Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 4:20 PM
Study NCT ID:
NCT00634959
Status:
COMPLETED
Last Update Posted:
2010-11-10
First Post:
2008-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077592', 'term': 'Maraviroc'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-09', 'studyFirstSubmitDate': '2008-03-05', 'studyFirstSubmitQcDate': '2008-03-05', 'lastUpdatePostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in viral load', 'timeFrame': 'Day 11'}, {'measure': 'UK-427,857 pharmacokinetics', 'timeFrame': 'Days 1-11'}], 'secondaryOutcomes': [{'measure': 'Physical examination', 'timeFrame': 'Days 1, 11, 40'}, {'measure': '12-lead ECG', 'timeFrame': 'Days 1-11 and Day 40'}, {'measure': 'Relationship of change in viral load (baseline to Day 11) versus mean receptor saturation (Day 10)', 'timeFrame': 'Days 1-11'}, {'measure': 'Time course of viral load from baseline to follow-up', 'timeFrame': 'Days 1-13 and Days 15, 19, 22, 25, 40'}, {'measure': 'CCR5 receptor saturation', 'timeFrame': 'Days 1, 5, 10, 11, 13, 15, 19, 40'}, {'measure': 'Adverse events', 'timeFrame': 'Days 1-40'}, {'measure': 'Relationship of change in viral load (baseline to Day 11) versus baseline susceptibility (IC50 and IC90)', 'timeFrame': 'Days 1-11'}, {'measure': 'Laboratory safety', 'timeFrame': 'Days 1, 3, 7, 11, 15, 40'}, {'measure': 'Relationship of change in viral load (baseline to Day 11) versus average and trough plasma concentrations (Day 10)', 'timeFrame': 'Days 1-11'}, {'measure': 'Supine/standing blood pressure and pulse rate', 'timeFrame': 'Days 1-11 and Day 40'}, {'measure': 'Time to rebound of viral load', 'timeFrame': 'Days 1-13 and Days 15, 19, 22, 25, 40'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV Infections', 'Treatment Naïve'], 'conditions': ['HIV']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001015&StudyName=Effects%20Of%20Food%20And%20Dose%20Regimen%20On%20The%20Antiviral%20Effects%20Of%20Maraviroc%20%28UK-427%2C857%29%20In%20Patients%20With%20Human%20Immunodeficiency%20Virus', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) in patients with human immunodeficiency virus (HIV)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asymptomatic HIV-1 infected male and female patients\n* Weight between 50 and 100kg and within the permitted range for their height\n* Patients with virus that targets CCR5 receptor\n\nExclusion Criteria:\n\n* Patients with a CD4 count \\<250 cells/mm3 or HIV viral load \\<5000 copies/mL\n* Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion\n* Patients with acquired immunodeficiency syndrome (AIDS) or a previous AIDS diagnosis\n* Patients who are taking or have taken antiretroviral drugs in the eight weeks prior to the study screening visit'}, 'identificationModule': {'nctId': 'NCT00634959', 'briefTitle': 'Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'An Investigation Into The Effects Of Food And Dose Regimen On Viral Load Response In HIV Infected Patients On Short-Term Monotherapy With UK-427,857 (Maraviroc)', 'orgStudyIdInfo': {'id': 'A4001015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Maraviroc (UK-427,857)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Maraviroc (UK-427,857)']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: Maraviroc (UK-427,857)']}, {'type': 'EXPERIMENTAL', 'label': '4', 'interventionNames': ['Drug: Maraviroc (UK-427,857)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '5', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Maraviroc (UK-427,857)', 'type': 'DRUG', 'otherNames': ['Celsentri, Selzentry'], 'description': '150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)', 'armGroupLabels': ['1']}, {'name': 'Maraviroc (UK-427,857)', 'type': 'DRUG', 'otherNames': ['Celsentri, Selzentry'], 'description': '100 mg oral tablet once daily while fasted on Days 1-10', 'armGroupLabels': ['2']}, {'name': 'Maraviroc (UK-427,857)', 'type': 'DRUG', 'otherNames': ['Celsentri, Selzentry'], 'description': '300 mg oral tablet once daily while fasted on Days 1-10', 'armGroupLabels': ['3']}, {'name': 'Maraviroc (UK-427,857)', 'type': 'DRUG', 'otherNames': ['Celsentri, Selzentry'], 'description': '150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only)', 'armGroupLabels': ['4']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Matching placebo oral tablet on Days 1-10 (fed and fasted)', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-2050', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '50931', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '60596', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}