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    Summary
    EudraCT Number:2015-001206-33
    Sponsor's Protocol Code Number:1-28/08/2014
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-27
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-001206-33
    A.3Full title of the trial
    A pilot phase II study of a nucleoside sparing regimen of Dolutegravir + Atazanavir/r in HIV-1 infected patients with detectable viremia (Dolatav Study)
    A pilot phase II study of a nucleoside sparing regimen of Dolutegravir + Atazanavir/r in HIV-1 infected patients with detectable viremia (Dolatav Study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pilot phase II study of a nucleoside sparing regimen of Dolutegravir + Atazanavir/r in HIV-1 infected patients with detectable viremia (Dolatav Study)
    Studio pilota, in aperto, sull'efficacia di un regime non contenente farmaci nucleosidici, con atazanavir/ritonavir associato a dolutegravir in pazienti con carica virale positiva (Studio Dolatav)
    A.3.2Name or abbreviated title of the trial where available
    DALATAV Study
    DOLATAV
    A.4.1Sponsor's protocol code number1-28/08/2014
    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 SponsorOSPEDALE SAN RAFFAELE
    B.1.3.4CountryItaly
    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 supportBristol-Myers Squibb S.r.l
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Ospedale San Raffaele
    B.5.2Functional name of contact pointMalattie Infettive
    B.5.3 Address:
    B.5.3.1Street AddressVia Stamira d'Ancona 20
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20127
    B.5.3.4CountryItaly
    B.5.4Telephone number0226437939
    B.5.5Fax number0226437030
    B.5.6E-maillazzarin.adriano@hsr.it
    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 REYATAZ - 300 MG CAPSULE RIGIDE - USO ORALE-FLACONE (POLIETILENE AD ALTA DENSITA') 30 CAPSULE
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB PHARMA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 300 mg
    D.3.2Product code A71IL
    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 INN00033201
    D.3.9.1CAS number 198904-31-3
    D.3.9.2Current sponsor code036196083/E
    D.3.9.3Other descriptive nameatazanavir sulfate
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeantiretrovirale
    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 - 100 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE(HDPE) 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderABBVIE LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 100 mg
    D.3.4Pharmaceutical form Film-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 INN00250700
    D.3.9.1CAS number 155213-67-5
    D.3.9.2Current sponsor code030081057/E
    D.3.9.3Other descriptive nameritonavir
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeantiretrovirale
    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 TIVICAY - 50 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderVIIV HEALTHCARE UK LTD
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTivicay
    D.3.4Pharmaceutical form Film-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 INN00330300
    D.3.9.1CAS number 1051375-16-6
    D.3.9.2Current sponsor codeJ05AX12
    D.3.9.3Other descriptive namedolutegravir
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 4
    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 - 200 MG 60 CAPSULE IN BLISTER USO ORALE
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB PHARMA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 200 mg
    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 INN00033201
    D.3.9.2Current sponsor code22997597
    D.3.9.3Other descriptive nameatazanavir sulfate
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 infected patients
    pazienti affetti da virus HIV-1
    E.1.1.1Medical condition in easily understood language
    pazienti affetti da infezione da HIV-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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10008922
    E.1.2Term Chronic infection with HIV
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the 24-week efficacy of a nucleos(t)ide sparing regimen of atazanavir 300 mg QD/ ritonavir 100 mg QD + Dolutegravir 50 mg QD for the management of virologic failure in HIV-1 infected, integrase inhibitor-na¿ve subjects.
    obiettivo primario dello studio ¿ esplorare in pazienti con infezione da HIV in fallimento virologico l'efficacia a 24 settimane di un regime di combinazione non contenente nucleosidici, con atazanavir 300mg/ritonavir 100 mg (ATV/r) e dolutegravir 50 mg QD
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety profile of DTG + ATV/r combination
    2. To evaluate the 4-week efficacy of DTG+ATV/r and the time to achieve undetectability
    3. To evaluate the immunological changes from baseline.
    4. To evaluate the Cthrough of DTG and ATV at day 8 and at week 4, 8, 12, 16, 24 or at discontinuation
    5. To detect potential risk factors related with the virological failure, including adherence and ATV and DTG concentrations
    6. To describe genotypic resistance mutations for protease inhibitor and integrase inhibitors in isolates from patients with virological failure
    Gli obiettivi secondari dello studio saranno: indagare il profilo di sicurezza della combinazione DTG + ATV/r (valutato in base all'incidenza ed alla severit¿ degli eventi avversi e delle alterazioni dei parametri laboratoristici), valutare il recupero immunologico durante il trattamento, descrivere la farmacocinetica di DTG e ATV, identificare i fattori di rischio correlati con l'eventuale fallimento del trattamento in studio e descrivere le mutazioni di farmacoresistenza secondarie al fallimento stesso.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects with age >18 years
    • Willing and able to provide informed consent
    • Failing a stable (at least 3 months) antiretroviral therapy (HIV-RNA > 200 copies/ml)
    • Any CD4 cell count
    • HBsAg non reactive
    • Virus susceptible to atazanavir, defined as a genotypic mutation score < 15 according to the HIV drug resistance database (Stanford University)
    • No previous exposure to integrase inhibitors
    • Absolute neutrophil count (ANC) ¿500/mm3
    • Haemoglobin¿8.0 g/dL
    • Platelet count¿60,000/mm3
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ¿ 5 ¿ ULN
    • Total bilirubin ¿ 2.5 x ULN
    • e-GFR> 60 ml/min using CKD-EPI equation
    Pazienti adulti, in fallimento virologico con l’attuale terapia antiretrovirale stabile da almeno 3 mesi (carica virale > 200 copie m/L )
    Nessuna precedente esposizione agli inibitori dell’integrasi.
