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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00062660 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Tipranavir Capsules Drug: Tipranavir Oral Solution |
| Study Type: | Expanded Access |
| Official Title: | Emergency Use Program for Highly Treatment-Experienced HIV+ Patients |
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients 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.
Contacts and Locations| Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Hide Study Locations| United States, Arizona | |
| 1182.58.31 | Completed |
| Scottsdale, Arizona, United States | |
| United States, California | |
| 1182.58.03 | Completed |
| San Francisco, California, United States | |
| 1182.58.29 | Completed |
| Los Angeles, California, United States | |
| 1182.58.42 Synergy Hematology/Oncology | Completed |
| Los Angeles, California, United States | |
| 1182.58.33 Kaiser Permanente Medical Center, Clinical Trials Unit | Completed |
| San Francisco, California, United States | |
| 1182.58.34 Campus Code 696446 | Completed |
| Los Angeles, California, United States | |
| 1182.58.43 | Completed |
| Los Angeles, California, United States | |
| United States, Connecticut | |
| 1182.58.37 AIDS Health Care Foundation | Completed |
| Los Angeles, Connecticut, United States | |
| 1182.58.41 Circle Medical, LLC | Completed |
| Norwalk, Connecticut, United States | |
| United States, District of Columbia | |
| 1182.58.28 | Completed |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| 1182.58.23 Hillsborough County Health Department | Completed |
| Tampa, Florida, United States | |
| 1182.58.40 Drs. Raben and Feldman Research Associates | Completed |
| South Miami, Florida, United States | |
| 1182.58.38 | Completed |
| Miami Beach, Florida, United States | |
| United States, Georgia | |
| 1182.58.36 Suite 525 | Completed |
| Atlanta, Georgia, United States | |
| United States, Hawaii | |
| 1182.58.08 | Completed |
| Honolulu, Hawaii, United States | |
| United States, Illinois | |
| 1182.58.22 | Completed |
| Chicago, Illinois, United States | |
| United States, Louisiana | |
| 1182.58.32 | Completed |
| New Orleans, Louisiana, United States | |
| United States, Massachusetts | |
| 1182.58.15 | Completed |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| 1182.58.19 Henry Ford Hospital | Completed |
| Detroit, Michigan, United States | |
| United States, Missouri | |
| 1182.58.04 Kansas City Free Health Clinic | Completed |
| Kansas City, Missouri, United States | |
| 1182.58.25 Wohl Clinic | Completed |
| St. Louis, Missouri, United States | |
| United States, Nevada | |
| 1182.58.02 Wellness Center | Completed |
| Las Vegas, Nevada, United States | |
| United States, New York | |
| 1182.58.09 Polari Medical Group | Completed |
| New York, New York, United States | |
| United States, North Carolina | |
| 1182.58.30 | Completed |
| Chapel Hill, North Carolina, United States | |
| United States, Ohio | |
| 1182.58.06 University of Cincinnati Medical Center, Infectious diseases | Completed |
| Cincinnati, Ohio, United States | |
| United States, Oregon | |
| 1182.58.35 | Completed |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| 1182.58.14 | Completed |
| Philadelphia, Pennsylvania, United States | |
| 1182.58.20 University of Pittsburgh | Completed |
| Pittsburgh, Pennsylvania, United States | |
| United States, South Carolina | |
| 1182.58.01 Boehringer Ingelheim Investigational Site | Completed |
| Columbia, South Carolina, United States | |
| United States, Tennessee | |
| 1182.58.10 Comprehensive Care Center | Completed |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| 1182.58.07 | Completed |
