Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-02 @ 3:47 AM
Study NCT ID:
NCT00917904
Status:
COMPLETED
Last Update Posted:
2011-12-14
First Post:
2009-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Expanded Safety Study of Dapivirine Gel 4789 in Africa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Kenya', 'Malawi', 'Rwanda', 'Tanzania']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C481671', 'term': 'Dapivirine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-13', 'studyFirstSubmitDate': '2009-06-08', 'studyFirstSubmitQcDate': '2009-06-08', 'lastUpdatePostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gynaecological examinations, including pelvic/speculum examination and colposcopy, and laboratory STI testing.', 'timeFrame': 'Week 0, 1, 2, 4, 6 & 10'}, {'measure': 'Safety laboratory tests', 'timeFrame': 'enrollment & last day of gel use'}, {'measure': 'Adverse event/serious adverse event reports', 'timeFrame': 'throughout study'}], 'secondaryOutcomes': [{'measure': 'Questionnaires concerning acceptability and adherence to daily use of vaginal gel.', 'timeFrame': 'Week 0, 2, 6 & 10'}, {'measure': 'Documentation of adherence to the DMA method including the Applicator Collection Checklist, focus groups and male interviews.', 'timeFrame': 'throughout study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV Infections', 'Acquired Immunodeficiency Syndrome', 'Healthy', 'HIV seronegativity'], 'conditions': ['HIV Infections', 'Acquired Immunodeficiency Syndrome', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ipmglobal.org/', 'label': 'IPM website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether dapivirine gel 4789 is safe for daily use by healthy women in South Africa.', 'detailedDescription': 'To reduce the influence of adherence as a factor in the interpretation of efficacy results, IPM is considering using a DOT (Directly Observed Therapy) based method for vaginal microbicide gel delivery in a future Phase III study. IPM has denoted this DOT based method as Daily Monitored Adherence (DMA). IPM014B is a Phase I/II study designed: (1) to assess and compare the safety of a once daily application of Dapivirine Gel 4789, 0.05% 2.5g and a matching vehicle placebo gel; (2) to assess the acceptability of a once daily application of Dapivirine gel 4789, 0.05% 2.5g and a matching vehicle placebo gel; and (3) to assess the feasibility of utilizing the DMA method for a large-scale phase III efficacy study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women 18 to 40 years of age inclusive who can give written informed consent\n2. Available for all visits and consent to follow all procedures scheduled for the study\n3. Agree to daily application of gel and monitoring as per Daily Monitored Adherence (DMA) method\n4. Healthy and self-reported sexually active\n5. HIV-negative as determined by a HIV rapid test at time of enrollment\n6. On a stable form of contraception and willing to continue on this stable method of contraception, OR, Have undergone surgical sterilisation at least 3 months prior to enrollment\n7. In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses\n8. Upon pelvic/speculum examination and colposcopy at the time of enrollment, the cervix and vagina appear normal as determined by the investigator\n9. Asymptomatic for genital infections at the time of enrollment\n10. Willing to refrain from use of vaginal products or objects within 14 days prior to enrollment and for the duration of the study\n11. Willing to answer acceptability and adherence questionnaires throughout the study\n12. Willing to refrain from participation in any other research study for the duration of this study\n13. Willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures\n\nExclusion Criteria:\n\n1. Currently pregnant or last pregnancy outcome within 3 months prior to enrolment\n2. Currently breast-feeding\n3. Participated in any other research study within 60 days prior to screening\n4. Previously participated in any HIV vaccine study\n5. Untreated urogenital infections (either symptomatic or asymptomatic) within 2 weeks prior to enrollment\n6. Presence of abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy\n7. History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction\n8. Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation\n9. Any Grade 2, 3 or 4 baseline haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Experiences\n10. Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrollment\n11. Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex\n12. Any serious acute, chronic or progressive disease\n13. Any condition(s) that, in the opinion of the investigator, might interfere with adherence to study requirements or evaluation of the study objectives'}, 'identificationModule': {'nctId': 'NCT00917904', 'briefTitle': 'An Expanded Safety Study of Dapivirine Gel 4789 in Africa', 'organization': {'class': 'INDUSTRY', 'fullName': 'International Partnership for Microbicides, Inc.'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety and Acceptability of Dapivirine Gel 4789, 0.05%, 2.5g, a Vaginal Microbicide, Conducted Using Daily Monitored Adherence in Healthy, HIV-Negative Women.', 'orgStudyIdInfo': {'id': 'IPM 014B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'vehicle placebo gel', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'dapivirine gel', 'interventionNames': ['Drug: dapivirine']}], 'interventions': [{'name': 'dapivirine', 'type': 'DRUG', 'description': 'dosage form: vaginal gel\n\ndosage: 1.25mg dapivirine/day\n\nfrequency: once daily\n\nduration: 6 weeks', 'armGroupLabels': ['dapivirine gel']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'dosage form: vaginal gel\n\nfrequency: once daily\n\nduration: 6 weeks', 'armGroupLabels': ['vehicle placebo gel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paarl', 'state': 'Eastern Cape', 'country': 'South Africa', 'facility': 'Be Part Clinic, Mbekweni'}, {'city': 'Brits', 'state': 'North West', 'country': 'South Africa', 'facility': 'Madibeng Centre for Research', 'geoPoint': {'lat': -25.63473, 'lon': 27.78022}}, {'zip': '7975', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Desmond Tutu HIV Foundation, Masiphumelele', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'overallOfficials': [{'name': 'Dr Annalene Nel', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Immupeutics Medicine Technology Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Partnership for Microbicides, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Annalene Nel', 'oldOrganization': 'IPM'}}}}