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An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.

Primary Purpose

HIV Infections

Status
Approved for marketing
Phase
Locations
International
Study Type
Expanded Access
Intervention
Tipranavir
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Triple anti-retroviral class experienced patients with at least 2 previous PI-based regimens who had failed or are intolerant to currently approved HIV-1 treatments.
  2. Age equal or more than 18 years
  3. Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter
  4. Patient voluntarily provides written informed consent to participate, in compliance with local law.

Exclusion Criteria:

  1. Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir
  2. Required use of restricted medications.
  3. Female patients of childbearing potential who have a positive pregnancy test at baseline or are breast feeding.
  4. Any medical condition which in the opinion of the investigator would interfere with the patients' ability to participate in or adhere to the requirements of this protocol.
  5. Use of other investigational drugs, within 30 days prior to TPV boosted with ritonavir initiation and for the duration of study participation
  6. Hepatic impairment evidenced by the following baseline laboratory findings:

    • AST or ALT more than 5X ULN or total bilirubin more than 3.5X ULN
    • AST or ALT more 2.5X ULN and total bilirubin more 2X ULN

Sites / Locations

  • 1182.16.3202 Boehringer Ingelheim Investigational Site
  • 1182.16.3203 Boehringer Ingelheim Investigational Site
  • 1182.16.3205 Boehringer Ingelheim Investigational Site
  • 1182.16.3206 Boehringer Ingelheim Investigational Site
  • 1182.16.3207 Boehringer Ingelheim Investigational Site
  • 1182.16.3211 Boehringer Ingelheim Investigational Site
  • 1182.16.3204 Boehringer Ingelheim Investigational Site
  • 1182.16.3201 Boehringer Ingelheim Investigational Site
  • 1182.16.3208 Boehringer Ingelheim Investigational Site
  • 1182.16.3212 Boehringer Ingelheim Investigational Site
  • 1182.16.3209 Boehringer Ingelheim Investigational Site
  • 1182.16.5511 Unidade de Pesquisa Clínica (UPC) - AIDS
  • 1182.16.5505 Hospital São José de Doenças Infecciosas de Fortaleza
  • 1182.16.5502 Hospital Nossa Senhora da Conceiç
  • 1182.16.5504 Hospital das Clínicas de Porto Alegre
  • 1182.16.5512 Ambulatório de DST/ AIDS - RS
  • 1182.16.5509
  • 1182.16.5513 Centro de Pesquisa Hospital Evandro Chagras
  • 1182.16.5510
  • 1182.16.5501 UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo
  • 1182.16.5506 Casa da AIDS da FMUSP
  • 1182.16.5507 Hospital do Servidor Público Estadual de São Paulo
  • 1182.16.5508
  • 1182.16.1118
  • 1182.16.1104 University of Alberta H-Site
  • 1182.16.1101 St. Paul's Hospital
  • 1182.16.1111 Downtown Infectious Diseases Clinic
  • 1182.16.1125 St. Boniface General Hospital
  • 1182.16.1131 The Moncton Hospital
  • 1182.16.1128 Centre for Clinical Research
  • 1182.16.1112 McMaster University Medical Centre
  • 1182.16.1126 HIV Care Programme
  • 1182.16.1132 Infectious Diseases Consultant
  • 1182.16.1102 Canadian Immunodeficiency Research Collaborative Inc.
  • 1182.16.1107 Sunnybrook & Woman's College Health Science Centre
  • 1182.16.1109 Infectious Diseases and HIV
  • 1182.16.1110 Toronto East General Hospital
  • 1182.16.1114 Toronto General Hospital
  • 1182.16.1115
  • 1182.16.1124
  • 1182.16.1106 Positive Care Clinic
  • 1182.16.1120 Metropolitan Campus
  • 1182.16.1116 Immune Deficiency Treatment Centre
  • 1182.16.1103 Hopital Notre Dame CHUM
  • 1182.16.1113 Montreal Chest Institute, McGill University Health Centre
  • 1182.16.1117 Clinique medicale l'Actuel
  • 1182.16.1119
  • 1182.16.1122 Infectious Diseases
  • 1182.16.1130 Clinique Medicale LORI
  • 1182.16.4501 Boehringer Ingelheim Investigational Site
  • 1182.16.4502 Boehringer Ingelheim Investigational Site
  • 1182.16.4504 Boehringer Ingelheim Investigational Site
  • 1182.16.3491 Boehringer Ingelheim Investigational Site
  • 1182.16.3464 Boehringer Ingelheim Investigational Site
  • 1182.16.3001 "Andreas Syggros"Hospital of Dermatological & Veneral Diseas
  • 1182.16.3002 "Greek Red Cross" Hospital, 3rd Internal Medicine Clinic
