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    Summary
    EudraCT Number:2005-002114-38
    Sponsor's Protocol Code Number:G9901441
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-11-10
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2005-002114-38
    A.3Full title of the trial
    Ensayo randomizado para determinar el tratamiento óptimo de pacientes con infección por VIH en quienes la terapia con TARGA de primera y segunda línea ha fracasado
    A.3.2Name or abbreviated title of the trial where available
    Options in management with antiretrovirals
    A.4.1Sponsor's protocol code numberG9901441
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number19619965
    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 SponsorMedical Research Council Clinical Trials Unit
    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.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
    human Immunodeficiency virus (HIV) infection.
    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 study will compare different strategies for the management of patients with HIV infection for whom first and second line HAART has failed.

    The OPTIMA study aims to evaluate (a) the effect of mega-ART compared to standard-ART and (b) the effect of an intended 3-month ARDFP compared to no ARDFP in the management of patients for whom previous HAART therapy has failed.
    E.2.2Secondary objectives of the trial
    The impact of mega-ART and ARDFP on cost and Quality Adjusted Life Years will be determined; lifetime costs and outcomes will be modelled to determine whether these strategies are cost-effective.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Ability to provide Informed Consent
    2) Age of 18 years or more
    3) Serologic or virologic diagnosis of HIV infection
    4) Had failure* of at least two different multi-drug regimens that included drugs of all 3 classes that the patient can tolerate
    Or
    laboratory evidence of resistance** to drugs in each of the 3 classes
    5) Had at least 3 months of current ART and is still on treatment (unless a new failure*, defined as (c) below)
    6) Two most recent results (which can include screening) on current ART of :
    CD4+ T-cell count £ 300 cells/mm3 or £ 15%,
    and plasma viral load ³ 5,000 copies/ml (by Roche Amplicor, v1.0) or
    ³ 2,500 copies/ml (by bDNA: Bayer v3.0/Chiron v3.0, or PCR: Roche Amplicor Monitor/COBAS v1.5)

    *Failure (since availability of viral load tests) is defined as:
    (a) failure to suppress plasma viral load after 24 weeks of therapy, or
    (b) a rebound of at least 0.5 log10 in plasma viral load from nadir, or
    (c) less than 0.5 log10 drop by (bDNA: Bayer v 3.0/Chiron v3.0, or PCR: Roche AmplicorMonitor/COBAS v1.5) or less than 1.0 log10 drop (Roche Amplicor v1.0), in plasma viral load after at least 4 weeks continuous treatment with a current new multi-drug regimen
    OR
    (in the therapeutic era before viral load testing was available) failure is defined as:
    CD4 decline >50% from peak treatment response, or below pretreatment level, or clinical progression of HIV disease.

    ** Resistance (this could be from screening susceptibility test) is defined either as:
    (a) genotypic (defined as the presence of primary mutations associated with resistance to at least 2 drugs in each class), OR
    (b) phenotypic evidence of 3-class resistance
    E.4Principal exclusion criteria
    b. Exclusion Criteria:

    1)Pregnancy, breast-feeding or planned pregnancy
    2)Likelihood of poor protocol follow-up or if Mega-ART is not feasible (due to significant intolerance of many ART drugs)
    3)Serious, uncontrolled major opportunistic infection (OI) within 14 days of screening
    4)Likelihood of early death due to non HIV-disease
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint: Time to new or recurrent AIDS event or Death

    Secondary Endpoint: Time to development of a new non-HIV related
    serious adverse event
    Other outcomes that will be assessed are:
    1. Quality of Life
    2. Incidence of grade 3 or 4 clinical or laboratory adverse events
    3. Changes in CD4 counts, viral load and resistance
    4. Process measures including haematology profiles, electrolytes, renal function, liver function, pancreatic function, and lipid levels)
    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 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) 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 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 Yes
    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 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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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 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) Information not present in EudraCT
    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 2005-11-10. 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.3.3.6.1Details of subjects incapable of giving consent
    Exclusion criteria : Pregnancy, breast-feeding or planned pregnancy
    F.3.3.7Others Information not present in EudraCT
    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 66
    F.4.2.2In the whole clinical trial 504
    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 Decision2006-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-03-07
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