| Houston, Texas, United States | |
| 1182.58.18 University of Texas Southwest Medical Center at Dallas | Completed |
| Dallas, Texas, United States | |
| 1182.58.039 Olmos Park Medical Associates | Completed |
| San Antonio, Texas, United States | |
| United States, Washington | |
| 1182.58.11 Swedish Medical Center | Completed |
| Seattle, Washington, United States | |
| United States, Wisconsin | |
| 1182.58.44 VW Hospital and Clinics | Completed |
| Madison, Wisconsin, United States | |
| Australia, New South Wales | |
| 1182.58.61003 The Prince of Wales Hospital | Completed |
| Randwick, New South Wales, Australia | |
| 1182.58.61008 St Vincents Hospital | Completed |
| Darlinghurst, New South Wales, Australia | |
| 1182.58.61002 Royal North Shore Hospital | Completed |
| St Leonards, New South Wales, Australia | |
| 1182.58.61005 Royal Prince Alfred Hospital | Completed |
| Camperdown, New South Wales, Australia | |
| 1182.58.61006 Albion Street Clinic | Completed |
| Surry Hills, New South Wales, Australia | |
| 1182.58.61025 Immunology Department | Completed |
| Westmead, New South Wales, Australia | |
| 1182.58.61012 Bigge Park Centre | Completed |
| Liverpool, New South Wales, Australia | |
| 1182.58.61011 St Vincents Hospital | Completed |
| Darlinghurst, New South Wales, Australia | |
| 1182.58.61007 407 Doctors Pty Ltd | Completed |
| Darlinghusrst, New South Wales, Australia | |
| 1182.58.61019 407 Bouke Street | Completed |
| Darlinghusrst, New South Wales, Australia | |
| 1182.58.61014 St Vincents Hospital | Completed |
| Darlinghurst, New South Wales, Australia | |
| 1182.58.61022 Sexual Health Clinic | Completed |
| Kingswood, New South Wales, Australia | |
| Australia, Queensland | |
| 1182.58.61016 Princess Alexandra Hospital | Completed |
| Woolloongabba, Queensland, Australia | |
| 1182.58.61024 | Completed |
| Nambour, Queensland, Australia | |
| 1182.58.61009 Level 6 | Completed |
| Herston, Queensland, Australia | |
| 1182.58.61010 Biala Building | Completed |
| Brisbane, Queensland, Australia | |
| Australia, South Australia | |
| 1182.58.61020 | Completed |
| Adelaide, South Australia, Australia | |
| 1182.58.61015 Flinders Medical Centre | Completed |
| Bedford Park, South Australia, Australia | |
| Australia, Victoria | |
| 1182.58.61001 88 Rathdowne Street Carlton | Completed |
| Carlton, Victoria, Australia | |
| 1182.58.61017 Department of Infectious Diseases | Completed |
| Clayton, Victoria, Australia | |
| 1182.58.61023 | Completed |
| Melbourne, Victoria, Australia | |
| 1182.58.61013 Melbourne Sexual Health Clinic | Completed |
| Melbourne, Victoria, Australia | |
| 1182.58.61018 Melbourne Sexual Health Clinic | Completed |
| Carlton, Victoria, Australia | |
| 1182.58.61021 | Completed |
| South Yarra, Victoria, Australia | |
| Australia, Western Australia | |
| 1182.58.61004 Royal Perth Hospital | Completed |
| Perth, Western Australia, Australia | |
| Belgium | |
| 1182.58.3201 Boehringer Ingelheim Investigational Site | Completed |
| Antwerpen, Belgium | |
| 1182.58.3202 Boehringer Ingelheim Investigational Site | Completed |
| Bruxelles, Belgium | |
| 1182.58.3204 Boehringer Ingelheim Investigational Site | Completed |
| Liège, Belgium | |
| 1182.58.3203 Boehringer Ingelheim Investigational Site | Completed |
| Bruxelles, Belgium | |
| Denmark | |
| 1182.58.4501 Afsnit M 5112 | Completed |
| Copenhagen Ø, Denmark | |
| 1182.58.4504 C Ambulatoriet | Completed |
| Odense C, Denmark | |
| 1182.58.4505 Infektionsmedicinsk ambulatorie Q | Completed |
| Århus C, Denmark | |
| France | |
| 1182.58.33001 Hôpital Saint Jacques | Completed |
| Besançon Cedex, France | |
