Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-28 @ 6:07 PM
Study NCT ID:
NCT00871234
Status:
COMPLETED
Last Update Posted:
2011-01-07
First Post:
2009-03-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Etravirine on Endothelial Function in HIV-uninfected Adults: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'C451734', 'term': 'etravirine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sgupta1@iupui.edu', 'phone': '317-274-7926', 'title': 'Samir K. Gupta, MD, MS', 'organization': 'Indiana University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Six weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Etravirine', 'description': 'Healthy volunteers receiving etravirine 200mg orally twice daily', 'otherNumAtRisk': 28, 'otherNumAffected': 15, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Neuropathic tingling or pain', 'notes': 'Both Grade 1; both resolved spontaneously within 3 days and were not treatment limiting.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'notes': 'Both Grade 2; both resolved within 3 days upon discontinuation of study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'notes': 'Both Grade 1; both resolved spontaneously within 11 days and were not treatment limiting.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/vomiting', 'notes': 'Both Grade 1; both resolved spontaneously within 2 days and were not treatment limiting.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'notes': 'All Grade 1; all resolved spontaneously within 11 days and were not treatment limiting.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'All Grade 1; all spontaneously resolved within 12 days and were not treatment-limiting.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'notes': 'Both Grade 1; both resolved spontaneously within 2 days and were not treatment limiting.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Flow-mediated Dilation (FMD) of the Brachial Artery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etravirine', 'description': 'Healthy volunteers receiving etravirine 200mg orally twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '-3.21', 'upperLimit': '0.97'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000'], 'paramType': 'Median Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.03', 'statisticalMethod': 'Wilcoxon signed-rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Entry and four weeks', 'description': 'FMD is measured as the percentage increase in brachial artery diameter after increase in blood flow. We measured the change in this percentage from entry (before etravirine was started) and again at four weeks after receiving etravirine.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FMD analysis was per protocol restricted to those who completed the four week trial. The safety analysis was ITT.'}, {'type': 'SECONDARY', 'title': 'Lipid Fractions', 'timeFrame': 'Four weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Insulin Sensitivity [(Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)]', 'timeFrame': 'Four weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'timeFrame': 'Four weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Inflammatory Biomarkers', 'timeFrame': 'Four weeks', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Endothelial Activation Biomarkers', 'timeFrame': 'Four weeks', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etravirine', 'description': 'Healthy volunteers receiving etravirine 200mg orally twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Recruitment occurred between April 2009 and March 2010. Participants were recruited via advertisements and word-of-mouth.', 'preAssignmentDetails': 'After participant enrollment, a screening visit was performed to determine eligibility. Participants may have been excluded from entering the study if they were found to be ineligible.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Etravirine', 'description': 'Healthy volunteers receiving etravirine 200mg orally twice daily'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '47'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-05', 'studyFirstSubmitDate': '2009-03-27', 'resultsFirstSubmitDate': '2010-12-07', 'studyFirstSubmitQcDate': '2009-03-27', 'lastUpdatePostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-07', 'studyFirstPostDateStruct': {'date': '2009-03-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow-mediated Dilation (FMD) of the Brachial Artery', 'timeFrame': 'Entry and four weeks', 'description': 'FMD is measured as the percentage increase in brachial artery diameter after increase in blood flow. We measured the change in this percentage from entry (before etravirine was started) and again at four weeks after receiving etravirine.'}], 'secondaryOutcomes': [{'measure': 'Lipid Fractions', 'timeFrame': 'Four weeks'}, {'measure': 'Insulin Sensitivity [(Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)]', 'timeFrame': 'Four weeks'}, {'measure': 'Blood Pressure', 'timeFrame': 'Four weeks'}, {'measure': 'Inflammatory Biomarkers', 'timeFrame': 'Four weeks'}, {'measure': 'Endothelial Activation Biomarkers', 'timeFrame': 'Four weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Endothelial function', 'Etravirine'], 'conditions': ['Endothelial Function', 'Lipids', 'Insulin Resistance', 'Inflammation', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and effects of etravirine, an HIV antiretroviral medication, on vascular function.', 'detailedDescription': 'We hypothesize that in HIV-uninfected subjects, etravirine 200mg twice daily for four weeks will have no effect on endothelial function. The primary objective of this study is to determine the effects of etravirine 200mg twice daily given for four weeks on endothelial function, measured as flow-mediated dilation (FMD) of the brachial artery, in HIV-uninfected subjects. Secondary objectives include determination of the effects of etravirine 200mg twice daily given for four weeks on safety measures, lipid fractions, HOMA-IR, blood pressure, inflammatory parameters, and endothelial activation parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18 years of age or older\n2. Negative ELISA for HIV-1 or HIV-2 at screening\n3. Negative hepatitis B surface antigen at screening\n4. Negative hepatitis C antibody at screening\n5. For women of reproductive potential, a negative urine pregnancy test at screening and willingness to use two forms of birth control during the course of the study\n6. No history of diabetes, hypertension, or dyslipidemia\n7. No anticipated changes or additions to other medical therapies during the course of the study\n\nExclusion Criteria:\n\n1. Inability to provide written, informed consent\n2. Known allergy/intolerance to etravirine or nitroglycerin\n3. Absolute neutrophil count \\< 750cell/mL at screening\n4. Hemoglobin \\<11g/dL at screening\n5. Platelet count \\<100,000/mL at screening\n6. Estimated creatinine clearance (per Cockcroft-Gault equation) \\<55 mL/min at screening\n7. Liver transaminases (AST or ALT) \\> 100 IU/mL or total bilirubin \\> 1.5mg/dL at screening\n8. Breastfeeding at screening and during the course of the study\n9. Hypotension, defined as SBP\\<90mmHg at time of each main study visit before brachial artery ultrasound measurements\n10. Receipt of investigational agents, cytotoxic chemotherapy, systemic glucocorticoids (\\>10mg/day of prednisone or the equivalent), or anabolic steroids within 30 days of each screening visit or each main study visit\n11. Use of sildenafil (Viagra or Silagra), vardenafil (Levitra), or tadalafil (Cialis), within 72 hours (before or after) of brachial artery reactivity testing\n12. Indwelling vascular catheters within any upper body vessel at time of brachial artery reactivity testing\n13. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements\n14. Acute therapy for serious infection or other serious medical illnesses (in the judgment of the site investigator) requiring systemic treatment and/or hospitalization within 14 days prior to each screening and study visit\n15. History of migraine headaches\n16. History of Raynaud's phenomenon\n17. History of cardiac arrythmias\n18. History of hypothyroidism or hyperthyroidism that is untreated (defined as a TSH outside the normal range on most recent testing during normal clinical care)\n19. History of carotid bruits.\n20. History of any tobacco use (cigarette smoking, cigar smoking, chewing tobacco) or nicotine replacement treatments (patch, gum) within one year of screening."}, 'identificationModule': {'nctId': 'NCT00871234', 'briefTitle': 'Effects of Etravirine on Endothelial Function in HIV-uninfected Adults: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Effects of Etravirine (INTELENCETM) on Endothelial Function in HIV-uninfected Adults: A Pilot Study', 'orgStudyIdInfo': {'id': '0812-18 (TMC125HIV4003)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Etravirine', 'type': 'DRUG', 'otherNames': ['INTELENCETM'], 'description': 'Two one-hundred mg tablets orally twice daily for four weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Infectious Diseases Research Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Samir K Gupta, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Samir K. Gupta, MD, MS', 'oldOrganization': 'Indiana University School of Medicine'}}}}