Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients
NCT ID: NCT00056641
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
328 participants
INTERVENTIONAL
2003-02-18
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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tipranavir
ritonavir
saquinavir
amprenavir
lopinavir
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
Boehringer Ingelheim Investigational Site
Berkeley, California, United States
Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
Boehringer Ingelheim Investigational Site
San Francisco, California, United States
Kaiser Permanente Medical Center
San Francisco, California, United States
San Francisco VAMC
San Francisco, California, United States
Boehringer Ingelheim Investigational Site
Norwalk, Connecticut, United States
Washington DC VA Medical Center
Washington D.C., District of Columbia, United States
North Broward Hospital District
Fort Lauderdale, Florida, United States
Boehringer Ingelheim Investigational Site
Fort Myers, Florida, United States
Boehringer Ingelheim Investigational Site
Miami, Florida, United States
Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
Boehringer Ingelheim Investigational Site
Sarasota, Florida, United States
Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
Boehringer Ingelheim Investigational Site
Vero Beach, Florida, United States
Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
Mercer University School of Medicine
Macon, Georgia, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Boehringer Ingelheim Investigational Site
Santa Fe, New Mexico, United States
Albany Medical College
Albany, New York, United States
Boehringer Ingelheim Investigational Site
New York, New York, United States
University of New York, Stony Brook
Stony Brook, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Boehringer Ingelheim Investigational Site
Huntersville, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UT Southwestern
Dallas, Texas, United States
Boehringer Ingelheim Investigational Site
Houston, Texas, United States
Boehringer Ingelheim Investigational Site
Annandale, Virginia, United States
Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales, Australia
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia
Instituut Tropische Geneeskunde
Antwerp, , Belgium
Centre Hospitalier Universitaire St. Pierre
Brussels, , Belgium
U.Z. Gent
Ghent, , Belgium
McMaster University Medical Centre
Hamilton, Ontario, Canada
Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canadian Immunodeficiency Research Collaborative Inc.
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
McGill University Health Centre, Suite A5-140
Monteal, Quebec, Canada
Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Montreal Chest Institute - McGill University Health Centre
Montreal, Quebec, Canada
Hvidovre Hospital
Hvidovre, , Denmark
Rigshospitalet
København Ø, , Denmark
Odense Universitetshospital
Odense C, , Denmark
Hôpital Pellegrin
Bordeaux, , France
Hôpital Côte de Nacre
Caen, , France
Hôpital Antoine Beclère
Clamart, , France
Hôpital de l'Hôtel Dieu
Lyon, , France
Hôpital Hôtel Dieu
Nantes, , France
Hôpital de l'Archet
Nice, , France
Hôpital Bichat Claude Bernard
Paris, , France
Hôpital de la Pité Salpêtrière
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Hôpital Saint Antoine
Paris, , France
Hôpital de Pontchaillou
Rennes, , France
Hôpital civil
Strasbourg, , France
Hôpital brabois
Vandœuvre-lès-Nancy, , France
Hôpital Paul Brousse
Villejuif, , France
Boehringer Ingelheim Investigational Site
Aachen, , Germany
Epimed GmbH
Berlin, , Germany
Universitätsklinikum Charité
Berlin, , Germany
Medizinische Universitätsklinik Bonn
Bonn, , Germany
Klinik I für Innere Medizin der
Cologne, , Germany
Boehringer Ingelheim Investigational Site
Düsseldorf, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Universitätsklinik Erlangen-Nürnberg
Erlangen, , Germany
Universitätsklinikum Essen
Essen, , Germany
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt am Main, , Germany
Boehringer Ingelheim Investigational Site
Freiburg im Breisgau, , Germany
Universitätsklinkum Freiburg
Freiburg im Breisgau, , Germany
ifi Institut für interdisziplinäre Infektiologie
Hamburg, , Germany
Universitätsklinik Hamburg-Eppendorf
Hamburg, , Germany
Med. Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Facharzt für Innere Medizin,
Mannheim, , Germany
Boehringer Ingelheim Investigational Site
München, , Germany
Medizinische Poliklinik
München, , Germany
Klinium Natruper Holz
Osnabrück, , Germany
Boehringer Ingelheim Investigational Site
Stuttgart, , Germany
1st Social Insurance Foundation (IKA) Pentelis
Athens, , Greece
Andreas Syggros Hosp.
Athens, , Greece
Evangelismos Hospital
Athens, , Greece
General Hospital "G. Gennimatas"
Athens, , Greece
Korgialenio-Benakio-Hellenic Red Cross General Hospital
Athens, , Greece
Sismanoglio Hospital
Athens, , Greece
University Hospital of Patras
Pátrai, , Greece
"Tzanio" Hospital
Piraeus, , Greece
AHEPA Hospital
Thessaloniki, , Greece
Fondazione S. Raffaele del Monte Tabor
Milan, , Italy
Ospedale Amedeo di Savoia
Torino, , Italy
OLVG
Amsterdam, , Netherlands
Slotervaart Hospital
Amsterdam, , Netherlands
Erasmus Medical Centre
Rotterdam, , Netherlands
Medical Centre Haaglanden
The Hague, , Netherlands
Hospital Condes Castro Guimarães
Cascais, , Portugal
Hospitais da Universidade de Coimbra
Coimbra, , Portugal
Department of Infeccious Diseases
Lisbon, , Portugal
Hospital de São João
Porto, , Portugal
Universitätsspital Basel
Basel, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Royal Free Hospital
London, , United Kingdom
SSAT/Crusaid Institute
London, , United Kingdom
St Mary's Hospital
London, , United Kingdom
Countries
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Other Identifiers
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1182.51
Identifier Type: -
Identifier Source: org_study_id