Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT00309205
Status:
COMPLETED
Last Update Posted:
2009-09-01
First Post:
2006-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C481671', 'term': 'Dapivirine'}, {'id': 'D014622', 'term': 'Vaginal Creams, Foams, and Jellies'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D053566', 'term': 'Feminine Hygiene Products'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'lastUpdateSubmitDate': '2009-08-31', 'studyFirstSubmitDate': '2006-03-30', 'studyFirstSubmitQcDate': '2006-03-30', 'lastUpdatePostDateStruct': {'date': '2009-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local and systemic safety and tolerability.'}]}, 'conditionsModule': {'keywords': ['HIV seronegativity'], 'conditions': ['HIV Infections', 'HIV-1']}, 'descriptionModule': {'briefSummary': 'Approximately 36 HIV-negative women, aged \\>18 and \\< 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers will receive investigational product for a total of 42 days.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-negative\n* Willing to participate and sign an informed consent form\n* Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.\n* Willing to use two forms of contraception during the study\n* Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.\n* Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses\n\nExclusion Criteria:\n\n* Currently pregnant or breast-feeding\n* Clinically detectable genital abnormality on the vulva, vaginal walls or cervix\n* Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion\n* Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization\n* Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment.\n* Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.'}, 'identificationModule': {'nctId': 'NCT00309205', 'briefTitle': 'A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium', 'organization': {'class': 'INDUSTRY', 'fullName': 'International Partnership for Microbicides, Inc.'}, 'officialTitle': 'A Phase I/II Single-Centre Double-Blinded Randomized Study of the Safety and Tolerability of TMC120 Vaginal Microbicide Gel vs. HEC-Based Universal Placebo Gel in Healthy HIV-Negative Women.', 'orgStudyIdInfo': {'id': 'IPM005B'}}, 'armsInterventionsModule': {'interventions': [{'name': 'dapivirine (TMC120) vaginal gel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2060', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'SGS Biopharma - Research Unit Stuivenberg', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': 'Zeda Rosenberg, ScD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Immupeutics Medicine Technology Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Partnership for Microbicides, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Zeda Rosenberg ScD', 'oldOrganization': 'International Partnership for Microbicides'}}}}