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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00056641 |
Purpose
This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients.
The primary objective is to determine the safety and pharmacokinetics of:
TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: tipranavir Drug: ritonavir Drug: saquinavir Drug: amprenavir Drug: lopinavir |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | An Open Label, Randomised, Parallel Group Pharmacokinetics Trial of TPV/RTV Alone or in Combination With RTV-Boosted SQV, APV or LPV, Plus an OBR in Multiple ARV Experienced Patients. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Boehringer Ingelheim Investigational Site | |
| Phoenix, Arizona, United States | |
| United States, California | |
| Boehringer Ingelheim Investigational Site | |
| Los Angeles, California, United States | |
| Boehringer Ingelheim Investigational Site | |
| San Francisco, California, United States | |
| San Francisco VAMC | |
| San Francisco, California, United States | |
| Boehringer Ingelheim Investigational Site | |
| Fountain Valley, California, United States | |
| Boehringer Ingelheim Investigational Site | |
| Berkeley, California, United States | |
| Kaiser Permanente Medical Center | |
| San Francisco, California, United States | |
| United States, Connecticut | |
| Boehringer Ingelheim Investigational Site | |
| Norwalk, Connecticut, United States | |
| United States, District of Columbia | |
| Washington DC VA Medical Center | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| Boehringer Ingelheim Investigational Site | |
| Orlando, Florida, United States | |
| North Broward Hospital District | |
| Fort Lauderdale, Florida, United States | |
| Boehringer Ingelheim Investigational Site | |
| Fort Myers, Florida, United States | |
| Boehringer Ingelheim Investigational Site | |
| Vero Beach, Florida, United States | |
| Boehringer Ingelheim Investigational Site | |
| Miami, Florida, United States | |
| Boehringer Ingelheim Investigational Site | |
| Sarasota, Florida, United States | |
| Boehringer Ingelheim Investigational Site | |
| Tampa, Florida, United States | |
| United States, Georgia | |
| Mercer University School of Medicine | |
| Macon, Georgia, United States | |
| Boehringer Ingelheim Investigational Site | |
| Atlanta, Georgia, United States | |
| United States, Kentucky | |
| University of Kentucky Medical Center | |
| Lexington, Kentucky, United States | |
| United States, Massachusetts | |
| Boehringer Ingelheim Investigational Site | |
| Boston, Massachusetts, United States | |
| Boehringer Ingelheim Investigational Site | |
| Springfield, Massachusetts, United States | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States | |
| United States, New Mexico | |
| Boehringer Ingelheim Investigational Site | |
| Santa Fe, New Mexico, United States | |
| United States, New York | |
| University of New York, Stony Brook | |
| Stony Brook, New York, United States | |
| Albany Medical College | |
| Albany, New York, United States | |
| Boehringer Ingelheim Investigational Site | |
| New York, New York, United States | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States | |
| Boehringer Ingelheim Investigational Site | |
| Huntersville, North Carolina, United States | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| United States, Texas | |
| UT Southwestern | |
| Dallas, Texas, United States | |
| Boehringer Ingelheim Investigational Site | |
| Houston, Texas, United States | |
| United States, Virginia | |
| Boehringer Ingelheim Investigational Site | |
| Annandale, Virginia, United States | |
| United States, Washington | |
| Boehringer Ingelheim Investigational Site | |
| Tacoma, Washington, United States | |
| Australia, New South Wales | |
| St. Vincent's Hospital | |
| Darlinghurst, New South Wales, Australia | |
| Boehringer Ingelheim Investigational Site | |
| Darlinghurst, New South Wales, Australia | |
| Belgium | |
| Centre Hospitalier Universitaire St. Pierre | |
| Bruxelles, Belgium | |
| Instituut Tropische Geneeskunde | |
| Antwerpen, Belgium | |
| U.Z. Gent | |
| Gent, Belgium | |
| Canada, Ontario | |
| Canadian Immunodeficiency Research Collaborative Inc. | |
| Toronto, Ontario, Canada | |
| Boehringer Ingelheim Investigational Site | |
| Toronto, Ontario, Canada | |
| McMaster University Medical Centre | |
| Hamilton, Ontario, Canada | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Boehringer Ingelheim Investigational Site | |
| Montreal, Quebec, Canada | |