  • 1182.16.3004 "Attiko" Hospital, 4th Internal Medicine Clinic, UOA
  • 1182.16.3005 Laiko Hospital, 2nd District Blood Donation Center & Haemato
  • 1182.16.3007 1st Social Insurance Foundation (IKA) Pentelis
  • 1182.16.3010 University Hospital of Patras
  • 1182.16.3008 "Tzanio" Hospital
  • 1182.16.3009 AHEPA Hospital
  • 1182.16.3932 Azienda Ospedaliera Umberto I
  • 1182.16.3923 Ospedale Santa Maria Annunziata
  • 1182.16.3952 Centro di riferimento oncologico
  • 1182.16.3958 A.O. Ospedale Clinico Consorziale
  • 1182.16.3920 Ospedali Riuniti di Bergamo
  • 1182.16.3946 Ospedale Policlinico S. Orsola Bologna
  • 1182.16.3938 Ospedale Civile Regionale
  • 1182.16.3901 Università di Brescia
  • 1182.16.3957 A.O. Spedali Civili di Brescia
  • 1182.16.3928 Azienda Ospedaliera
  • 1182.16.3964 Ospedale SS. Trinità
  • 1182.16.3947 U.O. Malattie Infettive
  • 1182.16.3961 Ospedale Pugliese
  • 1182.16.3954 Ospedale Civile
  • 1182.16.3963 Azienda Ospedaliera Arcispedale S. Anna
  • 1182.16.3924 Azienda Ospedaliera Careggi
  • 1182.16.3902 Ospedali Riuniti di Foggia
  • 1182.16.3911 U.O. di Malattie Infettive
  • 1182.16.3926 Azienda Ospedaliera
  • 1182.16.3927 Azienda Ospedaliera
  • 1182.16.3929 Malattie Infettive
  • 1182.16.3912 Ospedale "A. Manzoni"
  • 1182.16.3925 Azienda Ospedaliera Carlo Poma
  • 1182.16.3951 Ospedale Civile Umberto I
  • 1182.16.3903 Ospedale L. Sacco
  • 1182.16.3904 Ospedale Luigi Sacco
  • 1182.16.3910 Ospedale Luigi Sacco
  • 1182.16.3913 Fondazione Centro S. Raffaele del Monte Tabor
  • 1182.16.3953 ospedale Niguarda
  • 1182.16.3965 Ospedale Maggiore
  • 1182.16.3968 Azienda Ospedaliera Policlinico
  • 1182.16.3934 Azienda Ospedaliera D. Cotugno
  • 1182.16.3937 Azienda Ospedaliera D. Cotugno
  • 1182.16.3942 Azienda Ospedaliera di Padova
  • 1182.16.3914 Presidio Ospedaliero di Verbania
  • 1182.16.3948 U.O. Malattie Infettive ed Epatologia
  • 1182.16.3909 I.R.C.C.S. Policlinico San Matteo
  • 1182.16.3921 IRCCS Policlinico San Matteo
  • 1182.16.3966 Policlinico Monteluce
  • 1182.16.3955 Ospedale San Salvatore
  • 1182.16.3967 Ospedale Civile dello Spirito Santo
  • 1182.16.3944 Ospedale Cisanello
  • 1182.16.3931 Ospedale Santa Maria delle Croci
  • 1182.16.3930 Arcispedale S. Maria Nuova
  • 1182.16.3905 IRCCS Lazzaro Spallanzani
  • 1182.16.3906 IRCCS Lazzaro Spallanzani
  • 1182.16.3907 IRCCS Lazzaro Spallanzani
  • 1182.16.3908 IRCCS Lazzaro Spallanzani
  • 1182.16.3915 Azienda Policlinico Umberto I
  • 1182.16.3922 Università "La Sapienza"
  • 1182.16.3941 Istituto Nazionale per le Malattie Infettive
  • 1182.16.3960 Università Cattolica del Sacro Cuore
  • 1182.16.3945 Istituto Malattie Infettive Università Di Sassari
  • 1182.16.3970 Ospedale San Giuseppe Moscati
  • 1182.16.3917 Ospedale Amedeo di Savoia
  • 1182.16.3918 Ospedale Amedeo di Savoia
  • 1182.16.3919 Ospedale Amedeo di Savoia
  • 1182.16.3933 Azienda Ospedaliera Umberto I
  • 1182.16.3939 Ospedale Regionale
  • 1182.16.3940 Presidio Ospedaliero Cà Foncello
  • 1182.16.3943 Policlinico Universitario di Udine
  • 1182.16.3916 Ospedale di Circolo e Fondazione Macchi
  • 1182.16.3950 Ospedale SS. Giovanni e Paolo
  • 1182.16.3949 Policlinico Rossi "Borgo Roma"
  • 1182.16.3959 Ospedale Civile di Vicenza - USSL 6
  • 1182.16.3503 Centro Hospitalar de Lisboa
  • 1182.16.3502 Hospital São Francisco Xavier
  • 1182.16.3505 Hospital Santa Maria
  • 1182.16.3501 Unidade Local de Saúde de Matosinhos
  • 1182.16.3504 Hospital Joaquim Urbano
  • 1182.16.3419 Boehringer Ingelheim Investigational Site
  • 1182.16.3412 Boehringer Ingelheim Investigational Site
  • 1182.16.3432 Boehringer Ingelheim Investigational Site
  • 1182.16.3484 Boehringer Ingelheim Investigational Site
  • 1182.16.3487 Boehringer Ingelheim Investigational Site
  • 1182.16.3474 Boehringer Ingelheim Investigational Site
  • 1182.16.3440
  • 1182.16.3454 Boehringer Ingelheim Investigational Site
  • 1182.16.3438 Boehringer Ingelheim Investigational Site
  • 1182.16.3442 Boehringer Ingelheim Investigational Site
  • 1182.16.3448 Boehringer Ingelheim Investigational Site
  • 1182.16.3449 Boehringer Ingelheim Investigational Site
  • 1182.16.3463 Boehringer Ingelheim Investigational Site
