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Clinical Trial Details — Status: Approved for marketing

Administrative data

NCT number NCT00062660
Other study ID # 1182.58
Secondary ID
Status Approved for marketing
Phase N/A
First received June 10, 2003
Last updated November 29, 2016
Start date May 2003
Est. completion date April 2014

Study information

Verified date July 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics CommitteeAustria: Federal Ministry for Health and WomenBelgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health CanadaDenmark: Ministry of HealthFrance: Ministry of HealthGreat Britain:Ireland: Ministry of HealthItaly: Ministry of HealthNetherlands: Ministry of Health, Welfare and SportPortugal: National Pharmacy and Medicines InstituteRomania: Ministry of Public HealthSouth Africa: Medicines Control CouncilSpain: Ministry of HealthSwitzerland: Federal Office of Public HealthUnited States: Food and Drug Administration
Study type Expanded Access

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Approved for marketing
Enrollment 0
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 2 Years and older
Eligibility 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.

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Drug:
Tipranavir
Tipranavir 250 mg soft elastic capsules

Locations

Country Name City State
Australia 1182.58.61020 Adelaide South Australia
Australia 1182.58.61015 Flinders Medical Centre Bedford Park South Australia
Australia 1182.58.61010 Biala Building Brisbane Queensland
Australia 1182.58.61005 Royal Prince Alfred Hospital Camperdown New South Wales
Australia 1182.58.61001 88 Rathdowne Street Carlton Carlton Victoria
Australia 1182.58.61018 Melbourne Sexual Health Clinic Carlton Victoria
Australia 1182.58.61017 Department of Infectious Diseases Clayton Victoria
Australia 1182.58.61008 St Vincents Hospital Darlinghurst New South Wales
Australia 1182.58.61011 St Vincents Hospital Darlinghurst New South Wales
Australia 1182.58.61014 St Vincents Hospital Darlinghurst New South Wales
Australia 1182.58.61007 407 Doctors Pty Ltd Darlinghusrst New South Wales
Australia 1182.58.61019 407 Bouke Street Darlinghusrst New South Wales
Australia 1182.58.61009 Level 6 Herston Queensland
Australia 1182.58.61022 Sexual Health Clinic Kingswood New South Wales
Australia 1182.58.61012 Bigge Park Centre Liverpool New South Wales
Australia 1182.58.61013 Melbourne Sexual Health Clinic Melbourne Victoria
Australia 1182.58.61023 Melbourne Victoria
Australia 1182.58.61024 Nambour Queensland
Australia 1182.58.61004 Royal Perth Hospital Perth Western Australia
Australia 1182.58.61003 The Prince of Wales Hospital Randwick New South Wales
Australia 1182.58.61021 South Yarra Victoria
Australia 1182.58.61002 Royal North Shore Hospital St Leonards New South Wales
Australia 1182.58.61006 Albion Street Clinic Surry Hills New South Wales
Australia 1182.58.61025 Immunology Department Westmead New South Wales
Australia 1182.58.61016 Princess Alexandra Hospital Woolloongabba Queensland
Belgium 1182.58.3201 Boehringer Ingelheim Investigational Site Antwerpen
Belgium 1182.58.3202 Boehringer Ingelheim Investigational Site Bruxelles
Belgium 1182.58.3203 Boehringer Ingelheim Investigational Site Bruxelles
Belgium 1182.58.3204 Boehringer Ingelheim Investigational Site Liège
Denmark 1182.58.4505 Aarhus Universitetshospital Skejby Aarhus C
Denmark 1182.58.4501 Rigshospitalet København Ø
Denmark 1182.58.4504 Odense Universitetshospital Odense C
France 1182.58.33029 Hôpital Aix Aix en Provence cedex 1
France 1182.58.33001 Hôpital Saint Jacques Besançon cedex
