Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-29 @ 1:55 AM
Study NCT ID:
NCT00949234
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2009-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'C109078', 'term': 'lamivudine, zidovudine drug combination'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rlandovitz@mednet.ucla.edu', 'phone': '310-557-1891', 'title': 'Dr. Raphael Landovitz', 'organization': 'UCLA CARE Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Open label clinical trial of deploying PEP regimens at community based sites. Non-randomized and guidelines have subsequently evolved.'}}, 'adverseEventsModule': {'timeFrame': '24 Weeks', 'description': 'Some individuals reenrolled in the study if an HIV exposure occurred at a later date. 254 individuals were exposed to HIV once and received PEP; 11 individuals were exposed to HIV twice and received a PEP regimen twice; and 2 were exposed to HIV three times and received a PEP regimen for each of the three exposures. A total of 282 PEP regimens were initiated on 267 unique individuals. 282 was used as the denominator for report Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'PEP Group', 'description': 'An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into "moderate behavioral risk," or "high behavioral risk." Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.', 'otherNumAtRisk': 282, 'deathsNumAtRisk': 282, 'otherNumAffected': 155, 'seriousNumAtRisk': 282, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 78}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 39}], 'organSystem': 'General disorders'}, {'term': 'Mild to moderate abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 282, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}, {'units': 'HIV Exposure Events', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PEP Group', 'description': 'An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into "moderate behavioral risk," or "high behavioral risk." Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.'}], 'classes': [{'categories': [{'title': 'Retained at 24 Weeks', 'measurements': [{'value': '125', 'groupId': 'OG000'}]}, {'title': 'Not Retained at 24 Weeks', 'measurements': [{'value': '157', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'groupDescription': 'There was no power calculation for this analysis. The study was mainly descriptive, but Chi-square tests were used to determine if there were differences between individuals who were retained at the 24 Week Follow-up visit from individuals who were not retained at the 24 Week Follow-up visit.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '24 Weeks', 'unitOfMeasure': 'HIV Exposure Events', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'HIV Exposure Events', 'denomUnitsSelected': 'HIV Exposure Events', 'populationDescription': '254 individuals were exposed to HIV once and received PEP; 11 individuals were exposed to HIV twice and received a PEP regimen twice; and 2 were exposed to HIV three times and received a PEP regimen for each of the three exposures'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PEP Group', 'description': 'An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into "moderate behavioral risk," or "high behavioral risk." Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '267'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}]}], 'recruitmentDetails': 'Two community-based sites, Jeffrey Goodman Clinic and The OASIS Clinic, will serve as facilities at which participants may present for screening for post-exposure prophylaxis services, as well as sexually transmitted diseases.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PEP Group', 'description': 'An intake of inclusion and exclusion criteria will be performed by program personnel. HIV-testing and STI testing will be provided as well as a brief and directed history and physical examination. If all inclusion and no exclusion criteria are met, an initial dose of PEP medications will be provided for immediate ingestion. A 14-day supply of PEP medications will be provided. Participant information sheets regarding PEP will be provided. Initial safety laboratory measurements and assessment of necessary referral services will be made, and behavioral risk assessment will stratify participants into "moderate behavioral risk," or "high behavioral risk." Moderate risk participants will receive risk-reduction programming within the P-QUAD program; high-risk participants will be referred externally to existing LA County behavioral risk-reduction programming.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '266', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '253', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Transgender', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black/AA', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic/Latino(a)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'American Indian/Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '267', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 267}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-15', 'studyFirstSubmitDate': '2009-07-29', 'resultsFirstSubmitDate': '2017-10-02', 'studyFirstSubmitQcDate': '2009-07-29', 'lastUpdatePostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-15', 'studyFirstPostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit', 'timeFrame': '24 Weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['post exposure prophylaxis', 'biomedical prevention', 'HIV seronegativity'], 