VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients

Phase 3

Completed

Conditions: HIV Infections

Interventions: Drug: nevirapine IR
Drug: nevirapine XR

Registration Number: NCT00561925

Lead Sponsor: Boehringer Ingelheim

Brief Summary: The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment. Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1068

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nevirapine IR	nevirapine IR	200 mg BID
nevirapine XR	nevirapine XR	400 mg QD

Primary Outcome Measures

Name	Time	Method
Comparison of Proportion of Virologic Response at Week 48 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population	week 48	Primary endpoint was the number of patients with a sustained virologic response through week 48 using LLOQ = 50 copies/mL

Secondary Outcome Measures

Name	Time	Method
Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population	week 0 to 144
Occurrence of Rashes	until last patient completed 144 weeks (up to 193 weeks)	Frequency of patients with drug related rash events by functional grouping
Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population	week 0 to 144
Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population	week 144	Endpoint was the number of patients with a sustained virologic response through week 144 using LLOQ = 50 copies/mL
Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population	baseline, week 144
Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population	baseline, week 144
Occurrence of Elevations in Laboratory Measurement by DAIDS Grade	until last patient completed 144 weeks (up to 193 weeks)
Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication	week 0 to 144
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities	week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities	week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events	week 0 to 72
Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash	week 0 to 72
Relative Bioavailability Trough C_pre,ss,1	week 132	Relative bioavailability measured of trough concentrations. Analysis based on adjusted by-treatment geometric means, the adjusted geometric mean ratio of NVP XR : NVP IR and it's 90% confidence interval with p-value and the inter-individual geometric coefficient of variation.
Occurrence of Hepatic Events	until last patient completed 144 weeks (up to 193 weeks)	Frequency of patients with hepatitis symptoms

