Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT01202305
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2010-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D021701', 'term': 'Sentinel Lymph Node Biopsy'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008197', 'term': 'Lymph Node Excision'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Inguinal LN'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2010-09-09', 'studyFirstSubmitQcDate': '2010-09-13', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV persistence', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'HIV persistence', 'Lymph node fibrosis'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'HIV medicines have led to dramatic improvements in health. However, there remains a concern for potential drug toxicities, cost of drugs, and need for life-long treatment. In addition, research has found that health is not completely restored in HIV-infected patients, even if they have been taking effective HIV medicines for a long time. This may be due to direct drug-toxicity, continued replication of the virus, and/or inflammation of the body in response to the virus. Therefore, a more complete understanding of how HIV stays in the body is necessary.\n\nRecent research has shown that one of the places that HIV can stay in the body is in lymphatic tissues such as lymph nodes (even in patients who have been taking HIV medicines for a long time). In addition, the amount of damage to the lymphatic tissues can predict how the immune system (CD4+ T cell count) will respond to therapy.\n\nThe investigators therefore propose a study in which lymph nodes from the groin area will be removed, with the goals of: 1) seeing how much HIV is in lymph nodes and 2) seeing how much damage has happened to the lymph node architecture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We propose a study in which inguinal lymph node biopsies will be performed on HIV-infected and uninfected subjects, with the goals of: 1) quantifying and characterizing residual virus in lymph nodes and 2) quantifying and comparing lymph node architecture in untreated subjects, HAART-suppressed subjects, elite controllers, and HIV-negative subjects. This research study will permit a lymph node biopsy to be performed and peripheral blood to be obtained from patients with HIV disease. Subjects with HIV or without HIV infection who have no contraindications to lymph node biopsy will be invited to participate in this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to give informed consent\n2. No contraindication to surgical procedures\n3. Palpable inguinal adenopathy at study entry\n4. For HIV seropositive subjects, meeting one of the following criteria: (1) on stable highly active antiretroviral therapy (HAART) with a recent undetectable viral load (\\< 50 copies/mL) ("HAART suppressed"), (2) antiretroviral untreated with an undetectable viral load (\\< 50 copies/mL) ("elite" controllers), or (3) antiretroviral untreated with a detectable viral load (\\> 1000 copies/mL) ("non-controllers")\n\nExclusion Criteria:\n\n1. Known anemia (HIV+ males Hct\\<34; females Hct\\<32) or contraindication to donating blood\n2. Blood coagulation disorder (including bleeding tendency or problems in past with blood clots)\n3. Platelets \\< 50,000/mm3\n4. PTT \\> 2x ULN\n5. INR \\> 1.5\n6. Pregnant'}, 'identificationModule': {'nctId': 'NCT01202305', 'briefTitle': 'The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies', 'orgStudyIdInfo': {'id': '10-03606'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV negative', 'interventionNames': ['Procedure: Lymph node biopsy']}, {'label': 'HIV positive', 'interventionNames': ['Procedure: Lymph node biopsy']}], 'interventions': [{'name': 'Lymph node biopsy', 'type': 'PROCEDURE', 'description': 'Inguinal lymph node biopsy', 'armGroupLabels': ['HIV negative', 'HIV positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marian Kerbleski, RN', 'role': 'CONTACT', 'email': 'Marian.Kerbleski@ucsf.edu', 'phone': '415-476-4082', 'phoneExt': '144'}, {'name': 'Steven Deeks, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Rebecca Hoh, RD', 'role': 'CONTACT', 'email': 'Rebecca.Hoh@ucsf.edu', 'phone': '415-502-2453'}], 'overallOfficials': [{'name': 'Steven Deeks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}