'conditions': ['HIV Prevention', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this program is to evaluate an effort to provide a comprehensive package of HIV prevention services of which post-exposure prophylaxis (medicines that may help prevent HIV infection after an exposure) can be a part. It will also include risk reduction information and testing for other sexually transmitted infections.', 'detailedDescription': 'The Los Angeles County P-QUAD program is a combined effort of County, City, public health, community, academic, and private agencies and individuals in an effort to provide a comprehensive package of HIV prevention services of which PEP can be an integral component. These services are designed to be easily accessible, non-judgmental, culturally, ethnically, and linguistically appropriate to the relevant populations, community-based, and independent of ability to pay or insurance/documentation status. They will also provide vital linkages to associated services, routine HIV testing, and primary health care.\n\nIn its initial pilot project, 2 community-based sites will serve as facilities at which patients may present for screening for post-exposure prophylaxis services, as well as sexually transmitted diseases. At the sites, initial eligibility and testing will be performed, and an initial 14-day supply of PEP medications will be provided if appropriate, and referrals will be initiated. All subjects who are provided an initial 14-day supply will be required to return to the site for the remainder of the 28-day course of medication, follow-up testing, adherence counseling, risk-reduction programming, and other appropriate referrals. Follow-up with patients by phone, email, and mobile-phone text message will be used as appropriate to maximize program retention.'}, '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* Able to understand and provide consent\n* High-Risk Exposure Characteristic\n* (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 (supersedes all "high-risk source" criteria below)\n\n * Sharing injection drug works which have been intravascular\n* High-Risk Source (one or more of the below)\n\n * Known HIV positive\n * MSM\n * MSM/W\n * IDU\n * CSW\n * Sexual perpetrator\n * From an endemic country (prevalence \\>1%)\n * Partner of one of the above\n* Exposure within 72 hours of presentation\n* Not known to be HIV positive\n* No countermanding concomitant medications or allergies\n* HIV-negative on presentation and without symptoms of PHI (do not withhold first dose pending these laboratory assessments).\n\nExclusion Criteria:\n\n* Patients \\<18 years of age\n* Unable to understand and provide consent\n* Exposure \\>72 hours of presentation\n* Known to be HIV positive\n* Currently in-progress of a course of PEP initiated via non-P-QUAD mechanisms\n* Any condition, which in the opinion of the intake provider, will seriously compromise the patient\'s ability to comply with the protocol, including\n\n * adherence to PEP medication dosing\n * Demonstrated HIV-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'}, 'identificationModule': {'nctId': 'NCT00949234', 'briefTitle': 'Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'A Pilot Project to Operationalize the Prevention Strategy of Post Exposure Prophylaxis Following Sexual Exposure to HIV in Combination With Educational Programming and Behavioral Risk Reduction Strategies in Los Angeles County', 'orgStudyIdInfo': {'id': 'PQUAD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Open-Label', 'description': 'This was an open-label demonstration project. Therefore, medications were not blinded and participants were made aware of the regimen they received for PEP.', 'interventionNames': ['Drug: tenofovir + emtricitabine, lopinavir/ritonavir']}], 'interventions': [{'name': 'tenofovir + emtricitabine, lopinavir/ritonavir', 'type': 'DRUG', 'otherNames': ['Truvada', 'Combivir'], 'description': 'The preferred regimen will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a creatinine clearance 30-49 mL/min, dosing of Truvada is 1 tablet by mouth every other day. For patients with creatinine clearance \\<30 mL/min or on hemodialysis, Truvada should not be used. For intolerance to Truvada, Combivir (zidovudine 300mg/lamivudine 150mg)will be available to be taken as 1 PO BID. For highest-risk category exposures (receptive anal intercourse with a known or suspected HIV-positive source patient or in cases of suspected source drug resistance, see Schema, below) one of the following should be added to the above "standard" treatment, creating an "expanded" regimen:\n\nPreferred: Lopinavir/ritonavir (200mg/50mg), 2 tablets orally twice daily or 4 tablets once daily', 'armGroupLabels': ['Open-Label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90028', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'L.A. Gay & Lesbian Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90059', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'OASIS Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Raphael J. Landovitz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Los Angeles County Department of Public Health', 'class': 'OTHER_GOV'}, {'name': 'AIDS Project Los Angeles', 'class': 'OTHER'}, {'name': 'Los Angeles LGBT Center', 'class': 'OTHER'}, {'name': 'The OASIS Clinic', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Director, UCLA Center for Clinical AIDS Research & Education (CARE)', 'investigatorFullName': 'Dr. Raphael Landovitz', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}