Clinical trial NCT00146328: Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects
Official title: A Long Term Open Label Rollover Trial Assessing the Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV-1 Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 997
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the long term safety and tolerability of multiple oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other antiretroviral medications.


Eligibility criteria: INCLUSION CRITERIA

1. Ability and willingness to give written informed consent in accordance with institutional and federal guidelines and to comply with the investigational nature of the study and the related requirements.
2. All subjects must have successfully completed participation in a combination tipranavir/ritonavir trial or have confirmed virologic failure in the 1182.12 or 1182.48 trials and are not able to obtain TPV by prescription. Successful completion of participation is defined as conclusion of required subject-weeks on assigned dosing (trial specific) and completion of required visits.
3. Male and female subjects 18 years and over.
4. Presence of Human Immunodeficiency Virus 1 (HIV-1) infection as documented by any licensed Enzyme Linked immunosorbent Assay (ELISA) test kit and confirmed by Western Blot, or HIV-1 culture, or HIV-1 antigen, or plasma HIV 1 Ribonucleic Acid (RNA) or a second antibody test by a method other than ELISA at any time prior to study entry.
5. Adherence to previous tipranavir/ritonavir dosing protocol and adherence to visit requirements of previous protocol (as assessed by principal investigator).
6. 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 (\<Common Toxicity Criteria (CTC) Grade 2).
   * Total Triglycerides ≤750 mg/dl (\<Division of AIDS (DAIDS) Grade 2).
   * Alanine aminotransferase (ALT) ≤3.0x upper limit of normal (ULN) and Aspartate aminotransferase (AST) ≤2.5x ULN (\<DAIDS Grade 1).
   * Any Grade Gamma Glutamyl transpeptidase(GGT) is acceptable.
   * Any Grade creatinine kinase is acceptable as long as there is no concurrent myopathy.
   * All other laboratory test values ≤DAIDS Grade 1.

EXCLUSION CRITERIA

1. Female subjects who are of reproductive potential who:

   * Have a positive serum beta human chorionic gonadotropin (B HCG) at Screening/Enrollment Visit.
   * Are not willing to use a reliable method of barrier contraception (such as diaphragm or condoms).
   * Are breast-feeding.
2. Subjects who are actively using injection drugs or other substance abuse (such as extensive alcohol or narcotic use) which is considered by the investigator to be a significant impairment to health and to protocol adherence.
3. Any medical condition(s) which, in the opinion of the investigator, would interfere with the subject's ability to participate in or adhere to the requirements of this protocol.
4. History of any illness or drug allergy which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering tipranavir/ritonavir to the subject.
5. Active use of any of the following:

   * Investigational HIV-1 vaccines.
   * Any new investigational antiretroviral agent that was not approved for use in the patients prior tipranavir trial.
   * Medications excluded during the trial period (see Section 4.2).
   * Herbal medications (e.g., St. John's Wort).
6. Active HIV-related or non HIV-related illness that may be negatively affected by use of tipranavir/ritonavir as determined by the investigator.

   If a subject must temporarily discontinue tipranavir/ritonavir at the recommendation of the investigator (at the completion of the previous tipranavir trial), then the subject may enroll in 1182.17 once the clinical illness has resolved, and after approval from the Boehringer Ingelheim Clinical Monitor or Local Clinical Monitor.
7. Clinically significant liver disease in the 90 days prior to baseline visit, regardless of baseline AST and/or ALT values.
8. Hypersensitivity to tipranavir or ritonavir.
9. Voluntary discontinuation of antiretroviral therapy (including tipranavir/ritonavir) for more than seven days from completion of previous tipranavir trial.

Primary outcomes:
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct.