  • 1182.16.3476 Boehringer Ingelheim Investigational Site
  • 1182.16.3430 Boehringer Ingelheim Investigational Site
  • 1182.16.3462 Boehringer Ingelheim Investigational Site
  • 1182.16.3429 Boehringer Ingelheim Investigational Site
  • 1182.16.3431 Boehringer Ingelheim Investigational Site
  • 1182.16.3488 Boehringer Ingelheim Investigational Site
  • 1182.16.3443 Boehringer Ingelheim Investigational Site
  • 1182.16.3411 Boehringer Ingelheim Investigational Site
  • 1182.16.3418 Boehringer Ingelheim Investigational Site
  • 1182.16.3427 Boehringer Ingelheim Investigational Site
  • 1182.16.3428 Boehringer Ingelheim Investigational Site
  • 1182.16.3439 Boehringer Ingelheim Investigational Site
  • 1182.16.3477 Boehringer Ingelheim Investigational Site
  • 1182.16.3445 Boehringer Ingelheim Investigational Site
  • 1182.16.3480 Boehringer Ingelheim Investigational Site
  • 1182.16.3498 Boehringer Ingelheim Investigational Site
  • 1182.16.3479 Boehringer Ingelheim Investigational Site
  • 1182.16.3423 Boehringer Ingelheim Investigational Site
  • 1182.16.3436 Boehringer Ingelheim Investigational Site
  • 1182.16.3437 Boehringer Ingelheim Investigational Site
  • 1182.16.3434 Boehringer Ingelheim Investigational Site
  • 1182.16.3470 Boehringer Ingelheim Investigational Site
  • 1182.16.3441 Boehringer Ingelheim Investigational Site
  • 1182.16.3490 Boehringer Ingelheim Investigational Site
  • 1182.16.3401 Boehringer Ingelheim Investigational Site
  • 1182.16.3402 Boehringer Ingelheim Investigational Site
  • 1182.16.3404 Boehringer Ingelheim Investigational Site
  • 1182.16.3405 Boehringer Ingelheim Investigational Site
  • 1182.16.3406 Boehringer Ingelheim Investigational Site
  • 1182.16.3407 Boehringer Ingelheim Investigational Site
  • 1182.16.3408 Boehringer Ingelheim Investigational Site
  • 1182.16.3409 Boehringer Ingelheim Investigational Site
  • 1182.16.3413 Boehringer Ingelheim Investigational Site
  • 1182.16.3424 Boehringer Ingelheim Investigational Site
  • 1182.16.3494 Boehringer Ingelheim Investigational Site
  • 1182.16.3426 Boehringer Ingelheim Investigational Site
  • 1182.16.3493 Boehringer Ingelheim Investigational Site
  • 1182.16.3492
  • 1182.16.3425 Boehringer Ingelheim Investigational Site
  • 1182.16.3410 Boehringer Ingelheim Investigational Site
  • 1182.16.3489 Boehringer Ingelheim Investigational Site
  • 1182.16.3472 Boehringer Ingelheim Investigational Site
  • 1182.16.3417 Boehringer Ingelheim Investigational Site
  • 1182.16.3496 Boehringer Ingelheim Investigational Site
  • 1182.16.3450 Boehringer Ingelheim Investigational Site
  • 1182.16.3497 Boehringer Ingelheim Investigational Site
  • 1182.16.3446 Boehringer Ingelheim Investigational Site
  • 1182.16.3453 Boehringer Ingelheim Investigational Site
  • 1182.16.3435 Boehringer Ingelheim Investigational Site
  • 1182.16.3455 Boehringer Ingelheim Investigational Site
  • 1182.16.3415 Boehringer Ingelheim Investigational Site
  • 1182.16.3420 Boehringer Ingelheim Investigational Site
  • 1182.16.3421 Boehringer Ingelheim Investigational Site
  • 1182.16.3422 Boehringer Ingelheim Investigational Site
  • 1182.16.3447 Boehringer Ingelheim Investigational Site
  • 1182.16.3495 Boehringer Ingelheim Investigational Site
  • 1182.16.3444 Boehringer Ingelheim Investigational Site
  • 1182.16.3456 Boehringer Ingelheim Investigational Site
  • 1182.16.3457 Boehringer Ingelheim Investigational Site
  • 1182.16.3458 Boehringer Ingelheim Investigational Site
  • 1182.16.3460 Boehringer Ingelheim Investigational Site
  • 1182.16.3461 Boehringer Ingelheim Investigational Site
  • 1182.16.3403 Boehringer Ingelheim Investigational Site
  • 1182.16.3467 Boehringer Ingelheim Investigational Site
  • 1182.16.3416 Boehringer Ingelheim Investigational Site
  • 1182.16.3482 Boehringer Ingelheim Investigational Site
  • 1182.16.3483 Boehringer Ingelheim Investigational Site
  • 1182.16.3471 Boehringer Ingelheim Investigational Site
  • 1182.16.3451 Boehringer Ingelheim Investigational Site
  • 1182.16.3452 Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 3, 2009
Last Updated
November 29, 2016
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00933205
Brief Title
An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.