    Qualsiasi conta dei linfociti CD4
    HbsAg negativi
    Virus sensibile ad atazanavir secondo il metodo della Stanford University
    E.4Principal exclusion criteria
    • Active AIDS-defining condition at Screening
    • Serious illness requiring systemic treatment and/or hospitalization
    • Current use of immunomodulant or immunosuppressive drugs
    • Requirement for any concomitant medications that are prohibited with any study drugs (see protocol section 3.6)
    • History or presence of hypersensitivity to any of the active substances or to the excipients
    • Alanine aminotransferase (ALT) more than 5 times the upper limit of normal (ULN), OR ALT more than 3xULN and bilirubin more than 1.5xULN (with >35% direct bilirubin)
    • Subjects positive for Hepatitis B at screening (HBsAg+)
    • Subjects with anticipated need for Hepatitis C virus (HCV) therapy during the study
    • Presence of moderate or severe hepatic impairment (defined as a Class B or C at Child Pugh Classification; appendix 7) or presence of unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice) or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    • Pregnancy or pregnancy wish; breastfeeding

    Moreover, all clinical conditions reported as an absolute contraindication in the summary of product characteristics of the study drugs, will be considered as exclusion criteria.
    - Donne in gravidanza o allattamento
    - AIDS defining events allo screening o SAE in corso di screening
    - Insufficienza epatica da moderata a grave (Classe B o C alla classificazione Child Pugh) e scompenso epatico
    - Con necessità di trattamento per epatite C
    - Uso di farmaci controindicati dallo studio (vedi sez.3.6 del protocollo)
    - Ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti per tutti i medicinali in studio.
    E.5 End points
    E.5.1Primary end point(s)
    • The proportion of patients with undetectable HIV RNA viral load ( < 50 copies/ml) at week 24.
    Proporzione di pazienti con viremia non rilevabile (intesa come carica virale < 50 copie m/L) alla settimana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 24
    settimana 24
    E.5.2Secondary end point(s)
    ¿ Proportion of patients with undetectable HIV RNA viral load (< 50 copies/ml) at Week 4.
    ¿ Change from baseline in CD4+ cell count.
    ¿ Time to achieve undetectability
    ¿ Occurrence of genotypic resistance mutations for protease inhibitor and integrase inhibitors in isolates from patients with virological failure
    ¿ Atazanavir and dolutegravir Cthrough
    ¿ Proportion of patients with adverse events (any grade), proportion of patients with = grade 2 adverse events or abnormal laboratory tests, proportion of patients with side effects leading to discontinuation; reasons for treatment discontinuation (e.g. due to AE/Loss of viral control/Death/Patient decision).
    ¿ changes in lipid (total TG, total COL, HDL-col, LDL-col, total COL/HDL ratio), clearance creatinine (using CKD-EPI equation) and glycemic profile changes from baseline.
    ¿ Changes of ECG parameters
    ¿ Adherence changes since the first evaluation
    1 Efficacia e sicurezza; proporzione di pazienti con viremia non rilevabile alla settimana 4. 2 Variazione del numero di cellule CD4 rispetto al basale. 3 Presenza di mutazioni genotipiche (test genotipico) in campioni di plasma e di resistenza fenotipica (test fenotipici) per inibitori della proteasi e della integrasi nei pazienti in fallimento virologico. Percentuale dei pazienti con grado 2, di eventi avversi o anormalit¿ di laboratorio, proporzione di pazienti con effetti collaterali che hanno portato alla sospensione , cambiamenti dei lipidi rispetto al basale (TG totale, COLt totale, HDL-col, LDL-col, totale COL/HDL). Atazanavir e dolutegravir Ctrought. 8. Modifiche riguardo l¿ aderenza rispetto alla week 4, 12 e 24. 9.Modifiche dell¿ECG rispetto alla baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All the secondary endpoints will be evaluated at each timepoint of the corresponding data collection, unless otherwise specified.
    tutti gli end points secondari verranno rilevati ad ogni momento previsto per la raccolta del dato
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.7.1Other trial design description
    pilota a singolo braccio
    a pilot single arm study
    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.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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 months13
    E.8.9.1In the Member State concerned days39
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months13
    E.8.9.2In all countries concerned by the trial days39
    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: 10
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    After the conclusion of the study, patients will be followed as per standard of care (HIV infection)
    dopo la conclusione dello studio i pazienti verranno seguiti secondo lo standard of care previsto per la cura della patologia infezione da HIV
    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 Decision2015-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-01
    P. End of Trial
    P.End of Trial StatusCompleted
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