and/or HIV-2 antibodies by 4th generation assay.
    5. Positive screen for sexually transmitted infections at screening visit
    6. High-risk behaviour for HIV-1 infection which is defined as having one of the
    following within three months before trial day 0 (first dose):
    i. had unprotected vaginal or anal sex with a known HIV-1 infected person or a casual partner.
    ii. engaged in sex work for money or drugs.
    iii. acquired a bacterial sexually transmitted disease.
    iv. having a known HIV-1 positive partner either currently or in the previous six months
    7. Females who are pregnant or breast-feeding.
    8. Clinically significant laboratory abnormalities
    9. Known hypersensitivity to peanut or soya, to the active substance or any of the excipients



    E.5 End points
    E.5.1Primary end point(s)
    Concentration of Maraviroc in fluid and tissue from the genital tract and rectal compartments at different time periods following a single oral administration of Maraviroc 300mg in HIV-1-negative healthy volunteers.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Samples are taken to evaluate this endpoint at different time points for each arm of the study as follows (each participant has 2 sampling time points in total - one after each of the 2 doses of IMP):
    Arm B: 1st sampling 2 hours post 1st Maraviroc 300g stat dose
    2nd sampling 24 hours post 2nd Maraviroc 300mg stat dose
    Arm C: 1st sampling 4 hours post 1st Maraviroc 300g stat dose
    2nd sampling 36 hours post 2nd Maraviroc 300mg stat dose
    Arm D: 1st sampling 6 hours post 1st Maraviroc 300mg stat dose
    2nd sampling 48 hours post 2nd Maraviroc 300mg stat dose
    Arm E: 1st sampling 12 hours post 1st Maraviroc 300mg stat dose
    2nd sampling 72 hours post 2nd Maraviroc 300mg stat dose
    E.5.2Secondary end point(s)
    Level of Maraviroc required in the plasma, vagina, rectum and urethra for 100% ex vivo protection from HIV-1

    A comparison of measuring Maraviroc drug levels by either Weck cell sponge and rovumeters
    E.5.2.1Timepoint(s) of evaluation of this end point
    Samples taken as above for primary endpoint and are then sent to the lab for quantification of protection from HIV-1 infection
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 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
    No maraviroc
    E.8.2.4Number of treatment arms in the trial5
    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 concerned2
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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: 54
    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 Yes
    F.3.2Patients No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 54
    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)
    There is no continued provision of any intervention after the study has finished.
    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 Decision2013-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-01
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