Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - tipranavir
Treatment: Drugs - ritonavir
Treatment: Drugs - saquinavir
Treatment: Drugs - amprenavir
Treatment: Drugs - lopinavir

Treatment: Drugs: tipranavir


Treatment: Drugs: ritonavir


Treatment: Drugs: saquinavir


Treatment: Drugs: amprenavir


Treatment: Drugs: lopinavir
Intervention code [1] 0 0
Treatment: Drugs
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
Country [4] 0 0
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
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
New Mexico
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Belgium
State/province [17] 0 0
Antwerpen
Country [18] 0 0
Belgium
State/province [18] 0 0
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
State/province [22] 0 0
Hvidovre
Country [23] 0 0
Denmark
State/province [23] 0 0
København Ø
Country [24] 0 0
Denmark
State/province [24] 0 0
Odense C
Country [25] 0 0
France
State/province [25] 0 0
Bordeaux cedex
Country [26] 0 0
France
State/province [26] 0 0
Caen
Country [27] 0 0
France
State/province [27] 0 0
Clamart
Country [28] 0 0
France
State/province [28] 0 0
Lyon Cedex 2
Country [29] 0 0
France
State/province [29] 0 0
Nantes
Country [30] 0 0
France
State/province [30] 0 0
Nice cedex 3
Country [31] 0 0
France
State/province [31] 0 0
Paris cedex 18
Country [32] 0 0
France
State/province [32] 0 0
Paris
Country [33] 0 0
France
State/province [33] 0 0
Rennes cedex 9
Country [34] 0 0
France
State/province [34] 0 0
Strasbourg
Country [35] 0 0
France
State/province [35] 0 0
Vandoeuvre les nancy
Country [36] 0 0
France
State/province [36] 0 0
Villejuif
Country [37] 0 0
Germany
State/province [37] 0 0
Aachen
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Bonn
Country [40] 0 0
Germany
State/province [40] 0 0
Düsseldorf
Country [41] 0 0
Germany
State/province [41] 0 0
Erlangen
Country [42] 0 0
Germany
State/province [42] 0 0
Essen
Country [43] 0 0
Germany
State/province [43] 0 0
Frankfurt/Main
Country [44] 0 0
Germany
State/province [44] 0 0
Freiburg
Country [45] 0 0
Germany
State/province [45] 0 0
Hamburg
Country [46] 0 0
Germany
State/province [46] 0 0
Hannover
Country [47] 0 0
Germany
State/province [47] 0 0
Heidelberg
Country [48] 0 0
Germany
State/province [48] 0 0
Köln
Country [49] 0 0
Germany
State/province [49] 0 0
Mannheim
Country [50] 0 0
Germany
State/province [50] 0 0
München
Country [51] 0 0
Germany
State/province [51] 0 0
Osnabrück
Country [52] 0 0
Germany
State/province [52] 0 0
Stuttgart
Country [53] 0 0
Greece
State/province [53] 0 0
Athens
Country [54] 0 0
Greece
State/province [54] 0 0
Patras
Country [55] 0 0
Greece
State/province [55] 0 0
Piraeus
Country [56] 0 0
Greece
State/province [56] 0 0
Thessaloniki
Country [57] 0 0
Italy
State/province [57] 0 0
Milano
Country [58] 0 0
Italy
State/province [58] 0 0
Torino
Country [59] 0 0
Netherlands
State/province [59] 0 0
Amsterdam
Country [60] 0 0
Netherlands
State/province [60] 0 0
Den Haag
Country [61] 0 0
Netherlands
State/province [61] 0 0
Rotterdam
Country [62] 0 0
Portugal
State/province [62] 0 0
Cascais
Country [63] 0 0
Portugal
State/province [63] 0 0
Coimbra
Country [64] 0 0
Portugal
State/province [64] 0 0
Lisbon
Country [65] 0 0
Portugal
State/province [65] 0 0
Porto
Country [66] 0 0
Switzerland
State/province [66] 0 0
Basel
Country [67] 0 0
Switzerland
State/province [67] 0 0
St. Gallen
Country [68] 0 0
Switzerland
State/province [68] 0 0
Zürich
Country [69] 0 0
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/ct2/show/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/ct2/show/NCT00056641