Clinical trial NCT00062660: Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection
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
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2003-06-12
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.


Eligibility 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.

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