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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00056641




Registration number
NCT00056641
Ethics application status
Date submitted
19/03/2003
Date registered
21/03/2003
Date last updated
1/12/2023

Titles & IDs
Public title
Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients
Scientific title
An Open Label, Randomized, Parallel-group Pharmacokinetics Trial of Tipranavir / Ritonavir (TPV/RTV), Alone or in Combination With RTV-boosted Saquinavir (SQV), Amprenavir (APV), or Lopinavir (LPV), Plus an Optimized Background Regimen, in Multiple Antiretroviral (ARV) Experienced Patients.
Secondary ID [1] 0 0
1182.51
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h)
Timepoint [1] 0 0
Day 14 to Day 28
Primary outcome [2] 0 0
Occurrence of adverse events; Proportion of patients with laboratory abnormalities; Proportion of patients with SAEs
Timepoint [2] 0 0
week 4
Secondary outcome [1] 0 0
Mean concentration (C12h) of TPV (TPV/r group); Mean concentration (C12h) of RTV (TPV/r group)
Timepoint [1] 0 0
Week 1 and 2
Secondary outcome [2] 0 0
Mean concentration (C12h) of TPV (PI/TPV/r group); Mean concentration (C12h) of RTV (PI/TPV/r group)
Timepoint [2] 0 0
Week 3 and 4
Secondary outcome [3] 0 0
Assessment of patient adherence
Timepoint [3] 0 0
Week 1 to 4
Secondary outcome [4] 0 0
Area under the Curve (AUC(0-12h)) of the 2nd PI (APV, LPV. SQV); Maximum concentration (Cmax) of the 2nd PI (APV, LPV. SQV); Concentration (C12h) of the 2nd PI (APV, LPV. SQV)
Timepoint [4] 0 0
week 2 and 4
Secondary outcome [5] 0 0
Change in AUC(0-12h) of TPV from week 2; Change in Cmax of TPV from week 2; Change in C12h of TPV from week 2
Timepoint [5] 0 0
week 4
Secondary outcome [6] 0 0
Change in AUC(0-12h) of RTV from week 2; Change in Cmax of RTV from week 2; Change in C12h of RTV from week 2
Timepoint [6] 0 0
week 4
Secondary outcome [7] 0 0
AUC(0-12h) of RTV; Cmax of RTV; C12h of RTV
Timepoint [7] 0 0
week 2 and 4
Secondary outcome [8] 0 0
Change in viral load; Proportion of virologic responders
Timepoint [8] 0 0
week 2, 4, 8, 16 and 24

Eligibility
Key inclusion criteria
Inclusion criteria:

* Signed informed consent prior to trial participation.
* Human Immunodeficiency Virus type 1 (HIV-1) infected males or females =18 years of age.
* Acceptable laboratory screening values in Trial 1182.12 (RESIST 1) or 1182.48 (RESIST 2), excluding genotype.
* Genotypic resistance report from screening visit of study RESIST 1 or RESIST 2 indicating at least three mutations at protease codons 33, 82, 84, and 90.
* At least 3 consecutive months experience taking ARVs from each of the classes of Nucleoside reverse transcriptase inhibitors (NRTI), Non-nucleoside reverse transcriptase inhibitor 1 (NNRTI), and Protease Inhibitor (PI) at some point in treatment history, with at least 2 PI-based regimens, one of which must be part of the current regimen, and current PI-based Anti-retroviral (ARV) medication regimen for at least 3 months prior to randomization.
* HIV-1 viral load =1000 copies/mL at screening.
* 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:

* Anti-retroviral (ARV) medication naïve.
* Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the last 3 months.
* Female patients of child-bearing potential 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 a use barrier method of contraception, or
* require ethinyl estradiol administration.
* Prior tipranavir use.
* Use of investigational medications within 30 days before study entry or during the trial.
* Further exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not 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
18/02/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
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United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
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Kentucky
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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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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United States of America
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Washington
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Belgium
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Antwerpen
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Belgium
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Bruxelles
Country [19] 0 0
Belgium
State/province [19] 0 0
Gent
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Denmark
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Hvidovre
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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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Bordeaux cedex
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France
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Caen
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France
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Clamart
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France
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Lyon Cedex 2
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France
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Nantes
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France
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Nice cedex 3
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France
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Paris cedex 18
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France
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Paris
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France
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Rennes cedex 9
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France
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Strasbourg
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France
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Vandoeuvre les nancy
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France
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Villejuif
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Düsseldorf
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Frankfurt/Main
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Köln
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Germany
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Mannheim
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Germany
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München
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Germany
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Osnabrück
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Germany
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Stuttgart
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Greece
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Athens
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Greece
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Patras
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Greece
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Piraeus
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Greece
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Thessaloniki
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Italy
State/province [57] 0 0
Milano
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Italy
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Torino
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Netherlands
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Amsterdam
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Netherlands
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Den Haag
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Netherlands
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Rotterdam
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Portugal
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Cascais
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Portugal
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Coimbra
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Portugal
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Lisbon
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Portugal
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Porto
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Switzerland
State/province [66] 0 0
Basel
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Switzerland
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St. Gallen
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Switzerland
State/province [68] 0 0
Zürich
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United Kingdom
State/province [69] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients.

The primary objective is to determine the safety and pharmacokinetics of:

TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).
Trial website
https://clinicaltrials.gov/study/NCT00056641
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/study/NCT00056641