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT)
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT)
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL)
timeFrame: End of Trial (>288 weeks)
measure: Number of Patients With Adverse Events Leading to Death
timeFrame: End of Trial (>288 weeks)
Secondary outcomes:
measure: Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF)
timeFrame: Baseline to 192-240 week time interval
measure: Change From Baseline in CD4 Cell Count (LOCF)
timeFrame: Baseline to 192-240 week time interval
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 1182.17.39 MDS Pharma Services
state: Arizona
city: Phoenix
country: United States
facility: 1182.17.75 Boehringer Ingelheim Investigational Site
state: Arizona
city: Berkeley
country: United States
facility: 1182.17.89 Boehringer Ingelheim Investigational Site
state: California
city: Fountain Valley
country: United States
facility: 1182.17.60 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1182.17.106 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1182.17.15 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1182.17.40 Tower ID Medical
state: California
city: Los Angeles
country: United States
facility: 1182.17.46 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1182.17.47 University of Southern California
state: California
city: Los Angeles
country: United States
facility: 1182.17.73 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 1182.17.114 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 1182.17.128 Boehringer Ingelheim Investigational Site
state: California
city: San Francisco
country: United States
facility: 1182.17.37 Boehringer Ingelheim Investigational Site
state: California
city: San Francisco
country: United States
facility: 1182.17.58 Boehringer Ingelheim Investigational Site
state: California
city: San Francisco
country: United States
facility: 1182.17.96 Boehringer Ingelheim Investigational Site
state: California
city: Norwalk
country: United States
facility: 1182.17.87 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Washington
country: United States
facility: 1182.17.112 Boehringer Ingelheim Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: 1182.17.43 Boehringer Ingelheim Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: 1182.17.65 Boehringer Ingelheim Investigational Site
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: 1182.17.126 Boehringer Ingelheim Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: 1182.17.8 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1182.17.131 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1182.17.22 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 1182.17.64 Boehringer Ingelheim Investigational Site
state: Florida
city: Sarasota
country: United States
facility: 1182.17.129 Boehringer Ingelheim Investigational Site
state: Florida
city: South Miami
country: United States
facility: 1182.17.51 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1182.17.125 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1182.17.132 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1182.17.76 Boehringer Ingelheim Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: 1182.17.52 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 1182.17.77 Boehringer Ingelheim Investigational Site
state: Georgia
city: Macon
country: United States
facility: 1182.17.69 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 1182.17.136 Boehringer Ingelheim Investigational Site
state: Illinois
city: Chicago
country: United States
facility: 1182.17.70 Boehringer Ingelheim Investigational Site
state: Illinois
city: Evanston
country: United States
facility: 1182.17.36 Boehringer Ingelheim Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: 1182.17.1 Boehringer Ingelheim Investigational Site
state: Indiana
city: Wichita
country: United States
facility: 1182.17.32 University of Kansas School of Medicine - Wichita
state: Kansas
city: Lexington
country: United States
facility: 1182.17.102 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: 1182.17.21 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Portland
country: United States
facility: 1182.17.30 Boehringer Ingelheim Investigational Site
state: Maine
city: Baltimore
country: United States
facility: 1182.17.67 Boehringer Ingelheim Investigational Site
state: Maryland
city: Bethesda
country: United States
facility: 1182.17.86 Boehringer Ingelheim Investigational Site
state: Maryland
city: Boston
country: United States
facility: 1182.17.111 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: 1182.17.63 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Springfield
country: United States
facility: 1182.17.74 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: 1182.17.4 Boehringer Ingelheim Investigational Site
state: Michigan
city: Detroit
country: United States
facility: 1182.17.115 Boehringer Ingelheim Investigational Site
state: Michigan
city: Detroit
country: United States
facility: 1182.17.6 Boehringer Ingelheim Investigational Site
state: Michigan
city: Kansas City
country: United States
facility: 1182.17.62 Boehringer Ingelheim Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: 1182.17.59 Boehringer Ingelheim Investigational Site
state: Nevada
city: Camden
country: United States
facility: 1182.17.118 Early Intervention Program (EIP) Clinic
state: New Jersey
city: East Orange
country: United States
facility: 1182.17.93 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Hackensack
country: United States
facility: 1182.17.24 Hackensack University Medical Center
state: New Jersey
city: Hillsborough
country: United States
facility: 1182.17.34 ID Care, Inc.
