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    Summary
    EudraCT Number:2009-014694-40
    Sponsor's Protocol Code Number:SSAT033
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-014694-40
    A.3Full title of the trial
    A pilot evaluation of the pharmacokinetics, efficacy and safety of switching from efavirenz to maraviroc administered at 600mg then 300mg twice-daily in patients suppressed on an efavirenz-containing regimen as initial therapy
    A.3.2Name or abbreviated title of the trial where available
    Pharmacokinetics of switching from efavirenz to maraviroc
    A.4.1Sponsor's protocol code numberSSAT033
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    D. IMP Identification
    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
    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 pharmacokinetics (how a drug is absorbed, distributed and eliminated from the body) of maraviroc given at 600mg twice-daily for 2 weeks to male and female HIV-1 infected patients who have achieved viral suppression on an efavirenz-based therapy followed by 2 weeks of maraviroc 300mg twice-daily.
    E.2.2Secondary objectives of the trial
    To assess the maintenance of the viral suppression and the rise in CD4 (marker of immune system) when switching efavirenz to maraviroc.

    To assess the safety and tolerability of switching from efavirenz to maraviroc.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogentic Blood DNA Sample Sub-Study - Version 1.0 4th April 2009.

    Objectives:
    To investigate the link between genetic differences in DNA sequence in how genes react to drugs and drug exposure.
    E.3Principal inclusion criteria
    1. The ability to understand and sign a written informed consent form, prior to participation in any screening procedure and must be willing to comply with all study requirements.
    2. Males or non-pregnant, non-lactating females.
    3. Between 18 to 65 years, inclusive.
    4. Documented HIV-1 infection of at least 6 months duration.
    5. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.
    6. CD4 count > 50 cells/mm3 at screening (Note retesting of screening CD4 count is allowed).
    7. Receiving a first-line antiretroviral regimen including two NRTI with efavirenz, without any history of virological failure and agrees to remain on this regimen unless change is clinically indicated (history of drug switches is allowed only if the reason was tolerability/toxicity/convenience of dosing).
    8. Viral load <50 copies/ml at screening and for at least 12 weeks prior to screening visit (Note retesting of screening viral load is allowed).
    9. R5-tropic virus as determined by genotypic assay performed at screening visit.
    10. No medical, psychiatric or substance misuse disorders felt by the investigator to impact on the subject’s ability to participate in the study.
    E.4Principal exclusion criteria
    1. Dual, mixed or X4-tropic virus on geno2pheno tropism sample
    2. HIV-2 co-infection
    3. Any prior CCR5 antagonists
    4. Any genotypic resistance to NNRTI or backbone NRTI on screening or prior tests (or likely from treatment history)
    5. Disallowed concomitant medication as per the SPC for Truvada, Kivexa or Celsentri (see section 5.1.1)
    6. Any medical condition or psychiatric illness that may, in the opinion of the investigator, affect patient safety or the integrity of the results
    7. ALT or AST elevation greater than five times the upper limit of normal
    8. Estimated GFR (MDRD) less than 50ml/min
    9. Hepatitis B or C co-infection (defined as positive hepatitis B surface antigen or detectable hepatitis C RNA; hepatitis C antibody positive individuals with undetectable RNA will be eligible for inclusion)
    E.5 End points
    E.5.1Primary end point(s)
    Steady state plasma concentrations of maraviroc dosed at 600mg BID for 2 weeks followed by 300mg BID thereafter following cessation of efavirenz 600mg OD.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    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) Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    Completion of all trial procedures by participants (e.g. last follow-up visit)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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)
    At the end of the research study the participant will be switched back to their original combination or switch to another combination if they and their clinic doctor prefer. The participant will continue to take HIV drugs, they will be required to attend a follow up visit 30 days after their last dose of study medication to check how they are.
    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 Decision2009-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-20
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