Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-29 @ 1:34 PM
Study NCT ID:
NCT01024595
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
2009-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood, serum, PBMCs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-28', 'studyFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2009-12-02', 'lastUpdatePostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the persistence of specific immune responses, volunteers will be monitored for anti-Tat specific antibodies, anti-Tat proliferative response and in vitro γIFN and IL-4 production in response to Tat (Elispot).'}], 'secondaryOutcomes': [{'measure': 'To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'Tat protein'], 'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '2184372', 'type': 'BACKGROUND', 'citation': "Ensoli B, Barillari G, Salahuddin SZ, Gallo RC, Wong-Staal F. Tat protein of HIV-1 stimulates growth of cells derived from Kaposi's sarcoma lesions of AIDS patients. Nature. 1990 May 3;345(6270):84-6. doi: 10.1038/345084a0."}, {'pmid': '8416373', 'type': 'BACKGROUND', 'citation': 'Ensoli B, Buonaguro L, Barillari G, Fiorelli V, Gendelman R, Morgan RA, Wingfield P, Gallo RC. Release, uptake, and effects of extracellular human immunodeficiency virus type 1 Tat protein on cell growth and viral transactivation. J Virol. 1993 Jan;67(1):277-87. doi: 10.1128/JVI.67.1.277-287.1993.'}, {'pmid': '7935812', 'type': 'BACKGROUND', 'citation': "Ensoli B, Gendelman R, Markham P, Fiorelli V, Colombini S, Raffeld M, Cafaro A, Chang HK, Brady JN, Gallo RC. Synergy between basic fibroblast growth factor and HIV-1 Tat protein in induction of Kaposi's sarcoma. Nature. 1994 Oct 20;371(6499):674-80. doi: 10.1038/371674a0."}, {'pmid': '17117011', 'type': 'BACKGROUND', 'citation': 'Ensoli B, Fiorelli V, Ensoli F, Cafaro A, Titti F, Butto S, Monini P, Magnani M, Caputo A, Garaci E. Candidate HIV-1 Tat vaccine development: from basic science to clinical trials. AIDS. 2006 Nov 28;20(18):2245-61. doi: 10.1097/QAD.0b013e3280112cd1. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.hiv1tat-vaccines.info', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe, well tolerated and immunogenic. The present study is intended to extend the follow-up of the volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and cellular immune responses. The results of the present study will be key for the design of future phase II trials, particularly for the definition of the optimal schedule for boosting immunizations.\n\nAll individuals (27) will be enrolled in a 120-weeks observational study and monitored every 24 weeks for the following 3 years. During these visits, which are performed within the schedule indicated for the clinical monitoring of HIV-1 infected individuals, in addition to the routine virological, hematological and biochemical assessment, the anti-Tat specific humoral and cellular immune responses will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-1 Infected subject previously included in the Phase I Clinical Trial with Tat protein', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous participation to the phase I clinical trial ISS T-001'}, 'identificationModule': {'nctId': 'NCT01024595', 'acronym': 'ISS OBS T-001', 'briefTitle': 'Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Superiore di Sanità'}, 'officialTitle': 'Observational Study of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in Hiv-1 Infected Adult Volunteers', 'orgStudyIdInfo': {'id': 'ISS OBS T-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Without treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20127', 'city': 'Milan', 'country': 'Italy', 'facility': 'San Raffaele Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '00100', 'city': 'Rome', 'country': 'Italy', 'facility': 'I.R.C.C.S. Spallanzani Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00100', 'city': 'Rome', 'country': 'Italy', 'facility': 'S. Gallicano Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Adriano Lazzarin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Raffaele Hospital - Milan, Italy'}, {'name': 'Aldo Di Carlo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'S. Gallicano Hospital- Rome, Italy'}, {'name': 'Pasquale Narciso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'I.R.C.C.S. Spallanzani Hospital, Rome'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Superiore di Sanità', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Barbara Ensoli', 'oldOrganization': 'CNAIDS - Istituto Superiore di Sanita'}}}}