state: New Jersey
city: Santa Fe
country: United States
facility: 1182.17.50 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Albany
country: United States
facility: 1182.17.79 Boehringer Ingelheim Investigational Site
state: New York
city: Mount Vernon
country: United States
facility: 1182.17.103 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1182.17.105 Pollari Medical Group
state: New York
city: New York
country: United States
facility: 1182.17.130 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1182.17.3 Division of Infectious Diseases
state: New York
city: New York
country: United States
facility: 1182.17.42 Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: 1182.17.5 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1182.17.7 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1182.17.94 Boehringer Ingelheim Investigational Site
state: New York
city: Rochester
country: United States
facility: 1182.17.135 Boehringer Ingelheim Investigational Site
state: New York
city: Stony Brook
country: United States
facility: 1182.17.31 Boehringer Ingelheim Investigational Site
state: New York
city: Durham
country: United States
facility: 1182.17.53 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Huntersville
country: United States
facility: 1182.17.54 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Akron
country: United States
facility: 1182.17.134 Summa Health System
state: Ohio
city: Cincinnati
country: United States
facility: 1182.17.95 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 1182.17.26 Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: 1182.17.9 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: 1182.17.110 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: 1182.17.99 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: 1182.17.23 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: 1182.17.11 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: 1182.17.18 Vanderbilt AIDS Clinical Trials Center
state: Tennessee
city: Dallas
country: United States
facility: 1182.17.116 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1182.17.142 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1182.17.16 Nelson-Tebedo Clinic
state: Texas
city: Houston
country: United States
facility: 1182.17.122 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1182.17.68 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1182.17.97 Boehringer Ingelheim Investigational Site
state: Texas
city: Annandale
country: United States
facility: 1182.17.10 Boehringer Ingelheim Investigational Site
state: Virginia
city: Tacoma
country: United States
facility: 1182.17.92 Boehringer Ingelheim Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: 1182.17.100 Boehringer Ingelheim Investigational Site
state: Wisconsin
city: Capital Federal
country: Argentina
facility: 1182.17.5401 Fundacion Huesped
city: Capital Federal
country: Argentina
facility: 1182.17.5402 Funcei
city: Capital Federal
country: Argentina
facility: 1182.17.5403 consultorio externo "PETS"
city: Capital Federal
country: Argentina
facility: 1182.17.5404 Infectología
city: Capital Federal
country: Argentina
facility: 1182.17.5405 Dpto. de Enfermedades infecciosas (Pabellón 22)
city: Capital Federal
country: Argentina
facility: 1182.17.5406 Pabellón de Clínicas 2° Piso
city: Darlinghurst
country: Australia
facility: 1182.17.401 St. Vincent's Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: 1182.17.402 Taylor Square Private Clinic
state: New South Wales
city: DarlingHurst
country: Australia
facility: 1182.17.405 AIDS Research Initiative
state: New South Wales
city: Darlinghurst
country: Australia
facility: 1182.17.407 Holdsworth House General Practice
state: New South Wales
city: Darlinghurst
country: Australia
facility: 1182.17.408 407 Doctors Pty Ltd.
