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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00062660




Registration number
NCT00062660
Ethics application status
Date submitted
10/06/2003
Date registered
12/06/2003
Date last updated
30/11/2016

Titles & IDs
Public title
Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection
Scientific 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
Secondary ID [1] 0 0
1182.58
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - Tipranavir

Treatment: Drugs: Tipranavir
Tipranavir 250 mg soft elastic capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion 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.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
APPROVED_FOR_MARKETING
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2014
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
1182.58.61005 Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
1182.58.61008 St Vincents Hospital - Darlinghurst
Recruitment hospital [3] 0 0
1182.58.61011 St Vincents Hospital - Darlinghurst
Recruitment hospital [4] 0 0
1182.58.61014 St Vincents Hospital - Darlinghurst
Recruitment hospital [5] 0 0
1182.58.61007 407 Doctors Pty Ltd - Darlinghusrst
Recruitment hospital [6] 0 0
1182.58.61019 407 Bouke Street - Darlinghusrst
Recruitment hospital [7] 0 0
1182.58.61022 Sexual Health Clinic - Kingswood
Recruitment hospital [8] 0 0
1182.58.61012 Bigge Park Centre - Liverpool
Recruitment hospital [9] 0 0
1182.58.61003 The Prince of Wales Hospital - Randwick
Recruitment hospital [10] 0 0
1182.58.61002 Royal North Shore Hospital - St Leonards
Recruitment hospital [11] 0 0
1182.58.61006 Albion Street Clinic - Surry Hills
Recruitment hospital [12] 0 0
1182.58.61025 Immunology Department - Westmead
Recruitment hospital [13] 0 0
1182.58.61010 Biala Building - Brisbane
Recruitment hospital [14] 0 0
1182.58.61009 Level 6 - Herston
Recruitment hospital [15] 0 0
1182.58.61024 - Nambour
Recruitment hospital [16] 0 0
1182.58.61016 Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [17] 0 0
1182.58.61020 - Adelaide
Recruitment hospital [18] 0 0
1182.58.61015 Flinders Medical Centre - Bedford Park
Recruitment hospital [19] 0 0
1182.58.61001 88 Rathdowne Street Carlton - Carlton
Recruitment hospital [20] 0 0
1182.58.61018 Melbourne Sexual Health Clinic - Carlton
Recruitment hospital [21] 0 0
1182.58.61017 Department of Infectious Diseases - Clayton
Recruitment hospital [22] 0 0
1182.58.61013 Melbourne Sexual Health Clinic - Melbourne
Recruitment hospital [23] 0 0
1182.58.61023 - Melbourne
Recruitment hospital [24] 0 0
1182.58.61021 - South Yarra
Recruitment hospital [25] 0 0
1182.58.61004 Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Darlinghusrst
Recruitment postcode(s) [4] 0 0
- Kingswood
Recruitment postcode(s) [5] 0 0
- Liverpool
Recruitment postcode(s) [6] 0 0
- Randwick
Recruitment postcode(s) [7] 0 0
- St Leonards
Recruitment postcode(s) [8] 0 0
- Surry Hills
Recruitment postcode(s) [9] 0 0
- Westmead
Recruitment postcode(s) [10] 0 0
- Brisbane
Recruitment postcode(s) [11] 0 0
- Herston
Recruitment postcode(s) [12] 0 0
- Nambour
Recruitment postcode(s) [13] 0 0
- Woolloongabba
Recruitment postcode(s) [14] 0 0
- Adelaide
Recruitment postcode(s) [15] 0 0
- Bedford Park
Recruitment postcode(s) [16] 0 0
- Carlton
Recruitment postcode(s) [17] 0 0
- Clayton
Recruitment postcode(s) [18] 0 0
- Melbourne
Recruitment postcode(s) [19] 0 0
- South Yarra
Recruitment postcode(s) [20] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
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Georgia
Country [7] 0 0
United States of America
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Hawaii
Country [8] 0 0
United States of America
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Illinois
Country [9] 0 0
United States of America
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Louisiana
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United States of America
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Massachusetts
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Michigan
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Missouri
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Nevada
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United States of America
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New York
Country [15] 0 0
United States of America
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North Carolina
Country [16] 0 0
United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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United States of America
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Washington
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United States of America
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Wisconsin
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Belgium
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Antwerpen
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Belgium
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Bruxelles
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Belgium
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Liège
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Denmark
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Aarhus C
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Denmark
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København Ø
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Denmark
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Odense C
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France
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Aix en Provence cedex 1
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France
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Besançon cedex
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France
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Bobigny cedex
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Garches
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Lyon cedex 2
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Lyon cedex 3
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France
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Marseille cedex 5
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Mulhouse cedex 1
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France
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Paris cedex 20
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Paris
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Reims cedex
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Rennes cedex 9
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Toulon cedex
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Toulouse cedex 9
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Tourcoing
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Vandoeuvre Les Nancy
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Villejuif cedex
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Greece
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Athens
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Ireland
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Dublin 12
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Ireland
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Dublin
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Italy
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Brescia
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Italy
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Foggia
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Italy
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Milano
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Italy
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Rimini
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Italy
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S. Angelo Lodigiano (lo)
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Italy
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Torino
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Italy
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Verona
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Portugal
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Cascais
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Westville, Durban
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Genève
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Switzerland
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Zürich
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United Kingdom
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Beckenham
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United Kingdom
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Brighton
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Cardiff
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Chertsey
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Chichester
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United Kingdom
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Edinburgh
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United Kingdom
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Harrow
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Peterborough
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Woolwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00062660
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00062660