Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
- Conditions
- HIV Infections
- Interventions
- Drug: Comparator protease inhibitor(CPI)/low dose ritonavir(r)
- Registration Number
- NCT00144170
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load \> =1000 cells/mL, and genotype indicating at least one resistance conferring protease inhibitor-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 882
-
Signed informed consent prior to trial participation.
-
Human immunodeficiency virus-1 infected males or females >=18 years of age.
-
Screening genotypic resistance report indicating both of the following:
- at least one primary protease mutation at the following sites 30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M , and
- no more than two protease mutations on codons 33, 82, 84, or 90.
-
At least 3 consecutive months experience taking antiretrovirals from each of the classes of Nucleoside reverse transcriptase inhibitor(s), Non-nucleoside reverse transcriptase inhibitor(s), and Protease inhibitor(s) at some point in treatment history,
- with at least 2 Protease inhibitor-based regimens (minimum 3 months of exposure of each), one of which must be part of the current regimen, and
- current Protease inhibitor-based antiretroviral medication regimen for at least 3 months prior to randomisation.
-
Human immunodeficiency virus-1 viral load >=1000 copies/mL at screening.
-
Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply:
- Total cholesterol <=400 mg/dl or 10,36 mm/L.
- Total triglycerides <=750 mg/dl or 8,5 mm/L.
- Alanine aminotransferase <=3x upper limit of normal and aspartate aminotransferase <=2.5x upper limit of normal.
- Any Grade gamma-glutamyl transpeptidase is acceptable.
- Any Grade creatinine kinase is acceptable as long as there is no concurrent myopathy.
- All other laboratory test values <= Grade 1(Division of Acquired immune deficiency syndrome, National Institute of Health grading scale).
-
Acceptable medical history, as assessed by the investigator, with chest X-ray and electrocardiogram within 1 year of study participation.
-
Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system.
-
A prior Acquired immune deficiency syndrome-defining event is acceptable as long as it has resolved or the patient has been on stable treatment for at least 2 months (Acquired immune deficiency syndrome related complex is acceptable).
-
Antiretroviral medication naïve.
-
Patients on recent drug holiday, defined as off antiretroviral medications for at least 7 consecutive days within the last 3 months.
-
Alanine aminotransferase >3x upper limit of normal and aspartate aminotransferase >2.5x upper limit of normal at either screening visit.
-
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, or
- are not willing to use a barrier method of contraception, or
- require ethinyl estradiol administration
-
Prior tipranavir use.
-
Use of investigational medications within 30 days before study entry or during the trial. (T-20 [enfuvirtide] and Tenofovir (Viread), investigational at the time of writing of this protocol, will be allowed.)
-
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2).
-
Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.
-
In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tipranavir(TPV)/low dose ritonavir(r) Tipranavir (with low dose ritonavir) - Comparator protease inhibitor(CPI)/low dose ritonavir(r) Comparator protease inhibitor(CPI)/low dose ritonavir(r) -
- Primary Outcome Measures
Name Time Method Treatment Response at Week 48 after 48 weeks of treatment Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time to Treatment Failure Through 48 Weeks of Treatment after 48 weeks of treatment Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) \< 1.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in CD4+ Cell Count (Week 48) Baseline to Week 48 Mean Change From Baseline in CD4+ Cell Count (Week 56) Baseline to Week 56 Mean Change From Baseline in CD4+ Cell Count (Week 64) Baseline to Week 64 Mean Change From Baseline in CD4+ Cell Count (Week 72) Baseline to Week 72 Mean Change From Baseline in CD4+ Cell Count (Week 80) Baseline to Week 80 Treatment Response at Week 32 week 32 Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 72 week 72 Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 88 week 88 Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 96 after 96 weeks of treatment Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 2 week 2 Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 4 week 4 Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 8 week 8 Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 16 week 16 Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 24 Week 24 Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 40 week 40 Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 56 week 56 Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 64 week 64 Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Treatment Response at Week 80 week 80 Patients who experienced treatment response. Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time to Treatment Failure Through 96 Weeks of Treatment after 96 weeks of treatment Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) \< 1.
