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    Summary
    EudraCT Number:2014-002720-27
    Sponsor's Protocol Code Number:2014-002720-27
    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:2014-11-19
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-002720-27
    A.3Full title of the trial
    Simplification from Tenofovir plus Lamivudine or Emtricitabine plus Ritonavir-Boosted-Protease Inhibitor to Ritonavir-Boosted-Atazanavir plus Lamivudine in Virologically-Suppressed-HIV-Infected Adults with Osteopenia: a pilot study
    Estudio piloto de simplificación del tratamiento antirretroviral con Tenofovir +Lamivudina o Emtricitabina + Ritonavir/Inhibidor de la proteasa a Ritonavir/Atazanavir+Lamivudina, en adultos infectados por el VIH en supresión virológica, con osteopenia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Simplification from Tenofovir plus Lamivudine or Emtricitabine plus Ritonavir-Boosted-Protease Inhibitor to Ritonavir-Boosted-Atazanavir plus Lamivudine in Virologically-Suppressed-HIV-Infected Adults with Osteopenia: a pilot study
    Estudio piloto de simplificación del tratamiento antirretroviral con Tenofovir +Lamivudina o Emtricitabina + Ritonavir/Inhibidor de la proteasa a Ritonavir/Atazanavir+Lamivudina, en adultos infectados por el VIH en supresión virológica, con osteopenia.
    A.3.2Name or abbreviated title of the trial where available
    Osteosimply014
    Osteosimply014
    A.4.1Sponsor's protocol code number2014-002720-27
    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 SponsorFundació Clínic per a la Recerca Biomèdica
    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 supportBMS (Brystol Myers Squibb)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU Clinic (Clinical Trial Unit)
    B.5.2Functional name of contact pointJaime Camacho
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number34932275400
    B.5.5Fax number34932279877
    B.5.6E-mailjcamacho@clinic.ub.es
    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.2.1.2Country 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 Coated 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 INNLAMIVUDINE
    D.3.9.1CAS number 134678-17-4
    D.3.9.4EV Substance CodeSUB08392MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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 Norvir
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    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.3.1Product nameNorvir
    D.3.4Pharmaceutical form Coated 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 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 number100
    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 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 Reyataz
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB PHARMA EEIG
    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.3.1Product nameReyataz
    D.3.4Pharmaceutical form Capsule, hard
    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 INNAtazanavir
    D.3.9.3Other descriptive nameATAZANAVIR SULFATE
    D.3.9.4EV Substance CodeSUB20595
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    Chronic HIV infection.
    Infección VIH crónica
    E.1.1.1Medical condition in easily understood language
    Chronic HIV-1 infection.
    Infección VIH crónica
    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 assess the change in BMD by dual-energy X-ray (DXA) absorptiometry in HIV-infected adults with hip or spine T-score < -1.0 by DXA at week 48 after switching to r/ATV plus lamivudine.
    Evaluar el cambio en BMD (Densidad Mineral Ósea) a las 48 semanas de cambio de tratamiento a r/ATV+Lamivudina, mediante DXA (absorciometría RX de doble densidad), en adultos infectados por VIH con T-score < -1.0 de cadera o columna.
    E.2.2Secondary objectives of the trial
    To assess the effects of switching on:
    - Proportion of patients free of virologic failure (confirmed VL? 50 copies/mL) at 48 weeks
    - Adverse effects at 48 weeks
    - Bone turnover markers (BTMs): urinary N-terminal telopeptide of type-1 collagen (NTX), and bone-specific alkaline phosphatase at 48 weeks.
    - (i) Estimated glomerular filtration rate (eGFR) and phosphorus in blood sample; (ii) proximal tubule dysfunction parameters: glucose, protein, albumin, creatinin, phosphorus, beta-2 microglobuline and NAG in urine samples. at week 48 when compared to baseline
    Evaluar los efectos del cambio de terapia sobre:
    - Proporción de pacientes libres de fracaso virológico (CV?50 copias /mL) a las 48 semanas.
    - Acontecimientos adversos a las 48 semanas.
    - Marcadores de recambio óseo (BTMs) a las 48 semanas: telopéptido N-terminal del colágeno (NTX) en orina, y fosfatasa alcalina específica del hueso.
    - En la semana 48 y en comparación con visita basal: (i) Índice de filtración glomerular estimado (eGFR) y fósforo en muestra de sangre; (ii) parámetros de disfunción tubular proximal: glucosa, proteína, creatinina, fósforo, beta-2 microglobulina y NAG (n-acetilglucosaminidasa) en muestras de orina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult (18 years old or more) HIV-1-infected subjects.
    - Hip or spine T-scores between <-1.0 measured and >-2.5 mesured by dual-energy X-ray absorptiometry (DXA) (in the previous 24 weeks).
    - On stable cART based on TDF+3TC or FTC+r/PI for at least 24 weeks.
    - Having plasma HIV-1 RNA <50 copies/mL for at least the previous 24 weeks, including at least two samples.
    - Sujetos adultos infectados por VIH-1 ((18 años o más)
    - T-score de cadera o columna entre < -1.0 y >- 2.5 medido con absorciometría RX de doble energía (DXA) (en las 24 semanas previas).
    - En tratamiento estable antirretroviral basado en TDF+3TC ó FTC+r/PI durante al menos 24 semanas.