state: New South Wales
city: Surry Hills
country: Australia
facility: 1182.17.403 Albion Street Clinic
state: New South Wales
city: Melbourne
country: Australia
facility: 1182.17.404 Alfred Hospital
state: Victoria
city: Wien
country: Austria
facility: 1182.17.4301 Boehringer Ingelheim Investigational Site
city: Antwerpen
country: Belgium
facility: 1182.17.3209 Instituut Tropische Geneeskunde
city: Bruxelles
country: Belgium
facility: 1182.17.3201 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1182.17.3202 Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: 1182.17.3207 Boehringer Ingelheim Investigational Site
city: Luxembourg
country: Belgium
facility: 1182.17.3210 Centre Hospitalier de Luxembourg
city: Canela - Salvador - BA
country: Brazil
facility: 1182.17.5511 Universidade Federal da Bahia
city: Cerqueira César, São Paulo - SP
country: Brazil
facility: 1182.17.5508 I.I. Emilio Ribas
city: Cidade Nova - Rio de Janeiro - RJ
country: Brazil
facility: 1182.17.5509 (Unidade de Testes Terapêuticos)
city: Manguinhos - Rio de Janeiro - RJ
country: Brazil
facility: 1182.17.5502 Farmácia do Instituto de Pesquisa Evandro Chagas
city: Mercês - Curitiba - PR
country: Brazil
facility: 1182.17.5505 Instituto A-Z de Pesquisa e Ensino da PUC
city: Nova Iguaçu - Rio de Janeiro - RJ
country: Brazil
facility: 1182.17.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde
city: Sacoma - São Paulo - SP
country: Brazil
facility: 1182.17.5501 Hospital Dia
city: São Paulo - SP
country: Brazil
facility: 1182.17.5503 Instituto de Infectologia Emílio Ribas
city: São Paulo - SP
country: Brazil
facility: 1182.17.5504 Enfermaria de MI
city: São Paulo, SP
country: Brazil
facility: 1182.17.5510 Casa de AIDS
city: Vila Mariana, Sao Paulo - SP
country: Brazil
facility: 1182.17.5506 Centro de Referência e Treinamento - DST/AIDS
city: Vancouver
country: Canada
facility: 1182.17.902 Downtown Infectious Diseases Clinic
state: British Columbia
city: Hamilton
country: Canada
facility: 1182.17.913 McMaster University Medical Centre
state: Ontario
city: Ottawa
country: Canada
facility: 1182.17.901 Division of Infectious Diseases
state: Ontario
city: Toronto
country: Canada
facility: 1182.17.905 Canadian Immunodeficiency Research Collaborative Inc.
state: Ontario
city: Toronto
country: Canada
facility: 1182.17.906 Infectious Diseases & HIV - St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: 1182.17.907 University Health Network - Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: 1182.17.910 Sunnybrook & Women's College Health Science Centre
state: Ontario
city: Monteal
country: Canada
facility: 1182.17.914 Montreal General Hospital - McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: 1182.17.903 Montreal Chest Institute, McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: 1182.17.904 Clinique Medicale Du Quartier Latin
state: Quebec
city: Montreal
country: Canada
facility: 1182.17.915 Clinique medicale l'Actuel
state: Quebec
city: Aarhus N
country: Denmark
facility: 1182.17.4505 Boehringer Ingelheim Investigational Site
city: Copenhagen Ø
country: Denmark
facility: 1182.17.4501 Boehringer Ingelheim Investigational Site
city: Hvidovre
country: Denmark
facility: 1182.17.4502 Boehringer Ingelheim Investigational Site
city: Odense
country: Denmark
facility: 1182.17.4504 Boehringer Ingelheim Investigational Site
city: Bordeaux cedex
country: France
facility: 1182.17.33011 Hôpital Pellegrin
city: Bordeaux cedex
country: France
facility: 1182.17.33019 Hôpital Saint André
city: Caen cedex 5
country: France
facility: 1182.17.33020 Hôpital Côte de Nacre
city: Clamart
country: France
facility: 1182.17.33007 Hôpital Antoine Beclere
city: Lyon cedex 2
country: France
facility: 1182.17.33008 Hôpital de l'Hôtel Dieu
city: Lyon cedex 3
country: France
facility: 1182.17.33023 Hôpital Edouard Herriot
city: Marseille cedex 5
country: France
facility: 1182.17.33012 Hôpital de la Conception
