AzTrials
AzTrials

HIV InfectionsNCT00933205

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

A study testing Tipranavir in people with HIV Infections, run by Boehringer Ingelheim at 215 sites in 9 countries.

Approved For Marketing

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Tipranavir
How many people
Not given
Where
215 sitesin 9 countries
Study dates
May 2004to Jun 2008
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

215 sites in 9 countries.

215 sites in 9 countries

Spain83 sites

  • 1182.16.3419 Boehringer Ingelheim Investigational Site

    A Coruña

  • 1182.16.3412 Boehringer Ingelheim Investigational Site

    Alcalá de Henares (Madrid)

  • 1182.16.3432 Boehringer Ingelheim Investigational Site

    Alicante

  • 1182.16.3484 Boehringer Ingelheim Investigational Site

    Almería

  • 1182.16.3487 Boehringer Ingelheim Investigational Site

    Arrecife (Lanzarote)

  • 1182.16.3474 Boehringer Ingelheim Investigational Site

    Aviles (Asturias)

  • 1182.16.3440

    Badalona

  • 1182.16.3454 Boehringer Ingelheim Investigational Site

    Baracaldo (Vizcaya)

  • 1182.16.3438 Boehringer Ingelheim Investigational Site

    Barcelona

  • 1182.16.3442 Boehringer Ingelheim Investigational Site

    Barcelona

  • 1182.16.3448 Boehringer Ingelheim Investigational Site

    Barcelona

  • 1182.16.3449 Boehringer Ingelheim Investigational Site

    Barcelona

  • 1182.16.3463 Boehringer Ingelheim Investigational Site

    Bilbao

  • 1182.16.3476 Boehringer Ingelheim Investigational Site

    Cadiz

  • 1182.16.3430 Boehringer Ingelheim Investigational Site

    Cartagena

  • 1182.16.3462 Boehringer Ingelheim Investigational Site

    Castellon

  • 1182.16.3429 Boehringer Ingelheim Investigational Site

    Córdoba

  • 1182.16.3453 Boehringer Ingelheim Investigational Site

    Donostia / San Sebastian

  • 1182.16.3431 Boehringer Ingelheim Investigational Site

    El Palmar (murcia)

  • 1182.16.3488 Boehringer Ingelheim Investigational Site

    Gandia (Valencia)

  • 1182.16.3411 Boehringer Ingelheim Investigational Site

    Getafe (Madrid)

  • 1182.16.3418 Boehringer Ingelheim Investigational Site

    Gijón (asturias)

  • 1182.16.3443 Boehringer Ingelheim Investigational Site

    Girona

  • 1182.16.3427 Boehringer Ingelheim Investigational Site

    Granada

  • 1182.16.3428 Boehringer Ingelheim Investigational Site

    Granada

  • 1182.16.3439 Boehringer Ingelheim Investigational Site

    Granollers (Barcelona)

  • 1182.16.3477 Boehringer Ingelheim Investigational Site

    Hospitalet de Llobregat (Barcelona)

  • 1182.16.3480 Boehringer Ingelheim Investigational Site

    Huelva

  • 1182.16.3498 Boehringer Ingelheim Investigational Site

    Ibiza Town

  • 1182.16.3479 Boehringer Ingelheim Investigational Site

    Jaén

  • 1182.16.3423 Boehringer Ingelheim Investigational Site

    Jerez de la Frontera

  • 1182.16.3445 Boehringer Ingelheim Investigational Site

    L'Hospitalet de Llobregat

  • 1182.16.3436 Boehringer Ingelheim Investigational Site

    La Laguna (santa Cruz de Tenerife)

  • 1182.16.3434 Boehringer Ingelheim Investigational Site

    Las Palmas de Gran Canaria

  • 1182.16.3437 Boehringer Ingelheim Investigational Site

    Las Palmas de Gran Canarias

  • 1182.16.3470 Boehringer Ingelheim Investigational Site

    Leganés (Madrid)

