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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2004-001224-21
    Sponsor's Protocol Code Number:MV18220
    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:2004-12-23
    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 number2004-001224-21
    A.3Full title of the trial
    A 24 week, open label single arm study to evaluate the safety and efficacy of switching a toxicity causing antiretroviral (ARV) to enfuvirtide (ENF) and to assess resolution or improvement of ARV toxicities in patients with current, historical treatment-limiting toxicities
    A.3.2Name or abbreviated title of the trial where available
    SWITCH TOX study
    A.4.1Sponsor's protocol code numberMV18220
    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 assess the resolution or severity change of the offending ARV toxicity or new episodes of previous ARV toxicity after the toxicity causing ARV is switched to ENF at baseline. For the purpose of this study the offending toxicities will be stratified into two categories.

    Category l
    • Abnormal Liver Function Tests
    • Gastro Intestinal Toxicity (nausea, vomiting and /or diarrhea)
    • Lipid abnormalities
    • Hyperglycemia

    Category 2
    • Pancreatitis
    • Lactic Acidosis / Hepatic Steatosis
    • Peripheral Neuropathy
    • Hepatotoxity
    E.2.2Secondary objectives of the trial
    1) To assess the safety and tolerability of an ENF-based regimen over 24 weeks after the toxicity causing ARV is switched to ENF at baseline.
    • Treatment emergent abnormal laboratory tests
    • Discontinuations
    • Serious Adverse events
    • AIDS Defining Event’s Category C that are considered serious (appendix 7, see protocol)
    • Deaths

    2) To assess the maintenance of efficacy of an ENF based regimen at 24 weeks after the toxicity causing ARV is switched to ENF at baseline.
    • Proportion of patients who maintained or improved viral load response using mutually exclusive categories <50, ≥ 50 copies but <400 or ≥ 400 copies/ml at 24 weeks
    • Proportion of patients who maintain or improve baseline CD4 counts
    • Quality of life: Mean score changes from baseline in MOS-HIV instrument

    3) Adherence – 4 day recall questionnaire.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    • Ability to provide informed consent
    • Patients must be HIV-1 infected adults and triple-class experienced (NRTI, NNRTI, PI )
    • Experienced ≤ prior 12 ARVs in their HIV treatment
    • Patients who have current or prior treatment-limiting toxicities attributed to any ARV and who are still continuing on the offending ARV, or who have interrupted treatment (within 4 weeks prior to baseline day 1) due to any acute offending ARV related toxicity and who are willing to recommence their regimen combination minus the primary offending toxicity causing ARV while adding ENF to that regimen.
    • Patient must be willing to switch the toxicity causing ARV for ENF at baseline and must be willing to inject ENF subcutaneously BID.
    E.4Principal exclusion criteria
    • Prior exposure to enfuvirtide
    • Patients who need to change the entire treatment regimen during screening prior to baseline day 1.
    • Inability to self-inject (exception: if necessary, health care practitioner may administer injections or a caregiver if available, must be trained to administer the injections for the duration of the study)
    • Evidence of active opportunistic infection, intercurrent illness or any other condition that would preclude the patient from taking the prescribed antiretroviral regimen
    • Female patients who are pregnant, breastfeeding, or who plan to become pregnant during the study
    • Evidence of ongoing alcohol and/or drug or substance abuse that would result in the patient being unreliable in fulfilling the conditions of this protocol
    • Prior non-adherence to antiretroviral treatment regimens that would result in the patient being unreliable in fulfilling the conditions of this protocol
    • At the physician’s discretion, patients with Grade 4 AEs at screening.
    E.5 End points
    E.5.1Primary end point(s)
    ARV toxicity:
    • Grading of severity of current ARV toxicity by ACTG criteria, AHA guidelines or Table 3 (see protocol)
    • Assessment of change from baseline measurement in addition to grading severity and/or resolution of current ARV toxicities by ACTG, AHA Guidelines criteria or Table 3 (see protocol) over 24 weeks as:
    - Documentation of prior ARV toxicities at baseline and assessment of new episodes of ARV toxicities over 24 weeks recorded as adverse events
    - Laboratory tests; hematology, blood chemistry, LFTs, fasting lipids profiles and glucose, changes in values will be measured from baseline.
    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 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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.6 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 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
    Last follow-up (week 28) of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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 2004-12-23. 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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    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 Decision2004-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-10-23
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