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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00275444




Registration number
NCT00275444
Ethics application status
Date submitted
9/01/2006
Date registered
12/01/2006
Date last updated
1/12/2023

Titles & IDs
Public title
3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study
Scientific title
Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects
Secondary ID [1] 0 0
1182.52
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
Acquired immune deficiency syndrome (AIDS / HIV)

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

Treatment: Drugs: Tipranavir
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Virologic response after 2 weeks of functional monotherapy
Timepoint [1] 0 0
At week 2
Secondary outcome [1] 0 0
Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures.
Timepoint [1] 0 0
Up to 24 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

- Signed informed consent prior to trial participation.

- Human immunodeficiency virus 1 (HIV-1) infected males or females > 18 years of age.

- At least 3 months experience taking Nucleoside reverse transcriptase inhibitors
(NRTIs), Non-nucleoside reverse transcriptase inhibitor (NNRTIs), and Protease
inhibitors (PIs).

- Current PI-based Antiretroviral (ARV) medication regimen for at least 3 months prior
to randomization, and at least 3 months experience taking at least one other PI-based
regimen.

- HIV-1 viral load =1000 copies/mL at screening.

- Genotypic resistance report indicating one or more primary PI resistance mutation(s),
including 30N, 46I/L, 48V, 50V, 82A/F/T, 84V or 90M.

- Availability of 2 or more non-PI ARV medications by genotypic resistance testing, i.e.
2 drugs tested as "no evidence of resistance" or "possible resistance".

- Acceptable screening laboratory values that indicate adequate baseline organ function.

- Laboratory values are considered to be acceptable if severity is no higher than Grade
3 Gamma glutamyl transferase (GGT), Grade 2 cholesterol or triglycerides, and no
higher than Grade 1 for all other tests based on the "Division of Acquired Immune
Deficiency Syndrome" of National Institute of Health, USA - DAIDS - Grading Scale. All
laboratory values outside these limits are subject to approval by Boehringer Ingelheim
(BI).

- Further inclusion criteria apply.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- ARV medication naïve.

- Only one or no available ARV medications as determined by genotypic resistance
testing.

- Female subjects who:

- have a positive serum pregnancy test at screening or during the study;

- are breast feeding;

- are planning to become pregnant;

- are not willing to use two methods of contraception to include at least one
barrier method (e.g. latex condom plus spermicidal jelly/foam).

- Any active opportunistic infection within 60 days before study entry.

- Active Hepatitis B (HCB) or Hepatitis C (HCV) disease defined as HBsAg positive or HCV
RNA positive with Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) >
Grade 1.

- Prior tipranavir use.

- Use of investigational medications within 30 days before study entry or during the
trial.Some expanded access drugs may be acceptable; must be approved by BI. Tenofovir,
investigational at time of preparation of this protocol, is acceptable.

- Use of concomitant drugs which may significantly reduce plasma levels of the study
medications.

- Further exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
216
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Boehringer Ingelheim Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment postcode(s) [1] 0 0
- Darlinghurst
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
State/province [2] 0 0
California
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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South Carolina
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United States of America
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Texas
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United States of America
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Virginia
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Canada
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Ontario
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Canada
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Quebec
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France
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Le Kremlin Bicêtre cedex
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France
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Montpellier cedex 5
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France
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Nantes cedex 1
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France
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Paris cedex 10
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France
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Paris cedex 13
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France
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Paris cedex 18
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Germany
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Berlin
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Germany
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Frankfurt/Main
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Germany
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Köln
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Germany
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München
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Italy
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Milano
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Italy
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Pavia
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Netherlands
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Amsterdam
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Netherlands
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Rotterdam
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Spain
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Barcelona
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Spain
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Madrid
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United Kingdom
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London

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

Ethics approval
Ethics application status

Summary
Brief summary
A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose
ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple
antiretroviral experienced patients and the dose that achieves the best efficacy and safety
as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and
laboratory profile measures would be selected for further clinical study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00275444
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim Study Coordinator
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/ct2/show/NCT00275444