city: Marseille cedex 9
country: France
facility: 1182.17.33013 Hôpital Sainte Marguerite
city: Nantes cedex 1
country: France
facility: 1182.17.00336 Hôpital Hôtel Dieu
city: Nice cedex 3
country: France
facility: 1182.17.33010 Hôpital de l'Archet
city: Paris cedex 14
country: France
facility: 1182.17.33024 Groupe Hospitalier Cochin
city: Paris cedex 15
country: France
facility: 1182.17.33022 Hôpital Européen Georges Pompidou
city: Paris cedex 18
country: France
facility: 1182.17.00335 Hôpital Bichat Claude Bernard
city: Paris cedex 20
country: France
facility: 1182.17.00331 Hôpital Tenon
city: Paris
country: France
facility: 1182.17.00333 Hôpital Saint Louis
city: Paris
country: France
facility: 1182.17.00334 Hôpital de la Pitié Salpêtrière
city: Paris
country: France
facility: 1182.17.33014 Hôpital Saint Antoine
city: Rennes cedex 9
country: France
facility: 1182.17.33018 Hôpital de Pontchaillou
city: Strasbourg cedex
country: France
facility: 1182.17.33016 Hôpital Civil
city: Toulon
country: France
facility: 1182.17.00332 Hôpital du Chalucet
city: Vandoeuvre les Nancy
country: France
facility: 1182.17.33017 Hôpital Brabois Adultes
city: Villejuif cedex
country: France
facility: 1182.17.33021 Hôpital Paul Brousse
city: Aachen
country: Germany
facility: 1182.17.4911 Arzt für Innere Medizin
city: Berlin
country: Germany
facility: 1182.17.4901 Epimed GmbH c/o
city: Berlin
country: Germany
facility: 1182.17.4902 Charite, Campus Virchow-Klinikum
city: Bonn
country: Germany
facility: 1182.17.4918 Rheinische Friedrich-Wilhelm-Universität
city: Dortmund
country: Germany
facility: 1182.17.4906 ID-Ambulanz Klinikum Dortmund
city: Düsseldorf
country: Germany
facility: 1182.17.4912 Universitätsklinikum Düsseldorf
city: Düsseldorf
country: Germany
facility: 1182.17.4914 Arzt für Innere Medizin
city: Erlangen
country: Germany
facility: 1182.17.4908 Universitätskliniken Erlangen
city: Essen
country: Germany
facility: 1182.17.4904 Universitätsklinikum Essen
city: Frankfurt/Main
country: Germany
facility: 1182.17.4924 Klinikum der J. W.-Goethe-Universität
city: Freiburg/Breisgau
country: Germany
facility: 1182.17.4930 Universitätsklinikum Freiburg
city: Freiburg
country: Germany
facility: 1182.17.4928 Facharzt für Innere Medizin/Rheumatologie
city: Hamburg
country: Germany
facility: 1182.17.4916 Medizinisches Versorgungszentrum Hamburg
city: Hamburg
country: Germany
facility: 1182.17.4929 Universitätsklinikum Eppendorf
city: Hamburg
country: Germany
facility: 1182.17.4931 IPM Study Center GmbH
city: Hannover
country: Germany
facility: 1182.17.4920 Abteilung Klinische Immunologie
city: Heidelberg
country: Germany
facility: 1182.17.4909 Universitätsklinikum Heidelberg
city: Köln
country: Germany
facility: 1182.17.4905 Universitätsklinik Köln
city: Köln
country: Germany
facility: 1182.17.4926 Internist
city: Mannheim
country: Germany
facility: 1182.17.4923 Facharzt für Innere Medizin,
city: München
country: Germany
facility: 1182.17.4907 Medizinische Poliklinik
city: München
country: Germany
facility: 1182.17.4910 MUC Research GmbH
city: Osnabrück
country: Germany
facility: 1182.17.4915 Klinium Natruper Holz
city: Stuttgart
country: Germany
facility: 1182.17.4921 Arzt für Allgemeinmedizin
city: Athens
country: Greece
facility: 1182.17.3001 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1182.17.3002 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1182.17.3003 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1182.17.3004 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1182.17.3007 Boehringer Ingelheim Investigational Site
city: Patras
country: Greece
facility: 1182.17.3010 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1182.17.3009 Boehringer Ingelheim Investigational Site
city: Antella (fi)
country: Italy
facility: 1182.17.0409 Ospedale Santa Maria Annunziata
city: Busto Arsizio (va)
country: Italy
facility: 1182.17.0413 Ospedale di Circolo di Busto
