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    Summary
    EudraCT Number:2011-005981-39
    Sponsor's Protocol Code Number:KMON
    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:2012-01-30
    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 number2011-005981-39
    A.3Full title of the trial
    Pilot simplification study to Lopinavir/ritonavir 800/200 mg monotherapy regimen once daily
    Estudio PILOTO de simplificación a una pauta de Lopinavir/ritonavir 800/200 mg en monoterapia una vez al día.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot simplification study to Lopinavir/ritonavir 800/200 mg monotherapy regimen once daily
    Estudio PILOTO de simplificación a una pauta de Lopinavir/ritonavir 800/200 mg en monoterapia una vez al día.
    A.3.2Name or abbreviated title of the trial where available
    KMON
    KMON
    A.4.1Sponsor's protocol code numberKMON
    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 SponsorUnidad de VIH. Servicio de Enfermedades Infecciosas. Hospital de Bellvitge
    B.1.3.4CountrySpain
    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 supportAbbott España
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de VIH. Servicio de Enfermedades Infecciosas. Hospital de Bellvitge
    B.5.2Functional name of contact pointJuan Manuel Tiraboschi
    B.5.3 Address:
    B.5.3.1Street AddressEdificio Antigua Escuela de Enfermeria 3º planta. C/ Feixa Llarga S/N
    B.5.3.2Town/ cityHospitalet de Llobregat- Barcelona
    B.5.3.3Post code08097
    B.5.3.4CountrySpain
    B.5.4Telephone number00349333590112886
    B.5.5Fax number0034932607669
    B.5.6E-mailjmtiraboschi@bellvitgehospital.cat
    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 Kaletra 200 /50 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 INNLOPINAVIR
    D.3.9.1CAS number 192725-17-0
    D.3.9.4EV Substance CodeSUB02970MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.4EV Substance CodeSUB10342MIG
    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.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-1 positive patients
    Pacientes VIH-1 positivos
    E.1.1.1Medical condition in easily understood language
    HIV-1 positive patients
    Pacientes VIH-1 positivos
    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
    Efficacy in the control of viral replication (Viral load < 40 copies /ml)
    Eficacia en el control de la replicación viral (CV <40 copias/ml)
    E.2.2Secondary objectives of the trial
    1. Stability in plasmatic levels of Lopinavir/ritonavir during all the study visits
    2. Tolerability
    3. Adherence
    4. Satisfaction
    1-Estabilidad en los niveles plasmáticos de Lopinavir/ritonavir a lo largo de las visitas en el período de estudio
    2-Tolerancia
    3-Adherencia
    4-Satisfacción
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients older than 18, HIV positive
    2. Patients treated in monotherapy regimen (Lopinavir/ritonavir twice daily, 2-0-2), without any changes in the treatment regimen during the last 6 months
    3. Indetectable viral load (<40 copies/ml) during the last 6 months
    4. Patients that accept the participation in the sudy and sign the ICF
    1. Pacientes > de 18 años, infectados por VIH.
    2. En tratamiento con monoterapia con Lopinavir/ritonavir dos veces al día (2-0-2) estable, sin cambios en la pauta en los últimos 6 meses.
    3. CV indetectable (<40 copias/ml) en los últimos 6 meses (o en los últimos 2 controles analíticos).
    4. Aceptación y firma del consentimiento informado
    E.4Principal exclusion criteria
    1. Opportunistic disease, neoplasy or any other active disease with specific treatment
    2. Active addiction to ilegal drugs or active use of psychotropic drugs
    3. Mental retardation diagnosis, or mental dementia or severe psychiatric disease (excluding major depression disorder solved > 3 months)
    1. Enfermedad oportunista, neoplasia u otra manifestación de enfermedad activa que necesite tratamiento específico.
    2. Adicción activa a sustancias ilegales o consumo de sustancias psicotrópicas.
    3. Diagnóstico de retraso mental o de demencia de cualquier etiología o enfermedad psiquiátrica grave (excluyendo depresión mayor resuelta hace >3 meses).
    E.5 End points
    E.5.1Primary end point(s)
    plasmatic viral load < 40 copies/ml at week 48
    Carga Viral VIH en plasma <40 copias/ml en la semana 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 48
    semana 48
    E.5.2Secondary end point(s)
    1. Stability in plasmatic levels of Lopinavir/ritonavir during all the study visits
    2. Tolerability
    3. Adherence
    4. Satisfaction
    1-Estabilidad en los niveles plasmáticos de Lopinavir/ritonavir a lo largo de las visitas en el período de estudio
    2-Tolerancia
    3-Adherencia
    4-Satisfacción
    E.5.2.1Timepoint(s) of evaluation of this end point
    All the study visits
    A lo largo de todas las visitas del estudio
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    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 concerned2
    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 No
    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
    last patient last visit
    última visita del último paciente
    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 months4
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    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 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 state30
    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)
    Expected normal treatment of the condition
    Tratamiento habitual de la enfermedad del estudio
    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 Decision2012-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
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