  • 1182.16.3441 Boehringer Ingelheim Investigational Site

    Lleida

  • 1182.16.3490 Boehringer Ingelheim Investigational Site

    Logroño

  • 1182.16.3401 Boehringer Ingelheim Investigational Site

    Madrid

  • 1182.16.3402 Boehringer Ingelheim Investigational Site

    Madrid

  • 1182.16.3404 Boehringer Ingelheim Investigational Site

    Madrid

  • 1182.16.3405 Boehringer Ingelheim Investigational Site

    Madrid

  • 1182.16.3406 Boehringer Ingelheim Investigational Site

    Madrid

  • 1182.16.3407 Boehringer Ingelheim Investigational Site

    Madrid

  • 1182.16.3408 Boehringer Ingelheim Investigational Site

    Madrid

  • 1182.16.3409 Boehringer Ingelheim Investigational Site

    Madrid

  • 1182.16.3413 Boehringer Ingelheim Investigational Site

    Madrid

  • 1182.16.3424 Boehringer Ingelheim Investigational Site

    Málaga

  • 1182.16.3425 Boehringer Ingelheim Investigational Site

    Málaga

  • 1182.16.3494 Boehringer Ingelheim Investigational Site

    Manresa (Barcelona)

  • 1182.16.3426 Boehringer Ingelheim Investigational Site

    Marbella (Málaga)

  • 1182.16.3493 Boehringer Ingelheim Investigational Site

    Mataró

  • 1182.16.3492

    Mataró (Barcelona)

  • 1182.16.3410 Boehringer Ingelheim Investigational Site

    Móstoles (Madrid)

  • 1182.16.3489 Boehringer Ingelheim Investigational Site

    Navarra

  • 1182.16.3472 Boehringer Ingelheim Investigational Site

    Ourense

  • 1182.16.3417 Boehringer Ingelheim Investigational Site

    Oviedo (Asturias)

  • 1182.16.3496 Boehringer Ingelheim Investigational Site

    Palma de Mallorca

  • 1182.16.3450 Boehringer Ingelheim Investigational Site

    Plama de Mallorca

  • 1182.16.3497 Boehringer Ingelheim Investigational Site

    Reus (Tarragona)

  • 1182.16.3446 Boehringer Ingelheim Investigational Site

    Sabadell (Barcelona)

  • 1182.16.3435 Boehringer Ingelheim Investigational Site

    Santa Cruz de Tenerife

  • 1182.16.3455 Boehringer Ingelheim Investigational Site

    Santander

  • 1182.16.3415 Boehringer Ingelheim Investigational Site

    Santiago de Compostela

  • 1182.16.3420 Boehringer Ingelheim Investigational Site

    Seville

  • 1182.16.3421 Boehringer Ingelheim Investigational Site

    Seville

  • 1182.16.3422 Boehringer Ingelheim Investigational Site

    Seville

  • 1182.16.3447 Boehringer Ingelheim Investigational Site

    Tarragona

  • 1182.16.3495 Boehringer Ingelheim Investigational Site

    Tarragona

  • 1182.16.3444 Boehringer Ingelheim Investigational Site

    Terrassa

  • 1182.16.3456 Boehringer Ingelheim Investigational Site

    Valencia

  • 1182.16.3457 Boehringer Ingelheim Investigational Site

    Valencia

  • 1182.16.3458 Boehringer Ingelheim Investigational Site

    Valencia

  • 1182.16.3460 Boehringer Ingelheim Investigational Site

    Valencia

  • 1182.16.3461 Boehringer Ingelheim Investigational Site

    Valencia

  • 1182.16.3403 Boehringer Ingelheim Investigational Site

    Valladolid

  • 1182.16.3416 Boehringer Ingelheim Investigational Site

    Vigo

  • 1182.16.3467 Boehringer Ingelheim Investigational Site

    Vigo (Pontevedra)

  • 1182.16.3482 Boehringer Ingelheim Investigational Site

    Villajoyosa (alicante)

  • 1182.16.3483 Boehringer Ingelheim Investigational Site

    Vitoria-Gasteiz

  • 1182.16.3471 Boehringer Ingelheim Investigational Site

    Zamora

  • 1182.16.3451 Boehringer Ingelheim Investigational Site

    Zaragoza

  • 1182.16.3452 Boehringer Ingelheim Investigational Site

    Zaragoza

Other trials in Spain

Italy65 sites

  • 1182.16.3932 Azienda Ospedaliera Umberto I

    Ancona

  • 1182.16.3923 Ospedale Santa Maria Annunziata

    Antella (fi)

