Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-06 @ 6:49 PM
Study NCT ID:
NCT02160392
Status:
COMPLETED
Last Update Posted:
2014-06-10
First Post:
2014-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Female Upper Genital Tract in HIV-infected Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Endometrial and cervical lavage specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-06', 'studyFirstSubmitDate': '2014-06-05', 'studyFirstSubmitQcDate': '2014-06-06', 'lastUpdatePostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune characteristics', 'timeFrame': 'Single visit approximately 14-42 days after the first day of the last menstrual period.', 'description': 'Endometrial lavage (EML) and biopsy (EMB) samples were compared to cervicovaginal lavage (CVL) and fluid (CVF) samples from HIV-negative healthy women (N=x) and HIV-infected women (n=x) taking ART with plasma HIV RNA \\<40 copies/mL. All participants were in the luteal phase of the menstrual cycle. Immunologic study was completed using Luminex and flow cytometry. Concentrations of tenofovir (TFV), emtricitabine (FTC) and their active intracellular metabolites (TFVdp and FTCtp) were measured using LC-MS/MS in 11 HIV-infected women. HIV RNA was measured in plasma, EML and CVL using the Abbott RealTime HIV-1 assay (lower limit of detection 40 copies/mL).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'female', 'genital tract'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'The female upper genital tract is a unique compartment involved in HIV pathogenesis.', 'detailedDescription': 'The persistent detection of HIV in the female genital tract in spite of ART is unexplained, and it is possible the uterine endometrium serve as a reservoir. There are limited data regarding the interaction between HIV expression, antiretroviral therapy (ART) and host immune system in the uterine endometrium.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We enrolled HIV-1 positive menstruating women between ages 25-48 years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Regularly menstruating women (between 21-42 days)\n* between ages 25-50 years\n* Fully suppressed by antiretroviral therapy with plasma HIV RNA \\< 40 copies/mL within the last 6 months.\n\nExclusion Criteria:\n\n* Pregnant or planning pregnancy\n* Unwilling to use 2 forms of contraception (condoms + hormonal) if they did not have previous bilateral tubal ligation procedure\n* Intrauterine device in place\n* Untreated cervical infection (N. gonnorhea, C. trachomatis)\n* Taking immunosuppressive medications'}, 'identificationModule': {'nctId': 'NCT02160392', 'acronym': 'FUGTS', 'briefTitle': 'Female Upper Genital Tract in HIV-infected Women', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Virologic, Pharmacologic, and Immunologic Characterization of the Female Upper Genital Tract in HIV-infected Women', 'orgStudyIdInfo': {'id': 'FUGTS2010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endometrial biopsy', 'description': 'HIV + and HIV negative women underwent lower and upper genital tract sampling.', 'interventionNames': ['Procedure: Endometrial biopsy']}], 'interventions': [{'name': 'Endometrial biopsy', 'type': 'PROCEDURE', 'description': "Endometrial biopsy (EMB) specimens were collected via a 3 mm diameter plastic pipelle that was inserted into the uterus following EML. A sample of tissue was obtained by retracting the pipelle's plunger leading to negative suction and rotating the cannula for approximately 15 seconds.", 'armGroupLabels': ['Endometrial biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Lisa Rahangdale, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lisa Rahangdale, MD, MPH', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}