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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35485   clinical trials with a EudraCT protocol, of which   5826   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).
     
    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:2006-003109-23
    Sponsor's Protocol Code Number:0518-021
    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:2012-08-13
    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 number2006-003109-23
    A.3Full title of the trial
    A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK- 0518 Versus Efavirenz in Treatment Naïve HIV-Infected Patients, Each in Combination With TRUVADA?
    Estudio Multicéntrico, doble ciego, randomizado, con comparador activo, para evaluar la seguridad y actividad antiretroviral del MK0518 frente a Efavirenz en combinación con TRUVADA? en pacientes Naïve infectados con el virus del VIH
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK- 0518 Versus Efavirenz in Treatment Naïve HIV-Infected Patients, Each in Combination With TRUVADA?
    Estudio Multicéntrico, doble ciego, randomizado, con comparador activo, para evaluar la seguridad y actividad antiretroviral del MK0518 frente a Efavirenz en combinación con TRUVADA? en pacientes Naïve infectados con el virus del VIH
    A.4.1Sponsor's protocol code number0518-021
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp and Dohme de España
    B.1.3.4CountrySpain
    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 supportMerck Sharp and Dohme de España
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp and Dohme de España
    B.5.2Functional name of contact pointMerck Sharp and Dohme de España
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcarcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210738
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.com
    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 No
    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.3.2Product code MK-0518
    D.3.4Pharmaceutical form Tablet
    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.3.8INN - Proposed INNMK 0518
    D.3.9.2Current sponsor codeMK 0518
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 TRUVADA
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Tablet
    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.3.8INN - Proposed INNTENOFOVIR DISOPROXIL FUMARATE
    D.3.9.1CAS number 202138-50-9
    D.3.9.4EV Substance CodeSUB12607MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.4EV Substance CodeSUB01882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEfavirenz
    D.3.4Pharmaceutical form Tablet
    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.3.8INN - Proposed INNEFAVIRENZ
    D.3.9.1CAS number 154598-52-4
    D.3.9.4EV Substance CodeSUB06463MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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
    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 Infection
    Infección por el VIH-1
    E.1.1.1Medical condition in easily understood language
    HIV Infection
    Infección por el VIH-1
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10020162
    E.1.2Term HIV infection CDC Group I
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1.To evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared with efavirenz 600 mg q.h.s., each in combination therapy with TRUVADA?, as measured by proportion of patients achieving HIV RNA <50 copies/mL at Week 48.
    2.To evaluate the safety and tolerability of MK-0518 400 mg b.i.d. compared with efavirenz 600 mg q.h.s., each in combination therapy with TRUVADA?, as assessed by review of the accumulated safety data at Week 48.
    1.Evaluar la actividad antirretroviral de MK-0518 400 mg dos veces al día en comparación con efavirenz 600 mg al acostarse, ambos combinados con TRUVADA?, medida a partir de la proporción de pacientes que logra un valor de ARN del VIH < 50 copias/ml en la semana 48.
    2.Evaluar la seguridad y la tolerabilidad de MK-0518 400 mg dos veces al día en comparación con efavirenz 600 mg al acostarse, ambos en combinación con TRUVADA?, a juzgar por la evaluación de los datos de seguridad acumulados en la semana 48.
    E.2.2Secondary objectives of the trial
    1.Evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared with efavirenz 600 mg q.h.s., each in combination therapy with TRUVADA?, as measured by the following parameters at Week 48:
    ?Proportion of patients achieving HIV RNA <400 copies/mL.
    ?Change from baseline in CD4 cell counts.
    2.Evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared with efavirenz 600 mg q.h.s., each in combination therapy with TRUVADA?, as measured by the following parameters at Week 96:
    ?Proportion of patients achieving HIV RNA <50 copies/mL.
    ?Proportion of patients achieving HIV RNA <400 copies/mL.
    ?Change from baseline in CD4 cell counts.
    (Read the rest in the protocol)
    1.Evaluar la actividad antirretroviral de MK-0518 400 mg dos veces al día en comparación con efavirenz 600 mg al acostarse, ambos en combinación con TRUVADATM, medida por los siguientes parámetros en la semana 48:
    ?Proporción de pacientes que alcanzan un valor de ARN del VIH < 400 copias/ml.
    ?Variación del recuento de linfocitos CD4 respecto al valor basal.
    2.Evaluar la actividad antirretroviral de MK-0518 400 mg dos veces al día en comparación con efavirenz 600 mg al acostarse, ambos en combinación con TRUVADATM, medida por los siguientes parámetros en la semana 96:
    ?Proporción de pacientes que alcanzan un valor de ARN del VIH < 50 copias/ml.
