Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT00144105
Status:
TERMINATED
Last Update Posted:
2013-11-01
First Post:
2005-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.
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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 562}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-02'}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-31', 'studyFirstSubmitDate': '2005-09-02', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is the proportion of treatment responders at 48 weeks. A treatment responder is a patient with a viral load (VL) less than 50 copies/mL measured at two consecutive visits without prior rebound or change of ARV therapy.'}], 'secondaryOutcomes': [{'measure': 'Further analyses to evaluate the primary endpoint at 24, 96, and 156 weeks. Secondary endpoints include proportion of patients with VL< 400 copies/mL, change from baseline in CD4+ cell counts at each visit, time to a new CDC class C progression event.'}]}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Evaluation of safety and efficacy of Tipranavir (TPV) boosted with Ritonavir (RTV) versus an active control arm (Lopinavir / RTV) in antiretroviral (ARV) therapy naïve HIV-1 infected patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent prior to trial participation.\n2. HIV-1 infected males or females \\>= 18 years of age.\n3. No previous ARV therapy.\n4. Any CD4+ T lymphocyte count \\< 500 cells / µl.\n5. HIV-1 viral load \\>= 5000 copies/mL at screening.\n6. Screening laboratory values that indicate adequate baseline organ function.\n7. A prior AIDS defining event is acceptable as long as it has resolved or the subject has been on stable treatment (e.g. opportunistic infection; no ARV) for at least 2 weeks before screening\n\nExclusion criteria:\n\n1. Female patients of child-bearing potential who:\n\n * have a positive serum pregnancy test at screening or during the study,\n * are breast feeding,\n * are planning to become pregnant\n2. Use of investigational medications within 30 days before study entry or during the trial'}, 'identificationModule': {'nctId': 'NCT00144105', 'briefTitle': 'A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomised, Open Label, Active Controlled Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir Plus 100 mg or 200 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Comparison to 400 mg Lopinavir Plus 100 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Antiretroviral Therapy Naive Patients for 48 With Extension up to 156 Weeks', 'orgStudyIdInfo': {'id': '1182.33'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TPV500mg/RTV200mgBID', 'type': 'DRUG'}, {'name': 'TPV500mg/RTV100mgBID', 'type': 'DRUG'}, {'name': 'LPV400mg/RTV100mgBID', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'BsAs', 'country': 'Argentina', 'facility': 'Boehringer Ingelheim Investigational Site'}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundacion Huesped', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital de Agudos Teodoro Alvarez', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Haedo', 'country': 'Argentina', 'facility': 'Hospital Posadas', 'geoPoint': {'lat': -34.64239, 'lon': -58.59212}}, {'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St Vincents Hospital;', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'city': 'Liverpool', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'city': 'Surry Hills', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -33.88374, 'lon': 151.21282}}, {'city': 'Carlton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -37.8, 'lon': 144.96667}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'South Yarra', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': -37.83834, 'lon': 144.99149}}, {'city': 'Campinas - Sp', 'country': 'Brazil', 'facility': 'Unidade de Pesquisa Clínica (UPC) - AIDS'}, {'city': 'Curitiba - PR', 'country': 'Brazil', 'facility': 'Boehringer Ingelheim Investigational Site'}, {'city': 'Manguinhos - Rio de Janeiro - RJ', 'country': 'Brazil', 'facility': 'Boehringer Ingelheim Investigational Site'}, {'city': 'Mooca / São Paulo', 'country': 'Brazil', 'facility': 'Instituto de Crianca / Hospital das Clínicas-FMUSP'}, {'city': 'Nova Iguaçu - RJ', 'country': 'Brazil', 'facility': 'Hospital Geral de Nova Iguaçu - Ministério da Saúde'}, {'city': 'Rio de Janeiro - RJ', 'country': 'Brazil', 'facility': 'Universidade Federal do Rio de Janeiro'}, {'city': 'Sacoma - São Paulo', 'country': 'Brazil', 'facility': 'Hospital Dia'}, {'city': 'Salvador - BA', 'country': 'Brazil', 'facility': 'Universidade Federal da Bahia-Unidade Docente Assistencial d'}, {'city': 'Santos - Sp', 'country': 'Brazil', 'facility': 'Boehringer Ingelheim Investigational Site'}, {'city': 'São Paulo - Sp', 'country': 'Brazil', 'facility': 'Hospital do Servidor Público Estadual de São Paulo'}, {'city': 'São Paulo - SP', 'country': 'Brazil', 'facility': 'I.I. Emilio Ribas - Moléstias Infecciosas'}, {'city': 'São Paulo - SP', 'country': 'Brazil', 'facility': 'Instituto de Infectologia Emílio Ribas'}, {'city': 'São Paulo - Sp', 'country': 'Brazil', 'facility': 'UNIFESP/ Hospital São Paulo- Univers. 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