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    The EU Clinical Trials Register currently displays   43872   clinical trials with a EudraCT protocol, of which   7291   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-020988-20
    Sponsor's Protocol Code Number:P1093/ING112578
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-03-09
    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 number2010-020988-20
    A.3Full title of the trial
    A 48 week PhI/II multicentre open-label non-comparative study to evaluate PK, safety, tolerability & antiviral activity of DTG in HIV-1 infected children and adolescents of 6 weeks to <18 years of age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test a new drug dolutegravir for HIV infected children
    A.4.1Sponsor's protocol code numberP1093/ING112578
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01302847
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/200/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDAIDS
    B.1.3.4CountryUnited States
    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 supportViiV Healthcare UK Limited
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportNICHD
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline R&D
    B.5.2Functional name of contact pointDebra Steimers
    B.5.3 Address:
    B.5.3.1Street Address5 Moore Drive
    B.5.3.2Town/ cityResearch Triangle Park
    B.5.3.3Post codeNC 27709
    B.5.3.4CountryUnited States
    B.5.4Telephone number009194838419
    B.5.6E-maildeb.m.mccarty@gsk.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 namedolutegravir
    D.3.2Product code GSK1349572
    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 INNDolutegravir
    D.3.9.1CAS number 1051375-19-9
    D.3.9.2Current sponsor codeGSK1349572
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDolutegravir
    D.3.9.1CAS number 1051375-19-9
    D.3.9.2Current sponsor codeGSK1349572
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDolutegravir
    D.3.9.1CAS number 1051375-19-9
    D.3.9.2Current sponsor codeGSK1349572
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 in ART-experienced children.
    E.1.1.1Medical condition in easily understood language
    HIV-1 infection in children who have taken HIV medication 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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008922
    E.1.2Term Chronic infection with HIV
    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
    - To select a GSK1349572 dose for chronic dosing in infants, children and adolescents that achieves similar exposure to the GSK1349572 adult dose selected from the Phase IIb clinical trial in ART-naïve adult subjects
    - To determine the safety and tolerability of GSK1349572 in HIV-1 infected infants, children and adolescents at 24 and 48 weeks.
    - To evaluate the steady-state pharmacokinetics of GSK1349572 in combination with other antiretrovirals (OBT) in treatment-experienced HIV-1 infected infants, children and adolescents and to determine the dose of GSK1349572 that achieves a targeted AUC24 (primary PK endpoint) and C24h (secondary PK endpoint) in this population
    E.2.2Secondary objectives of the trial
    - To evaluate the antiviral activity of GSK1349572 in combination with an OBT by measuring virologic response in infants, children and adolescents at 24 and 48 weeks
    - To evaluate the effect on immunologic response from baseline to 24 and 48 weeks
    - To assess changes in HIV-1 genotype and phenotype to GSK1349572 and other components of the OBT in subjects experiencing virologic failure
    - To determine GSK1349572 exposure, its variability and clinical covariates that impact GSK1349572 disposition (e.g. age, weight) using intensive and sparse sampling and population pharmacokinetic analysis
    - To determine the extended long term (≥48 weeks) safety and tolerability of GSK1349572 in HIV-1 infected infants, children and adolescents
    - To explore the relationship between GSK1349572 exposure and the antiviral activity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    4.11. >6 weeks to <18 years at study entry
    4.12. Confirmed HIV-1 infection defined as positive results from two samples collected at different time points
    4.13. ARV treatment experienced (includes those who have received therapy to interrupt maternal-infant transmission) subjects currently on no ART:Must be off treatment ≥ 4 weeks AND must have HIV-1 RNA viral load greater than 1,000 copies/mL of plasma at screening
    4.14. ARV treatment experienced subjects currently on ART: Must be on an unchanged, failing therapeutic regimen for at least 8 weeks prior to screening (≤ 1 log drop in HIV-1 RNA within the previous 8 weeks prior to screening) AND must have an HIV-1 RNA viral load greater than 1,000 copies/mL of plasma at screening
    4.15. Demonstrated ability or willingness to swallow assigned study medications (tablets or pediatric formulation). NOTE: Tablets MAY NOT be crushed or dissolved.
