Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-05 @ 8:16 PM
Study NCT ID:
NCT00006327
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D015819', 'term': 'Substance Abuse, Intravenous'}], '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': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'count': 2500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-06', 'completionDateStruct': {'date': '2000-08'}, 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2000-10-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Recombinant Proteins', 'HIV-1', 'AIDS Serodiagnosis', 'Substance Abuse, Intravenous', 'Enzyme-Linked Immunosorbent Assay', 'Blotting, Western', 'HIV Envelope Protein gp120', 'AIDSVAX'], 'conditions': ['HIV Infections', 'HIV Seronegativity']}, 'referencesModule': {'references': [{'pmid': '20079620', 'type': 'DERIVED', 'citation': 'Martin M, Vanichseni S, Suntharasamai P, Mock PA, van Griensven F, Pitisuttithum P, Tappero JW, Chiamwongpaet S, Sangkum U, Kitayaporn D, Gurwith M, Choopanya K; Bangkok Vaccine Evaluation Group. Drug use and the risk of HIV infection amongst injection drug users participating in an HIV vaccine trial in Bangkok, 1999-2003. Int J Drug Policy. 2010 Jul;21(4):296-301. doi: 10.1016/j.drugpo.2009.12.002. Epub 2010 Jan 15.'}, {'pmid': '19149819', 'type': 'DERIVED', 'citation': 'Suntharasamai P, Martin M, Vanichseni S, van Griensven F, Mock PA, Pitisuttithum P, Tappero JW, Sangkum U, Kitayaporn D, Gurwith M, Choopanya K; Bangkok Vaccine Evaluation Group. Factors associated with incarceration and incident human immunodeficiency virus (HIV) infection among injection drug users participating in an HIV vaccine trial in Bangkok, Thailand, 1999-2003. Addiction. 2009 Feb;104(2):235-42. doi: 10.1111/j.1360-0443.2008.02436.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect intravenous drug users from becoming infected with HIV.', 'detailedDescription': 'Volunteers are immunized and followed for a minimum of 2 years. Any volunteer that becomes infected with HIV-1 is followed every 4 months post infection for up to 36 months. Behavior effects associated with study participation are assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nVolunteers may be eligible for this study if they:\n\n* Are 20 to 60 years old.\n* Are HIV-negative.\n* Have used intravenous drugs in the previous 12 months.\n* Are available and commit to 3 years of follow-up.\n* Have a Thai National ID or its equivalent such as government official ID or state enterprise ID.\n* Are able to understand the study and pass a test showing they understand it, and give written informed consent.\n\nExclusion Criteria\n\nVolunteers will not be eligible for this study if they:\n\n* Have a serious disease or condition, or history of a serious disease or condition such as lymphoma, that would interfere with the study.\n* Are HIV-positive.\n* Have ever received an experimental HIV-1 vaccine.\n* Have had or expect to have any treatments or medications that interfere with the immune system (e.g., long-term use of systemic steroids, chemotherapy, or radiation).\n* Have received a vaccine or immunoglobulin within 2 weeks of receiving the first study injection, or other vaccines within 4 weeks of the first study injection.\n* Have received immunoglobulins for a long time.\n* Have received non-licensed, research agents within 4 weeks of the first study injection.\n* Expect to miss study visits or plan to move within 36 months.\n* Are pregnant or breast-feeding or plan to become pregnant during the 36-month study period.\n* Are women who have sex with men and do not plan to use effective birth control.'}, 'identificationModule': {'nctId': 'NCT00006327', 'briefTitle': 'Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Phase III Trial to Determine the Efficacy of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand', 'orgStudyIdInfo': {'id': 'VAX 003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MN rgp120/HIV-1 and A244 rgp120/HIV-1', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Klongsan / Bangkok', 'country': 'Thailand', 'facility': 'Kachit Choopanya'}], 'overallOfficials': [{'name': 'Kachit Choopanya', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VaxGen', 'class': 'INDUSTRY'}}}}