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    Summary
    EudraCT Number:2008-001486-28
    Sponsor's Protocol Code Number:AVX-303
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-05-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-001486-28
    A.3Full title of the trial
    A phase 3, open-label 96-week extension study of the safety of apricitabine in treatment-experienced HIV-1 infected patients who have completed protocol AVX-301 or AVX-302 or who have met the criteria for open-label access to ATC because of
    virologic failure/lack of response.
    A.3.2Name or abbreviated title of the trial where available
    303
    A.4.1Sponsor's protocol code numberAVX-303
    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.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
    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 investigate the long-term safety and tolerability of ATC in treatment-experienced
    HIV-1 infected patients.
    E.2.2Secondary objectives of the trial
    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. (a) Patients who complete studies AVX-301 or AVX-302 and fulfill the following
    criteria:
    - Plasma HIV-1 RNA levels ≤2,000 copies/mL
    - Patients with plasma HIV-1 RNA levels >2,000 copies/mL should be discussed on an individual basis with the Sponsor.
    or
    (b) Patients who meet the criteria for open-label access to ATC because of virologic
    failure/lack of response in study AVX-301 or AVX-302, and who are withdrawn from
    those studies for that reason, and who fulfill the following criteria:
    - Demonstration of presence of M184V/I mutation, and absence of Q151M or 69 insertions, in reverse transcriptase at Screening.
    Note: Virologic failure is defined as the HIV-1 RNA level increasing by >1.0 log10
    copies/mL (confirmed on two separate occasions at least one week apart) from the
    nadir value recorded during the study.
    2. Unrestricted CD4+ cell count.
    3. 18 years of age, or older.
    4. Male, or non-pregnant, non-breastfeeding female patients, who agree to comply
    with the applicable contraceptive requirements of the protocol.
    5. The patient must understand and be able, willing and likely to fully comply with
    study procedures and restrictions.
    6. 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. Patients enrolled in study AVX-304.
    2. Considered unlikely to be ART compliant (OBR or investigational product) by the
    Investigator.
    3. Documented major protocol violation(s) during AVX-301 or AVX-302 including noncompliance with study medication and/or OBR.
    4. Prior withdrawal from AVX-301 or AVX-302 for any reason. Patients who wish to
    withdraw from AVX-301 or AVX-302 and enter AVX-303 on the grounds of protocol-defined virologic failure or lack of response must continue in AVX-301 or AVX-302 until screening for AVX-303 is complete and eligibility confirmed.
    5. Patients who have previously been enrolled into this study and subsequently
    withdrawn.
    6. Current acute or chronic hepatitis B virus infection (HBsAg positive and requiring
    treatment in the next 12 months).
    a. Previous, resolved HBV infection (HBsAg seronegative with seropositivity for IgG-anti-HBc and/or anti-HBs antibodies) is permitted.
    b. Well controlled HBV-infected patients not taking tenofovir as part of the OBR
    who have been receiving adefovir dipivoxil continuously since at least 30 days prior to screening in AVX-301, who meet the requirements for AST and ALT <3 x ULN and who continue to receive adefovir dipivoxil for the duration of the study may be enrolled.
    7. Current treatment for hepatitis C virus infection or treatment likely within 12 months.
    8. Current or relevant previous history of serious, severe or unstable (acute or
    progressive) physical or psychiatric illness, any medical disorder that may require
    treatment or make the patient unlikely to fully complete the study, or any condition
    that presents undue risk from the investigational product or procedures, as determined by the investigator. Also, any current or recurring disease or intolerance to investigational product that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessments, as determined by the Investigator.
    9. Clinically relevant abnormalities of medical history, physical examination, or
    laboratory parameters (hematology, biochemistry, urinalysis).
    10. Patients with any of the following abnormal clinical laboratory tests at Screening:
    a. hemoglobin <10.0g/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. The patient has, in the opinion of the Investigator, a dependence on alcohol or other substance abuse within 6 months of Screening.
    12. Active, serious infections (other than HIV-1 infection) requiring parenteral antimicrobial or antiparasitic therapy within 15 days prior to Screening.
    13. Female patients with a positive pregnancy test at Screening or Baseline, or who are breastfeeding, or who plan to become pregnant during the duration of the study
    and any follow up.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is defined as the safety and tolerability of ATC in treatment-experienced HIV-1 infected patients.
    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 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.8.3 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.8.5The 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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 201
    F.4.2.2In the whole clinical trial 1866
    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 Decision2008-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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