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:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00144105
First received: September 2, 2005
Last updated: May 23, 2012
Last verified: May 2012
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Purpose
Successfully screened patients are randomised to open label TPV 500 mg with RTV 100 mg or 200 mg BID or open label LPV 400 mg with RTV 100 mg BID. Background ARV therapy is Tenofovir 300 mg + Lamivudine 300 mg QD in all three treatment groups. The randomisation is stratified by CD4 cell count > 200 cells/µL at screening. The duration of the treatment is 156 weeks.
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
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.
| Estimated Enrollment: | 540 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | March 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144105
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| 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 | |
| Hospital do Servidor Público Estadual de São Paulo | |
| São Paulo - Sp, Brazil | |
| Instituto de Infectologia Emílio Ribas | |
| São Paulo - SP, Brazil | |
| I.I. Emilio Ribas - Moléstias Infecciosas | |
| 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 | |
| Hospital Ramón y Cajal | |
| Madrid, Spain | |
| Hospital 12 de octubre | |
| Madrid, Spain | |
| Boehringer Ingelheim Investigational Site | |
| 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 Pharmaceuticals
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: | May 23, 2012 |
| Health Authority: | Unspecified |
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 Antiviral Agents |
Ritonavir Tipranavir Anti-Infective Agents Therapeutic Uses Pharmacologic Actions HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on June 18, 2013