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    Summary
    EudraCT Number:2019-003955-13
    Sponsor's Protocol Code Number:MK-1439-066
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-06-10
    Trial 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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2019-003955-13
    A.3Full title of the trial
    A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and
    Efficacy of Doravirine in Participants With HIV-1 Aged 4 Weeks to <12 Years of Age and Weighing <35 kg
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DOR in HIV-infected children ages 4 weeks to <12 years and <35 kg
    A.3.2Name or abbreviated title of the trial where available
    DOR in HIV-infected children ages 4 weeks to <12 years and <35 kg
    A.4.1Sponsor's protocol code numberMK-1439-066
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04375800
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/115/2017
    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 pointJason Kim
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive - P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, New Jersey
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 (267) 305-2189
    B.5.6E-mailjason.kim@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 nameDoravirine
    D.3.2Product code MK-1439
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Yes
    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.3.9.2Current sponsor codeMK-1439
    D.3.9.3Other descriptive nameDOR (PIFELTRO™) and DOR/3TC/TDF (tradename (DELSTRIGO™) have been approved in EU
    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 number3.2
    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.3.1Product nameDoravirine
    D.3.2Product code MK-1439
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Yes
    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.3.9.2Current sponsor codeMK-1439
    D.3.9.3Other descriptive nameDOR (PIFELTRO™) and DOR/3TC/TDF (tradename (DELSTRIGO™) have been approved in EU
    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 number7.2
    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 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 nameDoravirine
    D.3.2Product code MK-1439
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Yes
    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.3.9.2Current sponsor codeMK-1439
    D.3.9.3Other descriptive nameDOR (PIFELTRO™) and DOR/3TC/TDF (tradename (DELSTRIGO™) have been approved in EU
    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 number30.4
    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: 4
    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 nameDoravirine
    D.3.2Product code MK-1439
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Yes
    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.3.9.2Current sponsor codeMK-1439
    D.3.9.3Other descriptive nameDOR (PIFELTRO™) and DOR/3TC/TDF (tradename (DELSTRIGO™) have been approved in EU
    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 number40
    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
    Pediatric HIV-1 infection
    E.1.1.1Medical condition in easily understood language
    Pediatric HIV-1 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 20.1
    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
    1. To evaluate the pharmacokinetics (PK) of doravirine (DOR) at steady state when given with 2 nucleoside/nucleotide analog reverse transcriptase inhibitors (NRTIs).
    2. To evaluate the safety and tolerability of DOR in combination with 2 NRTIs through Week 24.
    E.2.2Secondary objectives of the trial
    1. To evaluate the PK of DOR in combination with 2 NRTIs as assessed by sparse PK sampling through Week 24.
    2. To evaluate the safety and tolerability of DOR with 2 NRTIs through Weeks 48 and 96.
    3. To evaluate the antiretroviral activity of DOR with 2 NRTIs separately in treatment-naïve (TN) and virologically-suppressed (VS) participants as assessed by % with HIV-1 RNA <50 copies/mL; HIV-1 RNA <200 copies/mL; HIV-1 RNA ≥50 copies/mL; d) Log10 drop from baseline (BL) in plasma HIV-1 RNA (TN only), at Weeks 24, 48, and 96.
    4. To evaluate the immunologic effect of DOR with 2 NRTIs separately in TN and VS participants as measured by change from BL in CD4+ T-cell count at Weeks 24, 48, and 96.
    5. To evaluate the emergence of genotypic or phenotypic resistance to DOR or other components of the regimen in the resistance analysis subset.
    6. To evaluate adherence to DOR at Weeks 24, 48, and 96.
    7. To evaluate the acceptability and palatability of oral pellets/granules of DOR.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Intensive PK sampling and analyses
    E.3Principal inclusion criteria
    - Has HIV-1 infection confirmed at screening
    - Has treatment history defined as either TN or with documented viral suppression (HIV-1 RNA <50 copies/mL)
    - Body weight is >3 kg to <35 kg
    - If female, is not pregnant or breastfeeding, and one of the following applies:
    - is not a woman of childbearing potential (WOCBP)
    - is a WOCBP using an acceptable form of contraception, or is abstinent
    - if a WOCBP must have a negative pregnancy test (urine or serum) within 24 hours of the first dose of study intervention
    E.4Principal exclusion criteria
    - Has evidence of renal disease
    - Demonstrates evidence of liver disease
    - Has clinical or laboratory evidence of pancreatitis
    - Has any history of malignancy
    - Has presence of any active acquired immunodeficiency syndrome (AIDS)-defining Opportunistic Infection
    - Has an active diagnosis of hepatitis, including hepatitis B co-infection
    - Has current active tuberculosis and/or is being treated with a rifampicin-containing regimen
    - Has a medical condition that precludes absorption or intake of oral pellets/granules
    - Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound results of the study or interfere with participating for the entire duration of the study
    - Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or other prohibited therapy
    - Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from 45 days prior to Day 1 through the treatment period
    - Has a documented or known virologic resistance to DOR
    E.5 End points
    E.5.1Primary end point(s)
    1. Area under the concentration-time curve from 0 to 24 hours postdose (AUC0-24hr) of DOR with 2 NRTIs in plasma at steady-state
    2. Maximum concentration (Cmax) of DOR with 2 NRTIs in plasma at steady-state
    3. Concentration at 24 hours (C24) of DOR with 2 NRTIs in plasma at steady-state
    4. Time to maximum concentration (Tmax) of DOR with 2 NRTIs in plasma at steady-state
    5. Percentage of participants with ≥1 adverse event (AE)
    6. Percentage of participants with a Grade 3 or 4 AE
    7. Overall mortality
    8. Percentage of participants discontinuing from study treatment due to an AE
    9. Percentage of participants discontinuing from study treatment due to a DOR-related AE
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Predose and 1, 2, 4, 12, and 24 hours postdose on Day 42
    2. Predose and 1, 2, 4, 12, and 24 hours postdose on Day 42
    3. 24 hours postdose on Day 42
    4. Predose and 1, 2, 4, 12, and 24 hours postdose on Day 42
    5. Up to 24 weeks
    6. Up to 24 weeks
    7. Up to 24 weeks
    8. Up to 24 weeks
    9. Up to 24 weeks
    E.5.2Secondary end point(s)
    1. Plasma concentration of DOR with 2 NRTIs (sparse pharmacokinetics [PK])
    2. Percentage of participants with ≥1 AE
    3. Percentage of participants with Grade 3 or 4 AE
    4. Overall mortality
    5. Percentage of participants discontinuing from study treatment due to AE
    6. Percentage of participants discontinuing from study treatment due to DOR-related AE
    7. Percentage of participants with HIV-1 RNA <50 copies/mL
    8. Percentage of participants with HIV-1 RNA <200 copies/mL
    9. Percentage of VS participants with HIV-1 RNA ≥50 copies/mL
    10. Percentage of TN participants with log10 change from BL in HIV-1 RNA
    11. Percentage of TN participants with log10 change from BL in HIV-1 RNA
    12. Percentage of TN participants with log10 change from BL in HIV-1 RNA
    13. Change from baseline in CD4+ T-cell counts
    14. Change from baseline in CD4+ T-cell counts
    15. Change from baseline in CD4+ T-cell counts
    16. Viral resistance-associated substitutions (RASs) to DOR or other treatment components
    17. Adherence to DOR
    18. Scores on a 5-point hedonic scale of oral pellets/granules of DOR
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 1 predose, Week 4 predose, Week 8 random, Week 12 random, and Week 24 predose and 0.5-2 hours postdose
    2. Up to 48 and 96 weeks
    3. Up to 48 and 96 weeks
    4. Up to 48 and 96 weeks
    5. Up to 48 and 96 weeks
    6. Up to 48 and 96 weeks
    7. Weeks 24, 48, and 96
    8. Weeks 24, 48, and 96
    9. Weeks 24, 48, and 96
    10. Day 1 and Week 24
    11. Day 1 and Week 48
    12. Day 1 and Week 96
    13. Day 1 and Week 24
    14. Day 1 and Week 48
    15. Day 1 and Week 96
    16. Up to 96 weeks
    17. Up to 96 weeks
    18. Days 1 and 28
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Mexico
    Russian Federation
    South Africa
    Thailand
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 80
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 40
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 40
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 80
    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)
    At the end of the study’s 96 weeks of treatment, there will be a mechanism for all eligible participants to continue receiving study intervention without interruption.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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