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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPV500mg/RTV200mgBID | Drug | |||
| TPV500mg/RTV100mgBID | Drug | |||
| LPV400mg/RTV100mgBID | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion criteria:
Female patients of child-bearing potential who:
Use of investigational medications within 30 days before study entry or during the trial
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | BsAs | Argentina | ||||
| Fundacion Huesped |
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| Buenos Aires |
| Argentina |
| Hospital de Agudos Teodoro Alvarez | Buenos Aires | Argentina |
| Hospital Posadas | Haedo | Argentina |
| Boehringer Ingelheim Investigational Site | Darlinghurst | New South Wales | Australia |
| St Vincents Hospital; | Darlinghurst | New South Wales | Australia |
| Boehringer Ingelheim Investigational Site | Liverpool | New South Wales | Australia |
| Boehringer Ingelheim Investigational Site | Surry Hills | New South Wales | Australia |
| Boehringer Ingelheim Investigational Site | Carlton | Victoria | Australia |
| Alfred Hospital | Melbourne | Victoria | Australia |
| Boehringer Ingelheim Investigational Site | South Yarra | Victoria | Australia |
| Unidade de Pesquisa Clínica (UPC) - AIDS | Campinas - Sp | Brazil |
| Boehringer Ingelheim Investigational Site | Curitiba - PR | Brazil |
| Boehringer Ingelheim Investigational Site | Manguinhos - Rio de Janeiro - RJ | Brazil |
| Instituto de Crianca / Hospital das Clínicas-FMUSP | Mooca / São Paulo | Brazil |
| Hospital Geral de Nova Iguaçu - Ministério da Saúde | Nova Iguaçu - RJ | Brazil |
| Universidade Federal do Rio de Janeiro | Rio de Janeiro - RJ | Brazil |
| Hospital Dia | Sacoma - São Paulo | Brazil |
| Universidade Federal da Bahia-Unidade Docente Assistencial d | Salvador - BA | Brazil |
| Boehringer Ingelheim Investigational Site | Santos - Sp | Brazil |
| Hospital do Servidor Público Estadual de São Paulo | São Paulo - Sp | Brazil |
| I.I. Emilio Ribas - Moléstias Infecciosas | São Paulo - SP | Brazil |
| Instituto de Infectologia Emílio Ribas | São Paulo - SP | Brazil |
| UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo | São Paulo - Sp | Brazil |
| Centro de Referência e Treinamento - DST/AIDS | Vila Mariana - Sao Paulo | Brazil |
| Downtown Infectious Diseases Clinic | Vancouver | British Columbia | Canada |
| Boehringer Ingelheim Investigational Site | Winnipeg | Manitoba | Canada |
| McMaster University Medical Centre | Hamilton | Ontario | Canada |
| The Ottawa Hospital Riverside Campus | Ottawa | Ontario | Canada |
| Canadian Immunodeficiency Research Collaborative Inc. | Toronto | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Sunnybrook & Woman's College Health Science Centre | Toronto | Ontario | Canada |
| Toronto General Hospital | Toronto | Ontario | Canada |
| Boehringer Ingelheim Investigational Site | Whitby | Ontario | Canada |
| Montreal General Hospital - McGill University Health Centre | Monteal | Quebec | Canada |
| Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| Montreal Chest Institute, McGill University Health Centre | Montreal | Quebec | Canada |
| Boehringer Ingelheim Investigational Site | Bogotá | Colombia |
| Hôpital Jean Verdier | Bondy | France |
| Hôpital Bocage | Dijon | France |
| Hôpital Albert Michallon | La Tronche | France |
| Hop Hôtel Dieu | Lyon | France |
| Hôpital Gui de Chauliac | Montpellier | France |
| Hôpital Saint Antoine | Paris | France |
| Hôpital Bellevue | Saint-Etienne | France |
| Epimed GmbH | Berlin | Germany |
| Klinikum der Ruhr-Universität Bochum | Bochum | Germany |
| Universitätsklinik Köln | Cologne | Germany |
| Boehringer Ingelheim Investigational Site | Düsseldorf | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | Germany |
| Universitätsklinikum Essen | Essen | Germany |
| ifi Studien und Projekte GbR | Hamburg | Germany |
| Medizinische Poliklinik | München | Germany |
| Hospital de Especialidades no. 25 | Col. Morelos, Monterrey, N. L. | Mexico |
| Hospital Juan I. Menchaca IMSS | Col. Villaseñor, Guadalajara, Jal. | Mexico |
| Hospital Lopez Mateos | México | Mexico |
| Centre for AIDS Diagnostics and Therapy | Chorzów | Poland |
| Medical Academy of Szczecin | Szczecin | Poland |
| Hospital for Infectious Diseases | Warsaw | Poland |
| Department of Infectious Diseases | Wroclaw | Poland |
| Matei Bals Institute of Infectious Diseases | Bucharest | Romania |
| Victor Babes Clincial Hospital | Bucharest | Romania |
| Russian Federal Scientific | Moscow | Russia |
| City Hospital St Petersburg | Saint Petersburg | Russia |
| Boehringer Ingelheim Investigational Site | Badalona | Spain |
| Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| Hospital Clínico y Provincial | Barcelona | Spain |
| Ciutat Sanitaria Universitaria de Bellvitge | Hospitalet de Llobregat (Barcelona) | Spain |
| Boehringer Ingelheim Investigational Site | Madrid | Spain |
| Hospital 12 de octubre | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Spain |
| Boehringer Ingelheim Investigational Site | Málaga | Spain |
| Boehringer Ingelheim Investigational Site | Santa Cruz de Tenerife | Spain |
| Hospital Universitario Vírgen del Rocío | Seville | Spain |
| Hospital Mútua de Terrasa | Terrassa | Spain |
| Ramathibodhi Hospital | Bangkok | Thailand |
| King Chulalonkorn Hospital | Pathumwan, Bangkok | Thailand |
| Princess Margaret Hospital | Nassau | The Bahamas |
| Boehringer Ingelheim Investigational Site | Edinburgh | United Kingdom |
| North Middlesex Hospital | London | United Kingdom |
| Royal Free Hospital | London | United Kingdom |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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