Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-31 @ 2:25 AM
Study NCT ID:
NCT00925535
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2009-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'C531151', 'term': 'UK 453,061'}, {'id': 'D017828', 'term': 'Rifabutin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'dispFirstSubmitDate': '2010-09-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-17', 'studyFirstSubmitDate': '2009-06-19', 'dispFirstSubmitQcDate': '2010-09-02', 'studyFirstSubmitQcDate': '2009-06-19', 'dispFirstPostDateStruct': {'date': '2010-09-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lersivirine plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h', 'timeFrame': '20 days'}, {'measure': 'Rifabutin and 25-O-desacetyl-rifabutin plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h', 'timeFrame': '20 days'}], 'secondaryOutcomes': [{'measure': 'Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12 lead ECG and laboratory safety assessments', 'timeFrame': '58 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics HIV Tuberculosis Lersivirine UK-453', '061 Rifabutin', 'HIV Infections'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5271043&StudyName=Drug%20Interaction%20Study%20Between%20Rifabutin%20And%20Lersivirine%20%28UK-453%2C061%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Approximately 1/3 of persons living with HIV infection are co-infected with tuberculosis (TB). Rifabutin, used in the treatment of TB, is an inducer of drug metabolism thus may decrease concentrations of lersivirine if co-administered. Lersivirine is a modest inducer of drug metabolism, thus lersivirine may decrease concentrations of rifabutin as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lbs).\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.\n* History of regular alcohol consumption exceeding 7 drinks/week for women and 14 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor).\n* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.\n* Hypersensitivity/allergic reactions to any component of the study drugs.'}, 'identificationModule': {'nctId': 'NCT00925535', 'briefTitle': 'Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Rifabutin And Lersivirine (UK-453,061) In Healthy Subjects', 'orgStudyIdInfo': {'id': 'A5271043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment A', 'description': 'Lersivirine', 'interventionNames': ['Drug: Lersivirine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment B', 'description': 'Rifabutin', 'interventionNames': ['Drug: Rifabutin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': 'Lersivirine and Rifabutin', 'interventionNames': ['Drug: Lersivirine', 'Drug: Rifabutin']}], 'interventions': [{'name': 'Lersivirine', 'type': 'DRUG', 'description': '1000 mg once daily for 10 days', 'armGroupLabels': ['Treatment A']}, {'name': 'Rifabutin', 'type': 'DRUG', 'description': '300 mg once daily for 10 days', 'armGroupLabels': ['Treatment B']}, {'name': 'Lersivirine', 'type': 'DRUG', 'description': '1000 mg once daily for 10 days', 'armGroupLabels': ['Treatment C']}, {'name': 'Rifabutin', 'type': 'DRUG', 'description': '300 mg once daily for 10 days', 'armGroupLabels': ['Treatment C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '188770', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}