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    Summary
    EudraCT Number:2011-003447-21
    Sponsor's Protocol Code Number:MMC001
    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:2012-01-04
    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 number2011-003447-21
    A.3Full title of the trial
    Randomised controlled trial of the tolerability and completion of maraviroc compared to Kaletra© in combination with Truvada© for HIV post-exposure prophylaxis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomised controlled trial of the tolerability and completion of maraviroc compared to Kaletra© in combination with Truvada© for HIV post-exposure prophylaxis
    A.3.2Name or abbreviated title of the trial where available
    Maraviroc in HIV post exposure prophylaxis (MiPEP) Trial Version 1.0
    A.4.1Sponsor's protocol code numberMMC001
    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 SponsorCamden Provider Services
    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
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCamden Provider Services
    B.5.2Functional name of contact pointAngela Williams
    B.5.3 Address:
    B.5.3.1Street Address3rd Floor, Bedford House, 125-133 Camden High Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeNW1 7JR
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number020 3317 3765
    B.5.5Fax number020 7685 5788
    B.5.6E-mailangela.williams9@nhs.net
    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 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 nameMaraviroc
    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
    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
    Prophylaxis and prevention of HIV Infection.
    E.1.1.1Medical condition in easily understood language
    Prophylaxis and prevention of 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 14.1
    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
    Patients taking current combinations of PEP frequently report side effects and completion rates of the full 28 day course of medication is often poor. This may compromise the protective effect of PEP. The availability of a better tolerated combination would be beneficial to patients. Principal study objective is to compare the tolerability and completion rate between standard PEP drug combination and maraviroc based-PEP. Composite end point of completion of 28 days of allocated PEP regimen without grade 3 or 4 clinical or laboratory adverse events related to the PEP medication. Investigators will determine whether clinical or laboratory adverse events are related to the PEP medication at the time of the event. All adverse events will be reviewed by an independent panel.
    E.2.2Secondary objectives of the trial
    The objectives are to compare the following: Completion rates of the two PEP regimens Compare the numbers of patients experiencing side effects (clinical adverse events and blood/urine test abnormalities) between the two combinations Compare the numbers of patients who need to change or stop their PEP as well as the reasons why Compare the rates of missed tablets between the two groups We will collect information regarding the rate of people catching HIV or other sexually transmitted infections (gonorrhoea, Chlamydia, LGV, syphilis, hepatitis B and C) and any differences between the levels of sexual risk taking behaviour. This will focus upon the proportion of individuals reporting unprotected anal/vaginal intercourse in i) the three months preceding PEP, ii) while receiving PEP and iii) in the three months post completion of PEP with a potentially sero-discordant partner.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A patient attending one of four genitourinary medicine clinics and for whom PEP is considered appropriate by the clinician according to current guidelines including following occupational or non occupational exposure. 2. Willing to provide written informed consent. 3. 18 years old or older.
    E.4Principal exclusion criteria
    1. The baseline HIV test is reactive or positive 2. Currently receiving medication which would reduce the effectiveness of Kaletra / maraviroc (see appendix 1) 3. Currently receiving medication where the interaction would result in a dangerously high level of the concomitant drug (see appendix 1) 4. Pregnant or trying to become pregnant at the time of trial entry. 5. The source is known to have multi-drug resistant HIV and therefore more likely to have CXCR 4 tropic virus 6. History of active substance abuse or psychiatric illness that, in the opinion of the investigator, would preclude compliance with the protocol, dosing schedule or assessments. 7. Any other active clinically significant condition, or findings during screening medical history or examination, or abnormality on screening laboratory blood tests that would, in the opinion of the investigator, compromise the patient’s safety or outcome in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Composite end point of completion of 28 days of allocated PEP regimen without grade 3 or 4 clinical or laboratory adverse events.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This is a 4 month study to compare the tolerability and completion of maraviroc compared to Kaletra© in combination with Truvada© for HIV post exposure prophylaxis. Recruitment to the trial will be conducted over 12 months. Patients will be randomised to receive coformulated tenofovir disoproxil fumarate/emtricitabine (Truvada©) with either maraviroc (experimental arm) or lopinavir/ritonavir (Kaletra©) (control arm) for 28 days. Participants will be asked to visit the clinic on 3 occasions (Days 14 and 28, and Month 4 visits). This is the same number of clinic visits as suggested by current guidelines for PEP.
    E.5.2Secondary end point(s)
    • Completion rates of 28 days of allocated PEP regimen • Rates of Grade 1, 2, 3 or 4 clinical adverse events • Rates of grade 1, 2, 3 or 4 laboratory abnormalities • Rates and causes of regimen modification or discontinuation • Number of missed doses of Truvada® over 28 day course of PEP • Number of missed doses of Kaletra® or maraviroc over 28 day course of PEP • Number of doses of antidiarrhoeal medication taken • Number of doses of antiemetic taken • Number of days absent from work or college (not including days attending for clinic visits) • Number of clinic visits required • Rates of HIV seroconversion at month 4 after exposure. • Sexual behaviour- proportion of individuals reporting unprotected anal/vaginal intercourse in i) the three months preceding PEP, ii) while receiving PEP and iii) in the three months post completion of PEP with a potentially sero-discordant partner • Number of sexual partners in i) the three month period preceding PEP, ii) while receiving PEP and iii) the three month period following PEP • Rates of sexually transmitted infections (gonorrhoea, Chlamydia, LGV, syphilis, hepatitis B and C)
    E.5.2.1Timepoint(s) of evaluation of this end point
    This is a 4 month study to compare the tolerability and completion of maraviroc compared to Kaletra© in combination with Truvada© for HIV post exposure prophylaxis. Recruitment to the trial will be conducted over 12 months. Patients will be randomised to receive coformulated tenofovir disoproxil fumarate/emtricitabine (Truvada©) with either maraviroc (experimental arm) or lopinavir/ritonavir (Kaletra©) (control arm) for 28 days. Participants will be asked to visit the clinic on 3 occasions (Days 14 and 28, and Month 4 visits). This is the same number of clinic visits as suggested by current guidelines for PEP.
    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 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 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) Yes
    E.8.2.2Placebo No
    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 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 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
    End of trial is defined as the last subject last visit.
    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 months6
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days30
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state280
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 280
    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)
    Not applicable
    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 Decision2011-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-24
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