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.

This study has been terminated.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144105
First received: September 2, 2005
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: TPV500mg/RTV200mgBID
Drug: TPV500mg/RTV100mgBID
Drug: LPV400mg/RTV100mgBID
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 562
Study Start Date: February 2004
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144105

  Hide Study Locations
Locations
Argentina
Boehringer Ingelheim Investigational Site
BsAs, Argentina
Fundacion Huesped
Buenos Aires, Argentina
Hospital de Agudos Teodoro Alvarez
Buenos Aires, Argentina
Hospital Posadas
Haedo, Argentina
Australia, New South Wales
St Vincents Hospital;
Darlinghurst, New South Wales, Australia
Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales, Australia
Boehringer Ingelheim Investigational Site
Liverpool, New South Wales, Australia
Boehringer Ingelheim Investigational Site
Surry Hills, New South Wales, Australia
Australia, Victoria
Boehringer Ingelheim Investigational Site
Carlton, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Boehringer Ingelheim Investigational Site
South Yarra, Victoria, Australia
Bahamas
Princess Margaret Hospital
Nassau, Bahamas
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
I.I. Emilio Ribas - Moléstias Infecciosas
São Paulo - SP, Brazil
Instituto de Infectologia Emílio Ribas
São Paulo - 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
Centro de Referência e Treinamento - DST/AIDS
Vila Mariana - Sao Paulo, Brazil
Canada, British Columbia
Downtown Infectious Diseases Clinic
Vancouver, British Columbia, Canada
Canada, Manitoba
Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
Canada, Ontario
McMaster University Medical Centre
Hamilton, Ontario, Canada
The Ottawa Hospital Riverside Campus
Ottawa, Ontario, Canada
Sunnybrook & Woman's College Health Science Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Canadian Immunodeficiency Research Collaborative Inc.
Toronto, Ontario, Canada
Boehringer Ingelheim Investigational Site
Whitby, Ontario, Canada
Canada, Quebec
Montreal General Hospital - McGill University Health Centre
Monteal, Quebec, Canada
Montreal Chest Institute, McGill University Health Centre
Montreal, Quebec, Canada
Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Colombia
Boehringer Ingelheim Investigational Site
Bogotá, Colombia
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, France
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, Germany
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, 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, Poland
Romania
Victor Babes Clincial Hospital
Bucharest, Romania
Matei Bals Institute of Infectious Diseases
Bucharest, Romania
Russian Federation
Russian Federal Scientific
Moscow, Russian Federation
City Hospital St Petersburg
St. Petersburg, Russian Federation
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, Spain
Thailand
Ramathibodhi Hospital
Bangkok, Thailand
King Chulalonkorn Hospital
Pathumwan, Bangkok, Thailand
United Kingdom
Boehringer Ingelheim Investigational Site
Edinburgh, United Kingdom
Royal Free Hospital
London, United Kingdom
North Middlesex Hospital
London, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Investigator: Boehringer Ingelheim Study Coordinator
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00144105     History of Changes
Other Study ID Numbers: 1182.33
Study First Received: September 2, 2005
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014