  • 1182.16.3952 Centro di riferimento oncologico

    Aviano - PD

  • 1182.16.3958 A.O. Ospedale Clinico Consorziale

    Bari

  • 1182.16.3920 Ospedali Riuniti di Bergamo

    Bergamo

  • 1182.16.3946 Ospedale Policlinico S. Orsola Bologna

    Bologna

  • 1182.16.3938 Ospedale Civile Regionale

    Bolzano

  • 1182.16.3901 Università di Brescia

    Brescia

  • 1182.16.3957 A.O. Spedali Civili di Brescia

    Brescia

  • 1182.16.3928 Azienda Ospedaliera

    Busto Arsizio (va)

  • 1182.16.3964 Ospedale SS. Trinità

    Cagliari

  • 1182.16.3947 U.O. Malattie Infettive

    Catania

  • 1182.16.3961 Ospedale Pugliese

    Catanzaro

  • 1182.16.3954 Ospedale Civile

    Cuggiono-MI

  • 1182.16.3963 Azienda Ospedaliera Arcispedale S. Anna

    Ferrara

  • 1182.16.3924 Azienda Ospedaliera Careggi

    Florence

  • 1182.16.3902 Ospedali Riuniti di Foggia

    Foggia

  • 1182.16.3911 U.O. di Malattie Infettive

    Foggia

  • 1182.16.3926 Azienda Ospedaliera

    Genova

  • 1182.16.3927 Azienda Ospedaliera

    Genova

  • 1182.16.3929 Malattie Infettive

    Genova

  • 1182.16.3912 Ospedale "A. Manzoni"

    Lecco

  • 1182.16.3925 Azienda Ospedaliera Carlo Poma

    Mantua

  • 1182.16.3951 Ospedale Civile Umberto I

    Mestre-VE

  • 1182.16.3903 Ospedale L. Sacco

    Milan

  • 1182.16.3904 Ospedale Luigi Sacco

    Milan

  • 1182.16.3910 Ospedale Luigi Sacco

    Milan

  • 1182.16.3913 Fondazione Centro S. Raffaele del Monte Tabor

    Milan

  • 1182.16.3953 ospedale Niguarda

    Milan

  • 1182.16.3965 Ospedale Maggiore

    Milan

  • 1182.16.3968 Azienda Ospedaliera Policlinico

    Modena

  • 1182.16.3934 Azienda Ospedaliera D. Cotugno

    Naples

  • 1182.16.3937 Azienda Ospedaliera D. Cotugno

    Naples

  • 1182.16.3942 Azienda Ospedaliera di Padova

    Padova

  • 1182.16.3914 Presidio Ospedaliero di Verbania

    Pallanza (Verbania)

  • 1182.16.3948 U.O. Malattie Infettive ed Epatologia

    Parma

  • 1182.16.3909 I.R.C.C.S. Policlinico San Matteo

    Pavia

  • 1182.16.3921 IRCCS Policlinico San Matteo

    Pavia

  • 1182.16.3966 Policlinico Monteluce

    Perugia

  • 1182.16.3955 Ospedale San Salvatore

    Pesaro

  • 1182.16.3967 Ospedale Civile dello Spirito Santo

    Pescara

  • 1182.16.3944 Ospedale Cisanello

    Pisa

  • 1182.16.3931 Ospedale Santa Maria delle Croci

    Ravenna

  • 1182.16.3930 Arcispedale S. Maria Nuova

    Reggio Emilia

  • 1182.16.3905 IRCCS Lazzaro Spallanzani

    Roma

  • 1182.16.3906 IRCCS Lazzaro Spallanzani

    Roma

  • 1182.16.3907 IRCCS Lazzaro Spallanzani

    Roma

  • 1182.16.3908 IRCCS Lazzaro Spallanzani

    Roma

  • 1182.16.3915 Azienda Policlinico Umberto I

    Roma

  • 1182.16.3922 Università "La Sapienza"

