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    Summary
    EudraCT Number:2011-002107-15
    Sponsor's Protocol Code Number:
    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:2011-10-13
    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 number2011-002107-15
    A.3Full title of the trial
    A randomised, open label study to evaluate the efficacy and safety of maraviroc(MVC) as a switch for N(t)RTI or PI/r in HIV1 infected individuals with stable, well controlled plasma HIV RNA while taking their first N(t)RTI + PI/r regimen of cART.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Maraviroc switch study
    A.3.2Name or abbreviated title of the trial where available
    MARCH study
    A.4.1Sponsor's protocol code number
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01384682
    A.5.4Other Identifiers
    Name:Asutralian New Zealand Clinical Trials RegistryNumber:ACTRN12611000816954
    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 of New South Wales
    B.1.3.4CountryAustralia
    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 organisationBrighton and Sussex University Hospitals NHS Trust
    B.5.2Functional name of contact pointNicky Perry
    B.5.3 Address:
    B.5.3.1Street Address1 Abbey Road
    B.5.3.2Town/ cityBrighton
    B.5.3.3Post codeBN2 1ES
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01273523079
    B.5.5Fax number01273523080
    B.5.6E-mailnicky.perry@bsuh.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 Limited
    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 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 192725170
    D.3.9.2Current sponsor codeH-C-368
    D.3.9.3Other descriptive nameCelsentri
    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 to 600
    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
    Chronic HIV-1 Infection
    E.1.1.1Medical condition in easily understood language
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10008919
    E.1.2Term Chronic HIV 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
    The primary research question is to determine whether a switch to maraviroc in HIV+ patients who are on a stable regimen of anti HIV drugs provides an optimal balance of safety, efficacy and tolerabiltiy across a range of populations. The primary endpoint of the study is the number of participants with HIV viral load (level of HIV in the blood) less than 200 copies at 48 weeks after randomisation.
    E.2.2Secondary objectives of the trial
    There a number of secondary endpoints including

    Virological
    Immunologic and biomarker endpoints
    Clinical endpoints
    Metabolic and body composition
    Safety
    Adherence
    Quality of Life
    Resistance

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Documented HIV 1 infection by a licensed diagnostic test at any time prior to study entry
    2. Age >18 years
    3. HIV 1 RNA <200 copies/mL plasma for at least 24 weeks
    4. Stable (>24 weeks) ART including two N(t)RTIs and a PI/r
    5. No evidence of any primary HIV genotypic mutations in HIV reverse transcriptase or protease for all patients with available resistance testing results conducted prior to cART and/or during viral rebound/failure
    6. Provision of written, informed consent.
    E.4Principal exclusion criteria
    1. CXCR4 or CCR5/CXCR4 dual tropic HIV tropism or a nonreportable tropism result based on assessment using proviral DNA
    2. Anticipated need to modify current cART regimen for toxicity management in the next 6 months
    3. The following laboratory criteria,
    a. absolute neutrophil count (ANC) <750 cells/μL
    b. haemoglobin <8.0 g/dL
    c. platelet count <50,000 cells/μL
    d. serum AST, ALT >5 x upper limit of normal (ULN)
    4. Active hepatitis B coinfection
    5. Pregnant women or nursing mothers
    6. Current use of any prohibited medications as described in product specific information.
    7. Hypersensitivity to soy or peanuts
    8. Acute therapy for serious infection or other serious medical illness (in the judgement of the site Principal Investigator) requiring systemic treatment and/or hospitalisation
    9. Use of immunomodulators (e.g. systemic corticosteroids, recombinant interleukin 2 interferon) within 30 days prior to screening
    10. Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the study
    11. Patients unlikely to be able to remain in follow up for the protocol defined
    period
    12. Prisoners or subjects who are compulsorily detained (involuntary incarcerated).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the comparison of the switch arms to control arm of proportion of participants with HIV RNA < 200copies/ml after randomisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 48
    E.5.2Secondary end point(s)
    A number of secondary endpoints will be examined at or through to week 48 in this protocol. These will include, butnot limited to the following:
    Virologic endpoints
    •Proportion of participants with plasma HIV RNA <50 copies/mL
    •Time to virological failure (defined as plasma HIV RNA ≥200 copies/mL on randomised therapy, on two occasions at least seven days apart)
    •Time to loss of virological response, as defined by virological failure, permanent discontinuation of randomised treatment, new AIDS‐defining illness, death or withdrawal from the study
    •Changes from baseline in log plasma HIV RNA copies/mL
    •Frequency of plasma HIV RNA blips (defined as a plasma viral load result >200 copies/mL on randomised therapy following a previous result <200 copies/mL, with a follow‐up result <200 copies/mL at least seven days after the >200 copies/mL reading, in the absence of a change of any component of the ART regimen).
    Immunologic and biomarker endpoints
    •Changes from baseline in absolute and percentage CD4+ T cells
    •Changes from baseline in selected soluble markers of immune activation/coagulation.
    Clinical endpoints
    •Rate of opportunistic disease (AIDS) or death
    •Rates of Serious Non‐AIDS‐defining illness and Non‐AIDS‐related mortality.
    Metabolic and body composition endpoints
    •Changes from baseline in fasting lipids (TC, LDL‐c, HDL‐c and TG)
    •Changes in absolute CVD risk assessment using the Framingham risk equation
    •Changes from baseline in fasting glucose and insulin
    •Rates of initiation or changes in existing lipid‐lowering therapies
    •Changes from baseline in anthropometric changes derived from Dual‐energy X‐ray absorptiometry (DXA) scanning of peripheral and central adipose tissue
    •Changes from baseline in bone mineral density as measured by DXA
    •Changes in 10‐year fracture risk using the FRAX® algorithm
    •Changes from baseline in markers of bone turnover.
    Safety
    •Changes from baseline in selected serum biochemical parameters, including changes in estimated glomerular filtration rate
    •Proportions experiencing and types of SAEs
    •Proportions experiencing, types and severity of AEs.
    Adherence
    •Self‐reported adherence to randomised study medications.
    Quality of Life
    •Change from baseline health status scores as measured by the SF‐12 health status.
    Resistance endpoints
    •Patterns of genotypic resistance at virological failure.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 48
    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 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 trial3
    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 concerned31
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Canada
    Chile
    France
    Germany
    Ireland
    Japan
    Mexico
    Poland
    Spain
    Thailand
    United Kingdom
    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
    All randomised study participants should remain in follow‐up for the duration of the study, regardless of whether or not they continue to take randomly assigned therapy. Until all patients have completed 96 weeks of treatment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 544
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 130
    F.4.2.2In the whole clinical trial 380
    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 all the medications are licensed and widely available in the UK all antiretrovirals will continue once the study has completed.
    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 Decision2011-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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