Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-004681-55
    Sponsor's Protocol Code Number:1100.1526
    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:2008-10-06
    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 number2008-004681-55
    A.3Full title of the trial
    An open label, phase IIIb, randomized parallel group study to assess the efficacy and safety of switching HIV-1 infected patients successfully treated with a Nevirapine IR based regimen to Nevirapine XR 400 mg QD or remaining on Nevirapine IR 200 mg BIDbased regimen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Klinische Studie zur Untersuchung der Effektivität und Sicherheit der Umstellung von Nevirapine IR auf Nevirapine XR bei Patienten mit HIV-Infektion.
    A.4.1Sponsor's protocol code number1100.1526
    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 supportBoehringer Ingelheim Pharma GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Straße 173
    B.5.3.2Town/ cityIngelheim
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number0018002430127
    B.5.5Fax number0018008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.com
    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.3.4Pharmaceutical 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The patients for this trial are to be antiretroviral treatment-experienced, currently receiving nevirapine IR with a background therapy of fixed-dose combination (FDC) of 3TC + ABC, FTC + TDF or 3TC + /AZT, men and women ≥ 18 years of age, with an undetectable HIV-1 viral load, provided that the limit of detection of the test is below 100 copies/mL.
    All patients need to be on stable therapy with Nevirapine for at least 18 weeks with a viral load of < 50 copies/mL.
    E.1.1.1Medical condition in easily understood language
    Patienten mit HIV-Infektion, die aktuell Nevirapine IR in Kombination mit 3TC + ABC, FTC + TDF oder 3TC + AZT erhalten. Die Viruslast darf nicht nachweisbar sein.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy.
    E.2.2Secondary objectives of the trial
    Secondary objective of this study is to assess the safety and tolerance of NVP XR based regimen for HIV-1 infected patients who were receiving NVP IR based regimen for at least 18 prior weeks of therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    HIV infected subjects treated with a Viramune based regimen. A subject that meets the following inclusion criteria will be eligible for participation in this study:
    1. Signed and dated written informed consent prior to admission to the study in
    accordance with GCP and the local legislation.
    2. HIV-1 infected males or females ≥ 18 years. Patients without documented
    proceeding Western Blot for HIV may undergo testing at screening.
    3. Treatment with Viramune regimen for at least the preceding 18 weeks.
    4. Background therapy with one of the following for the previous 18 weeks:
    3TC/ABC (Kivexa® in EU; Epzicom in US), FTC/TDF (Truvada™) or 3TC/AZT
    (Combivir®). The combination drug may also be given as separate components. No
    other anti-retrovirals may be given in addition to nevirapne and background at the
    time of screening.
    5. An undetectable HIV viral load in the preceding 1-4 months, provided that the
    limit of detection of the test is below 100 copies/mL.
    6. An HIV viral load of < 50 copies/mL at screening (Visit 1).
    7. Acceptable screening laboratory values that indicate adequate baseline organ function with the following exceptions:
    • ALT and AST < 2.5 × ULN (DAIDS Grade 1).
    8. Willingness to abstain from ingesting medications that are listed as contraindicated in the SPC (or PI) or Investigator's Brochure during the study.
    9. Karnofsky performance score of ≥ 70 (listed in Appendix 10.4).
    E.4Principal exclusion criteria
    Subjects who meet one or more of the following criteria will be excluded from the study:
    1. Current treatment with an HIV protease inhibitor
    2. Participation in another trial or use of an investigational medicine within two months prior to Day 1 of this study
    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 double-barrier methods (simultaneous use of two diffeent
    methods such as diaphragm with spermicidal substance and condom) of
    contraception, or require ethinyl estradiol administration. Barrier methods of
    contraception include diaphragm with spermicidal substance, condom for females,
    cervical caps and condoms..
    4. Laboratory parameters > DAIDS grade 2:
    • Coagulation (PT, PTT, INR)
    • Hematology (absolute platelets, WBC, absolute neutrophil count, hemoglobin)
    • Biochemistry (total bilirubin, amylase, serum creatinine, fasting glucose, alkaline
    phosphatase)
    5. Laboratory parameters > DAIDS grade 3
    • Total triglycerides (total cholesterol no restriction)
    6. Hypersensitivity to any ingredients of the test products
    7. Active drug abuse or chronic alcoholism.
    8. Hepatic cirrhosis stage Child-Pugh B or C
    9. History of severe or acute illness within 60 days prior to Day 1, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the trial
    10. Inability to comply with protocol requirements
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is proportion of sustained virologic response (viral load < 50
    copies/mL) through Week 24. The time window of week 24 is defined as 24 ± 4 weeks from Day 1. A patient will be considered as a treatment failure at the earliest time of any one of the following events prior to Week 24:
    • A virologic failure defined by viral load ≥ 50 copies/mL measured at two consecutive
    visits, at least two weeks apart;
    • Change of ARV therapy: a change of ARV therapy is defined as either a permanent
    discontinuation of study medication NVP (XR or IR), or addition of new ARV drugs,
    or alterations in background therapy.
    • Patients who change between the three alternative background therapies because
    of toxicity of the background or for convenience are not considered treatment
    failures. In the case the background has to be discontinued due to its own toxicity
    or intolerance, the investigator has to construct a new NRTI-backbone choosing
    one of the other two background therapies allowed in this study. Convenience
    includes changing to a once-a-day scheduled background treatment if patients
    are randomized to receive nevirapine XR or other changes in schedule not
    related to virologic failure or toxicity. Patients who change background for
    reasons of convenience will only do so after having completed Visit 7 (Week 24).
    • Death;
    • Lost to follow-up.
    A change in the background therapy due to toxicity or intolerance clearly attributable to the background therapy is not considered as treatment failure. In the case the background has to be discontinued due to its own toxicity or intolerance, the investigator has to construct a new NRTI-backbone choosing one of the other two background therapies allowed in this study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    The secondary endpoints include:
    • Proportion of sustained virologic response (viral load < 50 copies/mL) through Week 48. The time window of Week 48 is defined as 48 ± 4 weeks from Day 1;
    • Proportion of sustained virologic response (viral load < 400 copies/mL) through Week 24;
    • Proportion of sustained virologic response (viral load < 400 copies/mL) through Week 48;
    • Time to treatment failure, defined as the time between the start of treatment and the time of treatment failure, prior to the time when the last patient is on treatment for 24 weeks;
    • Time to treatment failure, defined as the time between the start of treatment and the time of treatment failure, prior to the time when the last patient is on treatment for 48 weeks;
    • Change in VL and CD4+ cell count from baseline at each visit;
    • Genotypic resistance associated with virologic failure.
    Secondary pharmacokinetic endpoints include:
    • Trough nevirapine plasma concentrations at Visits 2 through 9 (Week 0 through Week 48)
    Safety endpoints include:
    • Adverse events (treatment related and unrelated);
    • Serious adverse events (including AIDS-defining events);
    • Occurrences of rashes and hepatic events;
    • Laboratory measurement abnormalities;
    • Change in laboratory test value from baseline at Week 24 and Week 48;
    • Incidence of AIDS progression or death at Week 24 and Week 48.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24 and week 48
    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 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) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    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 No
    E.8.2.3Other No
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    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
    End of trial will be the last visit of the last subject.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 415
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state113
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 293
    F.4.2.2In the whole clinical trial 400
    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)
    The treating physician will provide treatment as the further adequate standard treatment for the patient after the termination of the study medication with commercial supplies or in case of failure with a new one, according to the investigator's discretion and currently treatment guidelines.
    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 Decision2008-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-10
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon May 06 04:38:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA