Trial Synopsis

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.
Status: Terminated
Study Phase: Phase 2
Start Date: February 2004 | Completion Date: November 2006
Condition(s): HIV Infections
Full Title of Study
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
Overview
Evaluation of safety and efficacy of Tipranavir (TPV) boosted with Ritonavir (RTV)
versus an active control arm (Lopinavir / RTV) in antiretroviral (ARV) therapy naïve HIV1 infected patients
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment,
Masking: Open Label, Primary Purpose: Treatment
Investigator Details
Lead Sponsor
: Boehringer Ingelheim
: Boehringer Ingelheim Study Coordinator
Trial Location Details
Facility: Boehringer Ingelheim Investigational Site BsAs, Argentina
Facility: Fundacion Huesped Buenos Aires, Argentina
Facility: Hospital de Agudos Teodoro Alvarez Buenos Aires, Argentina
Facility: Hospital Posadas Haedo, Argentina
Facility: Boehringer Ingelheim Investigational Site Darlinghurst, Australia
Facility: St Vincents Hospital; Darlinghurst, Australia
Facility: Boehringer Ingelheim Investigational Site Liverpool, Australia
Facility: Boehringer Ingelheim Investigational Site Surry Hills, Australia
Facility: Boehringer Ingelheim Investigational Site Carlton, Australia
Facility: Alfred Hospital Melbourne, Australia
Facility: Boehringer Ingelheim Investigational Site South Yarra, Australia
Facility: Princess Margaret Hospital Nassau, Bahamas
Facility: Unidade de Pesquisa Clínica (UPC) - AIDS Campinas - Sp, Brazil
Facility: Boehringer Ingelheim Investigational Site Curitiba - PR, Brazil
Facility: Boehringer Ingelheim Investigational Site Manguinhos - Rio de Janeiro - RJ, Brazil
Facility: Instituto de Crianca / Hospital das Clínicas-FMUSP Mooca / São Paulo, Brazil
Facility: Hospital Geral de Nova Iguaçu - Ministério da Saúde Nova Iguaçu - RJ, Brazil
Facility: Universidade Federal do Rio de Janeiro Rio de Janeiro - RJ, Brazil
Facility: Hospital Dia Sacoma - São Paulo, Brazil
Facility: Universidade Federal da Bahia-Unidade Docente Assistencial d Salvador - BA,
Brazil
Facility: Boehringer Ingelheim Investigational Site Santos - Sp, Brazil
Facility: Hospital do Servidor Público Estadual de São Paulo São Paulo - Sp, Brazil
Facility: I.I. Emilio Ribas - Moléstias Infecciosas São Paulo - SP, Brazil
Facility: Instituto de Infectologia Emílio Ribas São Paulo - SP, Brazil
Facility: UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo São Paulo - Sp, Brazil
Facility: Centro de Referência e Treinamento - DST/AIDS Vila Mariana - Sao Paulo, Brazil
Facility: Downtown Infectious Diseases Clinic Vancouver, Canada
Facility: Boehringer Ingelheim Investigational Site Winnipeg, Canada
Facility: McMaster University Medical Centre Hamilton, Canada
Facility: The Ottawa Hospital Riverside Campus Ottawa, Canada
Facility: Canadian Immunodeficiency Research Collaborative Inc. Toronto, Canada
Facility: St. Michael's Hospital Toronto, Canada
Facility: Sunnybrook & Woman's College Health Science Centre Toronto, Canada
Facility: Toronto General Hospital Toronto, Canada
Facility: Boehringer Ingelheim Investigational Site Whitby, Canada
Facility: Montreal General Hospital - McGill University Health Centre Monteal, Canada
Facility: Boehringer Ingelheim Investigational Site Montreal, Canada
Facility: Montreal Chest Institute, McGill University Health Centre Montreal, Canada
Facility: Boehringer Ingelheim Investigational Site Bogotá, Colombia
Facility: Hôpital Jean Verdier Bondy cedex, France
Facility: Hôpital Bocage Dijon cedex, France
Facility: Hôpital Albert Michallon La Tronche, France
Facility: Hop Hôtel Dieu Lyon, France
Facility: Hôpital Gui de Chauliac Montpellier cedex 5, France
Facility: Hôpital Saint Antoine Paris, France
Facility: Hôpital Bellevue Saint Etienne, France
Facility: Epimed GmbH Berlin, Germany
Facility: Klinikum der Ruhr-Universität Bochum Bochum, Germany
Facility: Boehringer Ingelheim Investigational Site Düsseldorf, Germany
Facility: Universitätsklinikum Düsseldorf Düsseldorf, Germany
Facility: Universitätsklinikum Essen Essen, Germany
Facility: ifi Studien und Projekte GbR Hamburg, Germany
Facility: Universitätsklinik Köln Köln, Germany
Facility: Medizinische Poliklinik München, Germany
Facility: Hospital de Especialidades no. 25 Col. Morelos, Monterrey, N. L., Mexico
Facility: Hospital Juan I. Menchaca IMSS Col. Villaseñor, Guadalajara, Jal., Mexico
Facility: Hospital Lopez Mateos Mexico, Mexico
Facility: Centre for AIDS Diagnostics and Therapy Chorzow, Poland
Facility: Medical Academy of Szczecin Szczecin, Poland
Facility: Hospital for Infectious Diseases Warsaw, Poland
Facility: Department of Infectious Diseases Wroclaw, Poland
Facility: Matei Bals Institute of Infectious Diseases Bucharest, Romania
Facility: Victor Babes Clincial Hospital Bucharest, Romania
Facility: Russian Federal Scientific Moscow, Russian Federation
Facility: City Hospital St Petersburg St. Petersburg, Russian Federation
Facility: Boehringer Ingelheim Investigational Site Badalona, Spain
Facility: Boehringer Ingelheim Investigational Site Barcelona, Spain
Facility: Hospital Clínico y Provincial Barcelona, Spain
Facility: Ciutat Sanitaria Universitaria de Bellvitge Hospitalet de Llobregat (Barcelona), Spain
Facility: Boehringer Ingelheim Investigational Site Madrid, Spain
Facility: Hospital 12 de octubre Madrid, Spain
Facility: Hospital Ramón y Cajal Madrid, Spain
Facility: Boehringer Ingelheim Investigational Site Málaga, Spain
Facility: Boehringer Ingelheim Investigational Site Santa Cruz de Tenerife, Spain
Facility: Hospital Universitario Vírgen del Rocío Sevilla, Spain
Facility: Hospital Mútua de Terrasa Terrassa, Spain
Facility: Ramathibodhi Hospital Bangkok, Thailand
Facility: King Chulalonkorn Hospital Pathumwan, Bangkok, Thailand
Facility: Boehringer Ingelheim Investigational Site Edinburgh, United Kingdom
Facility: North Middlesex Hospital London, United Kingdom
Facility: Royal Free Hospital London, United Kingdom
Interventions
Drug: TPV500mg/RTV200mgBID
Drug: TPV500mg/RTV100mgBID
Drug: LPV400mg/RTV100mgBID
Information Source
ID Number: 1182.33
NCT Identifier: NCT00144105
Health Authority: United States: Food and Drug Administration
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT00144105
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