Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:57 PM
Study NCT ID:
NCT01024556
Status:
COMPLETED
Last Update Posted:
2016-03-04
First Post:
2009-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study on Anti-Tat Immune Response in HIV-1-infected HAART-treated Adult Subjects
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_WITH_DNA', 'description': 'whole blood, serum, PBMCs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-03', 'studyFirstSubmitDate': '2009-12-01', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of anti-Tat antibodies in sera of subjects, and of the proliferative response (CFSE) and the production of γIFN, IL-4 and IL-2 (Elispot) by peripheral blood mononuclear cells (PBMC) in response to Tat.'}], 'secondaryOutcomes': [{'measure': 'The decline of CD4+ T cell counts, the increase of HIV plasma viral load or the occurrence of AIDS-defining events were assessed to determine progression to disease.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV, HAART'], 'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '9789051', 'type': 'BACKGROUND', 'citation': 'Andre P, Groettrup M, Klenerman P, de Giuli R, Booth BL Jr, Cerundolo V, Bonneville M, Jotereau F, Zinkernagel RM, Lotteau V. An inhibitor of HIV-1 protease modulates proteasome activity, antigen presentation, and T cell responses. Proc Natl Acad Sci U S A. 1998 Oct 27;95(22):13120-4. doi: 10.1073/pnas.95.22.13120.'}, {'pmid': '2990040', 'type': 'BACKGROUND', 'citation': 'Arya SK, Guo C, Josephs SF, Wong-Staal F. Trans-activator gene of human T-lymphotropic virus type III (HTLV-III). Science. 1985 Jul 5;229(4708):69-73. doi: 10.1126/science.2990040.'}, {'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': '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.'}, {'pmid': '23152803', 'type': 'BACKGROUND', 'citation': 'Monini P, Cafaro A, Srivastava IK, Moretti S, Sharma VA, Andreini C, Chiozzini C, Ferrantelli F, Cossut MR, Tripiciano A, Nappi F, Longo O, Bellino S, Picconi O, Fanales-Belasio E, Borsetti A, Toschi E, Schiavoni I, Bacigalupo I, Kan E, Sernicola L, Maggiorella MT, Montin K, Porcu M, Leone P, Leone P, Collacchi B, Palladino C, Ridolfi B, Falchi M, Macchia I, Ulmer JB, Butto S, Sgadari C, Magnani M, Federico MP, Titti F, Banci L, Dallocchio F, Rappuoli R, Ensoli F, Barnett SW, Garaci E, Ensoli B. HIV-1 tat promotes integrin-mediated HIV transmission to dendritic cells by binding Env spikes and competes neutralization by anti-HIV antibodies. PLoS One. 2012;7(11):e48781. doi: 10.1371/journal.pone.0048781. Epub 2012 Nov 13.'}, {'pmid': '24961156', 'type': 'BACKGROUND', 'citation': 'Bellino S, Tripiciano A, Picconi O, Francavilla V, Longo O, Sgadari C, Paniccia G, Arancio A, Angarano G, Ladisa N, Lazzarin A, Tambussi G, Nozza S, Torti C, Foca E, Palamara G, Latini A, Sighinolfi L, Mazzotta F, Di Pietro M, Di Perri G, Bonora S, Mercurio VS, Mussini C, Gori A, Galli M, Monini P, Cafaro A, Ensoli F, Ensoli B. The presence of anti-Tat antibodies in HIV-infected individuals is associated with containment of CD4+ T-cell decay and viral load, and with delay of disease progression: results of a 3-year cohort study. Retrovirology. 2014 Jun 24;11:49. doi: 10.1186/1742-4690-11-49.'}, {'pmid': '25250026', 'type': 'BACKGROUND', 'citation': 'Ensoli B, Cafaro A, Monini P, Marcotullio S, Ensoli F. Challenges in HIV Vaccine Research for Treatment and Prevention. Front Immunol. 2014 Sep 8;5:417. doi: 10.3389/fimmu.2014.00417. eCollection 2014.'}, {'pmid': '25924841', 'type': 'BACKGROUND', 'citation': 'Ensoli F, Cafaro A, Casabianca A, Tripiciano A, Bellino S, Longo O, Francavilla V, Picconi O, Sgadari C, Moretti S, Cossut MR, Arancio A, Orlandi C, Sernicola L, Maggiorella MT, Paniccia G, Mussini C, Lazzarin A, Sighinolfi L, Palamara G, Gori A, Angarano G, Di Pietro M, Galli M, Mercurio VS, Castelli F, Di Perri G, Monini P, Magnani M, Garaci E, Ensoli B. HIV-1 Tat immunization restores immune homeostasis and attacks the HAART-resistant blood HIV DNA: results of a randomized phase II exploratory clinical trial. Retrovirology. 2015 Apr 29;12:33. doi: 10.1186/s12977-015-0151-y.'}, {'pmid': '26096836', 'type': 'BACKGROUND', 'citation': 'Cafaro A, Tripiciano A, Sgadari C, Bellino S, Picconi O, Longo O, Francavilla V, Butto S, Titti F, Monini P, Ensoli F, Ensoli B. Development of a novel AIDS vaccine: the HIV-1 transactivator of transcription protein vaccine. Expert Opin Biol Ther. 2015;15 Suppl 1:S13-29. doi: 10.1517/14712598.2015.1021328. Epub 2015 Jun 22.'}, {'pmid': '21085635', 'type': 'RESULT', 'citation': 'Ensoli B, Bellino S, Tripiciano A, Longo O, Francavilla V, Marcotullio S, Cafaro A, Picconi O, Paniccia G, Scoglio A, Arancio A, Ariola C, Ruiz Alvarez MJ, Campagna M, Scaramuzzi D, Iori C, Esposito R, Mussini C, Ghinelli F, Sighinolfi L, Palamara G, Latini A, Angarano G, Ladisa N, Soscia F, Mercurio VS, Lazzarin A, Tambussi G, Visintini R, Mazzotta F, Di Pietro M, Galli M, Rusconi S, Carosi G, Torti C, Di Perri G, Bonora S, Ensoli F, Garaci E. Therapeutic immunization with HIV-1 Tat reduces immune activation and loss of regulatory T-cells and improves immune function in subjects on HAART. PLoS One. 2010 Nov 11;5(11):e13540. doi: 10.1371/journal.pone.0013540.'