Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-26 @ 6:47 PM
Study NCT ID:
NCT01214759
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2010-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D000068898', 'term': 'Raltegravir Potassium'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Karen.J.Vigil@uth.tmc.edu', 'phone': '(713) 500-6703', 'title': 'Dr. Karen Vigil', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This is a pilot study with a small sample size.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were assessed at follow up visits at 2 weeks, 4 weeks, 3 months, and 6 months.', 'description': 'All adverse events that occurred are categorized as grade 1 (mild) by the Division of AIDS table for grading the severity of adult and pediatric adverse events. No grade 2 (moderate), grade 3 (severe), or grade 4 (potentially life threatening) adverse events occurred.', 'eventGroups': [{'id': 'EG000', 'title': 'Truvada and Raltegravir', 'description': 'Single arm\n\nTruvada: Tenofovir 200mg/emtricitabine 300mg once a day\n\nRaltegravir: Raltegravir 400mg twice a day', 'otherNumAtRisk': 85, 'otherNumAffected': 8, 'seriousNumAtRisk': 85, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loose stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delayed menstruation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nightmares', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Face pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada and Raltegravir', 'description': 'Single arm\n\nTruvada: Tenofovir 200mg/emtricitabine 300mg once a day\n\nRaltegravir: Raltegravir 400mg twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All who completed all study visits'}, {'type': 'SECONDARY', 'title': 'Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada and Raltegravir', 'description': 'Single arm\n\nTruvada: Tenofovir 200mg/emtricitabine 300mg once a day\n\nRaltegravir: Raltegravir 400mg twice a day'}], 'timeFrame': '28 days', 'description': 'Participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table for grading the severity of adult and pediatric adverse events were tested for clinical or laboratory abnormalities.', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table were tested for clinical or laboratory abnormalities, and since no participants experienced side effects greater than grade 1, no participants were tested for clinical or laboratory abnormalities.'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Truvada and Raltegravir', 'description': 'Single arm\n\nTruvada: Tenofovir 200mg/emtricitabine 300mg once a day\n\nRaltegravir: Raltegravir 400mg twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All who were enrolled'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Truvada and Raltegravir', 'description': 'Single arm\n\nTruvada: Tenofovir 200mg/emtricitabine 300mg once a day\n\nRaltegravir: Raltegravir 400mg twice a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': '28 Days nPEP Completion', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Truvada and Raltegravir', 'description': 'Single arm\n\nTruvada: Tenofovir 200mg/emtricitabine 300mg once a day\n\nRaltegravir: Raltegravir 400mg twice a day'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '8.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All who were enrolled'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-07', 'studyFirstSubmitDate': '2010-09-30', 'resultsFirstSubmitDate': '2016-01-07', 'studyFirstSubmitQcDate': '2010-10-01', 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-07', 'studyFirstPostDateStruct': {'date': '2010-10-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months', 'timeFrame': '6 months', 'description': 'This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study', 'timeFrame': '28 days', 'description': 'Participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table for grading the severity of adult and pediatric adverse events were tested for clinical or laboratory abnormalities.'}, {'measure': 'Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'prevention', 'prophylaxis', 'Raltegravir', 'Truvada'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '15660015', 'type': 'BACKGROUND', 'citation': 'Smith DK, Grohskopf LA, Black RJ, Auerbach JD, Veronese F, Struble KA, Cheever L, Johnson M, Paxton LA, Onorato IM, Greenberg AE; U.S. Department of Health and Human Services. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR Recomm Rep. 2005 Jan 21;54(RR-2):1-20.'}, {'pmid': '15577628', 'type': 'BACKGROUND', 'citation': 'Pinkerton SD, Martin JN, Roland ME, Katz MH, Coates TJ, Kahn JO. Cost-effectiveness of HIV postexposure prophylaxis following sexual or injection drug exposure in 96 metropolitan areas in the United States. AIDS. 2004 Oct 21;18(15):2065-73. doi: 10.1097/00002030-200410210-00011.'