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.
- Conditions
- HIV Infections
- Registration Number
- NCT00144105
- Lead Sponsor
- Boehringer Ingelheim
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 562
- 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
Exclusion criteria:
-
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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (62)
Boehringer Ingelheim Investigational Site
🇬🇧Edinburgh, United Kingdom
Hospital Posadas
🇦🇷Haedo, Argentina
Universidade Federal do Rio de Janeiro
🇧🇷Rio de Janeiro - RJ, Brazil
St Vincents Hospital;
🇦🇺Darlinghurst, New South Wales, Australia
Hospital Universitario Vírgen del Rocío
🇪🇸Sevilla, Spain
Hospital Geral de Nova Iguaçu - Ministério da Saúde
🇧🇷Nova Iguaçu - RJ, Brazil
Centro de Referência e Treinamento - DST/AIDS
🇧🇷Vila Mariana - Sao Paulo, Brazil
Hôpital Jean Verdier
🇫🇷Bondy cedex, France
Hôpital Bocage
🇫🇷Dijon cedex, France
Epimed GmbH
🇩🇪Berlin, Germany
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hôpital Saint Antoine
🇫🇷Paris, France
Hôpital Gui de Chauliac
🇫🇷Montpellier cedex 5, France
Medizinische Poliklinik
🇩🇪München, Germany
Hospital Lopez Mateos
🇲🇽Mexico, Mexico
Hospital for Infectious Diseases
🇵🇱Warsaw, Poland
Hospital Mútua de Terrasa
🇪🇸Terrassa, Spain
Royal Free Hospital
🇬🇧London, United Kingdom
Hospital de Agudos Teodoro Alvarez
🇦🇷Buenos Aires, Argentina
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Princess Margaret Hospital
🇧🇸Nassau, Bahamas
Instituto de Crianca / Hospital das Clínicas-FMUSP
🇧🇷Mooca / São Paulo, Brazil
Instituto de Infectologia Emílio Ribas
🇧🇷São Paulo - SP, Brazil
Downtown Infectious Diseases Clinic
🇨🇦Vancouver, British Columbia, Canada
Sunnybrook & Woman's College Health Science Centre
🇨🇦Toronto, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Montreal General Hospital - McGill University Health Centre
🇨🇦Monteal, Quebec, Canada
Hospital Clínico y Provincial
🇪🇸Barcelona, Spain
City Hospital St Petersburg
🇷🇺St. Petersburg, Russian Federation
Ciutat Sanitaria Universitaria de Bellvitge
🇪🇸Hospitalet de Llobregat (Barcelona), Spain
North Middlesex Hospital
🇬🇧London, United Kingdom
Hospital 12 de octubre
🇪🇸Madrid, Spain
Hospital Dia
🇧🇷Sacoma - São Paulo, Brazil
I.I. Emilio Ribas - Moléstias Infecciosas
🇧🇷São Paulo - SP, Brazil
Hôpital Bellevue
🇫🇷Saint Etienne, France
Centre for AIDS Diagnostics and Therapy
🇵🇱Chorzow, Poland
Medical Academy of Szczecin
🇵🇱Szczecin, Poland
Fundacion Huesped
🇦🇷Buenos Aires, Argentina
Unidade de Pesquisa Clínica (UPC) - AIDS
🇧🇷Campinas - Sp, Brazil
Hospital do Servidor Público Estadual de São Paulo
🇧🇷São Paulo - Sp, Brazil
UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo
🇧🇷São Paulo - Sp, Brazil
Hôpital Albert Michallon
🇫🇷La Tronche, France
Department of Infectious Diseases
🇵🇱Wroclaw, Poland
Victor Babes Clincial Hospital
🇷🇴Bucharest, Romania
ifi Studien und Projekte GbR
🇩🇪Hamburg, Germany
Universidade Federal da Bahia-Unidade Docente Assistencial d
🇧🇷Salvador - BA, Brazil
Klinikum der Ruhr-Universität Bochum
🇩🇪Bochum, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Hospital Juan I. Menchaca IMSS
🇲🇽Col. Villaseñor, Guadalajara, Jal., Mexico
McMaster University Medical Centre
🇨🇦Hamilton, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Montreal Chest Institute, McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Hospital de Especialidades no. 25
🇲🇽Col. Morelos, Monterrey, N. L., Mexico
Matei Bals Institute of Infectious Diseases
🇷🇴Bucharest, Romania
Canadian Immunodeficiency Research Collaborative Inc.
🇨🇦Toronto, Ontario, Canada
Russian Federal Scientific
🇷🇺Moscow, Russian Federation
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Universitätsklinik Köln
🇩🇪Köln, Germany
Ramathibodhi Hospital
🇹🇭Bangkok, Thailand
King Chulalonkorn Hospital
🇹🇭Pathumwan, Bangkok, Thailand
The Ottawa Hospital Riverside Campus
🇨🇦Ottawa, Ontario, Canada
Hop Hôtel Dieu
🇫🇷Lyon, France