France 1182.58.33022 Hôpital Avicenne Bobigny cedex
France 1182.58.33020 Hôpital Antoine Beclère Clamart cedex
France 1182.58.33028 Hôpital Louis Mourier Colombes
France 1182.58.33027 Hôpital Dijon cedex
France 1182.58.33034 Hôpital Raymond Poincarré Garches
France 1182.58.33006 Hôpital Bicêtre Le Kremlin Bicêtre cedex
France 1182.58.33019 Hôpital de l'Hôtel Dieu Lyon cedex 2
France 1182.58.33031 Hôpital edouard Herriot Lyon cedex 3
France 1182.58.33009 Hôpital de la Conception Marseille cedex 5
France 1182.58.33023 Hôpital Sainte Marguerite Marseille cedex 9
France 1182.58.33030 Hôpital Saint Eloi Montpellier
France 1182.58.33032 Hôpital Emile Muller Mulhouse cedex 1
France 1182.58.33008 Hôpital Hôtel Dieu Nantes cedex 1
France 1182.58.33003 Hôpital de l'Archet Nice cedex 3
France 1182.58.33018 Hôpital Saint Antoine Paris
France 1182.58.33024 Hôpital Necker Paris
France 1182.58.33013 Hôpital Saint Louis Paris cedex 10
France 1182.58.33014 Hôpital Cochin Paris cedex 14
France 1182.58.33007 Hôpital Georges Pompidou Paris cedex 15
France 1182.58.33005 Hôpital Bichat Paris cedex 18
France 1182.58.33017 Hôpital Bichat Claude Bernard Paris cedex 18
France 1182.58.33033 Hôpital Tenon Paris cedex 20
France 1182.58.33035 Hôpital des Abîmes Pointe A Pitre
France 1182.58.33012 Hôpital Robert Debré Reims cedex
France 1182.58.33026 Hôpital Ponchaillou Rennes cedex 9
France 1182.58.33015 Hôpital Civil Strasbourg cedex
France 1182.58.33025 Hôpital Foch Suresnes cedex
France 1182.58.33021 Hôpital Chalucet Toulon cedex
France 1182.58.33002 Hôpital Purpan Toulouse cedex 9
France 1182.58.33016 Tourcoing
France 1182.58.33010 Hôpital Brabois Vandoeuvre Les Nancy
France 1182.58.33011 Hôpital Paul Brousse Villejuif cedex
Greece 1182.58.3001 Athens
Ireland 1182.58.44016 St James Hospital, Dept of Genito Urinary Medicine Dublin
Ireland 1182.58.44029 Our Lady For Sick Children Dublin 12
Italy 1182.58.3903 Università di Brescia Brescia
Italy 1182.58.3904 Ospedali Riuniti di Foggia Foggia
Italy 1182.58.3901 Ospedale Luigi Sacco Milano
Italy 1182.58.3902 Ospedale L. Sacco Milano
Italy 1182.58.3907 Presidio Ospedaliero di Rimini Rimini
Italy 1182.58.3905 Presidio Dalmati S. Angelo Lodigiano (lo)
Italy 1182.58.3906 Ospedale Infantile Regina Margherita Torino
Italy 1182.58.3908 Centro Medicina Preventiva Verona
Portugal 1182.58.35102 Hospital Condes Castro Guimarães Cascais
South Africa 1182.58.27095 Boehringer Ingelheim Investigational Site Cape Town
South Africa 1182.58.27098 Boehringer Ingelheim Investigational Site Cape Town
South Africa 1182.58.27099 Boehringer Ingelheim Investigational Site Cape Town
South Africa 1182.58.27096 Boehringer Ingelheim Investigational Site Durban
South Africa 1182.58.27097 Boehringer Ingelheim Investigational Site Westville, Durban
Switzerland 1182.58.4101 Boehringer Ingelheim Investigational Site Basel
Switzerland 1182.58.4103 Boehringer Ingelheim Investigational Site Bern
Switzerland 1182.58.4104 Boehringer Ingelheim Investigational Site Genève
Switzerland 1182.58.4107 Boehringer Ingelheim Investigational Site Genève
Switzerland 1182.58.4102 Boehringer Ingelheim Investigational Site Zürich
Switzerland 1182.58.4105 Boehringer Ingelheim Investigational Site Zürich
United Kingdom 1182.58.44020 Beckenham Hospital Beckenham
United Kingdom 1182.58.44004 Boehringer Ingelheim Investigational Site Brighton
United Kingdom 1182.58.44002 Boehringer Ingelheim Investigational Site Cardiff
United Kingdom 1182.58.44025 Boehringer Ingelheim Investigational Site Chertsey
United Kingdom 1182.58.44019 Boehringer Ingelheim Investigational Site Chichester