| 1182.58.33002 Hôpital Purpan | Completed |
| Toulouse Cedex 9, France | |
| 1182.58.33003 Hôpital de l'Archet | Completed |
| Nice Cedex 3, France | |
| 1182.58.33005 Hôpital Bichat | Completed |
| Paris Cedex 18, France | |
| 1182.58.33006 Hôpital Bicêtre | Completed |
| Le Kremlin Bicêtre Cedex, France | |
| 1182.58.33007 Hôpital Georges Pompidou | Completed |
| Paris Cedex 15, France | |
| 1182.58.33008 Hôpital Hôtel Dieu | Completed |
| Nantes Cedex 1, France | |
| 1182.58.33009 Hôpital de la Conception | Completed |
| Marseille Cedex 5, France | |
| 1182.58.33010 Hôpital Brabois | Completed |
| Vandoeuvre Les Nancy, France | |
| 1182.58.33022 Hôpital Avicenne | Completed |
| Bobigny Cedex, France | |
| 1182.58.33023 Hôpital Sainte Marguerite | Completed |
| Marseille Cedex 9, France | |
| 1182.58.33024 Hôpital Necker | Completed |
| Paris, France | |
| 1182.58.33033 Hôpital Tenon | Completed |
| Paris Cedex 20, France | |
| 1182.58.33026 Hôpital Ponchaillou | Completed |
| Rennes Cedex 9, France | |
| 1182.58.33027 Hôpital | Completed |
| Dijon Cedex, France | |
| 1182.58.33028 Hôpital Louis Mourier | Completed |
| Colombes, France | |
| 1182.58.33029 Hôpital Aix | Completed |
| Aix En Provence Cedex 1, France | |
| 1182.58.33030 Hôpital Saint Eloi | Completed |
| Montpellier, France | |
| 1182.58.33031 Hôpital edouard Herriot | Completed |
| Lyon Cedex 3, France | |
| 1182.58.33032 Hôpital Emile Muller | Completed |
| Mulhouse Cedex 1, France | |
| 1182.58.33025 Hôpital Foch | Recruiting |
| Suresnes Cedex, France | |
| 1182.58.33034 Hôpital Raymond Poincarré | Completed |
| Garches, France | |
| 1182.58.33011 Hôpital Paul Brousse | Completed |
| Villejuif Cedex, France | |
| 1182.58.33012 Hôpital Robert Debré | Completed |
| Reims Cedex, France | |
| 1182.58.33014 Hôpital Cochin | Completed |
| Paris Cedex 14, France | |
| 1182.58.33015 Hôpital Civil | Completed |
| Strasbourg Cedex, France | |
| 1182.58.33019 Hôpital de l'Hôtel Dieu | Completed |
| Lyon Cedex 2, France | |
| 1182.58.33017 Hôpital Bichat Claude Bernard | Completed |
| Paris Cedex 18, France | |
| 1182.58.33018 Hôpital Saint Antoine | Completed |
| Paris, France | |
| 1182.58.33016 | Completed |
| Tourcoing, France | |
| 1182.58.33020 Hôpital Antoine Beclère | Completed |
| Clamart Cedex, France | |
| 1182.58.33021 Hôpital Chalucet | Completed |
| Toulon Cedex, France | |
| 1182.58.33013 Hôpital Saint Louis | Completed |
| Paris Cedex 10, France | |
| 1182.58.33035 Hôpital des Abîmes | Completed |
| Pointe A Pitre, France | |
| Greece | |
| 1182.58.3001 | Completed |
| Athens, Greece | |
| Ireland | |
| 1182.58.44016 St James Hospital, Dept of Genito Urinary Medicine | Completed |
| Dublin, Ireland | |
| 1182.58.44029 Our Lady For Sick Children | Completed |
| Dublin 12, Ireland | |
| Italy | |
| 1182.58.3901 Ospedale Luigi Sacco | Completed |
| Milano, Italy | |
| 1182.58.3902 Ospedale L. Sacco | Completed |
| Milano, Italy | |
| 1182.58.3903 Università di Brescia | Completed |
| Brescia, Italy | |
| 1182.58.3904 Ospedali Riuniti di Foggia | Completed |
| Foggia, Italy | |
| 1182.58.3905 Presidio Dalmati | Completed |
| S. Angelo Lodigiano (lo), Italy | |
| 1182.58.3906 Ospedale Infantile Regina Margherita | Completed |
| Torino, Italy | |
| 1182.58.3907 Presidio Ospedaliero di Rimini | Completed |
| Rimini, Italy | |
| 1182.58.3908 Centro Medicina Preventiva | Completed |
| Verona, Italy | |
| Portugal | |
| 1182.58.35102 Hospital de dia de Doenças Infecciosas | Recruiting |
| Cascais, Portugal | |
| Switzerland | |
| 1182.58.4101 Boehringer Ingelheim Investigational Site | Completed |
| Basel, Switzerland | |
| 1182.58.4103 Boehringer Ingelheim Investigational Site | Completed |
