Ignite Creation Date:
2025-12-24 @ 12:48 PM
Ignite Modification Date:
2026-02-17 @ 8:15 PM
Study NCT ID:
NCT05326061
Status:
RECRUITING
Last Update Posted:
2022-04-13
First Post:
2022-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vienna HIV Infection Via Sex Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D006069', 'term': 'Gonorrhea'}, {'id': 'D002690', 'term': 'Chlamydia Infections'}, {'id': 'D013587', 'term': 'Syphilis'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D002694', 'term': 'Chlamydiaceae Infections'}, {'id': 'D014211', 'term': 'Treponemal Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of HIV', 'timeFrame': 'Up to 10 years (=Study Period)', 'description': 'Time from inclusion to HIV infection'}], 'secondaryOutcomes': [{'measure': 'Incidence of sexually transmitted infections', 'timeFrame': 'Up to 10 years (=Study Period)', 'description': 'Time from inclusion to any sexually transmitted infections'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections', 'HIV Pre-Exposure Prophylaxis', 'Sexually Transmitted Diseases', 'Gonorrhea', 'Chlamydia', 'Syphilis']}, 'descriptionModule': {'briefSummary': 'The main objective of this prospective observational cohort study is to investigate the epidemiology, the risk factors and ultimately the incidence of novel HIV infections among individuals at high risk for acquiring HIV via sex practices.', 'detailedDescription': "We will include individuals at high-risk for HIV acquisition, i.e. HIV-negative MSM and transgender individuals who (i) do not use condoms consistently with casual partners and/or with HIV-positive partners who are not on treatment and/or (ii) recently acquired an STI and/or (iii) recently used PEP and/or (iv) frequently engage in 'chemsex' within the past 12 months Important clinical information on possible vectors for transmission (including but not limited to high-risk sex practices and sexualized drug use), use of HIV pre-exposure prophylaxis, incidence of sexually transmitted infections will be assessed and laboratory parameters will be obtained from blood, urine and mucosal secretion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting at the HIV- and/or STI ward of the Department of Dermatology at General Hospital of Vienna which are characterized as individuals at high risk for acquiring HIV will be considered as potential participants for the HIVEX registry.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. High risk for acquiring HIV defined as followed: HIV-negative MSM and transgender individuals who (i) do not use condoms consistently with casual partners and/or with HIV-positive partners who are not on treatment and/or (ii) recently acquired an STI and/or (iii) recently used PEP and/or (iv) frequently engage in 'chemsex'.\n2. Age \\>18 years and \\<100 years.\n3. Written informed consent for this registry study.\n\nExclusion Criteria:\n\n1\\. Withdrawal of the written informed consent."}, 'identificationModule': {'nctId': 'NCT05326061', 'acronym': 'HIVEX', 'briefTitle': 'Vienna HIV Infection Via Sex Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Characterization of Patients at High Risk for the Acquisition of Sexually Transmitted Infection With the Human Immunodeficiency Virus (HIV) - a Clinical Study', 'orgStudyIdInfo': {'id': '1051_2020'}}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'David Chromy, MD', 'role': 'CONTACT', 'email': 'david.chromy@meduniwien.ac.at', 'phone': '+4314040077360'}, {'name': 'Armin Rieger, MD', 'role': 'CONTACT', 'email': 'armin.rieger@meduniwien.ac.at', 'phone': '+4314040077360'}, {'name': 'Armin Rieger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Chromy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wolfgang Bauer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Katharina Grabmeier-Pfistershammer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Skoll, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'David Chromy, MD', 'role': 'CONTACT', 'email': 'david.chromy@meduniwien.ac.at', 'phone': '+43 1 40400 77360'}, {'name': 'Armin Rieger, MD', 'role': 'CONTACT', 'email': 'armin.rieger@meduniwien.ac.at', 'phone': '+43 1 40400 77360'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass.-Prof. Dr.med.univ.', 'investigatorFullName': 'Armin Rieger, MD', 'investigatorAffiliation': 'Medical University of Vienna'}}}}