Trial Locations

Locations (202): 1100.1486.0025 Boehringer Ingelheim Investigational Site
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Los Angeles, California, United States
1100.1486.0041 Boehringer Ingelheim Investigational Site
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Los Angeles, California, United States
1100.1486.0031 Boehringer Ingelheim Investigational Site
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Atlanta, Georgia, United States
1100.1486.0034 Boehringer Ingelheim Investigational Site
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Los Angeles, California, United States
1100.1486.0019 Boehringer Ingelheim Investigational Site
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Berkley, Michigan, United States
1100.1486.1013 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canada
1100.1486.0018 Boehringer Ingelheim Investigational Site
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Dallas, Texas, United States
1100.1486.0002 Boehringer Ingelheim Investigational Site
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Chicago, Illinois, United States
1100.1486.0028 Boehringer Ingelheim Investigational Site
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San Diego, California, United States
1100.1486.0012 Boehringer Ingelheim Investigational Site
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Miami, Florida, United States
1100.1486.0009 Boehringer Ingelheim Investigational Site
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Houston, Texas, United States
1100.1486.3205 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgium
1100.1486.3201 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgium
1100.1486.3314E Boehringer Ingelheim Investigational Site
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Caen cedex 5, France
1100.1486.4401 Boehringer Ingelheim Investigational Site
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Manchester, United Kingdom
1100.1486.4402 Boehringer Ingelheim Investigational Site
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Plaistow, London, United Kingdom
1100.1486.3404 Boehringer Ingelheim Investigational Site
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L'Hospitalet de Llobregat, Spain
1100.1486.0040 Boehringer Ingelheim Investigational Site
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Birmingham, Alabama, United States
1100.1486.0057 Boehringer Ingelheim Investigational Site
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Beverly Hills, California, United States
1100.1486.0010 Boehringer Ingelheim Investigational Site
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Macon, Georgia, United States
1100.1486.0013 Boehringer Ingelheim Investigational Site
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Phoenix, Arizona, United States
1100.1486.0001 Boehringer Ingelheim Investigational Site
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Beverly Hills, California, United States
1100.1486.0037 Boehringer Ingelheim Investigational Site
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Clearwater, Florida, United States
1100.1486.0014 Boehringer Ingelheim Investigational Site
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Wilton Manors, Florida, United States
1100.1486.6101 Boehringer Ingelheim Investigational Site
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Darlinghurst, New South Wales, Australia
1100.1486.6104 Boehringer Ingelheim Investigational Site
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Surry Hills, New South Wales, Australia
1100.1486.5401 Boehringer Ingelheim Investigational Site
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Capital Federal, Argentina
1100.1486.5404 Boehringer Ingelheim Investigational Site
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Capital Federal, Argentina
1100.1486.0020 Boehringer Ingelheim Investigational Site
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Lexington, Kentucky, United States
1100.1486.0006 Boehringer Ingelheim Investigational Site
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Kansas City, Missouri, United States
1100.1486.0053 Boehringer Ingelheim Investigational Site
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Boise, Idaho, United States
1100.1486.0027 Boehringer Ingelheim Investigational Site
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St. Louis, Missouri, United States
1100.1486.0055 Boehringer Ingelheim Investigational Site
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Charlotte, North Carolina, United States
1100.1486.0044 Boehringer Ingelheim Investigational Site
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Fort Worth, Texas, United States
1100.1486.0038 Boehringer Ingelheim Investigational Site
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Dallas, Texas, United States
1100.1486.0054 Boehringer Ingelheim Investigational Site
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Harlingen, Texas, United States
1100.1486.5407 Boehringer Ingelheim Investigational Site
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Capital Federal, Argentina
1100.1486.5408 Boehringer Ingelheim Investigational Site
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Capital Federal, Argentina
1100.1486.5403 Boehringer Ingelheim Investigational Site
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Mar del Plata, Argentina
1100.1486.5405 Boehringer Ingelheim Investigational Site
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Rosario, Argentina
1100.1486.3208 Boehringer Ingelheim Investigational Site
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Brugge, Belgium
1100.1486.3202 Boehringer Ingelheim Investigational Site
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Gent, Belgium
1100.1486.3303D Boehringer Ingelheim Investigational Site
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Paris, France
1100.1486.3301B Boehringer Ingelheim Investigational Site
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Nantes, France
1100.1486.3305B Boehringer Ingelheim Investigational Site
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Angers, France
1100.1486.3306A Boehringer Ingelheim Investigational Site
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Nice cedex 3, France
1100.1486.3318D Boehringer Ingelheim Investigational Site
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Toulon cedex, France
1100.1486.3310A Boehringer Ingelheim Investigational Site
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Villeneuve St Georges cedex, France