Official Title
An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options.
Study Type
Expanded Access

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Approved for marketing
Study Start Date
May 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The purpose of this Open Label Safety Study is to provide access to and evaluate the safety and tolerability of TPV/r in treatment-experienced patients with advanced HIV-1 infection who have failed at least two PI-containing regimens, and have limited treatment options.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tipranavir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Triple anti-retroviral class experienced patients with at least 2 previous PI-based regimens who had failed or are intolerant to currently approved HIV-1 treatments. Age equal or more than 18 years Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter Patient voluntarily provides written informed consent to participate, in compliance with local law. Exclusion Criteria: Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir Required use of restricted medications. Female patients of childbearing potential who have a positive pregnancy test at baseline or are breast feeding. Any medical condition which in the opinion of the investigator would interfere with the patients' ability to participate in or adhere to the requirements of this protocol. Use of other investigational drugs, within 30 days prior to TPV boosted with ritonavir initiation and for the duration of study participation Hepatic impairment evidenced by the following baseline laboratory findings: AST or ALT more than 5X ULN or total bilirubin more than 3.5X ULN AST or ALT more 2.5X ULN and total bilirubin more 2X ULN
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1182.16.3202 Boehringer Ingelheim Investigational Site
City
Antwerpen
Country
Belgium
Facility Name
1182.16.3203 Boehringer Ingelheim Investigational Site
City
Brussel
Country
Belgium
Facility Name
1182.16.3205 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1182.16.3206 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1182.16.3207 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1182.16.3211 Boehringer Ingelheim Investigational Site
City
Charleroi
Country
Belgium
Facility Name
1182.16.3204 Boehringer Ingelheim Investigational Site
City
Gent
Country
Belgium
Facility Name
1182.16.3201 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
1182.16.3208 Boehringer Ingelheim Investigational Site
City
Liège
Country
Belgium
Facility Name
1182.16.3212 Boehringer Ingelheim Investigational Site
City
Liège
Country
Belgium
Facility Name
1182.16.3209 Boehringer Ingelheim Investigational Site
City
Luxembourg
Country
Belgium
Facility Name
1182.16.5511 Unidade de Pesquisa Clínica (UPC) - AIDS
City
Campinas - Sp
Country
Brazil
Facility Name
1182.16.5505 Hospital São José de Doenças Infecciosas de Fortaleza
City
Fortaleza - Ce
Country
Brazil
Facility Name
1182.16.5502 Hospital Nossa Senhora da Conceiç
City
Porto Alegre - Rs
Country
Brazil
Facility Name
1182.16.5504 Hospital das Clínicas de Porto Alegre
City
Porto Alegre - Rs
Country
Brazil
Facility Name
1182.16.5512 Ambulatório de DST/ AIDS - RS
City
Porto Alegre - Rs
Country
Brazil
Facility Name
1182.16.5509
City
Rio de Janeiro - Rj
Country
Brazil
Facility Name
1182.16.5513 Centro de Pesquisa Hospital Evandro Chagras
City
Rio de Janeiro
Country
Brazil
Facility Name
1182.16.5510
City
Santos - Sp
Country
Brazil
Facility Name
1182.16.5501 UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo
City
São Paulo - Sp
Country
Brazil
Facility Name
1182.16.5506 Casa da AIDS da FMUSP
City
São Paulo - Sp
Country
Brazil
Facility Name
1182.16.5507 Hospital do Servidor Público Estadual de São Paulo
City
São Paulo - Sp
Country
Brazil
Facility Name
1182.16.5508
City
Vila Mariana
Country
Brazil
Facility Name
1182.16.1118
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
1182.16.1104 University of Alberta H-Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1182.16.1101 St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1182.16.1111 Downtown Infectious Diseases Clinic
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1182.16.1125 St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
