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.
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
1 other identifier
interventional
562
14 countries
80
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedNovember 1, 2013
October 1, 2013
2.8 years
September 2, 2005
October 31, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent prior to trial participation.
- HIV-1 infected males or females \>= 18 years of age.
- No previous ARV therapy.
- Any CD4+ T lymphocyte count \< 500 cells / µl.
- HIV-1 viral load \>= 5000 copies/mL at screening.
- Screening laboratory values that indicate adequate baseline organ function.
- A prior AIDS defining event is acceptable as long as it has resolved or the subject has been on stable treatment (e.g. opportunistic infection; no ARV) for at least 2 weeks before screening
You may not qualify if:
- Female patients of child-bearing potential who:
- have a positive serum pregnancy test at screening or during the study,
- are breast feeding,
- are planning to become pregnant
- Use of investigational medications within 30 days before study entry or during the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
Boehringer Ingelheim Investigational Site
BsAs, Argentina
Fundacion Huesped
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
Boehringer Ingelheim Study Coordinator
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 5, 2005
Study Start
February 1, 2004
Primary Completion
November 1, 2006
Last Updated
November 1, 2013
Record last verified: 2013-10