| Bern, Switzerland | |
| 1182.58.4104 Boehringer Ingelheim Investigational Site | Completed |
| Genève, Switzerland | |
| 1182.58.4105 Boehringer Ingelheim Investigational Site | Completed |
| Zürich, Switzerland | |
| 1182.58.4107 Boehringer Ingelheim Investigational Site | Recruiting |
| Genève, Switzerland | |
| 1182.58.4102 Boehringer Ingelheim Investigational Site | Completed |
| Zürich, Switzerland | |
| United Kingdom | |
| 1182.58.44002 Boehringer Ingelheim Investigational Site | Completed |
| Cardiff, United Kingdom | |
| 1182.58.44003 Boehringer Ingelheim Investigational Site | Completed |
| London, United Kingdom | |
| 1182.58.44004 Boehringer Ingelheim Investigational Site | Completed |
| Brighton, United Kingdom | |
| 1182.58.44005 Boehringer Ingelheim Investigational Site | Completed |
| London, United Kingdom | |
| 1182.58.44010 Boehringer Ingelheim Investigational Site | Completed |
| London, United Kingdom | |
| 1182.58.44031 Boehringer Ingelheim Investigational Site | Completed |
| London, United Kingdom | |
| 1182.58.44014 Boehringer Ingelheim Investigational Site | Completed |
| London, United Kingdom | |
| 1182.58.44008 Boehringer Ingelheim Investigational Site | Completed |
| London, United Kingdom | |
| 1182.58.44009 Boehringer Ingelheim Investigational Site | Completed |
| Edinburgh, United Kingdom | |
| 1182.58.44017 Boehringer Ingelheim Investigational Site | Completed |
| London, United Kingdom | |
| 1182.58.44023 Boehringer Ingelheim Investigational Site | Completed |
| Harrow, United Kingdom | |
| 1182.58.44024 Boehringer Ingelheim Investigational Site | Completed |
| Leeds, United Kingdom | |
| 1182.58.44025 Boehringer Ingelheim Investigational Site | Completed |
| Chertsey, United Kingdom | |
| 1182.58.44026 Boehringer Ingelheim Investigational Site | Completed |
| London, United Kingdom | |
| 1182.58.44027 Boehringer Ingelheim Investigational Site | Completed |
| London, United Kingdom | |
| 1182.58.44028 Boehringer Ingelheim Investigational Site | Completed |
| London, United Kingdom | |
| 1182.58.44018 Boehringer Ingelheim Investigational Site | Completed |
| London, United Kingdom | |
| 1182.58.44019 Boehringer Ingelheim Investigational Site | Completed |
| Chichester, United Kingdom | |
| 1182.58.44020 Beckenham Hospital | Completed |
| Beckenham, United Kingdom | |
| 1182.58.44022 Boehringer Ingelheim Investigational Site | Completed |
| Woolwich, United Kingdom | |
| 1182.58.44030 Boehringer Ingelheim Investigational Site | Completed |
| Woolwich, United Kingdom | |
| 1182.58.44011 Boehringer Ingelheim Investigational Site | Completed |
| Peterborough, United Kingdom | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 1182.58 |
| Study First Received: | June 10, 2003 |
| Last Updated: | November 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00062660 History of Changes |
| Health Authority: | Australia:; Austria: Federal Ministry for Health and Women; Belgium: Federal Agency for Medicines and Health Products; Canada: Health Canada; Denmark: The Ministry of the Interior and Health; France: Ministry of Health; Great Britain:; Ireland: Ministry of Health; Italy: Ministry of Health; Netherlands: Ministry of Health, Welfare and Sport; Portugal: National Pharmacy and Medicines Institute; Romania: Ministry of Public Health; South Africa:; Spain: Ministry of Health; Switzerland: Federal Office of Public Health; United States: Food and Drug Administration |
|
Anti-Infective Agents Disease Attributes RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Tipranavir Virus Diseases Pathologic Processes Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Emergencies Retroviridae Infections |