}, {'pmid': '33839064', 'type': 'DERIVED', 'citation': 'Tripiciano A, Picconi O, Moretti S, Sgadari C, Cafaro A, Francavilla V, Arancio A, Paniccia G, Campagna M, Pavone-Cossut MR, Sighinolfi L, Latini A, Mercurio VS, Pietro MD, Castelli F, Saracino A, Mussini C, Perri GD, Galli M, Nozza S, Ensoli F, Monini P, Ensoli B. Anti-Tat immunity defines CD4+ T-cell dynamics in people living with HIV on long-term cART. EBioMedicine. 2021 Apr;66:103306. doi: 10.1016/j.ebiom.2021.103306. Epub 2021 Apr 7.'}], 'seeAlsoLinks': [{'url': 'http://www.hiv1tat-vaccines.info', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The present study is designed as a prospective observational study directed at evaluating the frequency, magnitude, quality and persistence (primary endpoint) of the anti-Tat immune response in highly active antiretroviral therapy (HAART)-receiving HIV-1 infected individuals, and to prospectively evaluate the immunological, virological and clinical outcome of anti-Tat positive versus anti-Tat negative subjects under successful HAART (secondary endpoint), in order to determine the impact of anti-Tat immunity on HIV disease progression as well as the potential use of anti-Tat immune response assessment for the clinical and therapeutic management of HAART-treated infected patients. This survey provided important information for the design, planning and conduction of future therapeutic vaccine trials based on the HIV-1 Tat protein in HAART-treated patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hiv-1-infected haart-treated adult subjects', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of HIV-1 infection\n* To be under successful HAART treatment with plasma viremia \\<50 copies/ml in the last 6 months prior to initiation of the study, without a history of virologic rebound\n* Known CD4+ T cells nadir\n* Age ≥ 18 years old\n* Signed informed consent\n\nExclusion Criteria:\n\n* Current therapy with immunomodulators or immunosuppressive drugs, or chemotherapy for neoplastic disorders\n* Concomitant treatment for HBV or HCV infection'}, 'identificationModule': {'nctId': 'NCT01024556', 'acronym': 'ISS OBS T-002', 'briefTitle': 'Observational Study on Anti-Tat Immune Response in HIV-1-infected HAART-treated Adult Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Superiore di Sanità'}, 'officialTitle': 'Observational Study With Additional Diagnostic Procedures on Anti-Tat Immune Response in HIV-1-infected HAART-treated Adult Subjects', 'orgStudyIdInfo': {'id': 'ISS OBS T-002'}}, 'contactsLocationsModule': {'locations': [{'city': 'Latina', 'state': 'Rome', 'country': 'Italy', 'facility': 'S.M. Goretti Hospital', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}, {'city': 'Bari', 'country': 'Italy', 'facility': 'General Hospital of Bari', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Ferrara', 'country': 'Italy', 'facility': 'General Hospital-University of Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'A.M. Annunziata Hospital', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'L. Sacco Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'San Raffaele Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '41100', 'city': 'Modena', 'country': 'Italy', 'facility': 'General Hospital-University of Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'San Gallicano Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Amedeo di Savoia Hospital', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Roberto Esposito, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero - Universitaria Policlinico di Modena, Modena, Italy'}, {'name': 'Giovanni Di Perri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amedeo di Savoia Hospital, Turin, Italy'}, {'name': 'Adriano Lazzarin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Raffaele Hospital - Milan, Italy'}, {'name': 'Massimo Galli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'L. Sacco Hospital- Milan, Italy'}, {'name': 'Giampiero Carosi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '"Spedali Civili" di Brescia , Brescia, Italy'}, {'name': 'Florio Ghinelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero - Universitaria di Ferrara, Ferrara, Italy'}, {'name': 'Francesco Mazzotta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'S. M. Annunziata Hospital, Florence, Italy'}, {'name': 'Guido Palamara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'S. Gallicano Hospital- Rome, Italy'}, {'name': 'Fabrizio Soscia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'S. M. Goretti Hospital- Latina, Italy'}, {'name': 'Giuseppe Pastore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '"Ospedale Policlinico Consorziale"-Bari, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barbara Ensoli, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PHD', 'investigatorFullName': 'Barbara Ensoli, MD', 'investigatorAffiliation': 'Istituto Superiore di Sanità'}}}}