Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
Study NCT ID:
NCT00062660
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2016-11-30
First Post:
2003-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C107201', 'term': 'tipranavir'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-29', 'studyFirstSubmitDate': '2003-06-10', 'studyFirstSubmitQcDate': '2003-06-11', 'lastUpdatePostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To provide early access to tipranavir and evaluate the safety and tolerance of tipranavir combined with low dose of ritonavir in patients with progressive, HIV-1 disease who have failed or are intolerant to currently approved treatments for HIV infection, who are unable to participate in another tipranavir controlled clinical trial and have an urgent need for anti-HIV treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nPatients aho have a positive serology HIV antibody test confirmed by Western blot, p24 antigen assay, HIV-1 RNA or HIV culture and are highly pre-treated and virus resistant to multiple protease inhibitors.'}, 'identificationModule': {'nctId': 'NCT00062660', 'briefTitle': 'Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Open Label Safety Study to Evaluate the Safety of Tipranavir Plus Ritonavir When Used in Combination With Other Agents for the Treatment of Patients With HIV Infection Who Have Failed and/or Are Intolerant to Combination Antiretroviral Therapy and Have Limited Treatment Options', 'orgStudyIdInfo': {'id': '1182.58'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tipranavir', 'type': 'DRUG', 'description': 'Tipranavir 250 mg soft elastic capsules'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': '1182.58.31', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': '1182.58.29', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': '1182.58.34 Campus Code 696446', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': '1182.58.42 Synergy Hematology/Oncology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': '1182.58.43', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': '1182.58.03', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': '1182.58.33 Kaiser Permanente Medical Center, Clinical Trials Unit', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Los Angeles', 'state': 'Connecticut', 'country': 'United States', 'facility': '1182.58.37 AIDS Health Care Foundation'}, {'city': 'Norwalk', 'state': 'Connecticut', 'country': 'United States', 'facility': '1182.58.41 Circle Medical, LLC', 'geoPoint': {'lat': 41.1176, 'lon': -73.4079}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': '1182.58.28', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Miami Beach', 'state': 'Florida', 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{'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': '1182.58.06 University of Cincinnati Medical Center, Infectious diseases', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': '1182.58.35', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': '1182.58.14', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': '1182.58.20 University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': '1182.58.01 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': '1182.58.10 Comprehensive Care Center', 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