1182.16.1131 The Moncton Hospital
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
1182.16.1128 Centre for Clinical Research
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
1182.16.1112 McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1182.16.1126 HIV Care Programme
City
London
State/Province
Ontario
Country
Canada
Facility Name
1182.16.1132 Infectious Diseases Consultant
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
1182.16.1102 Canadian Immunodeficiency Research Collaborative Inc.
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1182.16.1107 Sunnybrook & Woman's College Health Science Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1182.16.1109 Infectious Diseases and HIV
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1182.16.1110 Toronto East General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1182.16.1114 Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1182.16.1115
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1182.16.1124
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1182.16.1106 Positive Care Clinic
City
Whitby
State/Province
Ontario
Country
Canada
Facility Name
1182.16.1120 Metropolitan Campus
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
1182.16.1116 Immune Deficiency Treatment Centre
City
Monteal
State/Province
Quebec
Country
Canada
Facility Name
1182.16.1103 Hopital Notre Dame CHUM
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1182.16.1113 Montreal Chest Institute, McGill University Health Centre
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1182.16.1117 Clinique medicale l'Actuel
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1182.16.1119
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1182.16.1122 Infectious Diseases
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1182.16.1130 Clinique Medicale LORI
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1182.16.4501 Boehringer Ingelheim Investigational Site
City
Copenhagen
Country
Denmark
Facility Name
1182.16.4502 Boehringer Ingelheim Investigational Site
City
Hvidovre
Country
Denmark
Facility Name
1182.16.4504 Boehringer Ingelheim Investigational Site
City
Odense C
Country
Denmark
Facility Name
1182.16.3491 Boehringer Ingelheim Investigational Site
City
Vic (Barcelona)
Country
El Salvador
Facility Name
1182.16.3464 Boehringer Ingelheim Investigational Site
City
Vizcaya
Country
El Salvador
Facility Name
1182.16.3001 "Andreas Syggros"Hospital of Dermatological & Veneral Diseas
City
Athens
Country
Greece
Facility Name
1182.16.3002 "Greek Red Cross" Hospital, 3rd Internal Medicine Clinic
City
Athens
Country
Greece
Facility Name
1182.16.3004 "Attiko" Hospital, 4th Internal Medicine Clinic, UOA
City
Athens
Country
Greece
Facility Name
1182.16.3005 Laiko Hospital, 2nd District Blood Donation Center & Haemato
City
Athens
Country
Greece
Facility Name
1182.16.3007 1st Social Insurance Foundation (IKA) Pentelis
City
Athens
Country
Greece
Facility Name
1182.16.3010 University Hospital of Patras
City
Patras
Country
Greece
Facility Name
1182.16.3008 "Tzanio" Hospital
City
Piraeus
Country
Greece
Facility Name
1182.16.3009 AHEPA Hospital
City
Thessaloniki
Country
Greece
Facility Name
1182.16.3932 Azienda Ospedaliera Umberto I
City
Ancona
Country
Italy
Facility Name
1182.16.3923 Ospedale Santa Maria Annunziata
City
Antella (fi)
Country
Italy
Facility Name
1182.16.3952 Centro di riferimento oncologico
City
Aviano - PD
Country
Italy
Facility Name
1182.16.3958 A.O. Ospedale Clinico Consorziale
City
Bari
Country
Italy
Facility Name
1182.16.3920 Ospedali Riuniti di Bergamo
City
Bergamo
Country
Italy
Facility Name
1182.16.3946 Ospedale Policlinico S. Orsola Bologna
City
Bologna
Country
Italy
Facility Name
1182.16.3938 Ospedale Civile Regionale
City
Bolzano
Country
Italy
Facility Name
1182.16.3901 Università di Brescia
City
Brescia
Country
Italy
Facility Name
1182.16.3957 A.O. Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
1182.16.3928 Azienda Ospedaliera
City
Busto Arsizio (va)
Country
Italy
Facility Name
1182.16.3964 Ospedale SS. Trinità
City
Cagliari
Country
Italy
Facility Name
1182.16.3947 U.O. Malattie Infettive
City
Catania
Country
Italy
Facility Name
1182.16.3961 Ospedale Pugliese
City
Catanzaro
Country
Italy
Facility Name
1182.16.3954 Ospedale Civile
City
Cuggiono-MI
Country
Italy
Facility Name
1182.16.3963 Azienda Ospedaliera Arcispedale S. Anna
City
Ferrara
Country
Italy
Facility Name
1182.16.3924 Azienda Ospedaliera Careggi
City
Firenze
Country
Italy
Facility Name
1182.16.3902 Ospedali Riuniti di Foggia
City
Foggia
Country
Italy
Facility Name
1182.16.3911 U.O. di Malattie Infettive
City
Foggia
Country
Italy
Facility Name
1182.16.3926 Azienda Ospedaliera
City
Genova
Country
Italy
Facility Name
1182.16.3927 Azienda Ospedaliera
City
Genova
Country
Italy
Facility Name
1182.16.3929 Malattie Infettive
City
Genova
Country
Italy
Facility Name
1182.16.3912 Ospedale "A. Manzoni"
City
Lecco
Country
Italy
Facility Name
1182.16.3925 Azienda Ospedaliera Carlo Poma
City
Mantova
Country
Italy
Facility Name
1182.16.3951 Ospedale Civile Umberto I
City
Mestre-VE
Country
Italy
Facility Name
1182.16.3903 Ospedale L. Sacco
City
Milano
Country
Italy
Facility Name
1182.16.3904 Ospedale Luigi Sacco
City
Milano
Country
Italy
Facility Name
1182.16.3910 Ospedale Luigi Sacco
City
Milano
Country
Italy
Facility Name
1182.16.3913 Fondazione Centro S. Raffaele del Monte Tabor
City
Milano
Country
Italy
Facility Name
1182.16.3953 ospedale Niguarda
City
Milano
Country
Italy
Facility Name
1182.16.3965 Ospedale Maggiore
City
Milano
Country
Italy
Facility Name
1182.16.3968 Azienda Ospedaliera Policlinico
City
Modena
Country
Italy
Facility Name
1182.16.3934 Azienda Ospedaliera D. Cotugno
City
Napoli
Country
Italy
Facility Name
1182.16.3937 Azienda Ospedaliera D. Cotugno
City
Napoli
Country
Italy
Facility Name
1182.16.3942 Azienda Ospedaliera di Padova
City
Padova
Country
Italy
Facility Name
1182.16.3914 Presidio Ospedaliero di Verbania
City
PALLANZA (Verbania)
Country
Italy
Facility Name
1182.16.3948 U.O. Malattie Infettive ed Epatologia
City
Parma
Country
Italy
Facility Name
1182.16.3909 I.R.C.C.S. Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
1182.16.3921 IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
1182.16.3966 Policlinico Monteluce
City
Perugia
Country
Italy
Facility Name
1182.16.3955 Ospedale San Salvatore
City
Pesaro
Country
Italy
Facility Name
1182.16.3967 Ospedale Civile dello Spirito Santo
City
Pescara
Country
Italy
Facility Name
1182.16.3944 Ospedale Cisanello
City
Pisa
Country
Italy
Facility Name
1182.16.3931 Ospedale Santa Maria delle Croci
City
Ravenna
Country
Italy
Facility Name
1182.16.3930 Arcispedale S. Maria Nuova
City
Reggio Emilia
Country
Italy
Facility Name
1182.16.3905 IRCCS Lazzaro Spallanzani
City
Roma
Country
Italy
Facility Name
1182.16.3906 IRCCS Lazzaro Spallanzani
City
Roma
Country
Italy
Facility Name
1182.16.3907 IRCCS Lazzaro Spallanzani
City
Roma
Country
Italy
Facility Name
1182.16.3908 IRCCS Lazzaro Spallanzani
City
Roma
Country
Italy
Facility Name
1182.16.3915 Azienda Policlinico Umberto I
City
Roma
Country
Italy
Facility Name
1182.16.3922 Università "La Sapienza"
City
Roma
Country
Italy
Facility Name
1182.16.3941 Istituto Nazionale per le Malattie Infettive
City
Roma
Country
Italy
Facility Name
1182.16.3960 Università Cattolica del Sacro Cuore
City
Roma
Country
Italy
Facility Name
1182.16.3945 Istituto Malattie Infettive Università Di Sassari
City
Sassari
Country
Italy
Facility Name
1182.16.3970 Ospedale San Giuseppe Moscati
City
Statte (ta)
Country
Italy
Facility Name
1182.16.3917 Ospedale Amedeo di Savoia
City
Torino
Country
Italy
Facility Name
1182.16.3918 Ospedale Amedeo di Savoia
City
Torino
Country
Italy
Facility Name
1182.16.3919 Ospedale Amedeo di Savoia
City
Torino
Country
Italy
Facility Name
1182.16.3933 Azienda Ospedaliera Umberto I
City
Torrette Di Ancona
Country
Italy
Facility Name
1182.16.3939 Ospedale Regionale
City
Torrette Di Ancona
Country
Italy
Facility Name
1182.16.3940 Presidio Ospedaliero Cà Foncello
City
Treviso
Country
Italy
Facility Name
1182.16.3943 Policlinico Universitario di Udine
City
Udine
Country
Italy
Facility Name
1182.16.3916 Ospedale di Circolo e Fondazione Macchi
City
Varese
Country
Italy
Facility Name
1182.16.3950 Ospedale SS. Giovanni e Paolo
City
Venezia
Country
Italy
Facility Name
1182.16.3949 Policlinico Rossi "Borgo Roma"
City
Verona
Country
Italy
Facility Name
1182.16.3959 Ospedale Civile di Vicenza - USSL 6
