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   39185   clinical trials with a EudraCT protocol, of which   6421   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:2008-006873-33
    Sponsor's Protocol Code Number:A4001031
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-01-22
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2008-006873-33
    A.3Full title of the trial
    AN OPEN-LABEL, MULTICENTER, MULTIPLE-DOSE PHARMACOKINETIC AND 48-WEEK SAFETY AND EFFICACY TRIAL OF MARAVIROC IN COMBINATION WITH OPTIMIZED BACKGROUND THERAPY FOR THE TREATMENT OF ANTIRETROVIRAL-EXPERIENCED CCR5-TROPIC HIV-1 INFECTED CHILDREN 2-18 YEARS OF AGE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of safety and efficacy of maraviroc in children aged from 2-18 years of age infected with HIV
    A.4.1Sponsor's protocol code numberA4001031
    A.5.4Other Identifiers
    Name:GSK codeNumber:MVC115367
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/109/2008
    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 supportViiV Healthcare UK Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationViiV Healthcare UK Limited
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address980 Great West Road
    B.5.3.2Town/ cityBrentford, Middlesex
    B.5.3.3Post codeTW8 9GS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+440208380623
    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 nameMaraviroc
    D.3.2Product code UK-427,857
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INN4,4-difluoro-N-{(1S)-3-[3-(3-isopropyl- 5-methyl-4H-1,2,4-triazol-4-yl)- 8-azabicyclo[3.2.1]oct-8-yl]-1- phenylpropyl}cyclohexanecarboxamide
    D.3.9.1CAS number 376348-65-1
    D.3.9.2Current sponsor codeUK427,857
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 nameMaraviroc
    D.3.2Product code UK-427,857
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INN4,4-difluoro-N-{(1S)-3-[3-(3-isopropyl- 5-methyl-4H-1,2,4-triazol-4-yl)- 8-azabicyclo[3.2.1]oct-8-yl]-1- phenylpropyl}cyclohexanecarboxamide
    D.3.9.1CAS number 376348-65-1
    D.3.9.2Current sponsor codeUK427,857
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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 nameMaraviroc
    D.3.2Product code UK-427,857
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INN4,4-difluoro-N-{(1S)-3-[3-(3-isopropyl- 5-methyl-4H-1,2,4-triazol-4-yl)- 8-azabicyclo[3.2.1]oct-8-yl]-1- phenylpropyl}cyclohexanecarboxamide
    D.3.9.1CAS number 376348-65-1
    D.3.9.2Current sponsor codeUK427,857
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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: 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 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 nameMaraviroc
    D.3.2Product code UK-427,857
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    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 INN4,4-difluoro-N-{(1S)-3-[3-(3-isopropyl- 5-methyl-4H-1,2,4-triazol-4-yl)- 8-azabicyclo[3.2.1]oct-8-yl]-1- phenylpropyl}cyclohexanecarboxamide
    D.3.9.1CAS number 376348-65-1
    D.3.9.2Current sponsor codeUK427,857
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Treatment
    E.1.1.1Medical condition in easily understood language
    HIV
    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 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
     To determine the pharmacokinetic profile(s) and dosing schedule(s) for maraviroc in treatment experienced HIV-1 infected children and adolescents on different background therapies;
     To determine the safety and tolerability of maraviroc in HIV-1 infected children and adolescents.
    E.2.2Secondary objectives of the trial
     Describe the efficacy of multiple dose administration of maraviroc in treatment experienced children infected with CCR5 tropic HIV-1;
     Describe tropism changes over time.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment
    into the study:
    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 study;
    2. Subjects 2-18 years of age available for follow-up period of at least 48 weeks;
    3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
    4. HIV-1 RNA ≥1,000 copies/mL measured by Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test;
    5. Stable pre-study ARV regimen for at least 4 weeks prior to Screening Visit or no pre-study ARV regimen for at least 4 weeks prior to Screening Visit:
     If already receiving ARV therapy prior to Screening Visit, component ARV drugs must not be changed in the prior 4-week period. However, change in dose (for weight gain) or change in formulation of ARV drug is allowed. Subjects will be required to remain on their existing regimen during the Screening period.
     Subjects with unchanged ARV regimen for at least 4 weeks prior to Screening and experiencing virologic failure (defined as plasma HIV-1 RNA ≥1,000 copies/mL).
    6. Experience/intolerance 6 months (sequential or cumulative) with at least 2 ARV drug classes;
    7. Willing to remain on treatment without any changes or additions to OBT regimen, except for toxicity management or upon meeting criteria for virologic failure;
    8. ****For Women of Child Bearing Potential (WOCBP), a negative urine pregnancy test at the Baseline Visit. Serum pregnancy tests may be performed in lieu of urine pregnancy tests where mandated.
