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    Summary
    EudraCT Number:2012-001573-93
    Sponsor's Protocol Code Number:MK-1439-007
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-001573-93
    A.3Full title of the trial
    Multicenter, Double-Blind, Randomized, 2-Part, Dose Ranging Study to
    Compare the Safety, and Antiretroviral Activity of MK-1439 Plus
    TRUVADA™ Versus Efavirenz Plus TRUVADA™ in Antiretroviral Treatment-Naïve, HIV-1 Infected Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study investigating a new medicine - MK-1439 in patients diagnosed with HIV-1 without previous treatment for this disease. The study has 2 parts and neither the doctor or patient will know the treatment group. All the patients will be treated with Truvada, some of the patients will be treated in addition with MK-1439, while the others will be treated in addition with Efavirenz.
    A.4.1Sponsor's protocol code numberMK-1439-007
    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 & Co.,Inc.
    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.5.3.4CountryUnited States
    B.5.4Telephone number+1267-305-7403
    B.5.5Fax number+1267-305-6545
    B.5.6E-mailhedy.teppler@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.3.2Product code MK-1439
    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 INNMK-1439
    D.3.9.2Current sponsor codeMK-1439
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number100
    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.IMP: 2
    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.3.2Product code MK-1439
    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 INNMK-1439
    D.3.9.2Current sponsor codeMK-1439
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number25
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 SUSTIVA
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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.3.4Pharmaceutical 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 INNEFAVIRENZ
    D.3.9.1CAS number 154598-52-4
    D.3.9.4EV Substance CodeSUB06463MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral naïve HIV-infected patients.
    E.1.1.1Medical condition in easily understood language
    Human immunodeficiency virus type 1 (HIV-1) infection in HIV-infected patients not treated previously.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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
    Part I
    1. Objective: Evaluate the safety and tolerability of MK-1439, at the studied doses, compared to efavirenz, each in combination with TRUVADA™ for 24 weeks.
    2. Objective: Evaluate the antiretroviral activity of MK-1439, at the
    studied doses, compared to efavirenz, each in combination with
    TRUVADA™ for 24 weeks, as measured by the proportion of patients with HIV RNA <40 copies/mL at Week 24.

    Part I and Part II Combined
    1. Objective: Evaluate the safety and tolerability of MK-1439, at the final selected dose, compared to efavirenz, each in ombination with TRUVADA™ for 24 weeks.
    2. Objective: Evaluate the central nervous system adverse events (CNS events) associated with the use of the final selected dose of MK-1439 compared with efavirenz, each in combination with TRUVADA™ as measured by the proportion of patients with CNS events by Week 8 and by Week 24.
    E.2.2Secondary objectives of the trial
    Part I
    Objective: Evaluate the antiretroviral activity and immunological effect of MK-1439, at the studied doses, compared to efavirenz, each in combination with TRUVADA™ for 24 weeks, as measured by a) proportion of patients with HIV RNA <200 copies/mL at Week 24, and b) change from baseline in CD4 cell count at Week 24.

    Part I and Part II Combined
    1. Objective: Evaluate the antiretroviral activity and immunological
    effect of MK-1439, at the final selected dose, compared to efavirenz, each in combination with TRUVADA™ at 24 weeks, as measured by a) proportion of patients with HIV RNA <200 copies/mL at Week 24, and b) change from baseline in CD4 cell count at Week 24.
    2. Objective: Evaluate the safety and antiretroviral activity and
    immunological effect of MK-1439, at the final selected dose, compared to efavirenz, each in combination with TRUVADA™ for 48 and 96 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is a male or female of at least 18 years of age on the day of signing the informed consent. Patient provides written informed consent for the trial. The patient will also provide consent for Future Biomedical Research; however, the patient may participate in the main trial without participating in Future Biomedical Research.
    2. Patient is HIV-1 positive as determined by a positive ELISA and has screening plasma HIV RNA (completed by the central laboratory) ≥ 1,000 copies/mL within 45 days prior to the treatment phase of this study.
    3. Patient has a screening CD4 cell count ≥100 cells/mm3(completed by the central laboratory) within 45 days prior to the treatment phase of this study.
    4. Patient is naïve to antiretroviral therapy (ART).
    5. Patient has had the following laboratory values within 45 days prior to the treatment phase of this study:
    a) Serum creatinine within normal limits.
    b) INR ≤1.2
    c) Urinalysis within normal limits.
