Back to resultsA 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.
Primary Purpose
HIV Infections
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TPV500mg/RTV200mgBID
TPV500mg/RTV100mgBID
LPV400mg/RTV100mgBID
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility 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
Sites / Locations
- Boehringer Ingelheim Investigational Site
- Fundacion Huesped
- Hospital de Agudos Teodoro Alvarez
- Hospital Posadas
- Boehringer Ingelheim Investigational Site
- St Vincents Hospital;
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Alfred Hospital
- Boehringer Ingelheim Investigational Site
- Princess Margaret Hospital
- Unidade de Pesquisa Clínica (UPC) - AIDS
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Instituto de Crianca / Hospital das Clínicas-FMUSP
- Hospital Geral de Nova Iguaçu - Ministério da Saúde
- Universidade Federal do Rio de Janeiro
- Hospital Dia
- Universidade Federal da Bahia-Unidade Docente Assistencial d
- Boehringer Ingelheim Investigational Site
- Hospital do Servidor Público Estadual de São Paulo
- I.I. Emilio Ribas - Moléstias Infecciosas
- Instituto de Infectologia Emílio Ribas
- UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo
- Centro de Referência e Treinamento - DST/AIDS
- Downtown Infectious Diseases Clinic
- Boehringer Ingelheim Investigational Site
- McMaster University Medical Centre
- The Ottawa Hospital Riverside Campus
- Canadian Immunodeficiency Research Collaborative Inc.
- St. Michael's Hospital
- Sunnybrook & Woman's College Health Science Centre
- Toronto General Hospital
- Boehringer Ingelheim Investigational Site
- Montreal General Hospital - McGill University Health Centre
- Boehringer Ingelheim Investigational Site
- Montreal Chest Institute, McGill University Health Centre
- Boehringer Ingelheim Investigational Site
- Hôpital Jean Verdier
- Hôpital Bocage
- Hôpital Albert Michallon
- Hop Hôtel Dieu
- Hôpital Gui de Chauliac
- Hôpital Saint Antoine
- Hôpital Bellevue
- Epimed GmbH
- Klinikum der Ruhr-Universität Bochum
- Boehringer Ingelheim Investigational Site
- Universitätsklinikum Düsseldorf
- Universitätsklinikum Essen
- ifi Studien und Projekte GbR
- Universitätsklinik Köln
- Medizinische Poliklinik
- Hospital de Especialidades no. 25
- Hospital Juan I. Menchaca IMSS
- Hospital Lopez Mateos
- Centre for AIDS Diagnostics and Therapy
- Medical Academy of Szczecin
- Hospital for Infectious Diseases
- Department of Infectious Diseases
- Matei Bals Institute of Infectious Diseases
- Victor Babes Clincial Hospital
- Russian Federal Scientific
- City Hospital St Petersburg
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Hospital Clínico y Provincial
- Ciutat Sanitaria Universitaria de Bellvitge
- Boehringer Ingelheim Investigational Site
- Hospital 12 de octubre
- Hospital Ramón y Cajal
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Hospital Universitario Vírgen del Rocío
- Hospital Mútua de Terrasa
- Ramathibodhi Hospital
- King Chulalonkorn Hospital
- Boehringer Ingelheim Investigational Site
- North Middlesex Hospital
- Royal Free Hospital
Outcomes
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.
Full Information
NCT ID
NCT00144105
First Posted
September 2, 2005
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT00144105
Brief Title
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.
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Study Start Date
February 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
562 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
TPV500mg/RTV200mgBID
Intervention Type
Drug
Intervention Name(s)
TPV500mg/RTV100mgBID
Intervention Type
Drug
Intervention Name(s)
LPV400mg/RTV100mgBID
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
BsAs
Country
Argentina
Facility Name
Fundacion Huesped
City
Buenos Aires
Country
Argentina
Facility Name
Hospital de Agudos Teodoro Alvarez
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Posadas
City
Haedo
Country
Argentina
Facility Name
Boehringer Ingelheim Investigational Site
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
St Vincents Hospital;
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
Boehringer Ingelheim Investigational Site
City
Liverpool
State/Province
New South Wales
Country
Australia
Facility Name
Boehringer Ingelheim Investigational Site
City
Surry Hills
State/Province
New South Wales
Country
Australia
Facility Name
Boehringer Ingelheim Investigational Site
City
Carlton
State/Province
Victoria
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Boehringer Ingelheim Investigational Site
City
South Yarra
State/Province
Victoria
Country
Australia
Facility Name
Princess Margaret Hospital
City
Nassau
Country
Bahamas
Facility Name
Unidade de Pesquisa Clínica (UPC) - AIDS
City
Campinas - Sp
Country
Brazil
Facility Name
Boehringer Ingelheim Investigational Site
City
Curitiba - PR
Country
Brazil
Facility Name
Boehringer Ingelheim Investigational Site
City
Manguinhos - Rio de Janeiro - RJ
Country
Brazil
Facility Name
Instituto de Crianca / Hospital das Clínicas-FMUSP
City
Mooca / São Paulo
Country
Brazil
Facility Name
Hospital Geral de Nova Iguaçu - Ministério da Saúde
City
Nova Iguaçu - RJ
Country
Brazil
Facility Name
Universidade Federal do Rio de Janeiro
City
Rio de Janeiro - RJ
Country
Brazil
Facility Name
Hospital Dia
City
Sacoma - São Paulo
Country
Brazil
Facility Name
Universidade Federal da Bahia-Unidade Docente Assistencial d
City
Salvador - BA
Country
Brazil
Facility Name
Boehringer Ingelheim Investigational Site
City
Santos - Sp
Country
Brazil
Facility Name
Hospital do Servidor Público Estadual de São Paulo
City
São Paulo - Sp
Country
Brazil
Facility Name
I.I. Emilio Ribas - Moléstias Infecciosas
City
São Paulo - SP
Country
Brazil
Facility Name
Instituto de Infectologia Emílio Ribas
City
São Paulo - SP
Country
Brazil
Facility Name
UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo
City
São Paulo - Sp
Country
Brazil
Facility Name
Centro de Referência e Treinamento - DST/AIDS
City
Vila Mariana - Sao Paulo
Country
Brazil
Facility Name
Downtown Infectious Diseases Clinic
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
The Ottawa Hospital Riverside Campus
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Canadian Immunodeficiency Research Collaborative Inc.