City
Vicenza
Country
Italy
Facility Name
1182.16.3503 Centro Hospitalar de Lisboa
City
Lisboa
Country
Portugal
Facility Name
1182.16.3502 Hospital São Francisco Xavier
City
Lisbon
Country
Portugal
Facility Name
1182.16.3505 Hospital Santa Maria
City
Lisbon
Country
Portugal
Facility Name
1182.16.3501 Unidade Local de Saúde de Matosinhos
City
Matosinhos
Country
Portugal
Facility Name
1182.16.3504 Hospital Joaquim Urbano
City
Porto
Country
Portugal
Facility Name
1182.16.3419 Boehringer Ingelheim Investigational Site
City
A Coruña
Country
Spain
Facility Name
1182.16.3412 Boehringer Ingelheim Investigational Site
City
Alcalá de Henares (Madrid)
Country
Spain
Facility Name
1182.16.3432 Boehringer Ingelheim Investigational Site
City
Alicante
Country
Spain
Facility Name
1182.16.3484 Boehringer Ingelheim Investigational Site
City
Almeria
Country
Spain
Facility Name
1182.16.3487 Boehringer Ingelheim Investigational Site
City
Arrecife (Lanzarote)
Country
Spain
Facility Name
1182.16.3474 Boehringer Ingelheim Investigational Site
City
Aviles (Asturias)
Country
Spain
Facility Name
1182.16.3440
City
Badalona
Country
Spain
Facility Name
1182.16.3454 Boehringer Ingelheim Investigational Site
City
Baracaldo (Vizcaya)
Country
Spain
Facility Name
1182.16.3438 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1182.16.3442 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1182.16.3448 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1182.16.3449 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1182.16.3463 Boehringer Ingelheim Investigational Site
City
Bilbao
Country
Spain
Facility Name
1182.16.3476 Boehringer Ingelheim Investigational Site
City
Cadiz
Country
Spain
Facility Name
1182.16.3430 Boehringer Ingelheim Investigational Site
City
Cartagena
Country
Spain
Facility Name
1182.16.3462 Boehringer Ingelheim Investigational Site
City
Castellón
Country
Spain
Facility Name
1182.16.3429 Boehringer Ingelheim Investigational Site
City
Cordoba
Country
Spain
Facility Name
1182.16.3431 Boehringer Ingelheim Investigational Site
City
El Palmar (MURCIA)
Country
Spain
Facility Name
1182.16.3488 Boehringer Ingelheim Investigational Site
City
Gandia (Valencia)
Country
Spain
Facility Name
1182.16.3443 Boehringer Ingelheim Investigational Site
City
Gerona
Country
Spain
Facility Name
1182.16.3411 Boehringer Ingelheim Investigational Site
City
Getafe (Madrid)
Country
Spain
Facility Name
1182.16.3418 Boehringer Ingelheim Investigational Site
City
Gijón (ASTURIAS)
Country
Spain
Facility Name
1182.16.3427 Boehringer Ingelheim Investigational Site
City
Granada
Country
Spain
Facility Name
1182.16.3428 Boehringer Ingelheim Investigational Site
City
Granada
Country
Spain
Facility Name
1182.16.3439 Boehringer Ingelheim Investigational Site
City
Granollers (Barcelona)
Country
Spain
Facility Name
1182.16.3477 Boehringer Ingelheim Investigational Site
City
Hospitalet de Llobregat (Barcelona)
Country
Spain
Facility Name
1182.16.3445 Boehringer Ingelheim Investigational Site
City
Hospitalet de Llobregat
Country
Spain
Facility Name
1182.16.3480 Boehringer Ingelheim Investigational Site
City
Huelva
Country
Spain
Facility Name
1182.16.3498 Boehringer Ingelheim Investigational Site
City
Ibiza
Country
Spain
Facility Name
1182.16.3479 Boehringer Ingelheim Investigational Site
City
Jaen
Country
Spain
Facility Name
1182.16.3423 Boehringer Ingelheim Investigational Site
City
Jerez de la Frontera
Country
Spain
Facility Name
1182.16.3436 Boehringer Ingelheim Investigational Site
City
La Laguna (santa Cruz de Tenerife)
Country
Spain
Facility Name
1182.16.3437 Boehringer Ingelheim Investigational Site
City
Las Palmas de Gran Canarias
Country
Spain
Facility Name
1182.16.3434 Boehringer Ingelheim Investigational Site
City
Las Palmas de Gran Canaria
Country
Spain
Facility Name
1182.16.3470 Boehringer Ingelheim Investigational Site
City
Leganés (Madrid)
Country
Spain
Facility Name
1182.16.3441 Boehringer Ingelheim Investigational Site
City
Lleida
Country
Spain
Facility Name
1182.16.3490 Boehringer Ingelheim Investigational Site
City
Logroño
Country
Spain
Facility Name