}, {'pmid': '11181146', 'type': 'BACKGROUND', 'citation': 'Kahn JO, Martin JN, Roland ME, Bamberger JD, Chesney M, Chambers D, Franses K, Coates TJ, Katz MH. Feasibility of postexposure prophylaxis (PEP) against human immunodeficiency virus infection after sexual or injection drug use exposure: the San Francisco PEP Study. J Infect Dis. 2001 Mar 1;183(5):707-14. doi: 10.1086/318829. Epub 2001 Feb 1.'}, {'pmid': '7502044', 'type': 'BACKGROUND', 'citation': 'Tsai CC, Follis KE, Sabo A, Beck TW, Grant RF, Bischofberger N, Benveniste RE, Black R. Prevention of SIV infection in macaques by (R)-9-(2-phosphonylmethoxypropyl)adenine. Science. 1995 Nov 17;270(5239):1197-9. doi: 10.1126/science.270.5239.1197.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and tolerability of the combination of truvada and raltegravir given for 28 days for the prevention of HIV infection.', 'detailedDescription': 'Non-Occupational Post-Exposure Prophylaxis (nPEP) after sexual exposure to HIV is recommended by the Centers for Disease Control (CDC). Although no efficacy data exist for Post-Exposure Prophylaxis (PEP) after sexual exposure, PEP has been shown to reduce HIV transmission in other exposure situations such as occupational exposures and mother-to-child transmission. The role in nPEP of the newer agents approved for the treatment of HIV infection remains unknown. The anti-HIV drug raltegravir works early in the life cycle of the virus, before it integrates with human DNA. It has few side effects and drug interactions what makes it an ideal drug for an nPEP regimen.\n\nWe aim to asses the safety and tolerability of the combination of truvada and raltegravir for nPEP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must be at least 18 years of age\n* HIV uninfected on the basis of a negative HIV rapid test, EIA or Western blot, and without any signs or symptoms of acute HIV infection\n* Able to understand and provide consent\n* High-Risk Exposure Characteristic (One or more of the below, unprotected or with failed condom use):\n\n * Receptive Anal Intercourse\n * Insertive Anal Intercourse\n * Receptive Vaginal Intercourse\n * Insertive Vaginal Intercourse\n * Receptive Oral Intercourse with Intraoral Ejaculation with known HIV+ source\n* High-Risk Source (One or more of the below):\n\n * Known HIV positive\n * MSM\n * MSM/W\n * CSW\n* Sexual perpetrator Partner of one of the above\n* Exposure within 72 hours of presentation\n* Not known to be HIV-1 positive\n* No countermanding concomitant medications or allergies\n\nExclusion Criteria:\n\n* Patients \\<18 years of age\n* Unable to understand and provide consent\n* Non-occupational exposure to HIV-1 not recent enough to commence the first dose of study medication within 72 hours from the exposure\n* Known to be HIV positive\n* Any condition which in the opinion of the intake provider will seriously compromise the patient's ability to comply with the protocol, including adherence to nPEP medication\n* Demonstrated HIV-1 positive on rapid testing\n* Unwillingness to commit to barrier-method (male and/or female condom) use until HIV negative status is confirmed 6 months after exposure\n* Unwillingness of breast-feeding women to transition to formula feeding\n* Any active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures\n* Pregnancy\n* Chronic hepatitis B infection, diagnosed by either positive serum HBsAg or positive serum HBV DNA; or prior lamivudine or other therapy for hepatitis B\n* Creatinine clearance less than 30 mL/min as calculated by Cockcroft-Gault formula\n* Unwillingness to participate in study procedures, including Mental Health referral and intervention\n* Known intolerance or allergy to tenofovir DF, emtricitabine or raltegravir\n* Use of prohibited concomitant medication: dilantin, phenobarbital and rifampin which cannot be used with raltegravir"}, 'identificationModule': {'nctId': 'NCT01214759', 'briefTitle': 'Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'A Pilot Project to Assess the Safety and Tolerability of Truvada Plus Raltegravir as Post-exposure Prophylaxis (nPEP) Following Sexual Exposure to Human Immunodeficiency Virus (HIV)', 'orgStudyIdInfo': {'id': 'UT-NPEP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Truvada and Raltegravir', 'description': 'Single arm', 'interventionNames': ['Drug: Truvada', 'Drug: Raltegravir']}], 'interventions': [{'name': 'Truvada', 'type': 'DRUG', 'otherNames': ['Tenofovir 200mg/emtricitabine 300mg'], 'description': 'Tenofovir 200mg/emtricitabine 300mg once a day', 'armGroupLabels': ['Truvada and Raltegravir']}, {'name': 'Raltegravir', 'type': 'DRUG', 'otherNames': ['Isentress'], 'description': 'Raltegravir 400mg twice a day', 'armGroupLabels': ['Truvada and Raltegravir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Karen J Vigil, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor - Internal Medicine', 'investigatorFullName': 'Karen Vigil', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}