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NCT00144105 Clinical Trial

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.

HIV Infections Clinical Trial

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00144105
Other study ID # 1182.33
Secondary ID
Status Terminated
Phase Phase 2
First received September 2, 2005
Last updated October 31, 2013
Start date February 2004

Study information
Verified date October 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 562
Est. completion date
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Signed informed consent prior to trial participation.

2. HIV-1 infected males or females >= 18 years of age.

3. No previous ARV therapy.

4. Any CD4+ T lymphocyte count < 500 cells / µl.

5. HIV-1 viral load >= 5000 copies/mL at screening.

6. Screening laboratory values that indicate adequate baseline organ function.

7. 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:

1. 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

2. Use of investigational medications within 30 days before study entry or during the trial

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• TPV500mg/RTV200mgBID

• TPV500mg/RTV100mgBID

• LPV400mg/RTV100mgBID

Locations
Country Name City State
Argentina Boehringer Ingelheim Investigational Site BsAs
Argentina Fundacion Huesped Buenos Aires
Argentina Hospital de Agudos Teodoro Alvarez Buenos Aires
Argentina Hospital Posadas Haedo
Australia Boehringer Ingelheim Investigational Site Carlton Victoria
Australia 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 Alfred Hospital Melbourne Victoria
Australia Boehringer Ingelheim Investigational Site South Yarra Victoria
Australia Boehringer Ingelheim Investigational Site Surry Hills New South Wales
Bahamas Princess Margaret Hospital Nassau
Brazil 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
Canada McMaster University Medical Centre Hamilton 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 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 Downtown Infectious Diseases Clinic Vancouver British Columbia
Canada Boehringer Ingelheim Investigational Site Whitby Ontario
Canada Boehringer Ingelheim Investigational Site Winnipeg Manitoba
Colombia Boehringer Ingelheim Investigational Site Bogotá
France Hôpital Jean Verdier Bondy cedex
France Hôpital Bocage Dijon cedex
France Hôpital Albert Michallon La Tronche
France Hop Hôtel Dieu Lyon
France Hôpital Gui de Chauliac Montpellier cedex 5
France Hôpital Saint Antoine Paris
France Hôpital Bellevue Saint Etienne
Germany Epimed GmbH Berlin
Germany Klinikum der Ruhr-Universität Bochum Bochum
Germany Boehringer Ingelheim Investigational Site Düsseldorf
Germany Universitätsklinikum Düsseldorf Düsseldorf
Germany Universitätsklinikum Essen Essen
Germany ifi Studien und Projekte GbR Hamburg
Germany Universitätsklinik Köln Köln
Germany Medizinische Poliklinik München
Mexico Hospital de Especialidades no. 25 Col. Morelos, Monterrey, N. L.
Mexico Hospital Juan I. Menchaca IMSS Col. Villaseñor, Guadalajara, Jal.
Mexico Hospital Lopez Mateos Mexico
Poland Centre for AIDS Diagnostics and Therapy Chorzow
Poland Medical Academy of Szczecin Szczecin
Poland Hospital for Infectious Diseases Warsaw
Poland Department of Infectious Diseases Wroclaw
Romania Matei Bals Institute of Infectious Diseases Bucharest
Romania Victor Babes Clincial Hospital Bucharest
Russian Federation Russian Federal Scientific Moscow
Russian Federation City Hospital St Petersburg St. Petersburg
Spain 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 Sevilla
Spain Hospital Mútua de Terrasa Terrassa
Thailand Ramathibodhi Hospital Bangkok
Thailand King Chulalonkorn Hospital Pathumwan, Bangkok
United Kingdom Boehringer Ingelheim Investigational Site Edinburgh
United Kingdom North Middlesex Hospital London
United Kingdom Royal Free Hospital London

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Argentina,  Australia,  Bahamas,  Brazil,  Canada,  Colombia,  France,  Germany,  Mexico,  Poland,  Romania,  Russian Federation,  Spain,  Thailand,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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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