    Roma

  • 1182.16.3941 Istituto Nazionale per le Malattie Infettive

    Roma

  • 1182.16.3960 Università Cattolica del Sacro Cuore

    Roma

  • 1182.16.3945 Istituto Malattie Infettive Università Di Sassari

    Sassari

  • 1182.16.3970 Ospedale San Giuseppe Moscati

    Statte (ta)

  • 1182.16.3917 Ospedale Amedeo di Savoia

    Torino

  • 1182.16.3918 Ospedale Amedeo di Savoia

    Torino

  • 1182.16.3919 Ospedale Amedeo di Savoia

    Torino

  • 1182.16.3933 Azienda Ospedaliera Umberto I

    Torrette Di Ancona

  • 1182.16.3939 Ospedale Regionale

    Torrette Di Ancona

  • 1182.16.3940 Presidio Ospedaliero Cà Foncello

    Treviso

  • 1182.16.3943 Policlinico Universitario di Udine

    Udine

  • 1182.16.3916 Ospedale di Circolo e Fondazione Macchi

    Varese

  • 1182.16.3950 Ospedale SS. Giovanni e Paolo

    Venezia

  • 1182.16.3949 Policlinico Rossi "Borgo Roma"

    Verona

  • 1182.16.3959 Ospedale Civile di Vicenza - USSL 6

    Vicenza

Other trials in Italy

Canada26 sites

  • 1182.16.1118

    Calgary, Alberta

  • 1182.16.1104 University of Alberta H-Site

    Edmonton, Alberta

  • 1182.16.1128 Centre for Clinical Research

    Halifax, Nova Scotia

  • 1182.16.1112 McMaster University Medical Centre

    Hamilton, Ontario

  • 1182.16.1126 HIV Care Programme

    London, Ontario

  • 1182.16.1131 The Moncton Hospital

    Moncton, New Brunswick

  • 1182.16.1116 Immune Deficiency Treatment Centre

    Monteal, Quebec

  • 1182.16.1103 Hopital Notre Dame CHUM

    Montreal, Quebec

  • 1182.16.1113 Montreal Chest Institute, McGill University Health Centre

    Montreal, Quebec

  • 1182.16.1117 Clinique medicale l'Actuel

    Montreal, Quebec

  • 1182.16.1119

    Montreal, Quebec

  • 1182.16.1122 Infectious Diseases

    Montreal, Quebec

  • 1182.16.1130 Clinique Medicale LORI

    Montreal, Quebec

  • 1182.16.1132 Infectious Diseases Consultant

    Oakville, Ontario

  • 1182.16.1102 Canadian Immunodeficiency Research Collaborative Inc.

    Toronto, Ontario

  • 1182.16.1107 Sunnybrook & Woman's College Health Science Centre

    Toronto, Ontario

  • 1182.16.1109 Infectious Diseases and HIV

    Toronto, Ontario

  • 1182.16.1110 Toronto East General Hospital

    Toronto, Ontario

  • 1182.16.1114 Toronto General Hospital

    Toronto, Ontario

  • 1182.16.1115

    Toronto, Ontario

  • 1182.16.1124

    Toronto, Ontario

  • 1182.16.1101 St. Paul's Hospital

    Vancouver, British Columbia

  • 1182.16.1111 Downtown Infectious Diseases Clinic

    Vancouver, British Columbia

  • 1182.16.1106 Positive Care Clinic

    Whitby, Ontario

  • 1182.16.1120 Metropolitan Campus

    Windsor, Ontario

  • 1182.16.1125 St. Boniface General Hospital

    Winnipeg, Manitoba

Other trials in Canada

Brazil12 sites

  • 1182.16.5511 Unidade de Pesquisa Clínica (UPC) - AIDS

    Campinas - Sp

  • 1182.16.5505 Hospital São José de Doenças Infecciosas de Fortaleza

    Fortaleza - Ce

  • 1182.16.5502 Hospital Nossa Senhora da Conceiç

    Porto Alegre - Rs

  • 1182.16.5504 Hospital das Clínicas de Porto Alegre

    Porto Alegre - Rs

  • 1182.16.5512 Ambulatório de DST/ AIDS - RS

    Porto Alegre - Rs

  • 1182.16.5513 Centro de Pesquisa Hospital Evandro Chagras

    Rio de Janeiro

  • 1182.16.5509

    Rio de Janeiro - Rj

  • 1182.16.5510

    Santos - Sp

  • 1182.16.5501 UNIFESP/ Hospital São Paulo- Univers. Federal de São Paulo

    São Paulo - Sp

  • 1182.16.5506 Casa da AIDS da FMUSP

    São Paulo - Sp

  • 1182.16.5507 Hospital do Servidor Público Estadual de São Paulo

    São Paulo - Sp

  • 1182.16.5508

    Vila Mariana

Other trials in Brazil

Belgium11 sites

  • 1182.16.3202 Boehringer Ingelheim Investigational Site

    Antwerp

  • 1182.16.3203 Boehringer Ingelheim Investigational Site

    Brussels

  • 1182.16.3205 Boehringer Ingelheim Investigational Site

    Brussels

  • 1182.16.3206 Boehringer Ingelheim Investigational Site

    Brussels

  • 1182.16.3207 Boehringer Ingelheim Investigational Site

    Brussels

  • 1182.16.3211 Boehringer Ingelheim Investigational Site

    Charleroi

  • 1182.16.3204 Boehringer Ingelheim Investigational Site

    Ghent

  • 1182.16.3201 Boehringer Ingelheim Investigational Site

    Leuven

  • 1182.16.3208 Boehringer Ingelheim Investigational Site

    Liège

  • 1182.16.3212 Boehringer Ingelheim Investigational Site

    Liège

  • 1182.16.3209 Boehringer Ingelheim Investigational Site

    Luxembourg

Other trials in Belgium

Greece8 sites

  • 1182.16.3001 "Andreas Syggros"Hospital of Dermatological & Veneral Diseas

    Athens

  • 1182.16.3002 "Greek Red Cross" Hospital, 3rd Internal Medicine Clinic

    Athens

  • 1182.16.3004 "Attiko" Hospital, 4th Internal Medicine Clinic, UOA

    Athens

  • 1182.16.3005 Laiko Hospital, 2nd District Blood Donation Center & Haemato

    Athens

  • 1182.16.3007 1st Social Insurance Foundation (IKA) Pentelis

    Athens

  • 1182.16.3010 University Hospital of Patras

    Pátrai

  • 1182.16.3008 "Tzanio" Hospital

    Piraeus

  • 1182.16.3009 AHEPA Hospital

    Thessaloniki

Other trials in Greece

Portugal5 sites

  • 1182.16.3502 Hospital São Francisco Xavier

    Lisbon

  • 1182.16.3503 Centro Hospitalar de Lisboa

    Lisbon

  • 1182.16.3505 Hospital Santa Maria

    Lisbon

  • 1182.16.3501 Unidade Local de Saúde de Matosinhos

    Matosinhos Municipality

  • 1182.16.3504 Hospital Joaquim Urbano

    Porto

Other trials in Portugal

Denmark3 sites

  • 1182.16.4501 Boehringer Ingelheim Investigational Site

    Copenhagen

  • 1182.16.4502 Boehringer Ingelheim Investigational Site

    Hvidovre

  • 1182.16.4504 Boehringer Ingelheim Investigational Site

    Odense C

Other trials in Denmark

El Salvador2 sites

  • 1182.16.3491 Boehringer Ingelheim Investigational Site

    Vic (Barcelona)

  • 1182.16.3464 Boehringer Ingelheim Investigational Site

    Vizcaya

Other trials in El Salvador

About this study

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.

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.

Conditions
HIV Infections
Being tested
Tipranavir
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TipranavirDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2009 (estimated)
  2. Study startMay 2004
  3. Primary completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT00933205
Sponsor's protocol ID
1182.16
Status last verified
Oct 2013
First submitted
3 Jul 2009
Last updated
30 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Tipranavir in people with HIV Infections, run by Boehringer Ingelheim at 215 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 215 sites in Spain, Italy, Canada, Brazil, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00933205.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in