1182.16.3401 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.16.3402 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.16.3404 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.16.3405 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.16.3406 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.16.3407 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.16.3408 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.16.3409 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.16.3413 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1182.16.3424 Boehringer Ingelheim Investigational Site
City
Malaga
Country
Spain
Facility Name
1182.16.3494 Boehringer Ingelheim Investigational Site
City
Manresa (Barcelona)
Country
Spain
Facility Name
1182.16.3426 Boehringer Ingelheim Investigational Site
City
Marbella (Málaga)
Country
Spain
Facility Name
1182.16.3493 Boehringer Ingelheim Investigational Site
City
Mataro
Country
Spain
Facility Name
1182.16.3492
City
Mataró (Barcelona)
Country
Spain
Facility Name
1182.16.3425 Boehringer Ingelheim Investigational Site
City
Málaga
Country
Spain
Facility Name
1182.16.3410 Boehringer Ingelheim Investigational Site
City
Móstoles (Madrid)
Country
Spain
Facility Name
1182.16.3489 Boehringer Ingelheim Investigational Site
City
Navarra
Country
Spain
Facility Name
1182.16.3472 Boehringer Ingelheim Investigational Site
City
Ourense
Country
Spain
Facility Name
1182.16.3417 Boehringer Ingelheim Investigational Site
City
Oviedo (Asturias)
Country
Spain
Facility Name
1182.16.3496 Boehringer Ingelheim Investigational Site
City
Palma de Mallorca
Country
Spain
Facility Name
1182.16.3450 Boehringer Ingelheim Investigational Site
City
Plama de Mallorca
Country
Spain
Facility Name
1182.16.3497 Boehringer Ingelheim Investigational Site
City
Reus (Tarragona)
Country
Spain
Facility Name
1182.16.3446 Boehringer Ingelheim Investigational Site
City
Sabadell (Barcelona)
Country
Spain
Facility Name
1182.16.3453 Boehringer Ingelheim Investigational Site
City
San Sebastian
Country
Spain
Facility Name
1182.16.3435 Boehringer Ingelheim Investigational Site
City
Santa Cruz de Tenerife
Country
Spain
Facility Name
1182.16.3455 Boehringer Ingelheim Investigational Site
City
Santander
Country
Spain
Facility Name
1182.16.3415 Boehringer Ingelheim Investigational Site
City
Santiago de Compostela
Country
Spain
Facility Name
1182.16.3420 Boehringer Ingelheim Investigational Site
City
Sevilla
Country
Spain
Facility Name
1182.16.3421 Boehringer Ingelheim Investigational Site
City
Sevilla
Country
Spain
Facility Name
1182.16.3422 Boehringer Ingelheim Investigational Site
City
Sevilla
Country
Spain
Facility Name
1182.16.3447 Boehringer Ingelheim Investigational Site
City
Tarragona
Country
Spain
Facility Name
1182.16.3495 Boehringer Ingelheim Investigational Site
City
Tarragona
Country
Spain
Facility Name
1182.16.3444 Boehringer Ingelheim Investigational Site
City
Terrassa
Country
Spain
Facility Name
1182.16.3456 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1182.16.3457 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1182.16.3458 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1182.16.3460 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1182.16.3461 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1182.16.3403 Boehringer Ingelheim Investigational Site
City
Valladolid
Country
Spain
Facility Name
1182.16.3467 Boehringer Ingelheim Investigational Site
City
Vigo (Pontevedra)
Country
Spain
Facility Name
1182.16.3416 Boehringer Ingelheim Investigational Site
City
Vigo
Country
Spain
Facility Name
1182.16.3482 Boehringer Ingelheim Investigational Site
City
Villajoyosa (ALICANTE)
Country
Spain
Facility Name
1182.16.3483 Boehringer Ingelheim Investigational Site
City
Vitoria
Country
Spain
Facility Name
1182.16.3471 Boehringer Ingelheim Investigational Site
City
Zamora
Country
Spain
Facility Name
1182.16.3451 Boehringer Ingelheim Investigational Site
City
Zaragoza
Country
Spain
Facility Name
1182.16.3452 Boehringer Ingelheim Investigational Site
City
zARAGOZA
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.16_U09-1827.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.16_literature.pdf
Description
Related Info

Learn more about this trial

An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.

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