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    Summary
    EudraCT Number:2005-001246-16
    Sponsor's Protocol Code Number:CCR104458
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-06-02
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2005-001246-16
    A.3Full title of the trial
    A Phase III, randomized, double-blind, placebo-controlled, multicenter, parallel group study to compare the efficacy and safety of GW873140 400mg BID in combination with a ritonavir-containing optimized background therapy (OBT) regimen versus placebo plus OBT over 48 weeks in HIV-1 infected, treatment-experienced subjects with drug-resistant CCR5/CXCR4-tropic virus.
    A.4.1Sponsor's protocol code numberCCR104458
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research and Development
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameGW873140
    D.3.2Product code GW873140
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 461023-63-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 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
    Treatment of HIV-1 infection
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To demonstrate the superiority of GW873140 400mg BID plus Optimised Background Therapy (OBT) compared to placebo plus OBT, as measured by the difference in plasma HIV-1 RNA average area under the curve minus baseline (AAUCMB) between the two treatment arms at 24 and 48 weeks.
    E.2.2Secondary objectives of the trial
    •Assess antiviral activity of GW873140 400mg BID plus OBT compared to PBO plus OBT as measured by:
    •Proportion with sustained plasma HIV-1 RNA <400 and <50copies/mL,.
    •Estimated TLOVR based on plasma HIV-1 RNA <400 and <50copies/mL
    •Proportion of subjects with a 1.0 log10 copies/mL decrease in plasma HIV-1 RNA from baseline
    •Evaluate safety and tolerability, immunologic markers, HIV disease progression, of antiretroviral resistance to GW873140 and other on-study drugs
    •Explore relationships between baseline HIV-1 resistance to on-study drugs and antiviral response.
    •Evaluate qualitative changes in viral tropism
    •Evaluate plasma PK of GW873140 400mg BID when used in combination with OBT.
    •Explore how bothersome certain symptoms are and how symptoms impact on health related QofL.
    •Evaluate adherence.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.HIV-1 infected subjects aged 18 years or older. Females must fall into one of the following categories:
    •Non-childbearing potential: defined as women who are surgically sterile or post-menopausal,
    •Childbearing potential has a negative pregnancy test result within 35 days prior to administration of investigational product (Day 1) and agrees to use a proven double barrier method of contraception.
    2.Screening plasma HIV-1 RNA ≥5000copies/mL There are no CD4 cell count entry restrictions, however investigators must exercise clinical discretion
    3.Total prior antiretroviral experience of at least 3 months and documented genotypic or phenotypic resistance to at least one compound in each of the following classes of antiretrovirals: NRTIs (includes NtRTI TDF), NNRTIs, and PIs.
    4.R5/X4-tropic virus according to viral tropism assessment at screening
    5.Current unchanged “pre-study” ART regimen for at least four weeks prior to screening; this pre-study regimen may be no ART. Subjects must remain on this regimen until randomization (Day 1).
    6.Subjects must be able to receive a RTV-boosted PI as part of their OBT regimen. The drugs in the OBT regimen will be chosen from the locally available antiretrovirals and must consist of between three and six drugs, one of which must be a RTV-boosted PI.
    7.Ability to understand and comply with protocol requirements
    8.Signed and dated written informed consent

    E.4Principal exclusion criteria
    1.Plasma sample tests as R5-tropic only, X4-tropic only, or non-phenotypeable based on viral tropism assessment at screening.
    2.Any acute laboratory abnormality at screening
    3.Subjects that make any changes to their ART regimen during the period beginning four weeks prior to screening until Day 1.
    4.Significant blood loss (≥500mL) within 56 days prior to screening
    5.Pregnant or lactating women.
    6.Previous participation in an experimental drug and/or vaccine trial(s) within 30 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine - whichever is longer, prior to screening
    7.Subjects with any prior receipt of an investigational CCR5 or CXCR4 antagonist are excluded.
    8.Any clinically significant finding on screening or baseline ECG
    9.History of clinically relevant pancreatitis or hepatitis within the previous 6 months. Asymptomatic individuals with chronic hepatitis B (HBV) or hepatitis C virus (HCV) infection will not be excluded
    10.Any condition which may interfere with the subject’s ability to comply with dosing schedule and/or protocol evaluations or might compromise safety of subject.
    11.Any evidence of active CDC Class C conditions or opportunistic infections.
    12.Any condition which might interfere with ADME of drug.
    13.History of a drug or other allergy or known hypersensitivity to any study medication or excipients.
    14.Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 30 days administration
    15.Current severe illness, including liver and renal failure, major organ allograft, malignancy requiring parenteral chemotherapy that can not be discontinued for the duration of the trial, or any other conditions which would make the subject unsuitable for the study
    16.Use of systemic immunosupressants and/or immunomodulators within 30 days prior to study Day 1.
    17.Anticipated continued need for prescription or over-the-counter (OTC) medications that are on the prohibited medication list within 30 days prior to study Day 1

    E.5 End points
    E.5.1Primary end point(s)
    •Antiviral activity of GW873140 400mg BID plus OBT versus placebo plus OBT, following 24 and 48 weeks of treatment as measured by plasma HIV-1 RNA AAUCMB.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 vist of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-06-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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.3.3.6.1Details of subjects incapable of giving consent
    Must have a negative pregnancy test result and agree to use a proven double barrier method of contraception. Hormonal contraceptives are not considered sufficient forms of contraception for this study.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 240
    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)
    Provisions will be made for subjects who are still responding to GW873140 when results of the Week 48 final analysis are available to continue to receive GW873140 until commercially available
    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 Decision2005-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
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