    Note: Clinically insignificant abnormalities on urinalysis may be
    permitted after retest, provided these are documented as clinically
    insignificant per investigator.
    d) Hemoglobin ≥9.0 g/dL (if female) or ≥10.0 g/dL (if male).
    e) Absolute neutrophil count ≥1000/mm3.
    f) Platelet count ≥100,000/ mm3.
    g) Total serum bilirubin less than or equal to the upper limit of normal.
    h) Alkaline phosphatase <1.5 x upper limit of normal.
    i) AST (SGOT) and ALT (SGPT) <1.5 x upper limit of normal.
    6. In the opinion of the investigator, the patient should be considered clinically stable with no signs or symptoms of acute infection, at the time of entry into the study; i.e., clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study.
    7. Patient who is of reproductive potential agrees to:
    • True abstinence: Abstinence is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., abstinence only on certain calendar days, abstinence only during ovulation period, use (or have their of symptothermal method, use of post-ovulation method) and withdrawal are not acceptable methods of
    contraception].
    • Personal use (or partner use) of 2 acceptable methods of birth control throughout the study and for 12 weeks post study. Acceptable methods of birth control are: oral contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, implantable contraceptives and vasectomy.
    E.4Principal exclusion criteria
    1. Male patient is planning to impregnate or provide sperm donation for the duration of the study plus an additional 12 weeks. Female patient is pregnant or breast-feeding, or expecting to conceive or donate eggs for the duration of the study plus an additional 12 weeks.
    2. Patient has received any approved or experimental antiretroviral
    agents or is anticipated to receive such medications (beyond those
    outlined as study medication in this protocol) during the course of the study.
    3. Patient has used any immunomodulators or immunosuppressive
    therapy within one month prior to treatment in this study. Short courses of corticosteroids (e.g., as for asthma exacerbation) are allowed.
    4. Patient requires or is anticipated to require any of the prohibited
    medications noted in Section 3.2.1.
    5. Patient has been treated for a viral infection other than HIV, such as hepatitis B, with an agent that is active against HIV including but not limited to adefovir, tenofovir disoproxil fumarate, lamivudine, emtricitabine, or entecavir. Note: Patients may be enrolled if treatment occurred prior to the diagnosis of HIV.
    6. Patient has significant hypersensitivity or other contraindication to any of the components of the study drugs (emtricitabine, tenofovir disoproxil fumarate, and/or efavirenz).
    7. Patient has documented or known HIV resistance to emtricitabine, tenofovir disoproxil fumarate, and/or efavirenz, based on genotypic resistance analysis.
    8. Patient has a history of renal or urinary obstructive disease, requires dialysis (hemodialysis, continuous ambulatory peritoneal dialysis [CAPD], or other forms of dialysis), or has a calculated creatinine clearance at time of screening of ≤80 mL/min, based on the Cockcroft-Gault equation which is as follows (and 0.85 times this value for females):
    Clcr (mL/min) = (140–age) x weight (in kg)____
    72 x serum creatinine (mg/dL)
    9. Patient with active Hepatitis C virus (HCV) co-infection (defined as detectable HCV RNA) or Hepatitis B virus (HBV) co-infection (defined as HBsAg positive). Patients with prior/inactive HCV infection (defined as undetectable HCV RNA) or past HBV infection (defined as HBsAg negative and HBsAb positive) may be enrolled.
    10. Patient has a history of alcohol or other substance abuse which in the opinion of the investigator would interfere with patient compliance or safety.
    11. Patient has any condition or prestudy laboratory abnormality, or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the patient.
    12. Patient has participated in a study with an investigational
    compound/device within one month of signing informed consent or is anticipating to participate in such a study involving an investigational compound/device during the course of this study.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients achieving HIV RNA <40 copies/mL at Week 24, and the safety and tolerability of MK-1439 compared with efavirenz when each is given in combination with TRUVADA™ through Week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24.
    E.5.2Secondary end point(s)
    1) Frequency of CNS events by Weeks 8 and 24. Secondarily, longer-term safety and efficacy data will be evaluated at Week 48 and Week 96.
    2) Efficacy Endpoints: Proportions of Patients With Virologic Responses, Change from Baseline in CD4 cell counts, Time-to-Loss-Of-Virologic-Response (TLOVR), Virologic Failure, Resistance.
    3) Safety Endpoints: Adverse Experiences, Central Nervous System (CNS) Events, Predefined Limits of Change in Laboratory Parameters.
    4) PK Endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 8, 24, 48 and 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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Australia
    Belgium
    Brazil
    Canada
    France
    Germany
    Italy
    Mexico
    Netherlands
    Poland
    Puerto Rico
    Romania
    Russian Federation
    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
    Last visit of last patient.
    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 months2
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days19
    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: 315
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 116
    F.4.2.2In the whole clinical trial 320
    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)
    After ending trial treatment participation, all subjects may receive standard of care treatment for their condition at the discretion of their treating physician.
    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 Decision2012-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-18
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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