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    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   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:2004-004358-24
    Sponsor's Protocol Code Number:MV18406
    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:2006-05-30
    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 number2004-004358-24
    A.3Full title of the trial
    A phase IIIb/IV randomised, controlled study evaluating an intensification treatment strategy of adding enfuvirtide (ENF) to an oral Highly Active AntiRetroviral Therapy (HAART) in treatment experienced patients.
    A.3.2Name or abbreviated title of the trial where available
    INTENSE Study
    A.4.1Sponsor's protocol code numberMV18406
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorF. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Fuzeon 90 mg/ml powder and solvent for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameFuzeon 90 mg/ml powder and solvent for solution for injection
    D.3.2Product code Ro 29-9800
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEnfuvirtide
    D.3.9.1CAS number 159519-65-0
    D.3.9.2Current sponsor codeRo 29-9800
    D.3.9.3Other descriptive nameENF, T-20
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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
    HIV Infection
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10020161
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the induction strategy of HAART alone (I1) compared to enfuvirtide (90 mg s.c.BID) in combination with HAART (ENF+HAART, I2)
    • To determine the overall induction/maintenance treatment strategy (with or without continued ENF) after 48 weeks of treatment
    • To compare different maintenance strategies for those patients who are qualified for entering the maintenance phase (M1, M2 and M3)
    • To assess the safety of induction phase (I1 vs I2) and maintenance phase (M1, M2, and M3).
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. HIV-1 infected adults ( > 18 years of age) previously treated with 2 or 3 different ARV classes with a CD4 lymphocyte count ≥200 cells/mm3 and HIV-1 RNA ≥ 1,000 copies/mL, while on their current “pre-study”ARV regimen

    2. Must currently be on ARV therapy, with no changes to that regimen for > 4 weeks prior to entering screening (patients on treatment interruption excluded). Patients must remain on their “pre-study”regimen unchanged except for toxicity management until BL1

    3. Must be able to create a study HAART regimen with at least 2 ARVs to which his/her virus show sensitivity by genotypic testing at screening (Genotypic Sensitivity Score or GSS ≥2).

    4. Must be willing and able to give written informed consent

    5. Must be willing and able to abide by the conditions of the protocol, including the possibility of being randomized to HAART or ENF+HAART as described in the Induction Phase as well as possibly being randomized to either stop or continue ENF in the Maintenance Phase

    6. Female subjects of childbearing potential must have a negative serum pregnancy test documented during screening for eligibility, and a negative urine pregnancy test within 24 hours prior to first dose of study medication. Female subjects of childbearing potential must agree to use a reliable form of effective barrier contraception (< 1% failure rate) for the duration of the study, and for 30 days after the last dose of study drug, or have documented sterility
    E.4Principal exclusion criteria
    1. Expected systemic hypersensitivity to enfuvirtide or to any of the excipients of the investigational medicinal product.
    2. History of prior use of enfuvirtide and/or T-1249
    3. Patients for whom standard of care, in the judgment of the investigator, would require immediate use of enfuvirtide or medications not permitted in the protocol.
    4. Patients on treatment interruption or patients interrupting ARV therapy within 4 weeks of screening or during the screening period for reasons other than toxicity management.
    5. Female subjects who are pregnant, breastfeeding, or who plan to become pregnant during the study.
    6. Any current clinical parameter of ACTG Grade 3 or laboratory parameter of ACTG Grade 4. Stable current clinical parameter of ACTG Grade 3 or Asymptomatic Grade 4 laboratory abnormalities will be permitted, at the discretion of the investigator (and following approval by the sponsor), if deemed clinically appropriate.
    7. Evidence of alcohol and/or drug (illicit or prescription) abuse within one year of entry that, in the judgment of the investigator, would result in the subject being unreliable in fulfilling the conditions of the protocol.
    8. Prior non-adherence to antiretroviral treatment regimens that, in the judgment of the investigator, would result in the subject being unreliable in fulfilling the conditions of the protocol.
    9. Inability to self-inject enfuvirtide as indicated in the protocol unless a care giver or partner/family member is available to be trained and to administer the injections for the duration of the study.
    10. Current severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study.
    11. Major organ allograft.
    12. Evidence of active, untreated opportunistic infection (including any abnormality on fundoscopic examination, unless deemed benign by an ophthalmologist), or unexplained temperature which is greater than or equal to 38.5 degrees C for seven consecutive days, within 30 days prior to the screening visit. Subjects who are on a stable anti-infective treatment or prophylaxis regimen are allowed in the study.
    13. Currently taking or anticipated to take during the course of the study, any immunomodulator, HIV vaccine, or investigational agent for any conditions other than HIV/AIDS.
    E.5 End points
    E.5.1Primary end point(s)
    The following two endpoints will be used to assess the virological response at week 24:
    • Percent of patients initially achieving viral suppression to < 50 copies/mL or
    • Percent of patients initially achieving viral suppression to < 400 copies/mL.
    In order to compare how soon patients will respond to the randomized treatment, the time to achieving initial viral suppression to < 50 copies/mL at week 24 will be used.
    For analyzing continuous endpoints:
    • Change from baseline in log10 (HIV-1 RNA) at week 24 or
    • Change from baseline in CD4 counts at week 24.
    At week 48:
    In order to compare induction/maintenance strategies for patients with or without continued ENF in their treatment regimen, the percent of patients achieving viral suppression < 50 copies/mL prior to or at week 48 will be used.
    For comparison of maintenance strategies, the time-to-loss virological response (i.e. 2 consecutive viral load values ≥ 50 copies/mL) will be the primary efficacy endpoint.
    Safety assessment will be based on comparison of the number and percent of patients that have specified events (pneumonias, SAEs and serious SAEs) during each of the treatment phases.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 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 Information not present in EudraCT
    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 is defined as the date of the last visit /last patient, however exceptions should be justified.
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 300
    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)
    N/A
    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 Decision2005-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-11-05
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