Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection
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
1 other identifier
expanded_access
N/A
12 countries
146
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2003
Longer than P75 for all trials
146 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 10, 2003
CompletedFirst Posted
Study publicly available on registry
June 12, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedNovember 30, 2016
July 1, 2014
10.9 years
June 10, 2003
November 29, 2016
Conditions
Interventions
Tipranavir 250 mg soft elastic capsules
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (146)
1182.58.31
Scottsdale, Arizona, United States
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
1182.58.03
San Francisco, California, United States
1182.58.33 Kaiser Permanente Medical Center, Clinical Trials Unit
San Francisco, California, United States
1182.58.37 AIDS Health Care Foundation
Los Angeles, Connecticut, United States
1182.58.41 Circle Medical, LLC
Norwalk, Connecticut, United States
1182.58.28
Washington D.C., District of Columbia, United States
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
1182.58.36 Suite 525
Atlanta, Georgia, United States
1182.58.08
Honolulu, Hawaii, United States
1182.58.22
Chicago, Illinois, United States
1182.58.32
New Orleans, Louisiana, United States
1182.58.15
Boston, Massachusetts, United States
1182.58.19 Henry Ford Hospital
Detroit, Michigan, United States
1182.58.04 Kansas City Free Health Clinic
Kansas City, Missouri, United States
1182.58.25 Wohl Clinic
St Louis, Missouri, United States
1182.58.02 Wellness Center
Las Vegas, Nevada, United States
1182.58.09 Polari Medical Group
New York, New York, United States
1182.58.30
Chapel Hill, North Carolina, United States
1182.58.06 University of Cincinnati Medical Center, Infectious diseases
Cincinnati, Ohio, United States
1182.58.35
Portland, Oregon, United States
1182.58.14
Philadelphia, Pennsylvania, United States
1182.58.20 University of Pittsburgh
Pittsburgh, Pennsylvania, United States
1182.58.01 Boehringer Ingelheim Investigational Site
Columbia, South Carolina, United States
1182.58.10 Comprehensive Care Center
Nashville, Tennessee, United States
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
1182.58.11 Swedish Medical Center
Seattle, Washington, United States
1182.58.44 VW Hospital and Clinics
Madison, Wisconsin, United States
1182.58.61005 Royal Prince Alfred Hospital
Camperdown, New South Wales, 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
1182.58.61022 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
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
1182.58.61020
Adelaide, South Australia, Australia
1182.58.61015 Flinders Medical Centre
Bedford Park, South Australia, 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
1182.58.61013 Melbourne Sexual Health Clinic
Melbourne, Victoria, Australia
1182.58.61023
Melbourne, Victoria, Australia
1182.58.61021
South Yarra, Victoria, Australia
1182.58.61004 Royal Perth Hospital
Perth, Western Australia, Australia
1182.58.3201 Boehringer Ingelheim Investigational Site
Antwerp, Belgium
1182.58.3202 Boehringer Ingelheim Investigational Site
Brussels, Belgium
1182.58.3203 Boehringer Ingelheim Investigational Site
Brussels, Belgium
1182.58.3204 Boehringer Ingelheim Investigational Site
Liège, Belgium
1182.58.4505 Aarhus Universitetshospital Skejby
Aarhus C, Denmark
1182.58.4501 Rigshospitalet
København Ø, Denmark
1182.58.4504 Odense Universitetshospital
Odense C, Denmark
1182.58.33029 Hôpital Aix
Aix-en-Provence, France
1182.58.33001 Hôpital Saint Jacques
Besançon, France
1182.58.33022 Hôpital Avicenne
Bobigny, France
1182.58.33020 Hôpital Antoine Beclère
Clamart, France
1182.58.33028 Hôpital Louis Mourier
Colombes, France
1182.58.33027 Hôpital
Dijon, France
1182.58.33034 Hôpital Raymond Poincarré
Garches, France
1182.58.33006 Hôpital Bicêtre
Le Kremlin-Bicêtre, France
1182.58.33019 Hôpital de l'Hôtel Dieu
Lyon, France
1182.58.33031 Hôpital edouard Herriot
Lyon, France
1182.58.33009 Hôpital de la Conception
Marseille, France
1182.58.33023 Hôpital Sainte Marguerite
Marseille, France
1182.58.33030 Hôpital Saint Eloi
Montpellier, France
1182.58.33032 Hôpital Emile Muller
Mulhouse, France
1182.58.33008 Hôpital Hôtel Dieu
Nantes, France
1182.58.33003 Hôpital de l'Archet
Nice, France
1182.58.33005 Hôpital Bichat
Paris, France
1182.58.33007 Hôpital Georges Pompidou
Paris, France
1182.58.33013 Hôpital Saint Louis
Paris, France
1182.58.33014 Hôpital Cochin
Paris, France
1182.58.33017 Hôpital Bichat Claude Bernard
Paris, France
1182.58.33018 Hôpital Saint Antoine
Paris, France
1182.58.33024 Hôpital Necker
Paris, France
1182.58.33033 Hôpital Tenon
Paris, France
1182.58.33035 Hôpital des Abîmes
Pointe à Pitre, France
1182.58.33012 Hôpital Robert Debré
Reims, France
1182.58.33026 Hôpital Ponchaillou
Rennes, France
1182.58.33015 Hôpital Civil
Strasbourg, France
1182.58.33025 Hôpital Foch
Suresnes, France
1182.58.33021 Hôpital Chalucet
Toulon, France
1182.58.33002 Hôpital Purpan
Toulouse, France
1182.58.33016
Tourcoing, France
1182.58.33010 Hôpital Brabois
Vandœuvre-lès-Nancy, France
1182.58.33011 Hôpital Paul Brousse
Villejuif, France
1182.58.3001
Athens, Greece
1182.58.44016 St James Hospital, Dept of Genito Urinary Medicine
Dublin, Ireland
1182.58.44029 Our Lady For Sick Children
Dublin, Ireland
1182.58.3903 Università di Brescia
Brescia, Italy
1182.58.3904 Ospedali Riuniti di Foggia
Foggia, Italy
1182.58.3901 Ospedale Luigi Sacco
Milan, Italy
1182.58.3902 Ospedale L. Sacco
Milan, 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
1182.58.35102 Hospital Condes Castro Guimarães
Cascais, Portugal
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
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
Geneva, Switzerland
1182.58.4107 Boehringer Ingelheim Investigational Site
Geneva, Switzerland
1182.58.4102 Boehringer Ingelheim Investigational Site
Zurich, Switzerland
1182.58.4105 Boehringer Ingelheim Investigational Site
Zurich, Switzerland
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 Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2003
First Posted
June 12, 2003
Study Start
May 1, 2003
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
November 30, 2016
Record last verified: 2014-07