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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   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:2007-003281-18
    Sponsor's Protocol Code Number:AVX-301
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-27
    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
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2007-003281-18
    A.3Full title of the trial
    A phase 2b/3, randomized, double blind, dose confirming study of the safety, efficacy and tolerability of apricitabine versus lamivudine in treatment-experienced HIV-1 infected patients with the M184V/I mutation in reverse transcriptase
    A.3.2Name or abbreviated title of the trial where available
    AVX-301
    A.4.1Sponsor's protocol code numberAVX-301
    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 SponsorAvexa Limited
    B.1.3.4CountryAustralia
    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 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 nameApricitabine
    D.3.2Product code ATC
    D.3.4Pharmaceutical form Capsule*
    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.3.8INN - Proposed INNApricitabine
    D.3.9.1CAS number 160707-69-7
    D.3.9.2Current sponsor codeATC
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.3.11.13.1Other medicinal product typenucleoside analogue reverse transcriptase inhibitor (NRTI)
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Epivir®
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    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 nameLamivudine
    D.3.2Product code 3TC
    D.3.4Pharmaceutical form Capsule*
    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.3.8INN - Proposed INNLamivudine
    D.3.9.2Current sponsor code3TC
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.3.11.13.1Other medicinal product typeA part of antiretroviral combination therapy
    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 placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    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
    HIV-1
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064446
    E.1.2Term HIV infection WHO clinical stage I
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To compare the antiretroviral efficacy of ATC to lamivudine (3TC) in treatment experienced, HIV-1 infected patients with the M184V/I mutation in reverse transcriptase.

    •To compare the safety and tolerability of ATC to lamivudine (3TC) in treatment experienced, HIV-1 infected patients.
    E.2.2Secondary objectives of the trial
    •To compare the effect of ATC vs. 3TC upon CD4+ and CD8+ T-cell counts.

    •To investigate the influence of increasing nucleoside associated mutations (NAMs) in reverse transcriptase upon the antiretroviral efficacy of ATC.

