Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-30 @ 3:53 PM
Study NCT ID:
NCT00517569
Status:
UNKNOWN
Last Update Posted:
2008-05-12
First Post:
2007-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gene Therapy With GX-12 in Combination With HAART for the HIV-1 Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D023241', 'term': 'Antiretroviral Therapy, Highly Active'}], 'ancestors': [{'id': 'D004359', 'term': 'Drug Therapy, Combination'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-05-08', 'studyFirstSubmitDate': '2007-08-16', 'studyFirstSubmitQcDate': '2007-08-16', 'lastUpdatePostDateStruct': {'date': '2008-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: adverse events and laboratory abnormalities', 'timeFrame': '36 weeks'}], 'secondaryOutcomes': [{'measure': 'Primary efficacy endpoint: plasma viral load Secondary efficacy endpoint: CD4 counts and HIV-1 Antigen specific IFN-gamma expressed T-lymphocytes', 'timeFrame': '24, 28, 32 and 36 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gene Therapy', 'GX-12', 'HIV-1', 'Interleukin', 'AIDS', 'HIV-1 type B infection', 'Treatment Naive'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety of GX-12 gene therapy combined with HAART in the HIV-1 infected patients and to investigate the efficacy with the value of plasma viral load and with CD4 counts and HIV-1 specific IFN-gamma expressed T-lymphocytes', 'detailedDescription': 'Currently, management of HIV infection and AIDS is mainly done by antiviral chemotherapy which inhibits reverse transcriptase or proteolytic enzyme. The HAART (highly active antiretroviral therapy) has indeed succeeded extraordinary in decrease of the mortality and in increase of the life expediency of AIDS patients. However, there have been some significant limitations of them (for example, treatment fatigues, the side effects, the emergency of resistant, high medical costs, etc.).\n\nRecently, there has been a number of bioresearch for immunotherapy to overcome these limitations of current medications. GX-12 is a genetic using a naked DNA with human IL-12 mutant as immune adjuvant. GX-12 is designed to vaccinate the individuals with HIV antigens, which is to result in enhancing the HIV specific immunity and to expand broadly the immune responses nonspecifically.\n\nIn this study, the safety and efficacy of GX-12 will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged between 18 and 50 years\n* HIV-1 type B infected but asymptomatic patient\n* Patient who has received HAART less than 6 months according to the standard management guidelines and reached to aviremia\n* Patient with appropriate immunity (i.e., CD4 counts\\>=400cells/ul and SI\\>3 by CD4+ T-cell proliferation in vitro assay)\n* Patient with negative HBV and HCV\n* Woman who is not childbearing or who has used any contraceptive at least for 3 months before study entry\n* Patients given a written consent\n\nExclusion Criteria:\n\n* Patient who has received other investigational drug or who participated into other study within 30 days before this study\n* Patient who had an experience of hypersensitivity to same drug (for example: a plasmid DNA, etc)\n* Patient who has received an immunosuppressant\n* Patient who has received other HIV vaccine\n* Patient who has received other interleukin(s)\n* Patient who experienced an opportunistic infection defined as AIDS before this study\n* Patient with any severe recurrent diarrhea or vomiting\n* Patient with clinically significant acute or chronic liver dysfunction, kidney dysfunction, hematological disorder, endocrine disorder, immune disorder, heart disease, infection, etc.\n* Patient with malignant tumor(s)\n* Patient with alcohol or drug abuse\n* Patient of potential harm due to drug interactions by HAART\n* Woman of pregnancy (positive pregnancy test) or beast feeding\n* Patient who is not appropriate at investigator's discretion, not specified in above"}, 'identificationModule': {'nctId': 'NCT00517569', 'briefTitle': 'Gene Therapy With GX-12 in Combination With HAART for the HIV-1 Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genexine, Inc.'}, 'officialTitle': 'Phase I Study for Assessment of Safety of Gene Therapy With GX-12 in Combination With HAART for the HIV-1 Infected Patients', 'orgStudyIdInfo': {'id': 'GX-12_HIV_I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'GX-12 combined with HAART', 'interventionNames': ['Genetic: GX-12', 'Drug: HAART']}], 'interventions': [{'name': 'GX-12', 'type': 'GENETIC', 'description': 'a mixed plasma DNA (HIV-1 antigen genes and human IL-12 mutant) 4, 8, 16mg, i.m., once every other weeks for 22 weeks (total 12 times)', 'armGroupLabels': ['1']}, {'name': 'HAART', 'type': 'DRUG', 'description': 'Highly active antiretroviral therapy; Discontinuation at 24 weeks; NB: The patients should be treated with 2 NRTIs+1 NNRTI or 2 NRTIs + 1 PI, according to the guidelines published by DHHS in the USA.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'MYOUNG-DON OH, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'mdohmd@snu.ac.kr', 'phone': '+82-2-2072-2211'}], 'overallOfficials': [{'name': 'KANG-WON CHOE, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genexine, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Seoul National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof. Kang-Won Choe / Principal Investigator', 'oldOrganization': 'Seoul National University Hospital'}}}}