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

A study testing Tipranavir in people with HIV Infections, run by Boehringer Ingelheim at 146 sites in 12 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 The sponsor has not verified this record for over two years, so it may be out of date.

Trial 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… Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: HIV Infections
What is being tested?: Tipranavir
Type of treatment: Pill or oral medicine
How many people: Not given
Where: 146 sitesin 12 countries
Study dates: May 2003to Apr 2014
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 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

None listed.

Trial locations and contacts

146 sites in 12 countries.

Country

City, postcode or hospital

146 sites in 12 countries

United States35 sites

1182.58.36 Suite 525
Atlanta, Georgia
1182.58.15
Boston, Massachusetts
1182.58.30
Chapel Hill, North Carolina
1182.58.22
Chicago, Illinois
1182.58.06 University of Cincinnati Medical Center, Infectious diseases
Cincinnati, Ohio
1182.58.01 Boehringer Ingelheim Investigational Site
Columbia, South Carolina
1182.58.18 University of Texas Southwest Medical Center at Dallas
Dallas, Texas
1182.58.19 Henry Ford Hospital
Detroit, Michigan
1182.58.08
Honolulu, Hawaii
1182.58.07
Houston, Texas
1182.58.04 Kansas City Free Health Clinic
Kansas City, Missouri
1182.58.02 Wellness Center
Las Vegas, Nevada
1182.58.29
Los Angeles, California
1182.58.34 Campus Code 696446
Los Angeles, California
1182.58.42 Synergy Hematology/Oncology
Los Angeles, California
1182.58.43
Los Angeles, California
1182.58.37 AIDS Health Care Foundation
Los Angeles, Connecticut
1182.58.44 VW Hospital and Clinics
Madison, Wisconsin
1182.58.38
Miami Beach, Florida
1182.58.10 Comprehensive Care Center
Nashville, Tennessee
1182.58.32
New Orleans, Louisiana
1182.58.09 Polari Medical Group
New York, New York
1182.58.41 Circle Medical, LLC
Norwalk, Connecticut
1182.58.14
Philadelphia, Pennsylvania
1182.58.20 University of Pittsburgh
Pittsburgh, Pennsylvania
1182.58.35
Portland, Oregon
1182.58.039 Olmos Park Medical Associates
San Antonio, Texas
1182.58.03
San Francisco, California
1182.58.33 Kaiser Permanente Medical Center, Clinical Trials Unit
San Francisco, California
1182.58.31
Scottsdale, Arizona
1182.58.11 Swedish Medical Center
Seattle, Washington
1182.58.40 Drs. Raben and Feldman Research Associates
South Miami, Florida
1182.58.25 Wohl Clinic
St Louis, Missouri
1182.58.23 Hillsborough County Health Department
Tampa, Florida
1182.58.28
Washington D.C., District of Columbia

Other trials in United States

France34 sites

1182.58.33029 Hôpital Aix
Aix-en-Provence
1182.58.33001 Hôpital Saint Jacques
Besançon
1182.58.33022 Hôpital Avicenne
Bobigny
1182.58.33020 Hôpital Antoine Beclère
Clamart
1182.58.33028 Hôpital Louis Mourier
Colombes
1182.58.33027 Hôpital
Dijon
1182.58.33034 Hôpital Raymond Poincarré
Garches
1182.58.33006 Hôpital Bicêtre
Le Kremlin-Bicêtre
1182.58.33019 Hôpital de l'Hôtel Dieu
Lyon
1182.58.33031 Hôpital edouard Herriot
Lyon
1182.58.33009 Hôpital de la Conception
Marseille
1182.58.33023 Hôpital Sainte Marguerite
Marseille
1182.58.33030 Hôpital Saint Eloi
Montpellier
1182.58.33032 Hôpital Emile Muller
Mulhouse
1182.58.33008 Hôpital Hôtel Dieu
Nantes
1182.58.33003 Hôpital de l'Archet
Nice
1182.58.33005 Hôpital Bichat
Paris
1182.58.33007 Hôpital Georges Pompidou
Paris
1182.58.33013 Hôpital Saint Louis
Paris
1182.58.33014 Hôpital Cochin
Paris
1182.58.33017 Hôpital Bichat Claude Bernard
Paris
1182.58.33018 Hôpital Saint Antoine
Paris
1182.58.33024 Hôpital Necker
Paris
1182.58.33033 Hôpital Tenon
Paris
1182.58.33035 Hôpital des Abîmes
Pointe à Pitre
1182.58.33012 Hôpital Robert Debré
Reims
1182.58.33026 Hôpital Ponchaillou
Rennes
1182.58.33015 Hôpital Civil
Strasbourg
1182.58.33025 Hôpital Foch
Suresnes
1182.58.33021 Hôpital Chalucet
Toulon
1182.58.33002 Hôpital Purpan
Toulouse
1182.58.33016
Tourcoing
1182.58.33010 Hôpital Brabois
Vandœuvre-lès-Nancy
1182.58.33011 Hôpital Paul Brousse
Villejuif

Other trials in France

Australia25 sites

1182.58.61020
Adelaide, South Australia
1182.58.61015 Flinders Medical Centre
Bedford Park, South Australia
1182.58.61010 Biala Building
Brisbane, Queensland
1182.58.61005 Royal Prince Alfred Hospital
Camperdown, New South Wales
1182.58.61001 88 Rathdowne Street Carlton
Carlton, Victoria
1182.58.61018 Melbourne Sexual Health Clinic
Carlton, Victoria
1182.58.61017 Department of Infectious Diseases
Clayton, Victoria
1182.58.61008 St Vincents Hospital
Darlinghurst, New South Wales
1182.58.61011 St Vincents Hospital
Darlinghurst, New South Wales
1182.58.61014 St Vincents Hospital
Darlinghurst, New South Wales
1182.58.61007 407 Doctors Pty Ltd
Darlinghusrst, New South Wales
1182.58.61019 407 Bouke Street
Darlinghusrst, New South Wales
1182.58.61009 Level 6
Herston, Queensland
1182.58.61022 Sexual Health Clinic
Kingswood, New South Wales
1182.58.61012 Bigge Park Centre
Liverpool, New South Wales
1182.58.61013 Melbourne Sexual Health Clinic
Melbourne, Victoria
1182.58.61023
Melbourne, Victoria
1182.58.61024
Nambour, Queensland
1182.58.61004 Royal Perth Hospital
Perth, Western Australia
1182.58.61003 The Prince of Wales Hospital
Randwick, New South Wales
1182.58.61021
South Yarra, Victoria
1182.58.61002 Royal North Shore Hospital
St Leonards, New South Wales
1182.58.61006 Albion Street Clinic
Surry Hills, New South Wales
1182.58.61025 Immunology Department
Westmead, New South Wales
1182.58.61016 Princess Alexandra Hospital
Woolloongabba, Queensland

Other trials in Australia

United Kingdom22 sites

1182.58.44020 Beckenham Hospital
Beckenham
1182.58.44004 Boehringer Ingelheim Investigational Site
Brighton
1182.58.44002 Boehringer Ingelheim Investigational Site
Cardiff
1182.58.44025 Boehringer Ingelheim Investigational Site
Chertsey
1182.58.44019 Boehringer Ingelheim Investigational Site
Chichester
1182.58.44009 Boehringer Ingelheim Investigational Site
Edinburgh
1182.58.44023 Boehringer Ingelheim Investigational Site
Harrow
1182.58.44024 Boehringer Ingelheim Investigational Site
Leeds
1182.58.44003 Boehringer Ingelheim Investigational Site
London
1182.58.44005 Boehringer Ingelheim Investigational Site
London
1182.58.44008 Boehringer Ingelheim Investigational Site
London
1182.58.44010 Boehringer Ingelheim Investigational Site
London
1182.58.44014 Boehringer Ingelheim Investigational Site
London
1182.58.44017 Boehringer Ingelheim Investigational Site
London
1182.58.44018 Boehringer Ingelheim Investigational Site
London
1182.58.44026 Boehringer Ingelheim Investigational Site
London
1182.58.44027 Boehringer Ingelheim Investigational Site
London
1182.58.44028 Boehringer Ingelheim Investigational Site
London
1182.58.44031 Boehringer Ingelheim Investigational Site
London
1182.58.44011 Boehringer Ingelheim Investigational Site
Peterborough
1182.58.44022 Boehringer Ingelheim Investigational Site
Woolwich
1182.58.44030 Boehringer Ingelheim Investigational Site
Woolwich

Other trials in United Kingdom

Italy8 sites

1182.58.3903 Università di Brescia
Brescia
1182.58.3904 Ospedali Riuniti di Foggia
Foggia
1182.58.3901 Ospedale Luigi Sacco
Milan
1182.58.3902 Ospedale L. Sacco
Milan
1182.58.3907 Presidio Ospedaliero di Rimini
Rimini
1182.58.3905 Presidio Dalmati
S. Angelo Lodigiano (lo)
1182.58.3906 Ospedale Infantile Regina Margherita
Torino
1182.58.3908 Centro Medicina Preventiva
Verona

Other trials in Italy

Switzerland6 sites

1182.58.4101 Boehringer Ingelheim Investigational Site
Basel
1182.58.4103 Boehringer Ingelheim Investigational Site
Bern
1182.58.4104 Boehringer Ingelheim Investigational Site
Geneva
1182.58.4107 Boehringer Ingelheim Investigational Site
Geneva
1182.58.4102 Boehringer Ingelheim Investigational Site
Zurich
1182.58.4105 Boehringer Ingelheim Investigational Site
Zurich

Other trials in Switzerland

South Africa5 sites

1182.58.27095 Boehringer Ingelheim Investigational Site
Cape Town
1182.58.27098 Boehringer Ingelheim Investigational Site
Cape Town
1182.58.27099 Boehringer Ingelheim Investigational Site
Cape Town
1182.58.27096 Boehringer Ingelheim Investigational Site
Durban
1182.58.27097 Boehringer Ingelheim Investigational Site
Westville, Durban

Other trials in South Africa

Belgium4 sites

1182.58.3201 Boehringer Ingelheim Investigational Site
Antwerp
1182.58.3202 Boehringer Ingelheim Investigational Site
Brussels
1182.58.3203 Boehringer Ingelheim Investigational Site
Brussels
1182.58.3204 Boehringer Ingelheim Investigational Site
Liège

Other trials in Belgium

Denmark3 sites

1182.58.4505 Aarhus Universitetshospital Skejby
Aarhus C
1182.58.4501 Rigshospitalet
København Ø
1182.58.4504 Odense Universitetshospital
Odense C

Other trials in Denmark

Ireland2 sites

1182.58.44016 St James Hospital, Dept of Genito Urinary Medicine
Dublin
1182.58.44029 Our Lady For Sick Children
Dublin

Other trials in Ireland

Greece1 site

1182.58.3001
Athens

Other trials in Greece

Portugal1 site

1182.58.35102 Hospital Condes Castro Guimarães
Cascais

Other trials in Portugal

About this study

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

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
Tipranavir 250 mg soft elastic capsules

Timeline

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

May 2003Apr 2014

First posted12 Jun 2003 (estimated)
Study startMay 2003
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: NCT00062660
Sponsor's protocol ID: 1182.58
Status last verified: Jul 2014
First submitted: 10 Jun 2003
Last updated: 30 Nov 2016
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
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Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00062660
Acronym / sponsor ID: 1182.58
Conditions: HIV Infections
Study type: Expanded access
Recruitment status: Approved For Marketing
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: May 2003
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 12 Jun 2003 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TipranavirTipranavir 250 mg soft elastic capsules	Drug	–

Primary outcome

Not reported in the source record.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

146 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tipranavir in people with HIV Infections, run by Boehringer Ingelheim at 146 sites in 12 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 1 inclusion and 0 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 146 sites in United States, France, Australia, United Kingdom, Italy and 7 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 NCT00062660.

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.