HIV InfectionsPhase 2NCT00056641
Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients
A Phase 2 study testing tipranavir, ritonavir and saquinavir in people with HIV Infections, run by Boehringer Ingelheim at 109 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- tipranavir, ritonavir and saquinavir
- How many people
- 328 participants
- Where
- 109 sitesin 13 countries
- Study dates
- 18 Feb 2003to 27 Jan 2004
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
109 sites in 13 countries.
109 sites in 13 countries
United States34 sites
Albany Medical College
Albany, New York
Boehringer Ingelheim Investigational Site
Annandale, Virginia
Boehringer Ingelheim Investigational Site
Atlanta, Georgia
Boehringer Ingelheim Investigational Site
Berkeley, California
Boehringer Ingelheim Investigational Site
Boston, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts
UT Southwestern
Dallas, Texas
Henry Ford Hospital
Detroit, Michigan
Duke University Medical Center
Durham, North Carolina
North Broward Hospital District
Fort Lauderdale, Florida
Boehringer Ingelheim Investigational Site
Fort Myers, Florida
Boehringer Ingelheim Investigational Site
Fountain Valley, California
Boehringer Ingelheim Investigational Site
Houston, Texas
Boehringer Ingelheim Investigational Site
Huntersville, North Carolina
University of Kentucky Medical Center
Lexington, Kentucky
Boehringer Ingelheim Investigational Site
Los Angeles, California
Mercer University School of Medicine
Macon, Georgia
Boehringer Ingelheim Investigational Site
Miami, Florida
Boehringer Ingelheim Investigational Site
New York, New York
Boehringer Ingelheim Investigational Site
Norwalk, Connecticut
Boehringer Ingelheim Investigational Site
Orlando, Florida
University of Pennsylvania
Philadelphia, Pennsylvania
Boehringer Ingelheim Investigational Site
Phoenix, Arizona
Boehringer Ingelheim Investigational Site
San Francisco, California
Kaiser Permanente Medical Center
San Francisco, California
San Francisco VAMC
San Francisco, California
Boehringer Ingelheim Investigational Site
Santa Fe, New Mexico
Boehringer Ingelheim Investigational Site
Sarasota, Florida
Boehringer Ingelheim Investigational Site
Springfield, Massachusetts
University of New York, Stony Brook
Stony Brook, New York
Boehringer Ingelheim Investigational Site
Tacoma, Washington
Boehringer Ingelheim Investigational Site
Tampa, Florida
Boehringer Ingelheim Investigational Site
Vero Beach, Florida
Washington DC VA Medical Center
Washington D.C., District of Columbia
Germany21 sites
Boehringer Ingelheim Investigational Site
Aachen
Epimed GmbH
Berlin
Universitätsklinikum Charité
Berlin
Medizinische Universitätsklinik Bonn
Bonn
Klinik I für Innere Medizin der
Cologne
Boehringer Ingelheim Investigational Site
Düsseldorf
Universitätsklinikum Düsseldorf
Düsseldorf
Universitätsklinik Erlangen-Nürnberg
Erlangen
Universitätsklinikum Essen
Essen
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt am Main
Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
Universitätsklinkum Freiburg
Freiburg im Breisgau
ifi Institut für interdisziplinäre Infektiologie
Hamburg
Universitätsklinik Hamburg-Eppendorf
Hamburg
Med. Hochschule Hannover
Hanover
Universitätsklinikum Heidelberg
Heidelberg
Facharzt für Innere Medizin,
Mannheim
Boehringer Ingelheim Investigational Site
München
Medizinische Poliklinik
München
Klinium Natruper Holz
Osnabrück
Boehringer Ingelheim Investigational Site
Stuttgart
France14 sites
Hôpital Pellegrin
Bordeaux
Hôpital Côte de Nacre
Caen
Hôpital Antoine Beclère
Clamart
Hôpital de l'Hôtel Dieu
Lyon
Hôpital Hôtel Dieu
Nantes
Hôpital de l'Archet
Nice
Hôpital Bichat Claude Bernard
Paris
Hôpital de la Pité Salpêtrière
Paris
Hôpital Européen Georges Pompidou
Paris
Hôpital Saint Antoine
Paris
Hôpital de Pontchaillou
Rennes
Hôpital civil
Strasbourg
Hôpital brabois
Vandœuvre-lès-Nancy
Hôpital Paul Brousse
Villejuif
Greece9 sites
1st Social Insurance Foundation (IKA) Pentelis
Athens
Andreas Syggros Hosp.
