Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-02-20 @ 8:25 PM
Study NCT ID:
NCT00614302
Status:
COMPLETED
Last Update Posted:
2009-10-02
First Post:
2008-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Population
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 428}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'lastUpdateSubmitDate': '2009-10-01', 'studyFirstSubmitDate': '2008-01-31', 'studyFirstSubmitQcDate': '2008-02-12', 'lastUpdatePostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study in the clinical practice the choice of a specific salvage regimen for multiexperienced patients.', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': 'Reason of each VL failure or switching', 'timeFrame': '48 weeks'}]}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Data collection for better patient characterization in a highly treatment experienced population. Studying the clinical practice for the treatment of HIV multiexperienced patients in the real life.\n\nThe research will be divided into two phases:\n\n* The first phase intends to define and understand the clinical practice using a questionnaire about general topics: definitions of multiexperienced patients and VL failure, therapeutic strategies and behaviour in particular cases.\n* The second part of the research will collect the clinical data of double PIs failure patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients double PIs failure\n\nExclusion Criteria:\n\nNot Applicable'}, 'identificationModule': {'nctId': 'NCT00614302', 'briefTitle': 'Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Patient Population', 'orgStudyIdInfo': {'id': '1182.130'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TPV', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ancona', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Bari', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Benevento', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.1307, 'lon': 14.77816}}, {'city': 'Bisceglie', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.24264, 'lon': 16.50104}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Busto', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site'}, {'city': 'Caserta', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 41.07262, 'lon': 14.33231}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Cremona', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.13325, 'lon': 10.02129}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Legnano', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.59788, 'lon': 8.91506}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Palermo', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Pavia', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Sassari', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Boehringer Ingelheim, Study Chair', 'oldOrganization': 'Boehringer Ingelheim'}}}}