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    Summary
    EudraCT Number:2008-000355-94
    Sponsor's Protocol Code Number:A4001075
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-16
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-000355-94
    A.3Full title of the trial
    AN OPEN-LABEL, PARALLEL GROUP, SINGLE AND MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERATION OF MARAVIROC ADMINISTERED TO SUBJECTS WITH VARIOUS DEGREES OF RENAL IMPAIRED AND NORMAL RENAL FUNCTION
    A.4.1Sponsor's protocol code numberA4001075
    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
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc.
    B.1.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name Celsentri
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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.2.1.1.1Trade name Norvir
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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.2.1.1.1Trade name Invirase
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500mg
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10062237
    E.1.2Term Renal impairment
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objectives:
    • Characterize the pharmacokinetics of MVC (150 mg) in the presence of Saquinavir/Ritonavir (SQV/r, a potent CYP3A4 inhibitor) in both healthy subjects and subjects with mild and moderate renal impairment.
    • Characterize the pharmacokinetics of MVC (300 mg) in healthy subjects, subjects with severe renal impairment and those receiving chronic hemodialysis.
    • Calculate the hemodialysis clearance of MVC in subjects with end stage renal disease (ESRD) undergoing hemodialysis.
    E.2.2Secondary objectives of the trial
    Assess the safety and tolerability of MVC in the absence and presence of a potent
    CYP3A4 inhibitor in subjects with various degrees of renal impairment or undergoing
    hemodialysis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects (female subjects must be of non childbearing potential, between the ages of 18 and 85 years, inclusive.
    2. Body Mass Index (BMI) of approximately 18 to 40 kg/m2 inclusive; and a total body weight >50 kg (110 lbs) determined at screening.
    3. Subjects must meet one of the following renal function categories:
    • Normal renal function (CLCR >80 mL/min).
    • Mild renal impairment (CLCR >50 and ≤80 mL/min).
    • Moderate renal impairment (CLCR ≥30 and ≤50 mL/min).
    • Severe renal impairment (CLCR <30 mL/min).
    • End stage renal disease receiving chronic hemodialysis 3 times a week for at least 6 weeks prior to screening.
    4. Stable renal function defined as ≤20% (25% for normal renal function) difference
    between 2 measurements of serum creatinine obtained on 2 occasions separated by at least 2 weeks; the second determination must have been obtained within the 28-day period prior to the start of study medication administration [this definition does not apply to subjects with end stage renal disease receiving chronic hemodialysis].
    5. Subjects in the normal renal function group must be healthy (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests) and not be receiving chronic treatment with any prescription or non-prescription medication.
    6. Willing and able to provide written informed consent and to be confined to the CRU as required by the protocol.
    7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    1. Women who are pregnant or nursing or women of childbearing potential.
    2. Subjects with known contraindications to maraviroc (and/or boosted saquinavir for
    subjects with normal, mild or moderate renal impairment) according to local labeling.
    3. Subjects with recent (within the last 3 months) history of myocardial infarction, unstable angina, coronary revascularization, stroke or TIA.
    4. Subjects with severe heart failure (New York Heart Association Functional Class IV) at screening.
    5. Subjects with acute renal disease.
    6. Subjects with a history of renal transplant. However, subjects with a history of renal transplant who have rejected the organ and are no longer receiving immunosuppressive drugs are eligible for the study provided that the graft has been non-functional for at least one year.
    7. For subjects receiving hemodialysis, subjects who have been hemodynamically unstable during or at the conclusion of dialysis, during the 2 weeks prior to dosing, as marked by symptomatic hypotension.
    8. Subjects with liver disease as assessed by clinical evaluation or subjects with an ALT or AST at Screening that is >2.5 x-upper limit of the reference range (ULRR) or a total bilirubin that is >1.5 x-ULRR at Screening.
    9. Subjects with any prior history of malignancy except for:
    • Basal cell carcinoma of the skin.
    • Squamous cell carcinoma of the skin that has been cancer free for >5 years.
    • Other malignancies (regardless of site) that have been cancer free for >10 years.
    10. Healthy subjects: Use of prescription drugs, vitamins and dietary supplements within seven days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
    11. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen may be used at doses of ≤1 g/day. Other exceptions may be granted by a qualified member of the Pfizer study management.
    12. Renal Impaired subjects: Received any of the following medications/supplements within 7 days or 5 half-lives (whichever was longer) prior to the first dose of study medication or during the study. These medications and supplements are prohibited for the duration of the study.
    • Any drug known to be a potent inhibitor of CYP3A, including erythromycin,
    clarithromycin, telithromycin, systemic azole antifungal therapy (including
    ketoconazole, itraconazole, voriconazole and fluconazole), nefazodone, fluvoxamine.
    • Any immunosuppressive drugs, including cyclosporine, tacrolimus, sirolimus.
    • Any protease inhibitors (with the exemption of boosted saquinavir as scheduled as part of the Study Design).
    • Any potent enzyme-inducing drug, including rifampin, phenytoin, St John’s Wort and
    carbamazepine.
    • Cimetidine, trimethoprim and cibenzoline.
    • Grapefruit juice.
    13. Positive urine (or saliva; for subjects with ESRD) drug screen for drugs of abuse or recreational drugs. Subjects with renal impairment will be eligible to participate if their urine drug screen is positive for a prescribed medication (eg, benzodiazepine, opioid, etc).
    14. History of regular alcohol consumption exceeding 7 drinks/week for women or 14
    drinks/week for men (1 drink = 5 ounces (150 mL) of wine, 12 ounces (360 mL) of beer, or 1.5 ounces (45 mL) of hard liquor) within 6 months of study medication.
    15. Treatment with an investigational drug within 28 days prior to the dose of study
    medication.
    16. Screening 12-lead ECG demonstrating a QTc >480 msec for subjects with renal
    impairment.
    17. Screening 12-lead ECG demonstrating a QTc >450 msec for subjects with normal renal function.
    18. Supine BP at Screening ≥160mm Hg systolic or ≥95mm Hg diastolic, on at least two occasions following at least 10 minutes of rest.
    19. Supine BP at Screening </=80mm Hg systolic or </=40mmg Hg diastolic, on at least two occasions following at least 10 minutes of rest.
    20. Any condition possibly affecting drug absorption, eg, gastrectomy or clinically
    significant diabetic gastroenteropathy.
    21. Donation of blood in excess of 500 mL within 56 days prior to dosing.
    22. History of sensitivity to heparin or heparin-induced thrombocytopenia if heparin was used to flush catheters.
    23. Unwilling to comply with the Life Style guidelines presented in the protocol.
    24. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results, and in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    25. Subjects with urinary incontinence.
    26. Subjects with AIDS/HIV.
    E.5 End points
    E.5.1Primary end point(s)
    AUCtlast/tau and Cmax for all subjects, secondary pharmacokinetic endpoints for MVC will be plasma protein binding, AUCinf, Tmax, and half-life (t1/2), as data permits.
    In addition, renal clearance (CLr) will be determined for subjects with normal, mild,
    moderate, and severe renal function and hemodialysis clearance will be determined for subjects with ESRD on hemodialysis
    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 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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned2
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    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) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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 Decision2008-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-21
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