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment after 48 weeks of treatment Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)\>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)\<1.
Time to Confirmed Virologic Failure Through 96 Weeks of Treatment after 96 weeks of treatment Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)\>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)\<1.
Virologic Response Week 2 through Week 96 (at any point during trial) Virologic response defined as Viral Load\<50 copies/mL
Virologic Response at Week 8 Week 8 Virologic response defined as Viral Load\<50 copies/mL
Virologic Response at Week 2 Week 2 Virologic response defined as Viral Load\<50 copies/mL
Virologic Response at Week 4 Week 4 Virologic response defined as Viral Load\<50 copies/mL
Virologic Response at Week 16 Week 16 Virologic response defined as Viral Load\<50 copies/mL
Virologic Response at Week 24 Week 24 Viral Load \< 50 copies/mL
Virologic Response at Week 32 Week 32 Virologic response defined as Viral Load\<50 copies/mL
Virologic Response at Week 40 Week 40 Virologic response defined as Viral Load\<50 copies/mL
Virologic Response at Week 48 Week 48 Virologic response defined as Viral Load\<50 copies/mL
Virologic Response at Week 56 Week 56 Virologic response defined as Viral Load\<50 copies/mL
Mean Change From Baseline in CD4+ Cell Count (Week 8) Baseline to Week 8 Mean Change From Baseline in CD4+ Cell Count (Week 16) Baseline to Week 16 Mean Change From Baseline in CD4+ Cell Count (Week 24) Baseline to Week 24 Mean Change From Baseline in CD4+ Cell Count (Week 32) Baseline to Week 32 Mean Change From Baseline in CD4+ Cell Count (Week 40) Baseline to Week 40 Virologic Response at Week 64 Week 64 Virologic response defined as Viral Load\<50 copies/mL
Virologic Response at Week 72 Week 72 Virologic response defined as Viral Load\<50 copies/mL
Virologic Response at Week 80 Week 80 Virologic response defined as Viral Load\<50 copies/mL
Virologic Response at Week 88 Week 88 Virologic response defined as Viral Load\<50 copies/mL
Virologic Response at Week 96 Week 96 Virologic response defined as Viral Load\<50 copies/mL
Median Change From Baseline in Viral Load (Week 2) Baseline to Week 2 Median Change From Baseline in Viral Load (Week 4) Baseline to Week 4 Median Change From Baseline in Viral Load (Week 8) Baseline to Week 8 Median Change From Baseline in Viral Load (Week 16) Baseline to Week 16 Median Change From Baseline in Viral Load (Week 24) Baseline to Week 24 Median Change From Baseline in Viral Load (Week 32) Baseline to Week 32 Median Change From Baseline in Viral Load (Week 40) Baseline to Week 40 Median Change From Baseline in Viral Load (Week 48) Baseline to Week 48 Median Change From Baseline in Viral Load (Week 56) Baseline to Week 56 Median Change From Baseline in Viral Load (Week 64) Baseline to Week 64 Median Change From Baseline in Viral Load (Week 72) Baseline to Week 72 Median Change From Baseline in Viral Load (Week 80) Baseline to Week 80 Median Change From Baseline in Viral Load (Week 88) Baseline to Week 88 Median Change From Baseline in Viral Load (Week 96) Baseline to Week 96 Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks Week 2 through Week 96 (at any point during trial) Virologic response defined as Viral Load\<400 copies/mL
Mean Change From Baseline in CD4+ Cell Count (Week 2) Baseline to Week 2 Mean Change From Baseline in CD4+ Cell Count (Week 4) Baseline to Week 4 Mean Change From Baseline in CD4+ Cell Count (Week 88) Baseline to Week 88 Mean Change From Baseline in CD4+ Cell Count (Week 96) Baseline to Week 96 Time to New Centers for Disease Control (CDC) Class C Progression Event or Death. up to 75 weeks of treatment Time to death or occurrence of AIDS-defining condition according to the US Centers for Disease Control and Prevention case definition.
The median and quartiles are underestimated since more than 92% of the observations (in both treatment arms) were censored and the estimation was restricted to the largest observed event time.
Trial Locations
- Locations (174)
1182.48.5202 Hospital Lopez Mateos
🇲🇽Mexico, Mexico
1182.48.3505 Hospital Egas Moniz
🇵🇹Lisboa, Portugal
1182.48.5201 Centro Médico La Raza IMSS
🇲🇽Mexico, D.F., Mexico
1182.48.5203 Centro Guadalajara, Jal.
🇲🇽Mexico, Mexico
1182.48.3501 Boehringer Ingelheim Investigational Site
🇵🇹Lisboa, Portugal
1182.48.4102 Universitätsspital Zürich
🇨🇭Zürich, Switzerland
1182.48.4505 Boehringer Ingelheim Investigational Site
🇩🇰Aarhus N, Denmark
1182.48.4504 Boehringer Ingelheim Investigational Site
🇩🇰Odense C, Denmark
1182.48.3309 Boehringer Ingelheim Investigational Site
🇫🇷Marseille cedex 9, France
1182.48.3306 Boehringer Ingelheim Investigational Site
🇫🇷Nice cedex 3, France
1182.48.3316 Boehringer Ingelheim Investigational Site
🇫🇷Paris cedex 10, France
1182.48.3323 Boehringer Ingelheim Investigational Site
🇫🇷Paris cedex 14, France
1182.48.3301 Boehringer Ingelheim Investigational Site
🇫🇷Paris cedex 18, France
1182.48.3319 Boehringer Ingelheim Investigational Site
🇫🇷Paris cedex 20, France
1182.48.3313 Boehringer Ingelheim Investigational Site
🇫🇷Strasbourg, France
1182.48.4929 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1182.48.4931 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1182.48.3403 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.48.3406 Boehringer Ingelheim Investigational Site
🇪🇸L'Hospitalet de Llobregat, Spain
1182.48.5403 Servicio de Infecciosas
🇦🇷Buenos Aires, Argentina
1182.48.5404 Servicio de Infecciosas
🇦🇷Buenos Aires, Argentina
1182.48.5401 Fundación Huésped
🇦🇷Buenos Aires, Argentina
1182.48.5406 Servicio de Immunocomprometido
🇦🇷Buenos Aires, Argentina
1182.48.3202 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1182.48.3206 Boehringer Ingelheim Investigational Site
🇧🇪Charleroi, Belgium
1182.48.5511 Universidade Federal da Bahia-Unidade Docente Assistencial d
🇧🇷Salvador - BA, Brazil
1182.48.5508 I.I. Emilio Ribas
🇧🇷São Paulo - SP, Brazil
1182.48.3317 Boehringer Ingelheim Investigational Site
🇫🇷Bordeaux, France
1182.48.5512 Cidade Universitária Zeferino Vaz-Clínica Médica FCM
🇧🇷Campinas - SP, Brazil
1182.48.4301 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1182.48.5510 INCOR e Hospital das Clínicas da Universidade de São Paulo
🇧🇷São Paulo - SP, Brazil
1182.48.5509 Universidade Federal do Rio de Janeiro
🇧🇷Rio de Janeiro - RJ, Brazil
1182.48.4502 Boehringer Ingelheim Investigational Site
🇩🇰Hvidovre, Denmark
1182.48.4501 Boehringer Ingelheim Investigational Site
🇩🇰København Ø, Denmark
1182.48.3209 Boehringer Ingelheim Investigational Site
🇧🇪Antwerpen, Belgium
1182.48.3311 Boehringer Ingelheim Investigational Site
🇫🇷Besancon cedex, France
1182.48.5504 Hospital do Servidor Público Estadual - IAMSPE
🇧🇷São Paulo - SP, Brazil
1182.48.5513 UNIFESP - Centro de Pesquisa Clinica
🇧🇷São Paulo - SP, Brazil
1182.48.3307 Boehringer Ingelheim Investigational Site
🇫🇷Bordeaux cedex, France
1182.48.5502 Fundação Oswaldo Cruz
🇧🇷Rio de Janeiro - RJ, Brazil
1182.48.3308 Boehringer Ingelheim Investigational Site
🇫🇷Marseille cedex 5, France
1182.48.3304 Boehringer Ingelheim Investigational Site
🇫🇷Lyon cedex 02, France
1182.48.3002 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1182.48.3007 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1182.48.3005 Boehringer Ingelheim Investigational Site
🇬🇷Goudi, Athens, Greece
1182.48.4926 Boehringer Ingelheim Investigational Site
🇩🇪Köln, Germany
1182.48.4907 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany
1182.48.4909 Boehringer Ingelheim Investigational Site
🇩🇪Heidelberg, Germany
1182.48.4923 Boehringer Ingelheim Investigational Site
🇩🇪Mannheim, Germany
1182.48.3001 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1182.48.3003 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1182.48.3004 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1182.48.3920 Boehringer Ingelheim Investigational Site
🇮🇹Antella (fi), Italy
1182.48.3919 Boehringer Ingelheim Investigational Site
🇮🇹Firenze, Italy
1182.48.3914 Boehringer Ingelheim Investigational Site
🇮🇹Torino, Italy
1182.48.4920 Boehringer Ingelheim Investigational Site
🇩🇪Hannover, Germany
1182.48.4905 Boehringer Ingelheim Investigational Site
🇩🇪Köln, Germany
1182.48.3417 Boehringer Ingelheim Investigational Site
🇪🇸Malaga, Spain
1182.48.3903 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1182.48.3906 Boehringer Ingelheim Investigational Site
🇮🇹Torino, Italy
1182.48.3909 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1182.48.3402 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.48.3409 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1182.48.4406 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1182.48.3922 Boehringer Ingelheim Investigational Site
🇮🇹Pavia, Italy
1182.48.3935 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1182.48.3931 Boehringer Ingelheim Investigational Site
🇮🇹Torino, Italy
1182.48.3106 Boehringer Ingelheim Investigational Site
🇳🇱Amsterdam, Netherlands
1182.48.3105 Boehringer Ingelheim Investigational Site
🇳🇱Nijmegen, Netherlands
1182.48.3407 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1182.48.3408 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1182.48.3415 Boehringer Ingelheim Investigational Site
🇪🇸Alicante, Spain
1182.48.4412 Boehringer Ingelheim Investigational Site
🇬🇧Edinburgh, United Kingdom
1182.48.3401 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1182.48.3404 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.48.3412 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.48.4404 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1182.48.4405 Boehringer Ingelheim Investigational Site
🇬🇧Brighton, United Kingdom
1182.48.3414 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1182.48.4418 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1182.48.4603 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1182.48.4601 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1182.48.3413 Boehringer Ingelheim Investigational Site
🇪🇸Sevilla, Spain
1182.48.3416 Boehringer Ingelheim Investigational Site
🇪🇸San Sebastian, Spain
1182.48.3420 Boehringer Ingelheim Investigational Site
🇪🇸Valencia, Spain
1182.48.5405 Hospital Muniz
🇦🇷Buenos Aires, Argentina
1182.48.3210 Boehringer Ingelheim Investigational Site