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook & Woman's College Health Science Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Whitby
State/Province
Ontario
Country
Canada
Facility Name
Montreal General Hospital - McGill University Health Centre
City
Monteal
State/Province
Quebec
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal Chest Institute, McGill University Health Centre
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Bogotá
Country
Colombia
Facility Name
Hôpital Jean Verdier
City
Bondy cedex
Country
France
Facility Name
Hôpital Bocage
City
Dijon cedex
Country
France
Facility Name
Hôpital Albert Michallon
City
La Tronche
Country
France
Facility Name
Hop Hôtel Dieu
City
Lyon
Country
France
Facility Name
Hôpital Gui de Chauliac
City
Montpellier cedex 5
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
Country
France
Facility Name
Hôpital Bellevue
City
Saint Etienne
Country
France
Facility Name
Epimed GmbH
City
Berlin
Country
Germany
Facility Name
Klinikum der Ruhr-Universität Bochum
City
Bochum
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Düsseldorf
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
ifi Studien und Projekte GbR
City
Hamburg
Country
Germany
Facility Name
Universitätsklinik Köln
City
Köln
Country
Germany
Facility Name
Medizinische Poliklinik
City
München
Country
Germany
Facility Name
Hospital de Especialidades no. 25
City
Col. Morelos, Monterrey, N. L.
Country
Mexico
Facility Name
Hospital Juan I. Menchaca IMSS
City
Col. Villaseñor, Guadalajara, Jal.
Country
Mexico
Facility Name
Hospital Lopez Mateos
City
Mexico
Country
Mexico
Facility Name
Centre for AIDS Diagnostics and Therapy
City
Chorzow
Country
Poland
Facility Name
Medical Academy of Szczecin
City
Szczecin
Country
Poland
Facility Name
Hospital for Infectious Diseases
City
Warsaw
Country
Poland
Facility Name
Department of Infectious Diseases
City
Wroclaw
Country
Poland
Facility Name
Matei Bals Institute of Infectious Diseases
City
Bucharest
Country
Romania
Facility Name
Victor Babes Clincial Hospital
City
Bucharest
Country
Romania
Facility Name
Russian Federal Scientific
City
Moscow
Country
Russian Federation
Facility Name
City Hospital St Petersburg
City
St. Petersburg
Country
Russian Federation
Facility Name
Boehringer Ingelheim Investigational Site
City
Badalona
Country
Spain
Facility Name
Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
Hospital Clínico y Provincial
City
Barcelona
Country
Spain
Facility Name
Ciutat Sanitaria Universitaria de Bellvitge
City
Hospitalet de Llobregat (Barcelona)
Country
Spain
Facility Name
Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
Hospital 12 de octubre
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Boehringer Ingelheim Investigational Site
City
Málaga
Country
Spain
Facility Name
Boehringer Ingelheim Investigational Site
City
Santa Cruz de Tenerife
Country
Spain
Facility Name
Hospital Universitario Vírgen del Rocío
City
Sevilla
Country
Spain
Facility Name
Hospital Mútua de Terrasa
City
Terrassa
Country
Spain
Facility Name
Ramathibodhi Hospital
City
Bangkok
Country
Thailand
Facility Name
King Chulalonkorn Hospital
City
Pathumwan, Bangkok
Country
Thailand
Facility Name
Boehringer Ingelheim Investigational Site
City
Edinburgh
Country
United Kingdom
Facility Name
North Middlesex Hospital
City
London
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.33_U07-1617.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.33_U07-1617_statement_2_new.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.33_literature.pdf
Description
Related Info
Learn more about this 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.
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