1100.1486.4902 Boehringer Ingelheim Investigational Site
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Berlin, Germany
1100.1486.4926 Boehringer Ingelheim Investigational Site
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Frankfurt, Germany
1100.1486.4901 Boehringer Ingelheim Investigational Site
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Freiburg, Germany
1100.1486.4929 Boehringer Ingelheim Investigational Site
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Frankfurt/Main, Germany
1100.1486.4405 Boehringer Ingelheim Investigational Site
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London, United Kingdom
1100.1486.4913 Boehringer Ingelheim Investigational Site
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Ulm/Donau, Germany
1100.1486.2704 Boehringer Ingelheim Investigational Site
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Pretoria, South Africa
1100.1486.4903 Boehringer Ingelheim Investigational Site
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München, Germany
1100.1486.4905 Boehringer Ingelheim Investigational Site
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Münster, Germany
1100.1486.0004 Boehringer Ingelheim Investigational Site
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Austin, Texas, United States
1100.1486.0017 Boehringer Ingelheim Investigational Site
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Bakersfield, California, United States
1100.1486.0035 Boehringer Ingelheim Investigational Site
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Long Beach, California, United States
1100.1486.0059 Boehringer Ingelheim Investigational Site
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Beverly Hills, California, United States
1100.1486.0032 Boehringer Ingelheim Investigational Site
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Sacramento, California, United States
1100.1486.0029 Boehringer Ingelheim Investigational Site
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Washington, District of Columbia, United States
1100.1486.0039 Boehringer Ingelheim Investigational Site
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Orlando, Florida, United States
1100.1486.0048 Boehringer Ingelheim Investigational Site
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Washington, District of Columbia, United States
1100.1486.0007 Boehringer Ingelheim Investigational Site
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Miami Beach, Florida, United States
1100.1486.0003 Boehringer Ingelheim Investigational Site
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Huntersville, North Carolina, United States
1100.1486.0026 Boehringer Ingelheim Investigational Site
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Chicago, Illinois, United States
1100.1486.5402 Boehringer Ingelheim Investigational Site
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Capital Federal, Argentina
1100.1486.5409 Boehringer Ingelheim Investigational Site
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Quilmes, Argentina
1100.1486.6102 Boehringer Ingelheim Investigational Site
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Darlinghurst, New South Wales, Australia
1100.1486.3207 Boehringer Ingelheim Investigational Site
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Brussel, Belgium
1100.1486.3203 Boehringer Ingelheim Investigational Site
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Bruxelles, Belgium
1100.1486.2603 Boehringer Ingelheim Investigational Site
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Gaborone, Botswana
1100.1486.2601 Boehringer Ingelheim Investigational Site
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Gaborone, Botswana
1100.1486.1004 Boehringer Ingelheim Investigational Site
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Winnipeg, Manitoba, Canada
1100.1486.1014 Boehringer Ingelheim Investigational Site
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Montreal, Quebec, Canada
1100.1486.1016 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canada
1100.1486.1005 Boehringer Ingelheim Investigational Site
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Montreal, Quebec, Canada
1100.1486.3305A Boehringer Ingelheim Investigational Site
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Angers, France
1100.1486.1010 Boehringer Ingelheim Investigational Site
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Montreal, Quebec, Canada
1100.1486.1011 Boehringer Ingelheim Investigational Site
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Quebec (Ste Foy), Quebec, Canada
1100.1486.3307A Boehringer Ingelheim Investigational Site
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Bondy, France
1100.1486.3317A Boehringer Ingelheim Investigational Site
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Bordeaux Cedex, France
1100.1486.3316A Boehringer Ingelheim Investigational Site
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Brest Cedex, France
1100.1486.3316B Boehringer Ingelheim Investigational Site
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Brest Cedex, France
1100.1486.3304A Boehringer Ingelheim Investigational Site
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Clamart, France
1100.1486.3301A Boehringer Ingelheim Investigational Site
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Nantes, France
1100.1486.3308A Boehringer Ingelheim Investigational Site
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Lyon Cedex 3, France
1100.1486.3301D Boehringer Ingelheim Investigational Site
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Nantes, France
1100.1486.3308C Boehringer Ingelheim Investigational Site
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Lyon Cedex 3, France
1100.1486.3301E Boehringer Ingelheim Investigational Site
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Nantes, France
1100.1486.3301C Boehringer Ingelheim Investigational Site
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Nantes, France
1100.1486.3301G Boehringer Ingelheim Investigational Site
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Nantes, France
1100.1486.3301H Boehringer Ingelheim Investigational Site
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Nantes, France
1100.1486.3301I Boehringer Ingelheim Investigational Site
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Nantes, France
1100.1486.3301F Boehringer Ingelheim Investigational Site
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Nantes, France
1100.1486.3303A Boehringer Ingelheim Investigational Site
