Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection

NCT ID: NCT00062660

Last Updated: 2016-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Study Start Date

2003-05-31

Study Completion Date

2014-04-30

Brief Summary

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To provide early access to tipranavir and evaluate the safety and tolerance of tipranavir combined with low dose of ritonavir in patients with progressive, HIV-1 disease who have failed or are intolerant to currently approved treatments for HIV infection, who are unable to participate in another tipranavir controlled clinical trial and have an urgent need for anti-HIV treatment.

Detailed Description

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Conditions

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HIV Infections

Interventions

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Tipranavir

Tipranavir 250 mg soft elastic capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients aho have a positive serology HIV antibody test confirmed by Western blot, p24 antigen assay, HIV-1 RNA or HIV culture and are highly pre-treated and virus resistant to multiple protease inhibitors.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1182.58.31

Scottsdale, Arizona, United States

Site Status

1182.58.29

Los Angeles, California, United States

Site Status

1182.58.34 Campus Code 696446

Los Angeles, California, United States

Site Status

1182.58.42 Synergy Hematology/Oncology

Los Angeles, California, United States

Site Status

1182.58.43

Los Angeles, California, United States

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1182.58.03

San Francisco, California, United States

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1182.58.33 Kaiser Permanente Medical Center, Clinical Trials Unit

San Francisco, California, United States

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1182.58.37 AIDS Health Care Foundation

Los Angeles, Connecticut, United States

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1182.58.41 Circle Medical, LLC

Norwalk, Connecticut, United States

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1182.58.28

Washington D.C., District of Columbia, United States

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1182.58.38

Miami Beach, Florida, United States

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1182.58.40 Drs. Raben and Feldman Research Associates

South Miami, Florida, United States

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1182.58.23 Hillsborough County Health Department

Tampa, Florida, United States

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1182.58.36 Suite 525

Atlanta, Georgia, United States

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1182.58.08

Honolulu, Hawaii, United States

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1182.58.22

Chicago, Illinois, United States

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1182.58.32

New Orleans, Louisiana, United States

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1182.58.15

Boston, Massachusetts, United States

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1182.58.19 Henry Ford Hospital

Detroit, Michigan, United States

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1182.58.04 Kansas City Free Health Clinic

Kansas City, Missouri, United States

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1182.58.25 Wohl Clinic

St Louis, Missouri, United States

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1182.58.02 Wellness Center

Las Vegas, Nevada, United States

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1182.58.09 Polari Medical Group

New York, New York, United States

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1182.58.30

Chapel Hill, North Carolina, United States

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1182.58.06 University of Cincinnati Medical Center, Infectious diseases

Cincinnati, Ohio, United States

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1182.58.35

Portland, Oregon, United States

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1182.58.14

Philadelphia, Pennsylvania, United States

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1182.58.20 University of Pittsburgh

Pittsburgh, Pennsylvania, United States

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1182.58.01 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

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1182.58.10 Comprehensive Care Center

Nashville, Tennessee, United States

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1182.58.18 University of Texas Southwest Medical Center at Dallas

Dallas, Texas, United States

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1182.58.07

Houston, Texas, United States

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1182.58.039 Olmos Park Medical Associates

San Antonio, Texas, United States

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1182.58.11 Swedish Medical Center

Seattle, Washington, United States

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1182.58.44 VW Hospital and Clinics

Madison, Wisconsin, United States

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1182.58.61005 Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

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1182.58.61008 St Vincents Hospital

Darlinghurst, New South Wales, Australia

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1182.58.61011 St Vincents Hospital

Darlinghurst, New South Wales, Australia

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1182.58.61014 St Vincents Hospital

Darlinghurst, New South Wales, Australia

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1182.58.61007 407 Doctors Pty Ltd

Darlinghusrst, New South Wales, Australia

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1182.58.61019 407 Bouke Street

Darlinghusrst, New South Wales, Australia

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1182.58.61022 Sexual Health Clinic

Kingswood, New South Wales, Australia

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1182.58.61012 Bigge Park Centre

Liverpool, New South Wales, Australia

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1182.58.61003 The Prince of Wales Hospital

Randwick, New South Wales, Australia

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1182.58.61002 Royal North Shore Hospital

St Leonards, New South Wales, Australia

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1182.58.61006 Albion Street Clinic

Surry Hills, New South Wales, Australia

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1182.58.61025 Immunology Department

Westmead, New South Wales, Australia

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1182.58.61010 Biala Building

Brisbane, Queensland, Australia

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1182.58.61009 Level 6

Herston, Queensland, Australia

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1182.58.61024

Nambour, Queensland, Australia

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1182.58.61016 Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

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1182.58.61020

Adelaide, South Australia, Australia

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1182.58.61015 Flinders Medical Centre

Bedford Park, South Australia, Australia

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1182.58.61001 88 Rathdowne Street Carlton

Carlton, Victoria, Australia

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1182.58.61018 Melbourne Sexual Health Clinic

Carlton, Victoria, Australia

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1182.58.61017 Department of Infectious Diseases

Clayton, Victoria, Australia

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1182.58.61013 Melbourne Sexual Health Clinic

Melbourne, Victoria, Australia

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1182.58.61023

Melbourne, Victoria, Australia

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1182.58.61021

South Yarra, Victoria, Australia

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1182.58.61004 Royal Perth Hospital

Perth, Western Australia, Australia

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1182.58.3201 Boehringer Ingelheim Investigational Site

Antwerp, , Belgium

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1182.58.3202 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

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1182.58.3203 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

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1182.58.3204 Boehringer Ingelheim Investigational Site

Liège, , Belgium

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1182.58.4505 Aarhus Universitetshospital Skejby

Aarhus C, , Denmark

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1182.58.4501 Rigshospitalet

København Ø, , Denmark

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1182.58.4504 Odense Universitetshospital

Odense C, , Denmark

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1182.58.33029 Hôpital Aix

Aix-en-Provence, , France

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1182.58.33001 Hôpital Saint Jacques

Besançon, , France

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1182.58.33022 Hôpital Avicenne

Bobigny, , France

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1182.58.33020 Hôpital Antoine Beclère

Clamart, , France

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1182.58.33028 Hôpital Louis Mourier

Colombes, , France

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1182.58.33027 Hôpital

Dijon, , France

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1182.58.33034 Hôpital Raymond Poincarré

Garches, , France

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1182.58.33006 Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

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1182.58.33019 Hôpital de l'Hôtel Dieu

Lyon, , France

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1182.58.33031 Hôpital edouard Herriot

Lyon, , France

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1182.58.33009 Hôpital de la Conception

Marseille, , France

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1182.58.33023 Hôpital Sainte Marguerite

Marseille, , France

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1182.58.33030 Hôpital Saint Eloi

Montpellier, , France

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1182.58.33032 Hôpital Emile Muller

Mulhouse, , France

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1182.58.33008 Hôpital Hôtel Dieu

Nantes, , France

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1182.58.33003 Hôpital de l'Archet

Nice, , France

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1182.58.33005 Hôpital Bichat

Paris, , France

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1182.58.33007 Hôpital Georges Pompidou

Paris, , France

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1182.58.33013 Hôpital Saint Louis

Paris, , France

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1182.58.33014 Hôpital Cochin

Paris, , France

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1182.58.33017 Hôpital Bichat Claude Bernard

Paris, , France

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1182.58.33018 Hôpital Saint Antoine

Paris, , France

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1182.58.33024 Hôpital Necker

Paris, , France

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1182.58.33033 Hôpital Tenon

Paris, , France

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1182.58.33035 Hôpital des Abîmes

Pointe à Pitre, , France

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1182.58.33012 Hôpital Robert Debré

Reims, , France

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1182.58.33026 Hôpital Ponchaillou

Rennes, , France

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1182.58.33015 Hôpital Civil

Strasbourg, , France

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1182.58.33025 Hôpital Foch

Suresnes, , France

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1182.58.33021 Hôpital Chalucet

Toulon, , France

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1182.58.33002 Hôpital Purpan

Toulouse, , France

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1182.58.33016

Tourcoing, , France

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1182.58.33010 Hôpital Brabois

Vandœuvre-lès-Nancy, , France

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1182.58.33011 Hôpital Paul Brousse

Villejuif, , France

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1182.58.3001

Athens, , Greece

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1182.58.44016 St James Hospital, Dept of Genito Urinary Medicine

Dublin, , Ireland

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1182.58.44029 Our Lady For Sick Children

Dublin, , Ireland

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1182.58.3903 Università di Brescia

Brescia, , Italy

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1182.58.3904 Ospedali Riuniti di Foggia

Foggia, , Italy

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1182.58.3901 Ospedale Luigi Sacco

Milan, , Italy

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1182.58.3902 Ospedale L. Sacco

Milan, , Italy

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1182.58.3907 Presidio Ospedaliero di Rimini

Rimini, , Italy

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1182.58.3905 Presidio Dalmati

S. Angelo Lodigiano (lo), , Italy

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1182.58.3906 Ospedale Infantile Regina Margherita

Torino, , Italy

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1182.58.3908 Centro Medicina Preventiva

Verona, , Italy

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1182.58.35102 Hospital Condes Castro Guimarães

Cascais, , Portugal

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1182.58.27095 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

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1182.58.27098 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

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1182.58.27099 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

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1182.58.27096 Boehringer Ingelheim Investigational Site

Durban, , South Africa

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1182.58.27097 Boehringer Ingelheim Investigational Site

Westville, Durban, , South Africa

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1182.58.4101 Boehringer Ingelheim Investigational Site

Basel, , Switzerland

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1182.58.4103 Boehringer Ingelheim Investigational Site

Bern, , Switzerland

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1182.58.4104 Boehringer Ingelheim Investigational Site

Geneva, , Switzerland

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1182.58.4107 Boehringer Ingelheim Investigational Site

Geneva, , Switzerland

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1182.58.4102 Boehringer Ingelheim Investigational Site

Zurich, , Switzerland

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1182.58.4105 Boehringer Ingelheim Investigational Site

Zurich, , Switzerland

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1182.58.44020 Beckenham Hospital

Beckenham, , United Kingdom

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1182.58.44004 Boehringer Ingelheim Investigational Site

Brighton, , United Kingdom

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1182.58.44002 Boehringer Ingelheim Investigational Site

Cardiff, , United Kingdom

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1182.58.44025 Boehringer Ingelheim Investigational Site

Chertsey, , United Kingdom

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1182.58.44019 Boehringer Ingelheim Investigational Site

Chichester, , United Kingdom

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1182.58.44009 Boehringer Ingelheim Investigational Site

Edinburgh, , United Kingdom

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1182.58.44023 Boehringer Ingelheim Investigational Site

Harrow, , United Kingdom

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1182.58.44024 Boehringer Ingelheim Investigational Site

Leeds, , United Kingdom

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1182.58.44003 Boehringer Ingelheim Investigational Site

London, , United Kingdom

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1182.58.44005 Boehringer Ingelheim Investigational Site

London, , United Kingdom

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1182.58.44008 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1182.58.44010 Boehringer Ingelheim Investigational Site

London, , United Kingdom

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1182.58.44014 Boehringer Ingelheim Investigational Site

London, , United Kingdom

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1182.58.44017 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1182.58.44018 Boehringer Ingelheim Investigational Site

London, , United Kingdom

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1182.58.44026 Boehringer Ingelheim Investigational Site

London, , United Kingdom

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1182.58.44027 Boehringer Ingelheim Investigational Site

London, , United Kingdom

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1182.58.44028 Boehringer Ingelheim Investigational Site

London, , United Kingdom

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1182.58.44031 Boehringer Ingelheim Investigational Site

London, , United Kingdom

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1182.58.44011 Boehringer Ingelheim Investigational Site

Peterborough, , United Kingdom

Site Status

1182.58.44022 Boehringer Ingelheim Investigational Site

Woolwich, , United Kingdom

Site Status

1182.58.44030 Boehringer Ingelheim Investigational Site

Woolwich, , United Kingdom

Site Status

Countries

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United States Australia Belgium Denmark France Greece Ireland Italy Portugal South Africa Switzerland United Kingdom

Other Identifiers

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1182.58

Identifier Type: -

Identifier Source: org_study_id