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:2011-002268-26
    Sponsor's Protocol Code Number:CTN240
    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:2012-11-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-002268-26
    A.3Full title of the trial
    Valacyclovir in Delaying Antiretroviral Treatment Entry (VALIDATE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    VALIDATE: Effect of Valacyclovir in people with HIV and HSV-2 coinfection
    A.3.2Name or abbreviated title of the trial where available
    Valacyclovir in Delaying Antiretroviral Treatment Entry (VALIDATE)
    A.4.1Sponsor's protocol code numberCTN240
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN66756285
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00860977
    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 SponsorUniversity Health Network, Toronto General Hospital
    B.1.3.4CountryCanada
    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 supportUniversity Health Network
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt Stephen's AIDS Trust
    B.5.2Functional name of contact pointAlice Shields
    B.5.3 Address:
    B.5.3.1Street AddressRoom 1 London House, 266 Fulham Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSW10 9EL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02033156101
    B.5.5Fax number02030550044
    B.5.6E-mailalice.shields@chelwest.nhs.uk
    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 Valtrex
    D.2.1.1.2Name of the Marketing Authorisation holderGSK
    D.2.1.2Country which granted the Marketing AuthorisationCanada
    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 nameapo-valacyclovir
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Capsule
    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.3.9.3Other descriptive nameValacyclovir
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 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
    Coinfection of Human Immunodeficiency Virus and Herpes Simplex Virus type 2
    E.1.1.1Medical condition in easily understood language
    Coinfection of Human Immunodeficiency Virus and Herpes Simplex Virus type 2
    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
    To compare time from baseline until reaching the primary endpoint, either CD4 count of ≤ 350 cells/mm3 measured on two consecutive occasions at least 1 month apart, or initiation of HAART (Highly Active Antiretroviral Treatment) for any reason, among adults with both stable untreated HIV and HSV-2 co-infection, between those randomized to valacyclovir compared to those randomized to placebo.

    i.e. Among adults co-infected with HIV and HSV-2 who are not using chronic suppressive anti-HSV therapy, and who are neither currently using nor appropriate for initiation of HAART according to current guidelines, can oral valacyclovir 500mg twice daily delay the time until the need for initiating HAART?
    E.2.2Secondary objectives of the trial
    -To compare the annual rate of change in the absolute CD4 cell count between study arms.
    -To compare the annual rate of change in the CD4 cell count percentage between study arms.
    -To compare the viral load between study arms.
    -To compare the rate of drug-related adverse events between study arms.
    -To compare the median frequency of HSV reactivations per year between study arms.
    -To compare the rate of acyclovir-resistant HSV between study arms.
    -To compare quality of life between study arms.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -adult (aged 18 years or older or as per Local/Provincial Guidelines)
    -documented HIV-1 infection (determined by EIA and Western blot)
    -documented HSV-2 seropositivity (determined by ELISA during screening
    -no use of chronic anti-HSV therapy for the past 6 months, and not anticipated to require chronic anti-HSV therapy during the study
    -antiretroviral naïve (no more than 14 days of total prior ARV exposure)
    -CD4 count within the 400-900 cells/mm3 range (inclusive) on two consecutive occasions, with at least one measurement within 4 weeks of initiating trial (baseline visit)
    -does not meet recommendations for initiating ARV therapy according to current guidelines
    E.4Principal exclusion criteria
    -pregnancy or actively planning to become pregnant
    -receiving chemotherapy, chronic steroid therapy or other immunomodulatory medications (e.g. interferon, azathioprine, methotrexate, TNF-alpha antagonists, etc.)
    -Estimated creatinine clearance <30 mL/min
    -Other medical condition likely to cause death within 24 months
    -Enrolled in a therapeutic HIV vaccine or immunotherapy trial
    -Enrolled in another trial investigating the impact of another intervention on HIV disease progression
    -HIV elite controller (EC), phenotypically defined here as documented duration of HIV infection of ≥5 years, a persistent CD4 cell count ≥500 cells/mm3, and a persistent plasma HIV viral load of <1000 copies/mL in the absence of antiretroviral therapy
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the time from baseline until reaching the primary endpoint, a composite of either a CD4 cell count ≤350 cells/mm3 measured on two consecutive occasions at least 1 month apart, or initiation of HAART for any reason, whichever occurs first. This endpoint was selected because reaching the treatment threshold for initiating HAART is an important clinical event signifying the need for lifelong therapy. The CD4 count of ≤350 cells/mm3 must be confirmed by a second measurement to verify the CD4 count is within the treatment range before initiating therapy. The primary endpoint also includes the initiation of HAART for any reason, since patients who start HAART outside these guidelines are also committed to lifelong therapy. This group may include individuals who choose to start therapy at earlier stages of disease (e.g. due to high viral load set-point), and some who develop HIV-related complications (e.g. tuberculosis) at higher CD4 cell counts, among others. For example, women who initiate HAART during pregnancy primarily for the prevention of mother-to-child transmission of HIV, and hepatitis B co-infected individuals who initiate HAART primarily for the purposes of treating their hepatitis B infection will also be considered to have met the primary endpoint. It was important not to restrict the primary endpoint to initiation of HAART alone, since some patients may not initiate HAART despite reaching treatment thresholds for reasons including patient anxiety, concerns about adherence, and lack of familiarity with guidelines.

    HAART initiation guidelines are continuously under evaluation, and it is recognized that there is a possibility that HIV treatment guidelines may change. However, this concern will not threaten the integrity of the study because the primary endpoint of this study is a composite of not only meeting the current CD4 threshold of 350 cells/mm3, but also the initiation of HAART for any reason, whichever occurs first. Finally, randomization in this trial will be stratified by site to help account for any variation in practice regarding initiation of HAART across sites.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to either a CD4 cell count ≤350 cells/mm3 measured on two consecutive occasions at least 1 month apart, or initiation of HAART for any reason (whichever occurs first).
    E.5.2Secondary end point(s)
    To compare the annual rate of change in the absolute CD4 cell count between study arms.
    To compare the annual rate of change in the CD4 cell count percentage between study arms.
    To compare the median log10 HIV viral load between study arms.
    To compare the rate of drug-related adverse events between study arms.
    To compare the median frequency of HSV reactivations year between study arms.
    To compare the rate of acyclovir-resistant HSV between study arms.
    To compare quality of life between study arms.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to end of study.
    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 No
    E.6.5Efficacy No
    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) No
    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 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
    The end of the trial is defined as 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 years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days29
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 480
    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)
    No treatment will be made available by the sponsor after participation in the trial ends. However, the study intervention is an existing licensed medication which can be prescribed by physicians if they deem it medicall appropriate. All such treatment after the research is finished will be as per the local standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-12
    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-Sun May 05 11:00:22 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA