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    Summary
    EudraCT Number:2004-001778-21
    Sponsor's Protocol Code Number:A4001028
    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:2005-06-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2004-001778-21
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Of A Novel CCR5 Antagonist, UK-427,857, In Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone For The Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Of A Novel CCR5 Antagonist, UK-427,857, In Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone For The Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects
    A.4.1Sponsor's protocol code numberA4001028
    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 SponsorViiV Healthcare UK Limited
    B.1.3.4CountryUnited Kingdom
    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 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.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.3.1Product nameUK,427-857
    D.3.2Product code NA
    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 INNANTIVIRALS FOR SYSTEMIC USE
    D.3.9.2Current sponsor code65,229
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number150
    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.2.1.2Country 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.3.4Pharmaceutical 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 INNProtease inhibitor
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.2.1.2Country 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.3.4Pharmaceutical 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 INNnon-nucleoside reverse transcriptase inhibitors
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number0
    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: 4
    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.2.1.2Country 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.3.4Pharmaceutical 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 INNnucleoside and nucleotide reverse transcriptase inhibitors
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number0
    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: 5
    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.2.1.2Country 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.3.4Pharmaceutical 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 INNEntry inhibitors
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number0
    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 treatment in combination with other agents
    Trattamento dell'HIV-1 in combinazione con altri agenti
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    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
    The primary objective is to confirm the hypothesis that UK-427,857 added to Optimized Background Therapy (OBT) provides an additional reduction in plasma HIV-1 RNA compared to OBT alone, as measured by the difference between each of the two UK-427,857 regimens versus the placebo regimen in the mean changes from baseline in plasma HIV-1 RNA at Week 48. An interim analysis will be performed at Week 24.
    Definire se UK-427,857 somministrato in combinazione con una terapia standard ottomizzata (OBT), produca un ulteriore diminuzione nel livello della carica virale, in confronto alla sola terapia con OBT. La valutazione sara` effettuata, per ognuno dei due dosaggi di UK-427,857 contro placebo, sulle variazioni medie della carica virale alla settimana 48 di trattamento rispetto al basale. E prevista un analisi ad interim alla settimana 24.La sicurezza sara` determinata valutando:-Segni vitali-Test dilab ( in particolare Test di gravidanza, epatite, ematologia, biochimica,enzimi epatici, metabolismo dei grassi, analisi delle urine)-Registrazione di qualsiasi evento avverso e trattamenti concomitanti.
    E.2.2Secondary objectives of the trial
    The secondary objectives include assessments of safety and tolerability of UK-427,857 when added to OBT versus OBT alone.
    -Confr.la % di sogg con livelli di HIV-1 RNA inferiori a 400 copie/mL,per ognuna delle 2 dosi di UK-427,857 alla sett 24 e 48 di tratt verso placebo-Confr.la % di sogg con livelli di HIV-1 RNA inferiori a 50 copie/mL per ognuna delle 2 dosi di UK-427,857 alla sett 24 e 48 di tratt verso placebo-Confr.la % di sogg che raggiungono almeno una riduz di 0.5 log10 in copie di HIV-1 RNA per ognuna delle 2 dosi di UK-427,857 verso placebo alla sett 24 e 48 di tratt rispetto al basale.- Confr.la % di sogg che raggiungono almeno una riduz di 1 log10 nei livelli di HIV-1 RNA per ognuna delle 2 dosi di UK-427,857 alla sett 24 e 48 di tratt rispetto al basale,verso placebo.-Det.il tempo per il raggiungim di perdita di risp virologica per ognuna delle 2 dosi di UK-427,857 durante le 48 sett di tratt verso placebo.-Confr.il cambiamento nella conta delle cellule CD4 e CD8 dal basale alle sett 24,48 di tratt per ognuna delle 2 dosi di UK-427,857 verso placebo.-etc
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide a signed and dated written informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. 2. Men or women at least 16 years of age (or minimum age as determined by local regulatory authorities or as legal requirements dictate) available for a follow-up period of at least 48 weeks. 3. HIV-1 RNA viral load of ≥5,000 copies/mL measured by Roche Amplicor HIV-1 Monitor (version 1.5) at the screening visit. 4. Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least 4 weeks. 5. Documented genotypic (http://iasusa.org/resistance_mutations/index.html as determined by the Monogram Bioscience (formerly Virologic) GeneSeq HIV drug resistance assay) or phenotypic (fold change of patient’s virus ≥ cutoff value based on Monogram Bioscience PhenoSense HIV drug resistance assay) resistance to 3 of the 4 antiretroviral drug classes [Nucleoside or nucleotide reverse transcriptase inhibitors (nRTIs), Non-nucleoside reverse transcriptase inhibitors (NNRTIs), Protease Inhibitors (PIs) or Entry Inhibitors (EIs)] OR Antiretroviral-class experience ≥6 months (sequential or cumulative) with at least three of the following: a. One nucleoside or nucleotide reverse transcriptase inhibitor b. One non-nucleoside reverse transcriptase inhibitor c. Two protease inhibitors (excluding low-dose ritonavir) d. Enfuvirtide 6. Be willing to initiate and remain on randomized treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure. 7. A negative urine pregnancy test at the baseline visit, prior to receiving the first dose of study medication, for Women of Child Bearing Potential (WOCBP). NOTE: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization or is not post-menopausal (ie, no menstrual periods for at least 2 years). Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products (intrauterine devices; barrier methods: eg, condom or diaphragm with spermicide) to prevent pregnancy, who are practicing abstinence, or who have a partner that is sterile (eg, vasectomy), should be considered to be of child bearing potential. 8. Effective barrier contraception for WOCBP and males. In addition, WOCBP must use another acceptable method of contraception for the duration of the study. Acceptable contraception includes, but is not limited to, oral, implanted or injectable hormone therapy and intrauterine devices.