    •To investigate the emergence of ATC-associated HIV-1 resistance mutations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for inclusion, each patient must fulfil each of the following criteria at Screening:
    1. 18 years of age, or older.
    2. Male, or non-pregnant, non-breastfeeding female patients, who agree to comply with the applicable contraceptive requirements of the protocol
    3. Documented laboratory diagnosis of HIV-1 infection (positive ELISA HIV-1 antibody test confirmed by Western Blot, p24 assay, HIV-1 RNA, or culture); if no record exists, must be tested at screening.
    4. Currently receiving stable ART regimen comprising at least three drugs, and containing either lamivudine or emtricitabine that is unchanged for at least 2 months prior to first dose of Investigational Product.
    5. Plasma HIV-1 RNA levels ≥2,000 copies/mL at Screening using the Roche Cobas Ampliprep / Cobas Taqman (dynamic range 40-10,000,000 copies per mL) performed at the central laboratory.
    6. Presence of the M184V/I mutation in reverse transcriptase at Screening.
    7. Unrestricted CD4+ cell count.
    8. The patient must understand and be able, willing and likely to fully comply with study procedures and restrictions.
    9. Written/marked, informed consent to participate in the study prior to the conduct of any study related procedures.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if any of the following criteria are met at Screening:
    1. Previous documented laboratory diagnosis of HIV-2 infection
    2. Presence of Q151M or 69 insertion mutations in reverse transcriptase.
    3. Considered to be significantly and chronically ART non-compliant by the Investigator.
    4. Current or recurring disease that could affect the action, absorption or disposition of the Investigational Product, or clinical or laboratory assessments, as determined by the investigator.
    5. Current acute or chronic Hepatitis B virus infection (HBsAg positive and requiring treatment in the next 12 months).
    - Previous, resolved HBV infection is permitted.
    - Well controlled HBV-infected patients not taking tenofovir as part of the OBR and who have been receiving adefovir dipivoxil for at least 30d prior to screening, who meet the requirements for AST and ALT < 3 times upper limit of normal range (ULN) and who continue on adefovir dipivoxil for the duration of the study may be enrolled. Adefovir dipivoxil should not be prescribed concurrently with tenofovir in this study due to concerns over potential renal toxicity.
    6. Current treatment for Hepatitis C virus infection or treatment likely during the duration of the study..
    7. Clinically relevant current or recurring disease, illness or laboratory abnormality likely to require treatment during the study that could affect interpretation of efficacy end-points (eg HIV-1 RNA levels), prevent the patient from fully complying with the study, or present undue risk from the Investigational Product or procedures, as determined by the Investigator.
    8. A new AIDS-defining condition (defined in Category C, Appendix 1) diagnosed within 42 days prior to the first dose of Investigational Product with the exception of
    a. CD4 cells <200/mm3
    b. Kaposi’s sarcoma (KS) confined to the skin
    c. HIV-wasting disease ie, wasting not related to any other known cause
    9. Patients who, within 42 days prior to the first dose of Investigational Product, have received any of the following:
    a. immunomodulating agents such as systemic corticosteroids (eg, prednisone or prednisolone exceeding 10mg/day or equivalent dose of any other corticosteroid for more than 7 days), interleukin (IL)-2, IFN-alpha, IFN-beta or IFN-gamma
    b. immunization other than for influenza and pneumococcus
    c. systemic chemotherapeutic agents
    d. an HIV prophylactic or immunotherapeutic vaccine
    10. Patients with any of the following abnormal clinical laboratory tests at Screening:
    a. Hemoglobin <10.0 g/dL for men and <9.0g/dL for women
    b. Neutrophil count < 750/mm3
    c. Platelet count <50,000/mm3
    d. AST or ALT ≥3 times the upper limit of normal (ULN)
    e. Total bilirubin is >1.5 x ULN, with the exception of patients receiving atazanavir or any other medication known to elevate the indirect bilirubin level as long as the direct bilirubin is less than the ULN.
    f. Lipase >3 times ULN
    g. Amylase >3 times ULN (unless serum lipase is ≤ 1.5 times ULN)
    h. Estimated Creatinine Clearance <50mL/min (estimated by Cockcroft and Gault equation)
    11. Known or suspected intolerance or hypersensitivity to ATC, lamivudine or any of the stated ingredients
    12. The patient has, in the opinion of the Investigator, a dependence on alcohol or other substance abuse within 6 months of Screening that will likely interfere with study compliance and/or make difficult the objective interpretation of clinical and/or laboratory data.
    13. Active, serious infections (other than HIV-1 infection) requiring parenteral antimicrobial or antiparasitic therapy within 15 days prior to Screening.
    14. Use of another investigational agent or participation in a clinical trial of an investigational agent up to 30 days before Screening. Patients enrolled in non-interventional, observation only studies, whose requirements do not conflict with those of this protocol, are eligible. Patients receiving tipranavir, darunavir, maraviroc, etravirine, or raltegravir through Expanded Access Schemes are eligible for Screening provided the local conditions of expanded access do not conflict with this protocol. Patients receiving other investigational antiretroviral agents may be eligible for Screening upon Sponsor approval, provided the local conditions of expanded access do not conflict with this protocol. Note that the retention or inclusion of Expanded Access agents in the new OBR on Day 0 requires separate approval
    15. Female patients with a positive pregnancy test at Screening or Baseline, or who are breastfeeding, or who plan to become pregnant.
    16. Patients that have previously been enrolled into this study and subsequently withdrawn.
    17. Patients that have previously received treatment with ATC.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is defined as the proportion of patients with plasma HIV-1 RNA <400 copies/mL at W24.
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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 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
    28 days from the last dose of study medication.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    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 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.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 201
    F.4.2.2In the whole clinical trial 1014
    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)
    There will be no further treatment; only normal standard of care expected.
    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 Decision2008-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-12
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