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    Summary
    EudraCT Number:2015-003616-20
    Sponsor's Protocol Code Number:1439A-030
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-02
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-003616-20
    A.3Full title of the trial
    A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects with Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MK-1439A in treatment-naïve HIV-1 infected subjects with NNRTI transmitted resistance.
    A.3.2Name or abbreviated title of the trial where available
    MK-1439A in treatment-naïve HIV-1 infected subjects with NNRTI transmitted resistance.
    A.4.1Sponsor's protocol code number1439A-030
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryFrance
    B.5.4Telephone number+1267305-1204
    B.5.5Fax number+1267305-6477
    B.5.6E-mailpeter_sklar@merck.com
    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 No
    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 nameMK-1439A
    D.3.2Product code MK-1439A
    D.3.4Pharmaceutical form 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 INNDORAVIRINE
    D.3.9.1CAS number 1338225-97-0
    D.3.9.3Other descriptive nameMK-1439
    D.3.9.4EV Substance CodeSUB177834
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLAMIVUDINE
    D.3.9.1CAS number 134678-17-4
    D.3.9.4EV Substance CodeSUB08392MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.3.9.4EV Substance CodeSUB12607MIG
    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
    Human Immunodeficiency Virus-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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1)To evaluate the antiretroviral activity of MK-1439A as measured by the proportion of subjects achieving HIV -1 RNA <50 copies/mL (by the Abbott RealTime HIV-1 Assay) at Week 48.
    2)To evaluate the safety and tolerability of MK-1439A, as assessed by review of the accumulated safety data by Week 48 and Week 96.
    E.2.2Secondary objectives of the trial
    1)To evaluate the antiretroviral activity of MK-1439A as measured by the proportion of subjects achieving HIV -1 RNA <50 copies/mL at Week 96.
    2)To evaluate the antiretroviral activity of MK-1439A as measured by the proportion of subjects achieving HIV -1 RNA below the limit of quantification of the Abbott RealTime HIV-1 Assay (<40 copies/mL) at Week 48 and Week 96.
    3) To evaluate the immunologic effect of MK-1439A, as measured by the change from baseline in CD4 cell count at Week 48 and Week 96.
    4) To evaluate the antiretroviral activity of MK-1439A as measured by the time-to-loss-of-virologic-response.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    E.3Principal inclusion criteria
    1.Be at least 18 years of age on the day of signing the informed consent.
    2.Understand the study procedures and voluntarily agree to participate by giving written informed consent (or have a legal representative provide written informed consent, if considered acceptable by local regulatory agencies and/or ERCs/IRBs) for the trial. The subject or his/her legal representative (if considered acceptable by local regulatory agencies and/or ERCs/IRBs) may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research
    3.Be HIV-1 positive as determined by a positive result on an enzyme-immunoassay, have screening plasma HIV-1 RNA (determined by the central laboratory) ≥ 1000 copies/mL within 30 days prior to the treatment phase of this study, and have HIV treatment indicated based on physician assessment. Local treatment guidelines should be considered in the decision to initiate therapy.
    4.Have a screening CD4 cell count ≥100 cells/mm3 (completed by the central laboratory) within 30 days prior to the treatment phase of this study.
    5.Be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents.
    6.Within one year prior to screening, have had a genotype performed confirming the presence of one and only one of the following NNRTI mutations: K103N, Y181C, G190A.
    7.Have the following laboratory values during the screening period of the trial: Alkaline phosphatase ≤ 3.0 x upper limit of normal; AST (SGOT) and ALT (SGPT) ≤ 5.0 x upper limit of normal; Hg ≥ 9.0 g/dl (if female) or ≥ 10.0 g/dl (if male); have calculated creatinine clearance at the time of screening ≥ 50 mL/min.
    8. Be clinically stable with no signs or symptoms of active infection at the time of entry into the study.
    9.Be highly unlikely to become pregnant or to impregnate a partner.
    E.4Principal exclusion criteria
    1.Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of this study or interfere with the subject’s participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
    2.Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence. The nature and potential clinical context of the subject’s illicit drug use, in relation to their exclusion from this trial, will be at the discretion of the Investigator.
    3.Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1, including, but not limited to, adefovir, tenofovir, entecavir, emtricitabine, or lamivudine.
    4.Has documented or known resistance to study drugs (MK-1439, lamivudine, and/or tenofovir) as defined below:
    a)Resistance to MK-1439 for the purpose of this study is considered to include mutant viruses containing any of the following NNRTI-associated mutations: L1001, K101E, K101P, K103S, V106A, V106I, V106M, V108I, E138K, E138A, E138G, E138O, E138R, V179L, Y181I, Y181V, Y188C, Y188H, Y188L, G190S, H221Y, P225H, F227C, F227V, F227L, M230I and M230L.
    b)Any double or triple NNRTI mutation that includes mutations from the above in combination with K103N, Y181C, or G190A.
    c)Resistance to lamivudine or tenofovir for the purpose of this study is considered to include following NRTI-associated mutations: M41L, A62V, K65R, D67N, K70E, K70R, L74V, V75I, F77L, Y115F, F116Y, Q151M, M184I, M184V, L210W. T215F, T215Y, K219E, and K219Q as well as the T69S insertion complex.
    5.Has participated in a study with an investigational compound/device within 30 days prior to signing informed consent or anticipates participating in such a during the course of the study.
    6.Has any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, TNF antagonists, or other immunosuppressant drugs during the course of the trial.
    7.Requires or is anticipated to require any of the prohibited medications noted in the protocol
    8.Has significant hypersensitivity or other contraindication to any of the components of the study drug as determined by the investigator.
    9.Has a current (active) diagnosis of acute hepatitis due to any cause.
    10.Has evidence of decompensated liver disease.
    11.Is pregnant, breastfeeding, or expecting to conceive.
    12.Is female and expecting to donate eggs (at any time during the study) or is male and is expecting to donate sperm (at any time during the study).
    13.Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the number of subjects achieving HIV -1 RNA <50 copies/mL (by the Abbott RealTime HIV-1 Assay) at Week 48. The primary safety endpoint will be an assessment of the safety and tolerability at Week 48 and at Week 96.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment Week 48 and Week 96.
    E.5.2Secondary end point(s)
    1)The proportion of subjects achieving HIV -1 RNA <50 copies/mL at Week 96.
    2)The proportion of subjects achieving HIV -1 RNA below the limit of quantification of the Abbott RealTime HIV-1 Assay (<40 copies/mL) at Week 48 and Week 96.
    3)Change from baseline in CD4 cell count at Week 48 and Week 96.
    4)Measurement of the time-to-loss-of-virologic-response.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment Week 48 and Week 96.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Canada
    France
    Germany
    Italy
    Spain
    United Kingdom
    United States
    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 overall trial ends when the last subject completes the last study-related phone-call or visit, discontinues from the trial or is lost to follow-up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Only if legal representative can provide written informed consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 60
    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 will be a mechanism for eligible study participants to continue treatment with MK-1439A after completing the study and without interruption, until it becomes locally available in the market (eligible study participants would: have completed the last scheduled study visit, be considered by the investigator to have derived benefit from study participation, for whom further treatment with MK1439A is considered clinically appropriate).
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-28
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