United Kingdom 1182.58.44009 Boehringer Ingelheim Investigational Site Edinburgh
United Kingdom 1182.58.44023 Boehringer Ingelheim Investigational Site Harrow
United Kingdom 1182.58.44024 Boehringer Ingelheim Investigational Site Leeds
United Kingdom 1182.58.44003 Boehringer Ingelheim Investigational Site London
United Kingdom 1182.58.44005 Boehringer Ingelheim Investigational Site London
United Kingdom 1182.58.44008 Boehringer Ingelheim Investigational Site London
United Kingdom 1182.58.44010 Boehringer Ingelheim Investigational Site London
United Kingdom 1182.58.44014 Boehringer Ingelheim Investigational Site London
United Kingdom 1182.58.44017 Boehringer Ingelheim Investigational Site London
United Kingdom 1182.58.44018 Boehringer Ingelheim Investigational Site London
United Kingdom 1182.58.44026 Boehringer Ingelheim Investigational Site London
United Kingdom 1182.58.44027 Boehringer Ingelheim Investigational Site London
United Kingdom 1182.58.44028 Boehringer Ingelheim Investigational Site London
United Kingdom 1182.58.44031 Boehringer Ingelheim Investigational Site London
United Kingdom 1182.58.44011 Boehringer Ingelheim Investigational Site Peterborough
United Kingdom 1182.58.44022 Boehringer Ingelheim Investigational Site Woolwich
United Kingdom 1182.58.44030 Boehringer Ingelheim Investigational Site Woolwich
United States 1182.58.36 Suite 525 Atlanta Georgia
United States 1182.58.15 Boston Massachusetts
United States 1182.58.30 Chapel Hill North Carolina
United States 1182.58.22 Chicago Illinois
United States 1182.58.06 University of Cincinnati Medical Center, Infectious diseases Cincinnati Ohio
United States 1182.58.01 Boehringer Ingelheim Investigational Site Columbia South Carolina
United States 1182.58.18 University of Texas Southwest Medical Center at Dallas Dallas Texas
United States 1182.58.19 Henry Ford Hospital Detroit Michigan
United States 1182.58.08 Honolulu Hawaii
United States 1182.58.07 Houston Texas
United States 1182.58.04 Kansas City Free Health Clinic Kansas City Missouri
United States 1182.58.02 Wellness Center Las Vegas Nevada
United States 1182.58.29 Los Angeles California
United States 1182.58.34 Campus Code 696446 Los Angeles California
United States 1182.58.37 AIDS Health Care Foundation Los Angeles Connecticut
United States 1182.58.42 Synergy Hematology/Oncology Los Angeles California
United States 1182.58.43 Los Angeles California
United States 1182.58.44 VW Hospital and Clinics Madison Wisconsin
United States 1182.58.38 Miami Beach Florida
United States 1182.58.10 Comprehensive Care Center Nashville Tennessee
United States 1182.58.32 New Orleans Louisiana
United States 1182.58.09 Polari Medical Group New York New York
United States 1182.58.41 Circle Medical, LLC Norwalk Connecticut
United States 1182.58.14 Philadelphia Pennsylvania
United States 1182.58.20 University of Pittsburgh Pittsburgh Pennsylvania
United States 1182.58.35 Portland Oregon
United States 1182.58.039 Olmos Park Medical Associates San Antonio Texas
United States 1182.58.03 San Francisco California
United States 1182.58.33 Kaiser Permanente Medical Center, Clinical Trials Unit San Francisco California
United States 1182.58.31 Scottsdale Arizona
United States 1182.58.11 Swedish Medical Center Seattle Washington
United States 1182.58.40 Drs. Raben and Feldman Research Associates South Miami Florida
United States 1182.58.25 Wohl Clinic St. Louis Missouri
United States 1182.58.23 Hillsborough County Health Department Tampa Florida
United States 1182.58.28 Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

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

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