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

November 29, 2016 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 10, 2003

First Submitted That Met QC Criteria

June 11, 2003

First Posted (Estimate)

June 12, 2003

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1182.58

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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