city: Ferrara
country: Italy
facility: 1182.17.0384 Azienda Ospedaliera Arcispedale S. Anna
city: Genova
country: Italy
facility: 1182.17.0397 Ospedale San Martino
city: Genova
country: Italy
facility: 1182.17.0412 S.C. Malattie Infettive
city: Lecco
country: Italy
facility: 1182.17.0411 Presidio Ospedaliero "A. Manzoni"
city: Macerata
country: Italy
facility: 1182.17.0389 Reparto Malattie Infettive
city: Milano
country: Italy
facility: 1182.17.0393 Fondazione Centro S. Raffaele del Monte Tabor
city: Modena
country: Italy
facility: 1182.17.0386 Policlinico Universitario
city: Napoli
country: Italy
facility: 1182.17.0388 Ospedale A. Cotugno
city: Pavia
country: Italy
facility: 1182.17.0385 IRCCS Policlinico San Matteo
city: Pavia
country: Italy
facility: 1182.17.0394 IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: 1182.17.0395 Azienda Policlinico Umberto I
city: Roma
country: Italy
facility: 1182.17.0419 I Cattedra Malattie Infettive
city: Torino
country: Italy
facility: 1182.17.0387 Ospedale Amedeo di Savoia
city: Torino
country: Italy
facility: 1182.17.0398 Ospedale Amedeo di Savoia
city: Torino
country: Italy
facility: 1182.17.0415 U.O.A. Malattie Infettive B
city: Col. La Raza, Mexico
country: Mexico
facility: 1182.17.5201 Centro Médico La Raza IMSS
city: Guadalajara
country: Mexico
facility: 1182.17.5203 Hospital Civil Nuevo de Guadalajara
city: Monterrey, N.l., Mexico
country: Mexico
facility: 1182.17.5206 Centro Medico San Vicente
city: Amsterdam
country: Netherlands
facility: 1182.17.3101 Boehringer Ingelheim Investigational Site
city: Groningen
country: Netherlands
facility: 1182.17.3108 Boehringer Ingelheim Investigational Site
city: Nijmegen
country: Netherlands
facility: 1182.17.3105 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 1182.17.202 Boehringer Ingelheim Investigational Site
city: Cascais
country: Portugal
facility: 1182.17.3502 Hospital Condes Castro Guimarães
city: Badalona
country: Spain
facility: 1182.17.705 Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: 1182.17.701 Hospital Clínico y Provincial de Barcelona
city: Madrid
country: Spain
facility: 1182.17.703 Hospital 12 de Octubre
city: Madrid
country: Spain
facility: 1182.17.704 Hospital Ramón y Cajal.
city: Madrid
country: Spain
facility: 1182.17.710 Hospital Gregorio Maranon
city: Madrid
country: Spain
facility: 1182.17.712 Hospital Clínico San Carlos
city: Malaga
country: Spain
facility: 1182.17.717 Hospital Clínico Universitario Vírgen de la Victoria
city: Sevilla
country: Spain
facility: 1182.17.713 Hospital Universitario Vírgen del Rocío
city: Valencia
country: Spain
facility: 1182.17.714 Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: 1182.17.720 Hospital La Fe
city: Vigo
country: Spain
facility: 1182.17.718 Complejo Hospitalario Xeral - Cíes
city: Basel
country: Switzerland
facility: 1182.17.4101 DIM / Abteilung für Infektiologie
city: Genève
country: Switzerland
facility: 1182.17.4104 Département de médicine interne Div. Des maladies infectieus
city: St. Gallen
country: Switzerland
facility: 1182.17.4103 DIM / Abteilung für Infektiologie
city: Zürich
country: Switzerland
facility: 1182.17.4102 Departement für Innere Medizin
city: Brighton
country: United Kingdom
facility: 1182.17.4405 Boehringer Ingelheim Investigational Site
city: Liverpool
country: United Kingdom
facility: 1182.17.4411 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1182.17.4404 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1182.17.4406 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1182.17.4408 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1182.17.4409 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1182.17.4414 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1182.17.4418 Boehringer Ingelheim Investigational Site
city: Portsmouth
country: United Kingdom
facility: 1182.17.4407
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: