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    Summary
    EudraCT Number:2018-004301-32
    Sponsor's Protocol Code Number:TMC278HTX2002
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2021-12-06
    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 number2018-004301-32
    A.3Full title of the trial
    A Phase 2, Open-label, Single-arm, Multicenter Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 years) who are Virologically Suppressed
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 years) who are Virologically Suppressed
    A.4.1Sponsor's protocol code numberTMC278HTX2002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/291/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Sciences Ireland UC
    B.1.3.4CountryBelgium
    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 supportJanssen Sciences Ireland UC
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street Address Archimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 Yes
    D.2.1.1.1Trade name Edurant®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 nameRilpivirine
    D.3.2Product code TMC278
    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 INNRilpivirine Hydrochloride
    D.3.9.1CAS number 700361-47-3
    D.3.9.2Current sponsor codeTMC278
    D.3.9.3Other descriptive nameR314585
    D.3.9.4EV Substance CodeSUB31460
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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: 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 nameRilpivirine hydrochloride
    D.3.2Product code TMC278
    D.3.4Pharmaceutical form Tablet
    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 INNRilpivirine hydrochloride
    D.3.9.1CAS number 700361-47-3
    D.3.9.2Current sponsor codeTMC278
    D.3.9.3Other descriptive nameRILPIVIRINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB31460
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    HIV-1 Infection
    E.1.1.1Medical condition in easily understood language
    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 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
    The primary objectives are:
    • To evaluate the steady-state pharmacokinetics (PK) of rilpivirine and determine the appropriate dose of rilpivirine in combination with other antiretrovirals (ARVs) in participants aged ≥2 to <12 years with a body weight of <25 kg.
    • To evaluate the safety and tolerability of rilpivirine in combination with other ARVs in participants aged ≥2 to <12 years over a 24-week treatment period.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To evaluate the safety and tolerability of rilpivirine in combination with other ARVs over a 48-week treatment period.
    • To evaluate the efficacy of rilpivirine in combination with other ARVs over a 24- and 48-week treatment period.
    • To evaluate population PK and PK/pharmacodynamic (PD) relationships for safety and efficacy of rilpivirine in combination with other ARVs.
    • To assess resistance in case of loss of virologic response to rilpivirine in combination with other ARVs.
    • To evaluate treatment adherence to rilpivirine in combination with other ARVs over a 24 and 48 week treatment period.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: A Substudy of TMC278HTX2002 to Evaluate the Pharmacokinetics of RPV Plus Other ARVs in HIV-1-infected Virologically Suppressed Children Aged ≥6 to <12 Years With Body Weight ≥25 kg
    Date: 18 February 2021
    Version: 1.0
    Objective: Obtain steady-state PK profiles of RPV in plasma, after at least 4 weeks of RPV treatment, of which at least 2 weeks on the RPV 25 mg qd dose, in HIV-1-infected virologically suppressed participants aged ≥6 years with body weight ≥25 kg on the day of intensive PK (substudy).

    E.3Principal inclusion criteria
    Each potential participant must satisfy all of the following criteria to be enrolled in the study:
    1. Aged ≥2 to <12 years at screening.
    2. Criteria Modified per Amendment 3 - 2.1 Weighing at least 10 kg at screening.
    3. Have documented chronic HIV-1 infection.
    4. On a stable ARV regimen for at least 6 months prior to screening and virologically suppressed, with documentes evidence of at least 2 plasma viral loads <50 HIV-1 RNA copies/mL: one within 2-12 months prior to screening and one at screening.
    5. Criterion deleted.
    6. Parent(s) (preferably both if available or as per local requirements) (or the participant’s legally acceptable representative[s]) must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to allow the child to participate in the study. Assent is also required from participants capable of understanding the nature of the study (typically aged ≥7 years).
    7. Can comply with the protocol requirements.
    8. Can switch from any ARV class.
    9. Never been treated with a therapeutic HIV vaccine.
    10. Otherwise healthy and medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participant’s source documents and initialed by the investigator.
    E.4Principal exclusion criteria
    Any potential participant who meets any of the following criteria will be excluded from participating in the study:
    1. Have previously documented HIV-2 infection.
    2. Have known or suspected acute (primary) HIV-1 infection.
    3. Taken any disallowed concomitant therapies within 4 weeks before the planned first dose of study intervention.
    4. A positive HLA-B*5701 test at screening (when the investigator considers ABC in the background regimen). In case of a positive test, ABC cannot be administered, but instead, the investigator can select another ARV in the background regimen.
    HLA-B*5701 testing is not required for participants with prior documented negative results.
    5. Any current or history of adrenal disorder.
    6. Any active clinically significant diseases (eg, pancreatitis, cardiac dysfunction, active and significant psychiatric disorders, clinical suspicion of adrenal insufficiency, and hepatic impairment) or findings at screening or medical history that, in the investigator’s opinion, would compromise the outcome of the study.
    7. A history of virologic failure to ARVs with or without availability of an HIV-1 genotype result at the time of failure.
    8. Documented genotype evidence of resistance to RPV or to the selected background ARVs from historical data available in the source documents.
    9. A known clinically significant allergy, hypersensitivity, or intolerance to RPV or its excipients or to the selected background ARVs.
    10. Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 90 days before the planned first dose of study intervention.
    11. Enrolled in clinical studies that include any blood sampling with a volume >50 mL taken within 6 months before the planned first administration of RPV, specimen collection, or other interventional procedure. Concurrent participation in non-interventional observational studies is allowed as long as there is no impact on the objectives of this study. Data collected in this study can be reported in the observational study.
    12. Any condition (including but not limited to the abuse of alcohol or drugs [eg, barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines]) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    13. A life expectancy of less than 6 months.
    E.5 End points
    E.5.1Primary end point(s)
    1. Area under the plasma concentration-time curve from time of administration up to 24 hours post dose of rilpivirine, as derived from the intensive PK assessments.
    2. Incidence of grade 3/4 AEs, SAEs, HIV-related events (including acquired immune deficiency syndrome [AIDS]-defining illnesses and Stage-3-defining Opportunistic Illnesses in HIV Infection), and AEs leading to discontinuation of study intervention through 24 weeks of study treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From time of administration up to 24 hours postdose of rilpivirine
    2. Until 24 weeks
    E.5.2Secondary end point(s)
    1. Incidence and severity of AEs/HIV-related events and their relatedness to RPV through 24 and 48 weeks of study treatment.
    2. Change from baseline over time and shift in toxicity grades/abnormalities versus reference for clinical laboratory parameters, ECG parameters, vital signs, and physical examination through 24 and 48 weeks of study treatment.
    3. Proportion of participants with HIV-1 RNA <50 and ≥50 copies/mL using the Food and Drug Administration (FDA) Snapshot approach through 24 and 48 weeks of study treatment.
    4. Proportion of participants with HIV-1 RNA <400 and ≥400 copies/mL using the FDA Snapshot approach through 24 and 48 weeks of study treatment
    5. Immunologic changes, measured by CD4+ cell count (absolute and percentage relative to total lymphocytes), through 24 and 48 weeks of study treatment.
    6. Pharmacokinetic parameters of RPV (other than area under the plasma concentration-time curve [AUC]), as derived from the intensive PK assessments.
    7. Pharmacokinetic parameters of rilpivirine, as derived by population PK modeling, through 24 and 48 weeks of study treatment.
    8. Viral genotype at the time of virologic failure through 24 and 48 weeks of study treatment.
    9. Treatment adherence, as assessed by the Pediatric European Network for the Treatment of AIDS (PENTA) adherence questionnaire and by study intervention accountability, through 24 and 48 weeks of study treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 to 4, 6 to 8: Through 24 and 48 weeks of study treatment
    5. Week 4, 8, 12, 24 and 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 No
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, resistance testing, treatment adherence, resistance-associated mutations (RAMs), RPV intake(only for participants scheduled for an intensive PK visit), treatment adherence, palatability and swallowability assessments
    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 trial2
    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 No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    South Africa
    Thailand
    Uganda
    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 years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days5
    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: 30
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients are to be children aged 2-11. Consent for treatment will ultimately be obtained from their parent.
    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 30
    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)
    Upon study completion, participants offered opportunity to continue study treatment in the pediatric rollover study TMC278IFD3004. Participants who don't roll over in study TMC278IFD3004 will be informed that study intervention will not be made available to them after they have completed/discontinued the study intervention phase and that they should return to their primary physician to determine standard of care.
    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: South Africa
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