Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00062660
First received: June 10, 2003
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Tipranavir

Study Type: Expanded Access     What is Expanded Access?
Official Title: An Open Label Safety Study to Evaluate the Safety of Tipranavir Plus Ritonavir When Used in Combination With Other Agents for the Treatment of Patients With HIV Infection Who Have Failed and/or Are Intolerant to Combination Antiretroviral Therapy and Have Limited Treatment Options

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Study Start Date: May 2003
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tipranavir
    Tipranavir 250 mg soft elastic capsules
  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062660

  Hide Study Locations
Locations
United States, Arizona
1182.58.31
Scottsdale, Arizona, United States
United States, California
1182.58.29
Los Angeles, California, United States
1182.58.34 Campus Code 696446
Los Angeles, California, United States
1182.58.42 Synergy Hematology/Oncology
Los Angeles, California, United States
1182.58.43
Los Angeles, California, United States
1182.58.33 Kaiser Permanente Medical Center, Clinical Trials Unit
San Francisco, California, United States
1182.58.03
San Francisco, California, United States
United States, Connecticut
1182.58.37 AIDS Health Care Foundation
Los Angeles, Connecticut, United States
1182.58.41 Circle Medical, LLC
Norwalk, Connecticut, United States
United States, District of Columbia
1182.58.28
Washington, District of Columbia, United States
United States, Florida
1182.58.38
Miami Beach, Florida, United States
1182.58.40 Drs. Raben and Feldman Research Associates
South Miami, Florida, United States
1182.58.23 Hillsborough County Health Department
Tampa, Florida, United States
United States, Georgia
1182.58.36 Suite 525
Atlanta, Georgia, United States
United States, Hawaii
1182.58.08
Honolulu, Hawaii, United States
United States, Illinois
1182.58.22
Chicago, Illinois, United States
United States, Louisiana
1182.58.32
New Orleans, Louisiana, United States
United States, Massachusetts
1182.58.15
Boston, Massachusetts, United States
United States, Michigan
1182.58.19 Henry Ford Hospital
Detroit, Michigan, United States
United States, Missouri
1182.58.04 Kansas City Free Health Clinic
Kansas City, Missouri, United States
1182.58.25 Wohl Clinic
St. Louis, Missouri, United States
United States, Nevada
1182.58.02 Wellness Center
Las Vegas, Nevada, United States
United States, New York
1182.58.09 Polari Medical Group
New York, New York, United States
United States, North Carolina
1182.58.30
Chapel Hill, North Carolina, United States
United States, Ohio
1182.58.06 University of Cincinnati Medical Center, Infectious diseases
Cincinnati, Ohio, United States
United States, Oregon
1182.58.35
Portland, Oregon, United States
United States, Pennsylvania
1182.58.14
Philadelphia, Pennsylvania, United States
1182.58.20 University of Pittsburgh
Pittsburgh, Pennsylvania, United States
United States, South Carolina
1182.58.01 Boehringer Ingelheim Investigational Site
Columbia, South Carolina, United States
United States, Tennessee
1182.58.10 Comprehensive Care Center
Nashville, Tennessee, United States
United States, Texas
1182.58.18 University of Texas Southwest Medical Center at Dallas
Dallas, Texas, United States
1182.58.07
Houston, Texas, United States
1182.58.039 Olmos Park Medical Associates
San Antonio, Texas, United States
United States, Washington
1182.58.11 Swedish Medical Center
Seattle, Washington, United States
United States, Wisconsin
1182.58.44 VW Hospital and Clinics
Madison, Wisconsin, United States
Australia, New South Wales
1182.58.61005 Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
1182.58.61014 St Vincents Hospital
Darlinghurst, New South Wales, Australia
1182.58.61011 St Vincents Hospital
Darlinghurst, New South Wales, Australia
1182.58.61008 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
1182.58.61022 Sexual Health Clinic
Kingswood, New South Wales, Australia
1182.58.61012 Bigge Park Centre
Liverpool, New South Wales, Australia
1182.58.61003 The Prince of Wales Hospital
Randwick, New South Wales, 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
Australia, Queensland
1182.58.61010 Biala Building
Brisbane, Queensland, Australia
1182.58.61009 Level 6
Herston, Queensland, Australia
1182.58.61024
Nambour, Queensland, Australia
1182.58.61016 Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Australia, South Australia
1182.58.61020
Adelaide, South Australia, Australia
1182.58.61015 Flinders Medical Centre
Bedford Park, South Australia, Australia
Australia, Victoria
1182.58.61018 Melbourne Sexual Health Clinic
Carlton, Victoria, Australia
1182.58.61001 88 Rathdowne Street Carlton
Carlton, Victoria, Australia
1182.58.61017 Department of Infectious Diseases
Clayton, Victoria, Australia
1182.58.61013 Melbourne Sexual Health Clinic
Melbourne, Victoria, Australia
1182.58.61023
Melbourne, Victoria, Australia
1182.58.61021
South Yarra, Victoria, Australia
Australia, Western Australia
1182.58.61004 Royal Perth Hospital
Perth, Western Australia, Australia
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, Belgium
Denmark
1182.58.4505 Aarhus Universitetshospital Skejby
Aarhus C, Denmark
1182.58.4501 Rigshospitalet
København Ø, Denmark
1182.58.4504 Odense Universitetshospital
Odense C, Denmark
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, France
Greece
1182.58.3001
Athens, Greece
Ireland
1182.58.44016 St James Hospital, Dept of Genito Urinary Medicine
Dublin, Ireland
1182.58.44029 Our Lady For Sick Children
Dublin 12, Ireland
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, Italy
Portugal
1182.58.35102 Hospital Condes Castro Guimarães
Cascais, Portugal
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, South Africa
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, Switzerland
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
1182.58.44026 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
1182.58.44027 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
1182.58.44003 Boehringer Ingelheim Investigational Site
London, United Kingdom
1182.58.44011 Boehringer Ingelheim Investigational Site
Peterborough, United Kingdom
1182.58.44030 Boehringer Ingelheim Investigational Site
Woolwich, United Kingdom
1182.58.44022 Boehringer Ingelheim Investigational Site
Woolwich, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00062660     History of Changes
Other Study ID Numbers: 1182.58
Study First Received: June 10, 2003
Last Updated: July 23, 2014
Health Authority: Australia: Human Research Ethics Committee
Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
Denmark: Ministry of Health
France: Ministry of Health
Great Britain:
Ireland: Ministry of Health
Italy: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
Portugal: National Pharmacy and Medicines Institute
Romania: Ministry of Public Health
South Africa: Medicines Control Council
Spain: Ministry of Health
Switzerland: Federal Office of Public Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Tipranavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014