Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-26 @ 10:33 PM
Study NCT ID:
NCT00973466
Status:
COMPLETED
Last Update Posted:
2011-01-13
First Post:
2009-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Sexually Transmitted Infections (STIs) in HIV-infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006561', 'term': 'Herpes Simplex'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-12', 'studyFirstSubmitDate': '2009-09-04', 'studyFirstSubmitQcDate': '2009-09-07', 'lastUpdatePostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of infection with C.trachomatis, N. gonorrhea and Seroprevalence of HSV 2 infection', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV-infection', 'Neisseria gonorrhea', 'Chlamydia trachomatis', 'Herpes simplex virus', 'prevalence'], 'conditions': ['HIV Infections', 'Neisseria Gonorrhoeae', 'Chlamydia Trachomatis', 'Herpes Simplex']}, 'descriptionModule': {'briefSummary': 'There has been an increase in incidence in sexually transmitted infections in HIV infected patients in the last years. In this study the investigators will prospectively evaluate the prevalence of symptomatic and asymptomatic infections with N. gonorrhea and Ch. trachomatis as well as the seroprevalence of Herpes simplex Type 2 infection in HIV-infected patients attending the clinic for infectious diseases at the Berne University Hospital. In addition, participants will be asked to fill out a questionnaire on sexual behaviour and sexual health.\n\nStudy hypothesis: STI prevalence is high in certain risk-groups to justify screening in regular intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive HIV-infected patients attending the Clinic for Infectious Diseases at Bern University Hospital will be asked to participate in the study if they were sexually active during the last 12 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-infection\n* Attending the Clinic for Infectious Diseases from May 09 to November 09\n* Sexually active during the last 12 months\n* Written informed consent\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00973466', 'acronym': 'CTNG', 'briefTitle': 'Prevalence of Sexually Transmitted Infections (STIs) in HIV-infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Prevalence of Asymptomatic and Symptomatic Infection of N. Gonorrheae and C. Trachomatis and Seroprevalence of HSV Typ 2 and Sexual Health Seeking Behaviour in People With HIV Infection in Bern', 'orgStudyIdInfo': {'id': 'KEK26/09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV-infection', 'description': 'All HIV-infected patients attending the Clinic for Infectious Diseases at Berne university hospital, having been sexually active during the past 12 months and having given written informed consent'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Clinic for Infectious Diseases, Berne University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Hansjakob Furrer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Berne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Hansjakob Furrer, Leitender Arzt', 'oldOrganization': 'University Hospital Inselspital, Berne'}}}}