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Paris, France
1100.1486.3303B Boehringer Ingelheim Investigational Site
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Paris, France
1100.1486.3303C Boehringer Ingelheim Investigational Site
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Paris, France
1100.1486.3312A Boehringer Ingelheim Investigational Site
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Paris, France
1100.1486.3318B Boehringer Ingelheim Investigational Site
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Toulon cedex, France
1100.1486.3309B Boehringer Ingelheim Investigational Site
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Saint Etienne, France
1100.1486.3309A Boehringer Ingelheim Investigational Site
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Saint Etienne, France
1100.1486.3312B Boehringer Ingelheim Investigational Site
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Paris, France
1100.1486.3318A Boehringer Ingelheim Investigational Site
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Toulon cedex, France
1100.1486.3318C Boehringer Ingelheim Investigational Site
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Toulon cedex, France
1100.1486.3302B Boehringer Ingelheim Investigational Site
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Toulouse cedex 9, France
1100.1486.3302C Boehringer Ingelheim Investigational Site
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Toulouse cedex 9, France
1100.1486.4928 Boehringer Ingelheim Investigational Site
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Berlin, Germany
1100.1486.3302A Boehringer Ingelheim Investigational Site
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Toulouse cedex 9, France
1100.1486.4932 Boehringer Ingelheim Investigational Site
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Bochum, Germany
1100.1486.4911 Boehringer Ingelheim Investigational Site
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Dortmund, Germany
1100.1486.4922 Boehringer Ingelheim Investigational Site
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Bonn, Germany
1100.1486.4919 Boehringer Ingelheim Investigational Site
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Düsseldorf, Germany
1100.1486.4906 Boehringer Ingelheim Investigational Site
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Essen, Germany
1100.1486.4908 Boehringer Ingelheim Investigational Site
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Erlangen, Germany
1100.1486.4916 Boehringer Ingelheim Investigational Site
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Frankfurt/Main, Germany
1100.1486.4909 Boehringer Ingelheim Investigational Site
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Hamburg, Germany
1100.1486.4920 Boehringer Ingelheim Investigational Site
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Hamburg, Germany
1100.1486.4930 Boehringer Ingelheim Investigational Site
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Freiburg, Germany
1100.1486.4907 Boehringer Ingelheim Investigational Site
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Köln, Germany
1100.1486.4925 Boehringer Ingelheim Investigational Site
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Hamburg, Germany
1100.1486.4923 Boehringer Ingelheim Investigational Site
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Hannover, Germany
1100.1486.4915 Boehringer Ingelheim Investigational Site
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Hannover, Germany
1100.1486.4910 Boehringer Ingelheim Investigational Site
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Kiel, Germany
1100.1486.4924 Boehringer Ingelheim Investigational Site
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Köln, Germany
1100.1486.4912 Boehringer Ingelheim Investigational Site
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München, Germany
1100.1486.4904 Boehringer Ingelheim Investigational Site
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München, Germany
1100.1486.4918 Boehringer Ingelheim Investigational Site
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Osnabrück, Germany
1100.1486.3531 Boehringer Ingelheim Investigational Site
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Dublin 8, Ireland
1100.1486.3532 Boehringer Ingelheim Investigational Site
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Dublin, Ireland
1100.1486.3907 Boehringer Ingelheim Investigational Site
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Treviso, Italy
1100.1486.4914 Boehringer Ingelheim Investigational Site
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Würzburg, Germany
1100.1486.3908 Boehringer Ingelheim Investigational Site
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Palermo, Italy
1100.1486.3901 Boehringer Ingelheim Investigational Site
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Torino, Italy
1100.1486.3905 Boehringer Ingelheim Investigational Site
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Pescara, Italy
1100.1486.3906 Boehringer Ingelheim Investigational Site
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Verbania, Italy
1100.1486.3103 Boehringer Ingelheim Investigational Site
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Arnhem, Netherlands
1100.1486.5204 Boehringer Ingelheim Investigational Site
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León, Mexico
1100.1486.5207 Boehringer Ingelheim Investigational Site
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Guadalajara, Mexico
1100.1486.3107 Boehringer Ingelheim Investigational Site
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Amsterdam, Netherlands
1100.1486.3101 Boehringer Ingelheim Investigational Site
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Rotterdam, Netherlands
1100.1486.3102 Boehringer Ingelheim Investigational Site
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Zwolle, Netherlands
1100.1486.4801 Boehringer Ingelheim Investigational Site
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Chorzow, Poland
1100.1486.3503 Boehringer Ingelheim Investigational Site
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Amadora, Portugal
1100.1486.3504 Boehringer Ingelheim Investigational Site
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Lisboa, Portugal
1100.1486.0033 Boehringer Ingelheim Investigational Site
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San Juan, Puerto Rico
1100.1486.4001 Boehringer Ingelheim Investigational Site
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Bucharest, Romania
