Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT00946556
Status:
COMPLETED
Last Update Posted:
2012-03-22
First Post:
2009-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-10-26', 'releaseDate': '2016-09-06'}], 'estimatedResultsFirstSubmitDate': '2016-09-06'}}, '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': 'D000077483', 'term': 'Valacyclovir'}], 'ancestors': [{'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-21', 'studyFirstSubmitDate': '2009-07-23', 'studyFirstSubmitQcDate': '2009-07-24', 'lastUpdatePostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of CD4+ T cells on a cervical cytobrush.', 'timeFrame': 'Monthly intervals for 5 months'}], 'secondaryOutcomes': [{'measure': 'Number of immature dendritic cells on a cervical cytobrush', 'timeFrame': 'Monthly intervals for 5 months'}, {'measure': 'Proinflammatory cytokine/chemokine levels in cervicovaginal secretions', 'timeFrame': 'Monthly intervals for 5 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['herpes simplex virus type 2', 'HIV', 'genital immunology', 'CD4+ T cell', 'valacyclovir', 'HIV seronegativity'], 'conditions': ['Herpes Simplex Type Two Infection', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '17314521', 'type': 'BACKGROUND', 'citation': 'Rebbapragada A, Wachihi C, Pettengell C, Sunderji S, Huibner S, Jaoko W, Ball B, Fowke K, Mazzulli T, Plummer FA, Kaul R. Negative mucosal synergy between Herpes simplex type 2 and HIV in the female genital tract. AIDS. 2007 Mar 12;21(5):589-98. doi: 10.1097/QAD.0b013e328012b896.'}, {'pmid': '24664172', 'type': 'DERIVED', 'citation': 'Yi TJ, Shannon B, Chieza L, Su D, Saunders M, Tharao W, Huibner S, Remis R, Raboud J, Kaul R. Valacyclovir therapy does not reverse herpes-associated alterations in cervical immunology: a randomized, placebo-controlled crossover trial. J Infect Dis. 2014 Sep 1;210(5):708-12. doi: 10.1093/infdis/jiu163. Epub 2014 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'Herpes simplex virus type 2 (HSV2), the most common cause of genital herpes, increases a woman\'s risk of HIV acquisition from 3-6 fold, perhaps because HSV2-infected women have increased numbers of HIV "target cells" (CD4 T cells and dendritic cells) in the cervical mucosa. However, recent clinical trials showed no impact of HSV2 suppression on HIV acquisition rates. The reasons for this negative result are unclear. The investigators propose to examine the effect of valacyclovir (a widely used herpes medication) treatment on cervical immunology and HIV target cells in the cervix. The study will take the form of a randomized, double-blind, placebo-controlled crossover trial. Primary endpoints will be (1) the number of CD4 T cells on a cervical cytobrush and (2) the number of immature dendritic cells per cervical cytobrush.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* HSV2 infected\n\nExclusion Criteria:\n\n* HIV infected\n* Pregnant\n* Taking HSV2 therapy\n* Current/recent (past 3 months) genital infection'}, 'identificationModule': {'nctId': 'NCT00946556', 'briefTitle': 'Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Examining the Ability of HSV2 Therapy to Reduce HIV Target Cell Numbers in the Cervix.', 'orgStudyIdInfo': {'id': 'HET-85518'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.', 'interventionNames': ['Drug: Valacyclovir', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Valacyclovir', 'description': 'Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.', 'interventionNames': ['Drug: Valacyclovir', 'Drug: Placebo']}], 'interventions': [{'name': 'Valacyclovir', 'type': 'DRUG', 'description': '1g po od for 2 months', 'armGroupLabels': ['Placebo', 'Valacyclovir']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo po od for 2 months', 'armGroupLabels': ['Placebo', 'Valacyclovir']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Women's Health In Women's Hands", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Rupert Kaul, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Rupert Kaul', 'investigatorAffiliation': 'University of Toronto'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-09-06', 'type': 'RELEASE'}, {'date': '2016-10-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rupert Kaul, Dr., University of Toronto'}}}}