🇧🇪Luxembourg, Belgium
1182.48.5505 Instituto A-Z de Pesquisa e Ensino da PUC
🇧🇷Curitiba - PR, Brazil
1182.48.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde
🇧🇷Nova Iguaçu - RJ, Brazil
1182.48.5501 Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia
🇧🇷São Paulo - SP, Brazil
1182.48.5503 I.I. Emilio Ribas - Moléstias Infecciosas
🇧🇷São Paulo - SP, Brazil
1182.48.5506 Centro de Referência e Treinamento - DST/AIDS
🇧🇷São Paulo - SP, Brazil
1182.48.3302 Boehringer Ingelheim Investigational Site
🇫🇷Caen, France
1182.48.3303 Boehringer Ingelheim Investigational Site
🇫🇷Clamart, France
1182.48.3318 Boehringer Ingelheim Investigational Site
🇫🇷Nantes, France
1182.48.3305 Boehringer Ingelheim Investigational Site
🇫🇷Le Kremlin Bicetre, France
1182.48.4906 Boehringer Ingelheim Investigational Site
🇩🇪Dortmund, Germany
1182.48.4910 Boehringer Ingelheim Investigational Site
🇩🇪München, Germany
1182.48.4919 Boehringer Ingelheim Investigational Site
🇩🇪Regensburg, Germany
1182.48.3405 Boehringer Ingelheim Investigational Site
🇪🇸Badalona, Spain
1182.48.3314 Boehringer Ingelheim Investigational Site
🇫🇷Vandoeuvre les nancy, France
1182.48.3310 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1182.48.3312 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1182.48.3410 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.48.3315 Boehringer Ingelheim Investigational Site
🇫🇷Rennes, France
1182.48.3320 Boehringer Ingelheim Investigational Site
🇫🇷Villejuif, France
1182.48.4911 Boehringer Ingelheim Investigational Site
🇩🇪Aachen, Germany
1182.48.4901 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1182.48.4902 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
1182.48.4903 Boehringer Ingelheim Investigational Site
🇩🇪Bochum, Germany
1182.48.4918 Boehringer Ingelheim Investigational Site
🇩🇪Bonn, Germany
1182.48.4912 Boehringer Ingelheim Investigational Site
🇩🇪Düsseldorf, Germany
1182.48.4904 Boehringer Ingelheim Investigational Site
🇩🇪Essen, Germany
1182.48.4908 Boehringer Ingelheim Investigational Site
🇩🇪Erlangen, Germany
1182.48.4924 Boehringer Ingelheim Investigational Site
🇩🇪Frankfurt/Main, Germany
1182.48.4916 Boehringer Ingelheim Investigational Site
🇩🇪Hamburg, Germany
1182.48.4928 Boehringer Ingelheim Investigational Site
🇩🇪Freiburg, Germany
1182.48.4930 Boehringer Ingelheim Investigational Site
🇩🇪Freiburg/Breisgau, Germany
1182.48.4913 Boehringer Ingelheim Investigational Site
🇩🇪Hannover, Germany
1182.48.4915 Boehringer Ingelheim Investigational Site
🇩🇪Osnabrück, Germany
1182.48.4921 Boehringer Ingelheim Investigational Site
🇩🇪Stuttgart, Germany
1182.48.4927 Boehringer Ingelheim Investigational Site
🇩🇪Stuttgart, Germany
1182.48.3006 Boehringer Ingelheim Investigational Site
🇬🇷Athens, Greece
1182.48.3010 Boehringer Ingelheim Investigational Site
🇬🇷Patras, Greece
1182.48.3008 Boehringer Ingelheim Investigational Site
🇬🇷Peraeus, Greece
1182.48.3531 Boehringer Ingelheim Investigational Site
🇮🇪Dublin 8, Ireland
1182.48.3009 Boehringer Ingelheim Investigational Site
🇬🇷Thessaloniki, Greece
1182.48.3932 Boehringer Ingelheim Investigational Site
🇮🇹Bergamo, Italy
1182.48.3926 Boehringer Ingelheim Investigational Site
🇮🇹Bari, Italy