    NOTE: WOCBP include any female who has experienced menarche. 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.****
    9. ****Effective barrier contraception for sexually active WOCBP and males. In addition, sexually active WOCBP must use another acceptable method of contraception for the duration of the study and up to 28 days following the last maraviroc dose. Acceptable contraception includes, but is not limited to, oral, implanted or injectable hormone therapy and intrauterine devices. Complete abstinence may be considered acceptable in some cases. The investigator may discuss the forms of contraception (including abstinence) with subject and/or guardian.****
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Subjects requiring treatment with more than 5 ARV agents in OBT regimen (low dose ritonavir is not considered a separate ARV agent);
    2. Prior treatment with maraviroc, another CCR5 antagonist or another experimental HIV entry inhibitor for more than 14 days;
    3. History of poor adherence with medication, active alcohol or substance abuse sufficient to prevent adherence to study medication and/or Follow-Up;
    4. Current systemic chemotherapy or history of malignancy;
    5. Lactating women or planned pregnancy during the trial period;
    6. Suspected or documented active, untreated HIV-1 related opportunistic infection or other condition requiring acute therapy (eg, Hepatitis C virus infection) at Baseline Visit;
    NOTE: Subjects on stable (>1 month) secondary OI prophylaxis regimen or chronic treatment (eg, Hepatitis C) are eligible for the study. Subjects on primary OI prophylaxis regimen of any duration are also eligible for the study;
    7. Treatment for an active opportunistic infection, or unexplained T>38.5°C for 7 consecutive days, within 30 days prior to Baseline Visit;
    8. Known hypersensitivity or history of allergy to any component of maraviroc, including soy lecithin or peanuts;
    9. Initiating therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or cytotoxic agent within 60 days prior to Baseline, or the expected need for such therapy during the study period;
    10. Documented or suspected acute hepatitis or pancreatitis within 30 days prior to Baseline Visit;
    11. Known ≥Grade 3 of any of the following laboratory tests at Screening or within 30 days prior to Baseline Visit:
     Neutrophil count, hemoglobin, platelets, AST, ALT, and creatinine, lipase; NOTE: Subjects with a change of two or more grades in AST or ALT between Screening and Baseline Visits must be reviewed by Pfizer.
     Total bilirubin ≥ Grade 3, unless ALL of the following are true:
     Current regimen includes atazanavir;
     ALT/AST ≤ 2.5 X ULN;
     No symptoms other than jaundice or icterus.
    NOTE: Subjects with a change of two or more grades in direct bilirubin between Screening and Baseline Visits must be reviewed by Pfizer.
     Other laboratory values ≥ Grade 3, must be reviewed by Pfizer.
    12. History of lactic acidosis within the 3 months prior to Screening. Lactic acidosis defined as:
     Either confirmed lactate ≥2 X ULN in subjects with ALT and AST values >2.5 X ULN without easily discernable etiology (eg, acute Hepatitis A, B, C or chronic Hepatitis B or C); OR
     New and persistent, otherwise unexplained nausea, vomiting, abdominal pain,
    abdominal distention, unexplained fatigue, and dyspnea.
    13. Cirrhosis of the liver;
    14. ****Abnormal renal function (creatinine clearance less than 90 mL/min as calculated based on local standards);
    15. Clinically significant malabsorption syndrome (>6 loose stools per day, for at least 7 consecutive days) within 30 days prior to Baseline;
    16. X4- or dual/mixed-tropic virus detected by the TrofileTM viral tropism assay or repeated assay failure;
    17. Concomitant therapy with other investigational agents (other than experimental
    ARV agents available through pre-approval access programs);
    18. Contraindicated medications that must be continued during the study period;
    19. 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;
    20. Use of gastrostomy tube for administration of maraviroc. (Other medications may be given through the gastrostomy tube).
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetics: Maraviroc PK parameter, average concentration (Cavg);

    Safety: Adverse events ≥Grade 3, Treatment discontinuation secondary to SAEs
    related to study drug.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24weeks, 48 weeks
    E.5.2Secondary end point(s)
    •Change from Baseline in log10 transformed HIV-1 RNA levels. This analysis will occur after all enrolled subjects have reached the end of 48 weeks or discontinued prior to reaching 48 weeks. This efficacy variable will also be analyzed at 24 weeks;
    •Percentage of subjects with HIV-1 RNA levels <400 copies/mL;
    •Percentage of subjects with HIV-1 RNA levels <48 copies/mL;
    •Percentage of subjects with at least a 1.0 log10 reduction in HIV-1 RNA from Baseline to 24 and 48 weeks;
    •Change from Baseline in CD4+ cell count;
    •Time to loss of virologic response (TLOVR);
    •Virus susceptibility (genotype and phenotype) at Screening and at the time of failure;
    •Virus tropism at Screening and at time of failure;
    •Association between Screening susceptibility and virological response.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24weeks, 48 weeks
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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 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 Information not present in EudraCT
    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 concerned4
    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
    Brazil
    Italy
    Portugal
    Puerto Rico
    South Africa
    Spain
    Thailand
    United States
    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
    LVLS.
    Study drug will be provided for subjects who benefit from maraviroc until:
    - An expanded access program replaces this protocol.
    - Maraviroc obtains appropriate regulatory approval for use in a pediatric population or is otherwise available.
    - The subject reaches the age of 18 years
    - The sponsor withdraws development of maraviroc in the pediatric population.
    - The physician/investigator decides that the subject is no longer benefitting from such maraviroc treatment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years16
    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 years16
    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 Yes
    F.1.1Number of subjects for this age range: 103
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 43
    F.1.2Adults (18-64 years) No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 103
    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)
    .
    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 Decision2009-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-06
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA