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    Summary
    EudraCT Number:2007-003654-29
    Sponsor's Protocol Code Number:1100.1486
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-09-10
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-003654-29
    A.3Full title of the trial
    A randomised, double blind, double dummy, parallel group, active
    controlled trial to evaluate the antiviral efficacy of 400 mg QD
    nevirapine extended release formulation in comparison to 200 mg BID
    nevirapine immediate release in combination with Truvada® in
    antiretroviral therapy naïve HIV-1 infected patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare the efficacy of nevirapine given once daily versus nevirapine given twice daily both in combination with Truvada for the treatment of HIV-infection.
    A.3.2Name or abbreviated title of the trial where available
    VERXVE
    A.4.1Sponsor's protocol code number1100.1486
    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 SponsorBoehringer Ingelheim Pharma GmbH & Co. KG
    B.1.3.4CountryGermany
    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 nameNevirapine Tablets, Extended Release, 400 mg
    D.3.2Product code Nevirapine K25% XR 400 mg
    D.3.4Pharmaceutical form Prolonged-release 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 INNNEVIRAPINE
    D.3.9.1CAS number 129618402
    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) 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.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 Viramune 200 mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Pharmaceuticals, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameViramune 200 mg Tablets
    D.3.4Pharmaceutical form 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 INNNEVIRAPINE
    D.3.9.1CAS number 129618402
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    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 placeboTablet
    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 infection
    E.1.1.1Medical condition in easily understood language
    HIV 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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10020160
    E.1.2Term HIV disease
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment.

    The objective of the additional extension phase is to collect additional data on the long term efficacy and safety of NVP XR.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Pharmacokinetic Substudy: Designated trial centers will participate in the pharmacokinetic substudy that includes intensive blood collection on Day 28. It is planned to include approximately 30 patients within this substudy. A patient who qualifies for the trial will automatically qualify for the PK substudy. A separate informed consent form will be required for participation in the substudy. Only study centers with previous experience and equipped in handling PK samples are eligible for participation in the substudy. It is anticipated that enrollment for the PK substudy will be finished before completion of the main study. In this case, the sponsor will inform the designated centers to continue enrollment for the main study without further enrollment into the PK substudy.
    E.3Principal inclusion criteria
    1. Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation
    2. HIV-1 infected males or females ≥18 years of age with positive serology (ELISA) confirmed by Western blot
    3. No previous antiretroviral treatment
    4. Males with CD4+ counts >50 - <400 cells/µl or females with CD4+ counts >50 <250 cells/µl
    5. Adequate renal function defined as a calculated creatinine clearance (CLCr) greater than or equal to 50 mL/min according to the Cockcroft-Gault formula as follows:
    Male: (140 – age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) = CLCr (mL/min).
    Female: (140 – age in years) x (weight in kg) divided by 72 x (serum creatinine in mg/dl) x 0.85 = CLCr (mL/min).
    6. Karnofsky score >70 (see Appendix 10.4)
    7. An HIV-1 viral load of ≥1,000 copies/mL
    8. Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent important opportunistic infections as defined in Appendix 10.2
    9. Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system (listed in Appendix 10.3) during the study.
    10. For centers participating in the PK substudy only: Written informed consent in accordance with GCP and local legislation for participation in the PK substudy.

    Patients who have successfully completed their week 144 visit of the main trial and given their written informed consent will enter the additional extension phase.
    E.4Principal exclusion criteria
    1. Active drug abuse or chronic alcoholism at the investigator’s discretion
    2. Active hepatitis B or C disease, defined as HBsAg-positive and/or HBV-DNA-positive or HCV-RNA-positive. Patients who are HBV DNA positive, HBsAg negative and hepatitis surface antibody positive will be allowed into the trial.
    3. Female patients of child-bearing potential who:
    a. have a positive serum pregnancy test at screening,
    b. are breast feeding,
    c. are planning to become pregnant,
    d. are not willing to use a barrier method of contraception, or
    e. are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives.
    Note: During participation in this study, females and males have to use barrier methods of contraception in addition or instead of ethinyl estradiol containing oral contraceptives. These barrier methods are: diaphragm with spermicide substance, condom for females, cervical caps and condoms.
    4. Laboratory parameters >DAIDS Grade 2
    However patients with DAIDs Grade 3 for the following laboratory parameters will be
    allowed into the trial: Eosinophils, Total cholesterol, LDL, HDL, Triglycerides, Total protein, Amylase accompanied by a normal lipase.
    5. ALT/AST > DAIDS Grade 1
    6. Hypersensitivity to any ingredients of the test products
    7. Previous use of Viramune® (nevirapine) or any other antiretroviral agents (does not include use of single dose NVP administered with or without an NRTI for the prevention of mother to child transmission at least 6 months prior to enrolment).
    8. Resistance to NNRTIs or either one of the components of Truvada® (emtricitabine or tenofovir disoproxil fumarate) or lamivudine (3TC) based on HIV-1 genotypic resistance testing report obtained at screening
    9. Patients who are receiving other concomitant treatments which are not permitted, as described in the prescribing information
    10. Use of investigational medications (any experimental agent other than the study regimen) within 30 days before study entry or during the trial
    11. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2)
    12. Patients who have been diagnosed with malignant disease and who are receiving systemic chemotherapy or are anticipated to receive any therapy during their participation in this trial.
    13. Patients who in the opinion of the investigator are not candidates for inclusion in the study
    14. Patient with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma
    15. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 8 weeks at screening visit
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is sustained virologic response through Week 48.
    A virologic response is defined by two consecutive measurements of VL <50 copies/mL, at least two weeks apart. A sustained virologic response has no virologic rebound or change of ARV therapy* through Week 48. The time window of Week 48 is defined as 48 ± 4 weeks from Day 1 (the day a patient starts treatment).
    A virologic rebound is defined by two consecutive measurements of VL ≥ 50 copies/mL, at least two weeks apart, after a virologic response.
    If there is unconfirmed change of VL status (rebound or response) at Week 48, then
    another measurement two weeks later is necessary to confirm whether the virologic rebound or response has occurred.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 48 weeks of treatment
    E.5.2Secondary end point(s)
    1. Time-to-loss-of-virologic response
    2. Virologic response by Week 48 as defined by VL <400 copies/mL
    3. Time to virologic response
    4. Time to new AIDS or AIDS-related progression event or death.
    5. Change from baseline in VL and CD4+ cell count at each visit.
    6. Genotypic resistance associated with virologic failure.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. from week 48 to week 144
    2. after 48 weeks
    3. between the start of lead-in period and the first viral load <50 copies/ mL prior to the time
    when the last enrolled patient is on treatment for 48 weeks
    4. throughout the study duration (from start to 144 weeks)
    5. at each visit throughout the study
    6. throughout the study, whenever virologic failure occurs
    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 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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    The additonal extension phase will be open label
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA71
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Botswana
    Canada
    France
    Germany
    Ireland
    Italy
    Mexico
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    South Africa
    Spain
    Switzerland
    United Kingdom
    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
    An end of trial (EOT) visit will be performed when a patient either completes the entire trial at Week 144 or discontinues early (note: Week 144 is the maximum treatment duration allowed for each patient). This visit should occur within one week of the last dose of study drug to evaluate efficacy, AEs/SAEs and the final laboratory test results. The EOT visit for early discontinuation is conducted to collect efficacy and safety information from patients who discontinue from Trial 1100.1486.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 958
    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 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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 958
    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)
    Standard of care based on physician judgment.
    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 Decision2007-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-24
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