1182.48.3908 Boehringer Ingelheim Investigational Site
🇮🇹Brescia, Italy
1182.48.3917 Boehringer Ingelheim Investigational Site
🇮🇹Ferrara, Italy
1182.48.3930 Boehringer Ingelheim Investigational Site
🇮🇹Ancona, Italy
1182.48.3929 Boehringer Ingelheim Investigational Site
🇮🇹Busto Arsizio (va), Italy
1182.48.3927 Boehringer Ingelheim Investigational Site
🇮🇹Genova, Italy
1182.48.3905 Boehringer Ingelheim Investigational Site
🇮🇹Genova, Italy
1182.48.3910 Boehringer Ingelheim Investigational Site
🇮🇹Macerata, Italy
1182.48.3925 Boehringer Ingelheim Investigational Site
🇮🇹Lecco, Italy
1182.48.3901 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1182.48.3907 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1182.48.3924 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1182.48.3915 Boehringer Ingelheim Investigational Site
🇮🇹Modena, Italy
1182.48.3934 Boehringer Ingelheim Investigational Site
🇮🇹Milano, Italy
1182.48.3916 Boehringer Ingelheim Investigational Site
🇮🇹Pavia, Italy
1182.48.3912 Boehringer Ingelheim Investigational Site
🇮🇹Napoli, Italy
1182.48.3921 Boehringer Ingelheim Investigational Site
🇮🇹Padova, Italy
1182.48.3902 Boehringer Ingelheim Investigational Site
🇮🇹Roma, Italy
1182.48.3904 Boehringer Ingelheim Investigational Site
🇮🇹Rimini, Italy
1182.48.3933 Boehringer Ingelheim Investigational Site
🇮🇹Treviso, Italy
1182.48.3101 Boehringer Ingelheim Investigational Site
🇳🇱Amsterdam, Netherlands
1182.48.5206 Centro Medico San Vicente
🇲🇽Monterrey, N.l., Mexico
1182.48.3110 Boehringer Ingelheim Investigational Site
🇳🇱Den Haag, Netherlands
1182.48.3104 Boehringer Ingelheim Investigational Site
🇳🇱Rotterdam, Netherlands
1182.48.3108 Boehringer Ingelheim Investigational Site
🇳🇱Groningen, Netherlands
1182.48.3502 Boehringer Ingelheim Investigational Site
🇵🇹Cascais, Portugal
1182.48.3411 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1182.48.3418 Boehringer Ingelheim Investigational Site
🇪🇸Vigo, Spain
1182.48.4602 Boehringer Ingelheim Investigational Site
🇸🇪Malmö, Sweden
1182.48.4103 Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland
1182.48.4411 Boehringer Ingelheim Investigational Site
🇬🇧Liverpool, United Kingdom
1182.48.4408 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1182.48.4409 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1182.48.4414 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1182.48.4417 Boehringer Ingelheim Investigational Site
🇬🇧Newcastle upon Tyne, United Kingdom
1182.48.4407 Boehringer Ingelheim Investigational Site
🇬🇧Portsmouth, United Kingdom
1182.48.5402 Fundación Huésped
🇦🇷Buenos Aires, Argentina
1182.48.3321 Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1182.48.3322 Boehringer Ingelheim Investigational Site
🇫🇷Lyon cedex 3, France
1182.48.4914 Boehringer Ingelheim Investigational Site
🇩🇪Düsseldorf, Germany
1182.48.3503 Boehringer Ingelheim Investigational Site
🇵🇹Coimbra, Portugal
1182.48.4104 Hopital Universitaire de Genève
🇨🇭Genève, Switzerland
1182.48.3201 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1182.48.3207 Boehringer Ingelheim Investigational Site
🇧🇪Gent, Belgium
1182.48.3504 Hospital de São João
🇵🇹Porto, Portugal
1182.48.4101 Universitätsspital Basel
🇨🇭Basel, Switzerland