Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00056641
- Lead Sponsor
- Boehringer Ingelheim
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 328
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change of the 2nd Protease Inhibitor (PI) (APV, LPV. SQV) mean concentration (C12h) Day 14 to Day 28 Occurrence of adverse events; Proportion of patients with laboratory abnormalities; Proportion of patients with SAEs week 4
- Secondary Outcome Measures
Name Time Method Change in viral load; Proportion of virologic responders week 2, 4, 8, 16 and 24 Mean concentration (C12h) of TPV (TPV/r group); Mean concentration (C12h) of RTV (TPV/r group) Week 1 and 2 Assessment of patient adherence Week 1 to 4 Mean concentration (C12h) of TPV (PI/TPV/r group); Mean concentration (C12h) of RTV (PI/TPV/r group) Week 3 and 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 week 4 AUC(0-12h) of RTV; Cmax of RTV; C12h of RTV 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 week 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) week 2 and 4
Trial Locations
- Locations (81)
UT Southwestern
🇺🇸Dallas, Texas, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Boehringer Ingelheim Investigational Site
🇩🇪Stuttgart, Germany
North Broward Hospital District
🇺🇸Fort Lauderdale, Florida, United States
Mercer University School of Medicine
🇺🇸Macon, Georgia, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of New York, Stony Brook
🇺🇸Stony Brook, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
St. Vincent's Hospital
🇦🇺Darlinghurst, New South Wales, Australia
McMaster University Medical Centre
🇨🇦Hamilton, Ontario, Canada
Montreal Chest Institute - McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre, Suite A5-140
🇨🇦Monteal, Quebec, Canada
Odense Universitetshospital
🇩🇰Odense C, Denmark
Hôpital Pellegrin
🇫🇷Bordeaux cedex, France
Hôpital Côte de Nacre
🇫🇷Caen, France
Hôpital Antoine Beclère
🇫🇷Clamart, France
Hôpital de l'Hôtel Dieu
🇫🇷Lyon Cedex 2, France
Hôpital de l'Archet
🇫🇷Nice cedex 3, France
Hôpital Hôtel Dieu
🇫🇷Nantes, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Hôpital Bichat Claude Bernard
🇫🇷Paris cedex 18, France
Hôpital Saint Antoine
🇫🇷Paris, France
Hôpital de la Pité Salpêtrière
🇫🇷Paris, France
Hôpital de Pontchaillou
🇫🇷Rennes cedex 9, France
Hôpital civil
🇫🇷Strasbourg, France
Hôpital brabois
🇫🇷Vandoeuvre les nancy, France
Universitätsklinikum Charité
🇩🇪Berlin, Germany
Hôpital Paul Brousse
🇫🇷Villejuif, France
Epimed GmbH
🇩🇪Berlin, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Klinikum der Johann Wolfgang Goethe-Universität
🇩🇪Frankfurt/Main, Germany
Medizinische Universitätsklinik Bonn
🇩🇪Bonn, Germany
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Universitätsklinik Erlangen-Nürnberg
🇩🇪Erlangen, Germany
ifi Institut für interdisziplinäre Infektiologie
🇩🇪Hamburg, Germany
Universitätsklinkum Freiburg
🇩🇪Freiburg, Germany
Universitätsklinik Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Med. Hochschule Hannover
🇩🇪Hannover, Germany
General Hospital "G. Gennimatas"
🇬🇷Athens, Greece
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Klinik I für Innere Medizin der
🇩🇪Köln, Germany
Facharzt für Innere Medizin,
🇩🇪Mannheim, Germany
Medizinische Poliklinik
🇩🇪München, Germany
Klinium Natruper Holz
🇩🇪Osnabrück, Germany
1st Social Insurance Foundation (IKA) Pentelis
🇬🇷Athens, Greece
Andreas Syggros Hosp.
🇬🇷Athens, Greece
University Hospital of Patras
🇬🇷Patras, Greece
Sismanoglio Hospital
🇬🇷Athens, Greece
Fondazione S. Raffaele del Monte Tabor
🇮🇹Milano, Italy
"Tzanio" Hospital
🇬🇷Piraeus, Greece
Medical Centre Haaglanden
🇳🇱Den Haag, Netherlands
Ospedale Amedeo di Savoia
🇮🇹Torino, Italy
Slotervaart Hospital
🇳🇱Amsterdam, Netherlands
Hospitais da Universidade de Coimbra
🇵🇹Coimbra, Portugal
Hospital Condes Castro Guimarães
🇵🇹Cascais, Portugal
Hospital de São João
🇵🇹Porto, Portugal
Universitätsspital Basel
🇨🇭Basel, Switzerland
Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland
Universitätsspital Zürich
🇨🇭Zürich, Switzerland
Royal Free Hospital
🇬🇧London, United Kingdom
SSAT/Crusaid Institute
🇬🇧London, United Kingdom
St Mary's Hospital
🇬🇧London, United Kingdom
U.Z. Gent
🇧🇪Gent, Belgium
AHEPA Hospital
🇬🇷Thessaloniki, Greece
Erasmus Medical Centre
🇳🇱Rotterdam, Netherlands
Instituut Tropische Geneeskunde
🇧🇪Antwerpen, Belgium
OLVG
🇳🇱Amsterdam, Netherlands
Evangelismos Hospital
🇬🇷Athens, Greece
Korgialenio-Benakio-Hellenic Red Cross General Hospital
🇬🇷Athens, Greece
Washington DC VA Medical Center
🇺🇸Washington, District of Columbia, United States
Centre Hospitalier Universitaire St. Pierre
🇧🇪Bruxelles, Belgium
Department of Infeccious Diseases
🇵🇹Lisbon, Portugal
Albany Medical College
🇺🇸Albany, New York, United States
Kaiser Permanente Medical Center
🇺🇸San Francisco, California, United States
San Francisco VAMC
🇺🇸San Francisco, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Rigshospitalet
🇩🇰København Ø, Denmark
Canadian Immunodeficiency Research Collaborative Inc.
🇨🇦Toronto, Ontario, Canada