1100.1486.7002 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
1100.1486.2712 Boehringer Ingelheim Investigational Site
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Bloemfontein, South Africa
1100.1486.4002 Boehringer Ingelheim Investigational Site
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Bucharest, Romania
1100.1486.7001 Boehringer Ingelheim Investigational Site
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St. Petersburg, Russian Federation
1100.1486.2703 Boehringer Ingelheim Investigational Site
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Cape Town, South Africa
1100.1486.2701 Boehringer Ingelheim Investigational Site
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Edenvale, South Africa
1100.1486.2710 Boehringer Ingelheim Investigational Site
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Johannesburg, South Africa
1100.1486.2702 Boehringer Ingelheim Investigational Site
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Port Elizabeth, South Africa
1100.1486.2706 Boehringer Ingelheim Investigational Site
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Nelspruit, South Africa
1100.1486.3401 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
1100.1486.3406 Boehringer Ingelheim Investigational Site
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Alcalá de Henares (Madrid), Spain
1100.1486.3402 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
1100.1486.3415 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
1100.1486.3417 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
1100.1486.3410 Boehringer Ingelheim Investigational Site
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Barcelona, Spain
1100.1486.3414 Boehringer Ingelheim Investigational Site
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Madrid, Spain
1100.1486.3405 Boehringer Ingelheim Investigational Site
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Madrid, Spain
1100.1486.3407 Boehringer Ingelheim Investigational Site
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Madrid, Spain
1100.1486.4109 Boehringer Ingelheim Investigational Site
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Bern, Switzerland
1100.1486.4101 Boehringer Ingelheim Investigational Site
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Basel, Switzerland
1100.1486.3408 Boehringer Ingelheim Investigational Site
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Valencia, Spain
1100.1486.3416 Boehringer Ingelheim Investigational Site
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Mataro, Spain
1100.1486.4107 Boehringer Ingelheim Investigational Site
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Genève, Switzerland
1100.1486.4104 Boehringer Ingelheim Investigational Site
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Lausanne, Switzerland
1100.1486.4108 Boehringer Ingelheim Investigational Site
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St. Gallen, Switzerland
1100.1486.4110 Boehringer Ingelheim Investigational Site
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Zürich, Switzerland
1100.1486.4406 Boehringer Ingelheim Investigational Site
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Birmingham, United Kingdom
1100.1486.4403 Boehringer Ingelheim Investigational Site
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London, United Kingdom
1100.1486.4404 Boehringer Ingelheim Investigational Site
🇬🇧
London, United Kingdom
1100.1486.4407 Boehringer Ingelheim Investigational Site
🇬🇧
London, United Kingdom
1100.1486.4408 Boehringer Ingelheim Investigational Site
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Manchester, United Kingdom
1100.1486.0046 Boehringer Ingelheim Investigational Site
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Annandale, Virginia, United States
1100.1486.2707 Boehringer Ingelheim Investigational Site
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Bloemfontein, South Africa
1100.1486.0023 Boehringer Ingelheim Investigational Site
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Washington, District of Columbia, United States
1100.1486.0043 Boehringer Ingelheim Investigational Site
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Fort Lauderdale, Florida, United States
1100.1486.2711 Boehringer Ingelheim Investigational Site
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Cape Town, South Africa
1100.1486.0050 Boehringer Ingelheim Investigational Site
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Vero Beach, Florida, United States
1100.1486.2709 Boehringer Ingelheim Investigational Site
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Cape Town, South Africa
1100.1486.0005 Boehringer Ingelheim Investigational Site
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Akron, Ohio, United States
1100.1486.4927 Boehringer Ingelheim Investigational Site
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Mainz, Germany
1100.1486.6103 Boehringer Ingelheim Investigational Site
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Brisbane, Queensland, Australia
1100.1486.3403 Boehringer Ingelheim Investigational Site
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Madrid, Spain
1100.1486.1002 Boehringer Ingelheim Investigational Site
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Vancouver, British Columbia, Canada
1100.1486.4804 Boehringer Ingelheim Investigational Site
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Warsaw, Poland
1100.1486.0024 Boehringer Ingelheim Investigational Site
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Ponce, Puerto Rico
1100.1486.4102 Boehringer Ingelheim Investigational Site
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Lugano, Switzerland
1100.1486.2605 Boehringer Ingelheim Investigational Site
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Francistown, Botswana
1100.1486.3501 Boehringer Ingelheim Investigational Site
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Lisboa, Portugal
1100.1486.4803 Boehringer Ingelheim Investigational Site
🇵🇱
Bydgoszcz, Poland
1100.1486.4106 Boehringer Ingelheim Investigational Site
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La Chaux-de-Fonds, Switzerland
1100.1486.3209 Boehringer Ingelheim Investigational Site
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Charleroi, Belgium
1100.1486.3204 Boehringer Ingelheim Investigational Site
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Liège, Belgium
1100.1486.3206 Boehringer Ingelheim Investigational Site
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Liège, Belgium