    4.16. Parent or legal guardian able and willing to provide signed informed consent.
    4.17. Female subjects who are of child bearing potential and who are engaging in sexual activity that could lead to pregnancy, must use two adequate birth control methods while on study and for 2 weeks after stopping study drug. Hormonal birth control alone (e.g., pills, shots, or slow release inserts placed under/on the skin) would not be considered adequate. An effective, medically accepted barrier method of contraception (e.g., female/male condoms, diaphragm or cervical cap with a cream or gel that kills sperm (excluding nonoxydyl-9), intrauterine device [IUD], others) also must be used during the study. Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.
    4.18. Males engaging in sexual activity that could lead to HIV-1 transmission must use a condom.
    4.19. Subjects must have available at least one fully active drug for the planned optimized background regimen (OBR). Historical genotypes obtained within 1 year of screening will be considered by the study team for determination of fully active drugs if screening genotype testing is inconclusive.
    E.4Principal exclusion criteria
    4.21. Presence of any active AIDS defining opportunistic infection
    4.22. Known ≥ Grade 3 of any of the following laboratory toxicities within 30 days prior to study entry: neutrophil count, hemoglobin, platelets, AST, ALT, lipase, serum creatinine and total bilirubin. A single repeat within the 30 days is allowed for eligibility determination.
    4.23. ANY known Grade 4 laboratory toxicities within 30 days prior to study entry.
    4.24. The following liver toxicities within 30 days prior to study entry: ALT > 3x ULN AND direct bilirubin is > 2x ULN
    4.25. Any prior history of malignancy, with the exception of localized malignancies such as squamous cell or basal cell carcinoma of the skin
    4.26. Clinical or symptomatic evidence of pancreatitis, as determined by the clinician
    4.27. Use of any disallowed medications at time of screening
    4.28. Known history of exposure to integrase inhibitor treatment by the subject or subject’s mother prior to delivery/cessation of breast feeding
    4.29. Known resistance to an integrase inhibitor
    4.210. Pregnancy or breastfeeding. NOTE: Infants who are receiving breast milk are eligible to enroll
    4.211. Subject is currently participating in or has participated in a study with a compound or device that is not commercially available within 30 days of signing informed consent, unless permission from both study teams is granted
    4.212. Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study to a non-IMPAACT study site
    4.213. Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator’s opinion, would compromise the outcome of this study
    4.214. Subject has used, or anticipates using, chronic systemic immunosuppressive agents or systemic interferon (e.g. for treatment of HCV infection) within 30 days prior to beginning GSK1349572 study treatment. Short courses of corticosteroids (e.g. prednisone or equivalent up to 2 mg/kg/day for 7 days) are permitted.
    4.215. Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
    4.216. Any ARV-treatment naïve subject

    E.5 End points
    E.5.1Primary end point(s)
    Toxicity through Week 24:
    - All adverse events or lab toxicities of Grade 3 or higher severity
    - Adverse events or lab toxicities of Grade 3 or higher severity judged to be at least possibly attributable to the study medication
    - Termination from treatment due to a suspected adverse drug reaction (SADR)
    - Death
    E.5.1.1Timepoint(s) of evaluation of this end point
    through week 24
    E.5.2Secondary end point(s)
    8.231. Toxicity through week 48 and beyond:
    - All adverse events or lab toxicities of grade 3 or higher severity.
    - Adverse events or lab toxicities of grade 3 or higher severity judged to be at least possibly attributable to the study medication.
    - Termination from treatment due to a suspected adverse drug reaction (SADR).
    - Death
    8.232. Plasma HIV-1 RNA (copies/ml) <400 copies/ml and <50 copies/ml.
    8.233. Pharmacokinetics: C24h, C0, Cmin, Cmax, CL/F, Vz/F and t1/2
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks and beyond
    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 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) 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 No
    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.8.3 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
    Argentina
    Brazil
    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
    Last Subject Last Visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years5
    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: 160
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 44
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 54
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 22
    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 160
    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)
    Study drug will be provided until any of the following events occur:
    • Until the age-appropriate formulations provided by the study are available from another source (e.g. government programs, aid programs, assistance programs etc.) to all subjects in each specific country; OR
    • Until subjects are no longer deriving benefit; OR
    • Until subjects meet a protocol-defined reason for discontinuation; OR
    • Until development of GSK1349572 is terminated
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation IMPAACT
    G.4.3.4Network Country United States
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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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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