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    Summary
    EudraCT Number:2007-001955-20
    Sponsor's Protocol Code Number:GIEU-006
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-08-23
    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 - PEI
    A.2EudraCT number2007-001955-20
    A.3Full title of the trial
    A PHASE II, RANDOMIZED, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND ANTIRETROVIRAL ACTIVITY OF DERMAVIR (LC002) PATCH IN TREATMENT-NAÏVE HIV-1-INFECTED PATIENTS
    A.4.1Sponsor's protocol code numberGIEU-006
    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 SponsorGenetic Immunity Kft.
    B.1.3.4CountryHungary
    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 nameLC002 DermaVir Patch
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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 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 placeboCutaneous solution
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment Naive HIV-1 infected patients
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020180
    E.1.2Term HIV positive
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objectives:
    1. To evaluate the safety and tolerability of the DermaVir patch (LC002) in antiretroviral therapy naïve adults infected with HIV-1.
    2. To establish a safe and well tolerated dosing regimen of the DermaVir patch (LC002) in antiretroviral therapy naïve adults infected with HIV-1.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    1. To assess the antiretroviral activity of the DermaVir patch (LC002) by HIV-1 RNA measurements in antiretroviral therapy naïve adults infected with HIV-1.
    2. To investigate changes in CD4+ and CD8+ T-cell counts during DermaVir patch (LC002) treatment in antiretroviral therapy naïve adults infected with HIV-1.
    3. To assess the immunogenicity of DermaVir patch (LC002) in antiretroviral therapy naïve adults infected with HIV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    10.1.1 Age: ≥18 and ≤50 years.
    10.1.2 Chronic HIV infection, for the purpose of the study defined as:
    confirmed time point of seroconversion for HIV antibodies at least 6
    months before study entry and no signs of symptomatic acute HIV
    infection in the 12 months before study entry.
    10.1.3 Plasma HIV RNA value ≥5,000 copies/mL and ≤ 150,000 c/mL.
    10.1.4 Patients must be antiretroviral therapy naïve
    10.1.5 Documented CD4+ T-cell count at screening ≥400 cells/mm3.
    10.1.6 Female study volunteers who are participating in sexual activity that could lead to pregnancy must agree to use two reliable methods of contraception, one of which must be a barrier method. A barrier method of contraception (condoms or cervical cap) together with another reliable form of contraception (condoms, with a spermicidal agent; a diaphragm or cervical cap with spermicide; an IUD; or hormonal-based contraception) must be used while receiving vaccine and for 6 weeks after stopping the vaccine. Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV-1 transmission. Sexually active female study volunteers without reproductive potential are eligible without requiring the use of contraception. Written documentation of missing reproductive potential needs to be confirmed by study investigator before vaccination.
    10.1.7 Male patients participating in the study must agree to not attempt to impregnate a female, or participate in sperm donation programs. Males engaging in sexual activity that could lead to pregnancy must use a condom from the date of receipt of the first study vaccine until six weeks after receipt of the last study vaccine. This needs to be documented in written form by study investigator and patient before vaccination.
    10.1.8 Patient must be able and willing to provide signed informed consent
    E.4Principal exclusion criteria
    10.2.1 Clinically relevant skin disease as determined by the investigator, such as:
    • Active atopic dermatitis
    • Active or history of psoriasis
    • Active urticaria
    • Known hypersensitivity to adhesive tape or Tegaderm®
    • History of keloid
    • Active or history of vitiligo
    • Melasma (acquired hyperpigmentation disorder)
    • Acute or chronic skin infections or history of recurrent skin infections
    10.2.2 Patients with tattoos, or changes in pigmentation at the selected skin immunization sites, will be excluded, if the study investigator decides this would have an impact on the study.
    10.2.3 Active acute or chronic illness (e.g Hepatitis C) that is in the opinion of the investigator clinically relevant and a contra-indication for enrollment in the study including active severe clinical HIV disease complications (all CDC clinical Category C complications, see Appendix III).
    10.2.4 Diagnosis of any chronic autoimmune diseases (e.g. Grave’s) or bleeding disorder that is in the opinion of the investigator clinically relevant and a contra-indication for enrollment in the study or insulin dependent diabetes mellitus.
    10.2.5 Greater than or equal to Grade 2 values for any of the following laboratory tests at screening, will be excluded [standard international units in italics].
    • Hemoglobin (Hgb) [less than or equal to 8.4 g/dL (less than or equal to 5.2 mmol/dl)]
    • Absolute neutrophil count (ANC) [less than or equal to 999/mm3, ≤0.999 x 109/L]
    • Platelets, decreased [less than or equal to 99,999/mm3, ≤99.999 x 109/L]
    • Liver Function Tests (LFTs) ALT (SGPT)/AST (SGOT) [greater than or equal to 2.5 times the upper limit of normal (ULN)]
    • Creatinine [greater than or equal to 1.5 x ULN]-use age and sex appropriate values (per DAIDS Table)
    • Total bilirubin [greater than or equal to 2.0 x ULN]
    • Any other clinical and laboratory toxicity (≥Grade 2) that is in the opinion of the investigator clinically relevant and a contra-indication for enrollment in the study.
    10.2.6 Prior treatment with any HIV vaccine.
    10.2.7 Treatment with any immune modulating agents (e.g. IL-2, IFN-γ, GM-CSF) or chemotherapy for malignancy within 12 months prior to screening.
    10.2.8 Receipt of any immunizations or vaccinations within 28 days of entry into this study.
    10.2.9 Systemic steroid therapy within the past 28 days.
    10.2.10 Breast-feeding.
    10.2.11 Pregnancy.
    10.2.12 Excessive exposure to the sun (sunbathing, tanning beds) or laser hair removal/tattoo removal etc. at or near the vaccine site within 2 weeks prior to study entry.
    10.2.13 Participation in any clinical trial of an experimental drug or device in the previous 30 days
    10.2.14 Patients with malignancy within 12 month prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of at least two > Grade 3 adverse event including signs/symptoms, lab toxicities, and/or clinical events that is possibly or definitely related to study treatment (as judged by the GIEU006 team, including site clinicians on the team, blinded to treatment arm) any time from the first day of study treatment until 42 days after the last study vaccine administration.
    Premature discontinuation of immunizations at the patient’s request for reasons having to do with the effects, or the perceived effects, of the vaccine product or the application procedure.
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    Immunogenicity
    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 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) No
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    Assessments of the primary safety endpoints will occur during the first 24 weeks of the study when patients will receive immunizations (including six weeks after the last immunization). Follow up of the patients and the accompanying safety measures will be done during all 282 weeks of the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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) Information not present in EudraCT
    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 state36
    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)
    Since the subjects participating in this study are HIV-1 positive patients and under medical supervision at the respective investigator, they will continue to stay under medical supervision after the end of the trial and will receive medical standard of care treatment if necessary.
    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 Decision2008-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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