Athens
Evangelismos Hospital
Athens
General Hospital "G. Gennimatas"
Athens
Korgialenio-Benakio-Hellenic Red Cross General Hospital
Athens
Sismanoglio Hospital
Athens
University Hospital of Patras
Pátrai
"Tzanio" Hospital
Piraeus
AHEPA Hospital
Thessaloniki
Canada7 sites
McMaster University Medical Centre
Hamilton, Ontario
McGill University Health Centre, Suite A5-140
Monteal, Quebec
Boehringer Ingelheim Investigational Site
Montreal, Quebec
Montreal Chest Institute - McGill University Health Centre
Montreal, Quebec
Boehringer Ingelheim Investigational Site
Toronto, Ontario
Canadian Immunodeficiency Research Collaborative Inc.
Toronto, Ontario
Toronto General Hospital
Toronto, Ontario
Netherlands4 sites
OLVG
Amsterdam
Slotervaart Hospital
Amsterdam
Erasmus Medical Centre
Rotterdam
Medical Centre Haaglanden
The Hague
Portugal4 sites
Hospital Condes Castro Guimarães
Cascais
Hospitais da Universidade de Coimbra
Coimbra
Department of Infeccious Diseases
Lisbon
Hospital de São João
Porto
Belgium3 sites
Instituut Tropische Geneeskunde
Antwerp
Centre Hospitalier Universitaire St. Pierre
Brussels
U.Z. Gent
Ghent
Denmark3 sites
Hvidovre Hospital
Hvidovre
Rigshospitalet
København Ø
Odense Universitetshospital
Odense C
Switzerland3 sites
Universitätsspital Basel
Basel
Kantonsspital St. Gallen
Sankt Gallen
Universitätsspital Zürich
Zurich
United Kingdom3 sites
Royal Free Hospital
London
SSAT/Crusaid Institute
London
St Mary's Hospital
London
Australia2 sites
Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales
St. Vincent's Hospital
Darlinghurst, New South Wales
Italy2 sites
Fondazione S. Raffaele del Monte Tabor
Milan
Ospedale Amedeo di Savoia
Torino
About this study
Official 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.
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).
- Conditions
- HIV Infections
- Being tested
- tipranavir, ritonavir, saquinavir, amprenavir, lopinavir
- 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
ritonavirDrug
saquinavirDrug
amprenavirDrug
lopinavirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h)
Measured: Day 14 to Day 28
Occurrence of adverse events; Proportion of patients with laboratory abnormalities; Proportion of patients with SAEs
Measured: week 4
Secondary outcomes (8)
Mean concentration (C12h) of TPV (TPV/r group); Mean concentration (C12h) of RTV (TPV/r group)
Measured: Week 1 and 2
Mean concentration (C12h) of TPV (PI/TPV/r group); Mean concentration (C12h) of RTV (PI/TPV/r group)
Measured: Week 3 and 4
Assessment of patient adherence
Measured: Week 1 to 4
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)
Measured: week 2 and 4
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
Measured: week 4
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
Measured: week 4
AUC(0-12h) of RTV; Cmax of RTV; C12h of RTV
Measured: week 2 and 4
Change in viral load; Proportion of virologic responders
Measured: week 2, 4, 8, 16 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2003 (estimated)
- Study start18 Feb 2003
- Primary completion27 Jan 2004
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 328 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056641
- Sponsor's protocol ID
- 1182.51
- Status last verified
- Nov 2023
- First submitted
- 19 Mar 2003
- Last updated
- 1 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00056641
- Acronym / sponsor ID
- 1182.51
- Conditions
- HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2003 (actual)
- Primary completion
- 27 Jan 2004 (actual)
- First posted
- 21 Mar 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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:
- Prior tipranavir use.
- Use of investigational medications within 30 days before study entry or during the trial.
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 |
|---|---|---|
| tipranavir | Drug | – |
| ritonavir | Drug | – |
| saquinavir | Drug | – |
| amprenavir | Drug | – |
| lopinavir | Drug | – |
Primary outcome
Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h)
Time frame: Day 14 to Day 28
Occurrence of adverse events; Proportion of patients with laboratory abnormalities; Proportion of patients with SAEs
Time frame: week 4
8 secondary outcomes
Mean concentration (C12h) of TPV (TPV/r group); Mean concentration (C12h) of RTV (TPV/r group)
Time frame: Week 1 and 2
Mean concentration (C12h) of TPV (PI/TPV/r group); Mean concentration (C12h) of RTV (PI/TPV/r group)
Time frame: Week 3 and 4
Assessment of patient adherence
Time frame: Week 1 to 4
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)
Time frame: week 2 and 4
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
Time frame: week 4
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
Time frame: week 4
AUC(0-12h) of RTV; Cmax of RTV; C12h of RTV
Time frame: week 2 and 4
Change in viral load; Proportion of virologic responders
Time frame: week 2, 4, 8, 16 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Related InfoLink provided by the sponsor.
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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 Coordinator study chair
Boehringer Ingelheim
109 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tipranavir, ritonavir and saquinavir in people with HIV Infections, run by Boehringer Ingelheim at 109 sites in 13 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 109 sites in United States, Germany, France, Greece, Canada and 8 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h) (time frame: Day 14 to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2023.