Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-01 @ 1:49 PM
Study NCT ID:
NCT01018095
Status:
COMPLETED
Last Update Posted:
2016-12-20
First Post:
2009-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trichomonas Vaginalis Recurrence Among HIV+ Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014245', 'term': 'Trichomonas Infections'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kissing@tulane.edu', 'phone': '5049887320', 'title': 'Patricia Kissinger, PhD', 'organization': 'Tulane University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Generalizability is always a concern in clinical trials, however our findings are likely generalizable to the majority of HIV-infected women in the U.S. though studies in Caucasian and Hispanic women are needed.'}}, 'adverseEventsModule': {'timeFrame': '4 years and 2 months', 'eventGroups': [{'id': 'EG000', 'title': '7 Day Dose', 'description': 'Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose', 'otherNumAtRisk': 135, 'otherNumAffected': 0, 'seriousNumAtRisk': 135, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Single Dose', 'description': 'Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose', 'otherNumAtRisk': 135, 'otherNumAffected': 0, 'seriousNumAtRisk': 135, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'TV Culture Positive Result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7 Day Dose', 'description': 'Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose'}, {'id': 'OG001', 'title': 'Single Dose', 'description': 'Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.045', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.25', 'ciUpperLimit': '1.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.191', 'groupDescription': 'It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.', 'statisticalMethod': 'Relative risk', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The measure of association at TOC and 3 months was calculated as a relative risk with 95% confidence interval.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at TOC was calculated as a relative risk with 95% confidence interval.'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '0.21', 'ciUpperLimit': '0.98', 'pValueComment': 'Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.'}], 'paramType': 'NUMBER', 'timeFrame': 'test-of-cure visit at 6-12 days post-treatment completion', 'description': "At the participants' test of cure (TOC) visits they were screened for Trichomonas vaginalis using (InPouch) culture. Presence of parasite will yield a culture positive result.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who returned for their test of cure visit'}, {'type': 'SECONDARY', 'title': 'TV Culture Positive Result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '7 Day Dose', 'description': 'Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose'}, {'id': 'OG001', 'title': 'Single Dose', 'description': 'Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '14.7'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '19.3', 'upperLimit': '28.9'}]}]}], 'analyses': [{'pValue': '=0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '.21', 'ciUpperLimit': '0.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.196', 'groupDescription': 'It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.', 'statisticalMethod': 'Relative risk', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The measure of association at TOC and 3 months was calculated as a relative risk with 95% confidence interval.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at 3 months was calculated as a relative risk with 95% confidence interval.'}], 'paramType': 'NUMBER', 'timeFrame': '3 months post-enrollment', 'description': 'Participants who returned for their follow up visits were tested for Trichomonas vaginalis using InPouch culture. If parasites are present, it will yield a culture positive result.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who returned for their 3 mo follow up visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '7 Day Dose', 'description': 'Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose'}, {'id': 'FG001', 'title': 'Single Dose', 'description': 'Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '62'}]}]}], 'recruitmentDetails': 'HIV-infected women undergoing a routine gynecological examination performed by a clinic health care provider between May 1, 2006 and July 17, 2009 were tested for Trichomonas Vaginalis (TV) by culture as standard of care practice in selected public HIV outpatient clinics in New Orleans, Louisiana; Houston, Texas; and Jackson, Mississippi.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '7 Day Dose', 'description': 'Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose'}, {'id': 'BG001', 'title': 'Single Dose', 'description': 'Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '40.7', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '40.1', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-16', 'studyFirstSubmitDate': '2009-11-20', 'resultsFirstSubmitDate': '2013-04-11', 'studyFirstSubmitQcDate': '2009-11-20', 'lastUpdatePostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-06', 'studyFirstPostDateStruct': {'date': '2009-11-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TV Culture Positive Result', 'timeFrame': 'test-of-cure visit at 6-12 days post-treatment completion', 'description': "At the participants' test of cure (TOC) visits they were screened for Trichomonas vaginalis using (InPouch) culture. Presence of parasite will yield a culture positive result."}], 'secondaryOutcomes': [{'measure': 'TV Culture Positive Result', 'timeFrame': '3 months post-enrollment', 'description': 'Participants who returned for their follow up visits were tested for Trichomonas vaginalis using InPouch culture. If parasites are present, it will yield a culture positive result.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Trichomonas Infections', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '30297322', 'type': 'DERIVED', 'citation': 'Kissinger P, Muzny CA, Mena LA, Lillis RA, Schwebke JR, Beauchamps L, Taylor SN, Schmidt N, Myers L, Augostini P, Secor WE, Bradic M, Carlton JM, Martin DH. Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial. Lancet Infect Dis. 2018 Nov;18(11):1251-1259. doi: 10.1016/S1473-3099(18)30423-7. Epub 2018 Oct 5.'}, {'pmid': '21423852', 'type': 'DERIVED', 'citation': 'Kissinger P, Mena L, Levison J, Clark RA, Gatski M, Henderson H, Schmidt N, Rosenthal SL, Myers L, Martin DH. A randomized treatment trial: single versus 7-day dose of metronidazole for the treatment of Trichomonas vaginalis among HIV-infected women. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):565-71. doi: 10.1097/QAI.0b013e3181eda955.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the 2 gram single dose of metronidazole is as effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among HIV-infected women.', 'detailedDescription': 'This is a Phase IV equivalency trial as both doses of metronidazole are listed in the the Centers for Disease Control and Prevention Treatment Guidelines for the treatment of T vaginalis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female\n* 18 years or older\n* HIV-positive\n* TV positive by either wet preparation or culture\n* ability to refrain from all alcohol use for 24 hours before and after taking oral metronidazole\n* willing to take metronidazole treatment\n\nExclusion Criteria:\n\n* pregnant\n* incarcerated\n* previously enrolled\n* currently taking disulfiram\n* alcoholism or known liver damage\n* medical contraindications to metronidazole\n* treated with metronidazole within the previous 14 days\n* requires treatment for B.V. per Amsel's criteria"}, 'identificationModule': {'nctId': 'NCT01018095', 'briefTitle': 'Trichomonas Vaginalis Recurrence Among HIV+ Women', 'organization': {'class': 'OTHER', 'fullName': 'Tulane University'}, 'officialTitle': 'Randomized Phase IV Trial of Metronidazole Single Dose Versus 7 Day Dose for Treatment of Trichomonas Vaginalis Among HIV-infected Women', 'orgStudyIdInfo': {'id': '543793'}, 'secondaryIdInfos': [{'id': 'U19AI061972', 'link': 'https://reporter.nih.gov/quickSearch/U19AI061972', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single dose', 'description': 'Metronidazole 2 gm single dose', 'interventionNames': ['Drug: Metronidazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': '7 day dose', 'description': 'Metronidazole 500 mg dose x 7 days', 'interventionNames': ['Drug: Metronidazole']}], 'interventions': [{'name': 'Metronidazole', 'type': 'DRUG', 'otherNames': ['Flagyl'], 'description': '2 gm single dose versus 7 day 500 mg BID dose', 'armGroupLabels': ['7 day dose', 'Single dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'HIV Outpatient Clinic', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'NOAIDS', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Crossroads Clinic', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '77009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Thomas St Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77040', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Northwest Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Patricia Kissinger, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tulane University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tulane University Health Sciences Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Patricia Kissinger', 'investigatorAffiliation': 'Tulane University Health Sciences Center'}}}}