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    The EU Clinical Trials Register currently displays   43846   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:2008-000674-20
    Sponsor's Protocol Code Number:SSAT 029
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-22
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-000674-20
    A.3Full title of the trial
    A phase III, double blind, multi centre, randomised placebo controlled, pilot study to assess the feasibility of switching individuals receiving efavirenz with continuing Central Nervous System (CNS) toxicity to TMC125
    A.3.2Name or abbreviated title of the trial where available
    Efavirenz taxicity switch to etravirine study
    A.4.1Sponsor's protocol code numberSSAT 029
    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 SponsorSt Stephen's Aids Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name Sustiva (NDC 0056-0510-30)
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Sqibb
    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 nameSustiva 600 mg film-coated tablets
    D.3.2Product code Efavirenz
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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 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 No
    D.IMP: 2
    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 Yes
    D.2.1.1.1Trade name IntelenceTM
    D.2.1.1.2Name of the Marketing Authorisation holderTibotec 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 nameEtravirine
    D.3.2Product code TMC125 (spray dry formulation - F060)
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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 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 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 placeboTablet
    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
    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
    To investigate whether switching from EFV to TMC125 is associated with improvement of EFV induced neuropsychiatric and central nervous system (CNS) toxicity
    E.2.2Secondary objectives of the trial
    •To investigate the impact of switching from EFV to TMC125 on HADS score.
    •To investigate the possibility of continued virological suppression in individuals switching from EFV to TMC125.
    •To investigate the possibility of continued immunological recovery in individuals switching from EFV to TMC125.
    •To investigate change in laboratory parameters when switching from EFV to TMC125.
    •To investigate the rate of non-CNS adverse events before and after switch to TMC125.
    •To investigate changes in adherence in individuals switching from EFV to TMC125.
    •To investigate changes in patient-perceived tolerability in individuals switching from EFV to TMC125
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who meet all of the following criteria are eligible for this trial:

    1.The subject is male or female aged 18 years or above
    2.The subject has a documented HIV-1 infection
    3.The subject has signed the Informed Consent Form voluntarily
    4.The subject is willing to comply with the protocol requirements
    5.The subject has an HIV-plasma viral load at Screening <50 HIV-1 RNA copies/mL
    6.The subject has a CD4 cell count at Screening >50 cells/mm3
    7.The subject has been on a stable ART, with at least 3 licensed agents, one of which being EFV, for at least 12 weeks at Screening, and is willing to stay on treatment until Baseline
    8.Symptomatic toxicity associated with the EFV after at least 12 weeks of therapy
    9.If the subject is female and of childbearing potential, she is using effective birth control methods and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial (or after last intake of investigational ARVs);
    Note: Hormone-based contraception may not be reliable when taking investigational agents; therefore, to be eligible for this trial, women of childbearing potential should either:
     Use a double barrier method to prevent pregnancy (i.e., using a condom with either spermicidal cream/foam/gel or diaphragm or cervical cap);
    OR
     Use hormone-based contraceptive in combination with a barrier contraceptive (i.e. male condom, diaphragm, or cervical cap with spermicide),
    OR
     Use an intrauterine device (IUD) in combination with a barrier contraceptive (i.e., male condom, diaphragm, or cervical cap with spermicide),
    OR
     Not engage in heterosexual sex, or have a vasectomised partner with confirmed sterility
    Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential

    Note: Spermicides containing non-oxynol-9 should not be used as this can potentially increase the rate of HIV-1 transmission

    Note: Use of an IUD can increase the risk of sexually transmitted infections, including HIV

    10.If the subject is a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until 30 days after the end of the trial (or after last intake of investigational ARVs)
    E.4Principal exclusion criteria
    Subjects meeting 1 or more of the following criteria cannot be selected:
    1.The subject has a primary HIV-1 infection
    2.The subject has an HIV-2 infection
    3.The subject is using any concomitant therapy disallowed by the protocol (as per SPC for EFV and TMC125)
    4.The subject has any condition (including but not limited to alcohol and drug use) which, in the opinion of the investigator, could compromise the subject’s safety or adherence to the protocol
    5.The subject’s life expectancy less than 6 months according to the judgement of the investigator
    6.The subject has a currently active AIDS defining illness (Category C conditions according to the Center for Disease Control [CDC] Classification System for HIV Infection 1993) with the following exceptions, which must be discussed with the sponsor prior to enrolment:
     Stable cutaneous Kaposi’s Sarcoma (i.e., no pulmonary or gastrointestinal involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the trial period
     Wasting syndrome due to HIV infection
    Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed if the medication used is not part of the disallowed medication
    7.The subject has any active clinically significant disease (e.g., pancreatic, cardiac dysfunction) or findings during Screening of medical history or physical examination that, in the investigator’s opinion, would compromise the outcome of the trial
    8.The subject has acute viral hepatitis including but not limited to A, B, or C
    9.The subject has chronic hepatitis B and/or C with aspartate aminiotransferease (AST) and/or alanine aminotransferease (ALT) >5 x upper limit of normal (ULN)
    Note: Subjects co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable and is not expected to require treatment during the trial period. Please refer to the package insert with respect to proper care if hepatitis B co-infection in case tenofovir, lamivudine and/or emtricitabine are included in the OBR
    10.The subject has received an investigational drug within 30 days prior to the trial drug administration
    11.The subject has previously demonstrated a clinically significant allergy or hypersensitivity to any of the excipients of the investigational medications administered in this trial.
    12.If the subject is female, she is pregnant or breastfeeding
    13.The subject has any grade 3 or grade 4 toxicity according to Division of AIDS (DAIDS) grading scale, except for:
     Grade 3 glucose elevation;
     Asymptomatic grade 3 pancreatic amylase elevation;
     Asymptomatic grade 3 triglyceride/cholesterol elevation;
     Asymptomatic grade 4 triglyceride elevation
    Note: Retesting of abnormal screening values that lead to exclusion will be allowed using any visits during the screening period (to reassess eligibility).
    14.The subject has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (International Normalized Ratio [INR] > 1.5 or albumin < 30g/L or bilirubin > 2.5 x ULN)
    Note: Subject can be included if elevated bilirubin is assessed at the time of screening as related to an administered ARV and not related to liver disease.
    15.The subject has previously received treatment with either TMC125, TMC120, or TMC278 in a previous clinical trial
    16.The subject has reported a resolution of their CNS toxicity between Screening and Baseline visits
    17.The subject has a general medical condition which, in the investigator’s opinion, interferes with the assessments and the completion of the trial.
    E.5 End points
    E.5.1Primary end point(s)
    The rate of neuropsychiatric and central nervous system (CNS) toxicity as measured by the proportion of patients experiencing grade 2-4 neuropsychiatric and CNS toxicity after 12 weeks (as defined by the ACTG adverse event scale [appendix 1]).
    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) 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) 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 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) Yes
    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
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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) 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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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 Decision2008-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-15
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    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.

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