| Montreal Chest Institute - McGill University Health Centre | |
| Montreal, Quebec, Canada | |
| McGill University Health Centre, Suite A5-140 | |
| Monteal, Quebec, Canada | |
| Denmark | |
| Rigshospitalet | |
| København Ø, Denmark | |
| Hvidovre Hospital | |
| Hvidovre, Denmark | |
| Odense Universitetshospital | |
| Odense C, Denmark | |
| France | |
| Hôpital Côte de Nacre | |
| Caen, France | |
| Hôpital Antoine Beclère | |
| Clamart, France | |
| Hôpital de l'Hôtel Dieu | |
| Lyon Cedex 2, France | |
| Hôpital de l'Archet | |
| Nice cedex 3, France | |
| Hôpital Pellegrin | |
| Bordeaux cedex, France | |
| Hôpital Saint Antoine | |
| Paris, France | |
| Hôpital de la Pité Salpêtrière | |
| Paris, France | |
| Hôpital Européen Georges Pompidou | |
| Paris, France | |
| Hôpital civil | |
| Strasbourg, France | |
| Hôpital brabois | |
| Vandoeuvre les nancy, France | |
| Hôpital Bichat Claude Bernard | |
| Paris cedex 18, France | |
| Hôpital Hôtel Dieu | |
| Nantes, France | |
| Hôpital Paul Brousse | |
| Villejuif, France | |
| Hôpital de Pontchaillou | |
| Rennes cedex 9, France | |
| Germany | |
| Epimed GmbH | |
| Berlin, Germany | |
| Universitätsklinikum Charité | |
| Berlin, Germany | |
| Medizinische Poliklinik | |
| München, Germany | |
| Universitätsklinik Erlangen-Nürnberg | |
| Erlangen, Germany | |
| Boehringer Ingelheim Investigational Site | |
| München, Germany | |
| ifi Institut für interdisziplinäre Infektiologie | |
| Hamburg, Germany | |
| Universitätsklinikum Düsseldorf | |
| Düsseldorf, Germany | |
| Medizinische Universitätsklinik Bonn | |
| Bonn, Germany | |
| Med. Hochschule Hannover | |
| Hannover, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Stuttgart, Germany | |
| Facharzt für Innere Medizin, | |
| Mannheim, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Freiburg, Germany | |
| Universitätsklinkum Freiburg | |
| Freiburg, Germany | |
| Universitätsklinikum Essen | |
| Essen, Germany | |
| Klinik I für Innere Medizin der | |
| Köln, Germany | |
| Universitätsklinikum Heidelberg | |
| Heidelberg, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Düsseldorf, Germany | |
| Klinium Natruper Holz | |
| Osnabrück, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Aachen, Germany | |
| Klinikum der Johann Wolfgang Goethe-Universität | |
| Frankfurt/Main, Germany | |
| Universitätsklinik Hamburg-Eppendorf | |
| Hamburg, Germany | |
| Greece | |
| Andreas Syggros Hosp. | |
| Athens, Greece | |
| Korgialenio-Benakio-Hellenic Red Cross General Hospital | |
| Athens, Greece | |
| University Hospital of Patras | |
| Patras, Greece | |
| 1st Social Insurance Foundation (IKA) Pentelis | |
| Athens, Greece | |
| General Hospital "G. Gennimatas" | |
| Athens, Greece | |
| Sismanoglio Hospital | |
| Athens, Greece | |
| Evangelismos Hospital | |
| Athens, Greece | |
| "Tzanio" Hospital | |
| Piraeus, Greece | |
| AHEPA Hospital | |
| Thessaloniki, Greece | |
| Italy | |
| Fondazione S. Raffaele del Monte Tabor | |
| Milano, Italy | |
| Ospedale Amedeo di Savoia | |
| TORINO, Italy | |
| Netherlands | |
| Erasmus Medical Centre | |
| Rotterdam, Netherlands | |
| OLVG | |
| Amsterdam, Netherlands | |
| Slotervaart Hospital | |
| Amsterdam, Netherlands | |
| Medical Centre Haaglanden | |
| Den Haag, Netherlands | |
| Portugal | |
| Department of Infeccious Diseases | |
| Lisbon, Portugal | |
| Hospital de São João | |
| Porto, Portugal | |
| Hospitais da Universidade de Coimbra | |
| Coimbra, Portugal | |
| Hospital Condes Castro Guimarães | |
| Cascais, Portugal | |
| Switzerland | |
| Universitätsspital Basel | |
| Basel, Switzerland | |
| Universitätsspital Zürich | |
| Zürich, Switzerland | |
| Kantonsspital St. Gallen | |
| St. Gallen, Switzerland | |
| United Kingdom | |
| SSAT/Crusaid Institute | |
| London, United Kingdom | |
| Royal Free Hospital | |
| London, United Kingdom | |
| St Mary's Hospital | |
| London, United Kingdom | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
| Study ID Numbers: | 1182.51 |
| Study First Received: | March 19, 2003 |
| Last Updated: | August 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00056641 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Saquinavir Infection Tipranavir Anti-Bacterial Agents Amprenavir Lopinavir Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections RNA Virus Infections HIV Protease Inhibitors |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Antibiotics, Antitubercular Protease Inhibitors Virus Diseases HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections Antitubercular Agents |