    ?Proporción de pacientes que alcanzan un valor de ARN del VIH < 400 copias/ml.
    ?Variación del recuento de linfocitos CD4 respecto al valor basal.
    (Leer el resto en el protocolo)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patient is a male or female at least 18 years of age on the day of signing the informed consent.
    2.Patient is HIV positive as determined by a positive result by enzyme-linked immunosorbent assay (ELISA) and has screening plasma HIV RNA (determined by the central laboratory) >5000 copies/mL within 60 days prior to the treatment phase of this study, and is indicated for treatment based on physician assessment. Local treatment guidelines should be considered in the decision to initiate therapy.
    3.Patient is naïve to ART.
    4.Patient has the following laboratory values within 35 days prior to the treatment phase of this study:
    4.1Serum creatinine ?2.0 x upper limit of normal
    4.2Alkaline phosphatase ?5.0 x upper limit of normal
    4.3AST (SGOT) and ALT (SGPT) ?5.0 x upper limit of normal
    5.Patient has a calculated creatinine clearance at time of screening >30 mL/min, based on the Cockcroft-Gault equation which is as follows (and 0.85X this value for females):
    Clcr (mL/min) = (140-age) x weight (in kg)
    72 x serum creatinine (mg/dL)
    6.In the opinion of the investigator, the patient should be considered clinically stable with no signs or symptoms of active infection, at the time of entry into the study; i.e., clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study.
    7.Patient who is of reproductive potential agrees to use an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, condoms, or abstinence.
    OR
    Patient who is not of reproductive potential ; is not sexually active, whose current partner(s) is/are not of reproductive potential, or whose sexual activity is exclusively homosexual is eligible without requiring the use of contraception.
    1.Pacientes de ambos sexos y mayores de 18 años el día de la firma del consentimiento informado.
    2.El paciente es positivo para el VIH, según se determina por un resultado positivo en un enzimoinmunoanálisis de adsorción (ELISA), y tiene un ARN del VIH en el plasma > 5.000 copias/ml durante la selección (determinado por el laboratorio central) en los 60 días previos a la fase de tratamiento de este estudio, y está indicado el tratamiento de acuerdo con la evaluación del médico. Deben valorarse las directrices de tratamiento locales en la decisión de iniciar el tratamiento.
    3.El paciente nunca ha recibido TAR.
    4.El paciente presenta los valores analíticos siguientes dentro de los 35 días previos a la fase de tratamiento de este estudio:
    4.1Creatinina sérica ?2,0 x límite superior de la normalidad
    4.2Fosfatasa alcalina ?5,0 x límite superior de la normalidad.
    4.3AST (SGOT) y ALT (SGPT) ?5,0 x límite superior de la normalidad.
    5.El paciente tiene un aclaramiento de creatinina calculado en el momento de la selección > 30 ml/min, según la ecuación de Cockroft-Gault, mostrada a continuación (0,85 X este valor en las mujeres):
    Clcr (ml/min) = _(140 - edad) x peso (en kg)_
    72 x creatinina sérica (mg/dl)
    6.En opinión del investigador, debe considerarse que el paciente está clínicamente estable, sin signos o síntomas de infección activa, en el momento de la entrada en el estudio, esto es, el estado clínico y los medicamentos crónicos no deberán haber cambiado como mínimo en las 2 semanas anteriores al comienzo del tratamiento en este estudio.
    7.La paciente está en edad de procrear y accede a utilizar un método anticonceptivo aceptable durante la totalidad del estudio. Un método anticonceptivo aceptable se define como un dispositivo intrauterino (DIU), un diafragma con espermicida, preservativos o abstinencia.
    O
    Podrán participar sin necesidad de usar anticonceptivos los pacientes que no tengan capacidad reproductiva ; no sean sexualmente activos o tengan una pareja actual que no tenga capacidad de procrear.
    E.4Principal exclusion criteria
    1.Patient has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the patient?s participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
    2.Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
    3.Patient has been treated for a viral infection other than HIV, such as hepatitis B, with an agent that is active against HIV including but not limited to adefovir, tenofovir, emtricitabine or lamivudine.
    Note: Patients may be enrolled if treatment occurred prior to the diagnosis of HIV.
    4.Patient has documented resistance to tenofovir, emtricitabine, and/or efavirenz.
    5.Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
    6.Patient has used another experimental HIV-integrase inhibitor.
    7.Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study. Short courses of corticosteroids (e.g., as for asthma exacerbation) will be allowed.
    8.Patient requires hemodialysis.
    9.Patient has significant hypersensitivity or other contraindication to any of the components of the study drugs.
    10.Patient has a current (active) diagnosis of acute hepatitis due to any cause. Patients with chronic hepatitis, including chronic hepatitis B and/or C, may enter the study as long as they have stable liver function tests and meet all inclusion criteria. Patients who, in the opinion of the investigator, have evidence of impairment of hepatic synthetic function, such as hypoalbuminemia or prolonged PT and PTT should be excluded.
    11.Patient is pregnant or breastfeeding, or expecting to conceive (within the duration of the study). Patient is expecting to donate eggs (within the duration of the study). Patient is expecting to donate sperm (within the duration of the study).
    1.El paciente tiene antecedentes o signos actuales de cualquier proceso, tratamiento, anomalía analítica u otra circunstancia que podrían confundir los resultados del estudio o interferir en su participación durante todo el estudio, de modo que no le conviene participar.
    2.En el momento de firmar el consentimiento informado, el paciente consume drogas o tiene antecedentes recientes (en el último año) de alcoholismo o drogadicción.
    3.Se ha tratado al paciente por una infección viral distinta del VIH, como la hepatitis B, con un fármaco que es activo frente al VIH, como, entre otros, adefovir, tenofovir, emtricitabina o lamivudina.
    Nota: podrá incluirse al paciente si el tratamiento fue anterior al diagnóstico del VIH.
    4.El paciente tiene resistencia documentada a tenofovir, emtricitabina y/o efavirenz.
    5.El paciente participa en la actualidad en un estudio sobre un compuesto o dispositivo experimental, o lo ha hecho en los 30 días previos a la firma del consentimiento informado.
    6.El paciente ha recibido otro inhibidor de la integrasa del VIH experimental.
    7.El paciente ha utilizado un tratamiento inmunodepresor sistémico durante el mes anterior al tratamiento en este estudio. Se permiten los ciclos cortos de corticosteroides (p. ej., para una exacerbación del asma).
    8.El paciente requiere hemodiálisis.
    9.El paciente presenta hipersensibilidad significativa o cualquier otra contraindicación a cualquiera de los componentes de los fármacos del estudio.
    10.El paciente tiene un diagnóstico actual (activo) de hepatitis aguda de cualquier causa. Los pacientes con hepatitis crónica, ya sea de tipo B o C, podrán entrar en el estudio siempre que tengan resultados estables en las pruebas de función hepática y que cumplan todos los criterios de inclusión. Se excluirá a los pacientes que, en opinión del investigador, presenten datos de alteración de la función sintética del hígado, como hipoalbuminemia o prolongación del TP y del TPT.
    11.La paciente está embarazada o lactando o espera concebir (durante el período del estudio). La paciente tiene previsto donar óvulos (durante el período del estudio). El paciente tiene previsto donar esperma (durante el período del estudio).
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy and Safety
    Eficacia y seguridad.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy: Proportion of patients achieving HIV RNA <50 copies/mL at Wk48 .
    Safety: safety and tolerability as assessed by review of the accumulated safety data at Week 48.
    Eficacia: proporción de pacientes que alcanzan un valor de ARN del VIH < 50 copias/ml en la semana 48.
    Seguridad: seguridad y tolerabilidad a juzgar por la evaluación de los datos de seguridad acumulados en la semana 48.
    E.5.2Secondary end point(s)
    Efficacy, tolerabilty, safety and evaluate nervous symptoms.
    Eficacia, seguridad y evaluar síntomas del sistema nervioso
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: Evaluate antriretroviral activity at week 48, 96
    Tolerability and safety: as assessed by review of the accumulated safety data up to Week 96.
    Nervous symptoms: as measured by proportion of patients with nervous system symptoms assessed by review of accumulated safety data up to Week 8.
    Eficacia: Evaluar la actividad antriretroviral en semana 48 y 96
    Tolerabilidad y seguridad: evaluados al revisar los datos de seguridad acumulados hasta semana 96
    Síntomas del sistema nervioso: evaluados al revisar los datos de seguridad acumulados hasta semana 8.
    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 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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    TRUVADA, Efavirenz
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Australia
    Brazil
    Canada
    Chile
    Colombia
    France
    Germany
    India
    Italy
    Mexico
    Peru
    Spain
    Thailand
    United States
    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
    Refer to protocol.
    Leer en el protocolo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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.1.2.1Number of subjects for this age range: 550
    F.1.3Elderly (>=65 years) No
    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 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 2012-08-13. Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 128
    F.4.2.2In the whole clinical trial 550
    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)
    Not applicable.
    No aplica.
    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 Decision2006-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-24
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA