Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-01 @ 4:21 AM
Study NCT ID:
NCT00840905
Status:
COMPLETED
Last Update Posted:
2012-11-07
First Post:
2009-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Examine the Human Papillomavirus Types Exposure in Women From Southern Africa and Brasil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Blood /plasma specimen 10cc'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 487}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-06', 'studyFirstSubmitDate': '2009-02-10', 'studyFirstSubmitQcDate': '2009-02-10', 'lastUpdatePostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the seroprevalence of HPV types 6,11,16,18 in HIV serOpositive women for Botswana, South Africa and Brazil', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HPV'], 'conditions': ['HIV', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'This is a study to determine what Human Papillomavirus HIV seropositive women in Botswana, South Africa and Brasil have been exposed to during their life. The Human Papillomavirus causes cervical cancer. Different types are more likely to lead to cancer than other types. A vaccine has been made to fight infection against HPV 16 and 18 which has been shown to cause cervical cancer in America and Europe. What HPV type cause cancer in other countries is not as well studied.\n\nHypothesis HPV serology will demonstrate that exposure to each HPV type in Gardisil (6,11,16,18) will be \\<50% in HIV seropositive women in resource limited countries.', 'detailedDescription': 'Plasma from HIV seropositive women will be taken and sent to MERCK in the USA to evaluate what the antibody titers of HPV 6,11,16 and 18. .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV seropositive women from South Africa, Botswana, and Brasil', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV seropositive women 18 years of age and older Consent signed per local IRB requirement\n\nExclusion Criteria:\n\n* Can not give blood'}, 'identificationModule': {'nctId': 'NCT00840905', 'briefTitle': 'A Study to Examine the Human Papillomavirus Types Exposure in Women From Southern Africa and Brasil', 'organization': {'class': 'OTHER', 'fullName': 'University of Witwatersrand, South Africa'}, 'officialTitle': 'A Pilot Observational Study to Determine the Prevalence of HPV Serology in HIV Seropositive Women From Subsaharan Africa and Brasil', 'orgStudyIdInfo': {'id': 'Merck P0806'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'HIV seropositive women from an HIV Antiretroviral therapy clinic in Johannesburg South Africa'}, {'label': '2', 'description': 'A cohort of HIV seropositive women from Gabarone Botswana'}, {'label': '3', 'description': 'A cohort of HIV seropositive women from Rio De Janeiro Brasil'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Habarone', 'country': 'Botswana', 'facility': 'Shahin Lockman'}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Fundacao Oswaldo Cruz', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'University of Witwatersrand/Helen Joseph Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'overallOfficials': [{'name': 'Cynthia S Firnhaber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical HIV Research Unit University of Witwatersrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cynthia S Firnhaber', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Cynthia S Firnhaber', 'investigatorAffiliation': 'University of Witwatersrand, South Africa'}}}}