    NA
    E.4Principal exclusion criteria
    1. Patients requiring treatment with more than 6 antiretroviral agents (excluding low-dose ritonavir). 2. Prior treatment with UK-427,857 or another experimental HIV entry inhibitor for more than 14 days. 3. Active alcohol or substance abuse sufficient, in the Investigator’s judgment, to prevent adherence to study medication and/or follow-up. 4. Lactating women, or planned pregnancy during the trial period. 5. Suspected or documented active, untreated HIV-1 related opportunistic infection (OI) or other condition requiring acute therapy (eg, hepatitis C virus infection) at the time of randomization [patients on a stable (>1 month) secondary OI prophylaxis regimen or chronic treatment (eg, for hepatitis C virus infection) are eligible for the study; patients on a primary OI prophylaxis regimen of any duration are also eligible for the study]. 6. Treatment for an active opportunistic infection, or unexplained temperature >38.5°C for 7 consecutive days, within 30 days prior to randomization. 7. Malignancy requiring parenteral chemotherapy that must be continued for the duration of the trial. 8. Initiating therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or cytotoxic agent within 60 days prior to randomization, or the expected need for such therapy during the study period. NOTE: Timethoprim-sulfamethoxaole may not be initiated 60 days prior to randomization but may be continued if the subject is on stable therapy. The use of isoniazid is prohibited. 9. Documented or suspected acute hepatitis or pancreatitis within 30 days prior to randomization. 10. Renal insufficiency defined as a serum creatinine greater than 3 times the upper limit of normal. 11. Total bilirubin, greater than 2.5 times the upper limit of normal (unless unconjugated hyperbilirubinemia due to atazanavir or indinavir). Changes of one or more grades in total bilirubin between screening and the randomization visit should be reviewed with the Pfizer medical monitor before the initiation of double-blind study medication. 12. AST or ALT greater than 5 times the upper limit of normal. Changes in one or more grades in AST or ALT between screening and the randomization visit should be reviewed with the Pfizer medical monitor before the initiation of double-blind study medication. 13. Cirrhosis of the liver. 14. Absolute neutrophil count ≤750 cells/mm3. 15. Platelet count ≤50,000 cells/mm3. 16. Hemoglobin ≤7 g/dL. 17. Clinically significant malabsorption syndrome (eg, ≥6 loose stools per day for at least 7 consecutive days) within 30 days prior to randomization. 18. Inability to tolerate oral medication. 19. X4-or dual/mixed-tropic virus detected by the PhenoSense™ viral entry assay or repeated assay failure. 20. Concomitant therapy with other investigational agents (other than experimental antiretroviral agents available through pre-approval access programs). 21. Contraindicated medications (eg, immunomodulators for the treatment of HIV-1 infection; interferon for the ongoing treatment of hepatitis C infection is permitted) being taken by the subject at the time of randomization that must be continued during the study period (See Section 5.5). 22. Any safety, behavioral, clinical, or administrative reasons that, in the Investigator’s judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
    NA
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to 48 weeks in HIV-1 RNA measured on a logarithmic [base 10] scale. An interim analysis will be performed at Week 24.
    -Variazione dal basale alla settimana 48 di trattamento dell'RNA di HIV-1 misurata su scala logaritmica di base 10.Alla settimana 24 sara' effettuata un analisi ad interim -% dei pazienti con meno di 50/400 copie di HIV-1 RNA per millilitro di plasma-Tempo di diminuzione della risposta virologica-Variazioni nella conta di CD4 e CD8- Cambiamenti nel genotipo, fenotipo e tropismo negli insuccessi terapeutici- % di pazienti con patologia che definisce l'AIDS
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial3
    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 concerned20
    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 Yes
    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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    pazienti HIV-1 positivi
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 500
    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 Decision2005-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-04-19
    The status of studies in GB is no longer updated from 1.1.2021
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