Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-17 @ 2:38 PM
Study NCT ID:
NCT01618058
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2012-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of HIV Infection in Participants of Seroconvert During Dapivirine Vaginal Ring Trials
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-05', 'studyFirstSubmitDate': '2012-06-08', 'studyFirstSubmitQcDate': '2012-06-11', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To identify HIV drug resistant mutations following recent seroconversion in plasma and vaginal secretions and change in resistant mutations over time in participants previously exposed to an ARV-based microbicide or a placebo.', 'timeFrame': '12 months', 'description': 'The primary outcome will be assessed by viral genotype assay at baseline and at exit from the protocol, to assess the occurrence and frequency of acquiring a drug resistant HIV virus during follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV Infections', 'Anti-HIV Agents', 'HIV-1'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '36189636', 'type': 'DERIVED', 'citation': 'Steytler J, van der Ryst E, Craig C, Van Baelen B, Nuttall J, van Niekerk N, Mellors J, Parikh U, Wallis C; IPM 007 Study Team. Clinical Presentation, Treatment Response, and Virology Outcomes of Women Who Seroconverted in the Dapivirine Vaginal Ring Trials-The Ring Study and DREAM. Clin Infect Dis. 2023 Feb 8;76(3):389-397. doi: 10.1093/cid/ciac804.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine if exposure to ARV-containing investigational products in IPM clinical trials will impact the natural history of HIV infection as measured by the virologic, immunologic and clinical outcomes of participants who become HIV-positive during the IPM 027 trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Both microbicide and placebo recipients in IPM 027 who have become HIV infected (HIV-1 or HIV-2) while participating in IPM 027 will be offered enrolment in IPM 007 at the exit visit of IPM 027, i.e. approximately 6 weeks after identification of HIV seroconversion.\n\nThis study includes all active IPM clinical research centres that enrol participants for IPM microbicide trials.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recent HIV seroconversion during participation in IPM 027, according to the HIV testing algorithm of that trial\n* Ability and willingness to provide informed consent\n* Willingness to give the research centre permission to share information with the primary health care provider (PHCP), and willingness to sign approved site-specific documentation to facilitate such sharing.\n\nExclusion Criteria:\n\n* Any condition that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.'}, 'identificationModule': {'nctId': 'NCT01618058', 'briefTitle': 'Observational Study of HIV Infection in Participants of Seroconvert During Dapivirine Vaginal Ring Trials', 'organization': {'class': 'INDUSTRY', 'fullName': 'International Partnership for Microbicides, Inc.'}, 'officialTitle': 'A Long-Term Observational Cohort Study of HIV Infection in Participants Who Seroconvert After Enrolment in Dapivirine Vaginal Ring Trials', 'orgStudyIdInfo': {'id': 'IPM 007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ARV-Treated Participants', 'description': 'Those participants who received dapivirine during HIV seroconversion', 'interventionNames': ['Drug: No Investigational Product']}, {'label': 'ARV-Naive Participants', 'description': 'Those participants who received placebo during HIV seroconversion', 'interventionNames': ['Drug: No Investigational Product']}], 'interventions': [{'name': 'No Investigational Product', 'type': 'DRUG', 'description': 'This study is observational in nature and no investigational product will be used.\n\nGroups: ARV-Treated Participants, ARV-Naive Participants', 'armGroupLabels': ['ARV-Naive Participants', 'ARV-Treated Participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kiyovu', 'state': 'Kigali', 'country': 'Rwanda', 'facility': 'Project Ubuzima'}, {'city': 'Ladysmith', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Qhakaza Mbokodo', 'geoPoint': {'lat': -28.55874, 'lon': 29.77896}}, {'city': 'Pinetown', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Prevention for HIV and AIDS Project (PHIVA)', 'geoPoint': {'lat': -29.82068, 'lon': 30.88674}}, {'zip': '0250', 'city': 'Brits', 'country': 'South Africa', 'facility': 'Madibeng Centre for Research (MCR)', 'geoPoint': {'lat': -25.63473, 'lon': 27.78022}}, {'zip': '3216', 'city': 'Plessislaer', 'country': 'South Africa', 'facility': 'Maternal, Adolescent and Child Health (MatCH)', 'geoPoint': {'lat': -29.63333, 'lon': 30.35}}], 'overallOfficials': [{'name': 'Linda-Gail Bekker', 'role': 'STUDY_CHAIR', 'affiliation': 'Desmond Tutu HIV Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Partnership for Microbicides, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}