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    Summary
    EudraCT Number:2015-000313-40
    Sponsor's Protocol Code Number:GS-US-236-0112
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-01-29
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-000313-40
    A.3Full title of the trial
    A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical research study to examine the pharmacokinetics, safety and efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in HIV-1 infected adolescents.
    A.4.1Sponsor's protocol code numberGS-US-236-0112
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01721109
    A.5.4Other Identifiers
    Name:IND numberNumber: 103,093
    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 SponsorGilead Sciences, 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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressGranta Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number+441223897 284
    B.5.6E-mailclinical.trials@gilead.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 Stribild
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Limited
    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 INNELVITEGRAVIR
    D.3.9.1CAS number 697761-98-1
    D.3.9.4EV Substance CodeSUB69759
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOBICISTAT
    D.3.9.1CAS number 1004316-88-4
    D.3.9.4EV Substance CodeSUB33760
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.4EV Substance CodeSUB01882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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, Type 1 (HIV-1) Infection
    E.1.1.1Medical condition in easily understood language
    Human Immunodeficiency Virus, Type 1 (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 17.1
    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 A:
    To evaluate the steady state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single tablet regimen (STR) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents.

    Part B:
    To evaluate the safety and tolerability of the EVG/COBI/FTC/TDF STR through Week 48 in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents.
    E.2.2Secondary objectives of the trial
    To evaluate the antiviral activity of the EVG/COBI/FTC/TDF STR through Week 48 in HIV-1 infected, ARV treatment-naive adolescents.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 12 years to < 18 years of age at Baseline
    - Able to give written assent prior to any screening evaluations
    - Parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements.
    - Plasma HIV-1 RNA levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
    - CD4+ cell count > 100 cells/μL
    - Weight ≥ 35 kg (77 lbs)
    - Screening genotype report provided by Gilead Sciences must show sensitivity to FTC and TDF using the GenoSure RT/PR assay
    - Able to swallow oral tablets
    - Adequate renal function: Estimated glomerular filtration rate ≥ 90 mL/min/1.73m2 (using Schwartz Formula)
    - Clinically normal ECG (or if abnormal, determined by the investigator to be not clinically significant)
    - Documented screening for active pulmonary tuberculosis per local standard of care within 6 months of a screening visit
    - Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
    - Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
    - Subjects with a positive Hepatitis B surface antigen screening test can participate in the study, providing that alternate therapy (other than TDF) for chronic Hepatitis B infection is available to the subjects as a part of local standard of care
    - Adequate hematologic function (absolute neutrophil count ≥ 500/mm3; platelets ≥ 50,000/mm3; hemoglobin ≥ 8.5 g/dL)
    - Negative serum pregnancy test for all female subjects
    - Male and female subjects of childbearing potential must agree to utilize highly effective contraception methods while on study treatment or agree to abstain from heterosexual intercourse throughout the study period and for 30 days following the last dose of study drug. (Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing. It is recommended that an oral contraceptive contain at least 30 μg of ethinyl estradiol if administered with EVG/COBI/FTC/TDF STR.)
    - Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of investigational medicinal product
    - Must be willing and able to comply with all study requirements
    - Life expectancy ≥ 1 year.
    E.4Principal exclusion criteria
    - A new AIDS-defining condition (CDC 1993 case definitions, with the exception of CD4+ cell count criteria) diagnosed within the 30 days prior to screening.
    - Prior treatment with any approved or investigational or experimental anti HIV-1 drug for any length of time (other than that given for prevention of mother-to-child transmission)
    - Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit.
    - Anticipated to require rifamycin treatment for mycobacterial infection while participating in the study. Note: prophylactic INH therapy for latent TB treatment is allowed.
    - Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
    - Pregnant or lactating subjects.
    - Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
    - Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
    - Have history of significant drug sensitivity or drug allergy.
    - Known hypersensitivity to the study drugs, the metabolites or formulation excipients
    - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening or expected to receive these agents during the study
    - A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline and must not be anticipated to require systemic therapy during the study.
    - Have previously participated in an investigational trial involving administration of any investigational agent within 30 days prior to the study dosing.
    - Participation in any other clinical trial without prior approval from sponsor is prohibited while participating in this trial.
    - Subjects receiving ongoing therapy with any of the medications listed in the table within the exclusion criteria section of the protocol (Protocol Section 4.3), including drugs not to be used with EVG, COBI, FTC, TDF or subjects with any known allergies to the excipients of EVG/COBI/FTC/TDF STR tablets.
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    PK parameter of AUCtau for EVG

    Part B:
    Incidence of treatment-emergent SAEs and all treatment-emergent adverse events.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Part A: Day 10
    - Part B: Baseline to Week 48 plus 30 days follow-up
    E.5.2Secondary end point(s)
    Part A
    PK parameters of Ctau and Cmax for EVG, AUCtau, Cmax, and Ctau for FTC, TFV and COBI.

    Part B:
    - The percentage of subjects with plasma HIV-1 RNA < 50 copies/mL at Weeks 24 and Week 48 as defined by the FDA snapshot analysis
    - The percentage of subjects with plasma HIV-1 RNA < 400 copies/mL at Weeks 24 and 48 as defined by the FDA snapshot analysis
    - The change from baseline in plasma log10 HIV-1 RNA (copies/mL) and in CD4+ cell count (cells/μL) and percentage at Weeks 24 and 48
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Part A: Day 10
    - Part B: Week 24 and Week 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 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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Other health-related outcomes.
    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) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    2-part, single-arm study
    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
    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 years9
    E.8.9.2In all countries concerned by the trial months2
    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: 50
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    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 50
    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 completion of Wk 48, all subjects receiving EVG/COBI/FTC/TDF STR (who complete 48 weeks of study treatment) will be given the option of an extension phase where Gilead will provide EVG/COBI/FTC/TDF STR until a) subject turns 18 and EVG/COBI/FTC/TDF STR is commercially available for use in adults in country enrolled or b) EVG/COBI/FTC/TDF STR becomes commercially available for use in adolescents in enrolled or c) Gilead terminates development of the EVG/COBI/FTC/TDF STR in the country.
    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
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