    - Con HIV-1 RNA en plasma <50 copias /mL durante al menos las 24 semanas previas, incluyendo al menos dos muestras.
    E.4Principal exclusion criteria
    - Pregnancy, breast-feeding status or plans for pregnancy in the short term.
    - Primary genotypic resistance mutations and/or previous virological failures to ATV or 3TC/FTC.
    - Chronic hepatitis B infection.
    - Patients with indication for therapy for the prevention of bone fractures.
    - 25-OH vitamin D deficiency (< 10ng/mL),
    - Hypogonadism (low total testosterone according to local reference range), untreated.
    - Hypothyroidism (low T4 and increased thyroid stimulating hormone levels according to local reference ranges)
    - Hyperparathyroidism (increased parathyroid hormone level with hypercalcaemia according to local reference ranges).
    - Having received oral corticosteroids or inhaled fluticasone (daily doses higher than 5 mg/d prednisone equivalent for 3 months or more).
    - Using anti-resorptive therapy (Calcium and vitamin D supplements are encouraged but not mandated)
    - BMI lower than 19.
    - Embarazo y lactancia, o previsión de embarazo a corto plazo.
    - Mutaciones de resistencia genotípica primaria y/o fracaso virológico previo a ATV o 3TC/FTC.
    - Infección crónica por hepatitis B.
    - Pacientes con indicación de terapia preventiva de fracturas óseas.
    - Deficiencia de vitamina D 25-OH (<10 ng/mL)
    .- Hipogonadismo no tratado (testosterona total referida al rango de referencia local).
    - Hipotiroidismo (T4 baja i niveles de TSH referida al rango de referencia local).
    - Hiperparatiroidismo (nivel de hormona paratiroidea elevado con hipercalcemia conforme a rangos de referencia locales).
    - Haya recibido costicosteroides orales o fluticasona inhalada (dosis diarias mayores 5 mg/d del equivalente de prednisona durante 3 meses o más).
    - Utilizar terapia antirresortiva ósea (los suplementos con calcio y vitamina D son recomendables pero no obligatorios)
    - IMC menor de 19
    E.5 End points
    E.5.1Primary end point(s)
    Change in BMD by dual-energy X-ray (DXA) absorptiometry at week 48.
    Cambios en densidad mineral ósea mediante absorciometría RX de doble energía (DXA) en la semana 48.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change in BMD by dual-energy X-ray (DXA) absorptiometry at week 48.
    Cambios en densidad mineral ósea mediante absorciometría RX de doble energía (DXA) en la semana 48.
    E.5.2Secondary end point(s)
    - Proportion of patients free of virologic failure (confirmed VL? 50 copies/mL) at 48 weeks
    - Proportion of patients with adverse effects at 48 weeks
    - Changes in bone turnover markers (BTMs): urinary N-terminal telopeptide of type-1 collagen (NTX), and bone-specific alkaline phosphatase at 48 weeks.
    - Changes from baseline to week 48 in: (i) estimated glomerular filtration rate (eGFR) and phosphorus in blood sample; (ii) proximal tubule dysfunction parameters: glucose, protein, albumin, creatinin, phosphorus, beta-2 microglobuline and NAG in urine samples.
    - Proporción de pacientes libres de fracaso virológico (CV?50 copias /mL) a las 48 semanas.
    - Proporción de pacientes con efectos adversos a las 48 semanas
    -Cambios en los marcadores de recambio óseo (BTMs) a las 48 semanas: telopéptido N-terminal del colágeno tipo-1 (NTX) en orina, y fosfatasa alcalina específica del hueso.
    - Cambios entre la visita basal y la semana 48 en: (i) Índice de filtración glomerular estimado (eGFR) y fósforo en muestra de sangre; (ii) parámetros de disfunción tubular proximal: glucosa, proteína, creatinina, fósforo, beta-2 microglobulina y NAG (n-acetilglucosaminidasa) en muestras de orina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Proportion of patients free of virologic failure (confirmed VL? 50 copies/mL) at 48 weeks
    - Proportion of patients with adverse effects at 48 weeks
    - Changes in bone turnover markers (BTMs): urinary N-terminal telopeptide of type-1 collagen (NTX), and bone-specific alkaline phosphatase at 48 weeks.
    - Changes from baseline to week 48 in: (i) estimated glomerular filtration rate (eGFR) and phosphorus in blood sample; (ii) proximal tubule dysfunction parameters: glucose, protein, albumin, creatinin, phosphorus, beta-2 microglobuline and NAG in urine samples.
    - Proporción de pacientes libres de fracaso virológico (CV?50 copias /mL) a las 48 semanas.
    - Proporción de pacientes con efectos adversos a las 48 semanas
    -Cambios en los marcadores de recambio óseo (BTMs) a las 48 semanas: telopéptido N-terminal del colágeno tipo-1 (NTX) en orina, y fosfatasa alcalina específica del hueso.
    - Cambios entre la visita basal y la semana 48 en: (i) Índice de filtración glomerular estimado (eGFR) y fósforo en muestra de sangre; (ii) parámetros de disfunción tubular proximal: glucosa, proteína, creatinina, fósforo, beta-2 microglobulina y NAG (n-acetilglucosaminidasa) en muestras de orina.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days
    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: 45
    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 Yes
    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 state45
    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)
    None
    Ninguno
    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 Decision2014-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-31
    P. End of Trial
    P.End of Trial StatusCompleted
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