3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study
- Conditions
- HIV Infections
- Registration Number
- NCT00275444
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Virologic response after 2 weeks of functional monotherapy At week 2
- Secondary Outcome Measures
Name Time Method Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures. Up to 24 weeks
Trial Locations
- Locations (44)
Mercer University School of Medicine
馃嚭馃嚫Macon, Georgia, United States
John's Hopkins University
馃嚭馃嚫Baltimore, Maryland, United States
Rush-Presbytarian-St Luke's Medical Center
馃嚭馃嚫Chicago, Illinois, United States
Albany Medical College
馃嚭馃嚫Albany, New York, United States
Vincent Lombardi Cancer Center
馃嚭馃嚫Washington, District of Columbia, United States
University of Louisville
馃嚭馃嚫Louisville, Kentucky, United States
H么pital de Chauliac
馃嚝馃嚪Montpellier cedex 5, France
Therafirst Medical Center
馃嚭馃嚫Fort Lauderdale, Florida, United States
H么pital Bichat Claude Bernard
馃嚝馃嚪Paris cedex 18, France
Klinikum der J.-W.-Goethe-Universit盲t
馃嚛馃嚜Frankfurt/Main, Germany
Klinik I f眉r Innere Medizin der
馃嚛馃嚜K枚ln, Germany
Academisch Medisch Centrum
馃嚦馃嚤Amsterdam, Netherlands
Community Research Initiative of New England
馃嚭馃嚫Springfield, Massachusetts, United States
H么pital Saint Louis
馃嚝馃嚪Paris cedex 10, France
1501 N.W. 9th Ave
馃嚭馃嚫Miami, Florida, United States
ID Care
馃嚭馃嚫Hillsborough, New Jersey, United States
Washington University
馃嚭馃嚫Saint Louis, Missouri, United States
HIV Outpatient Program (H.O.P)
馃嚭馃嚫New Orleans, Louisiana, United States
Medizinische Poliklinik
馃嚛馃嚜M眉nchen, Germany
IRCCS Policlinico San Matteo
馃嚠馃嚬Pavia, Italy
Hospital Cl铆nico y Provincial de Barcelona - HIV
馃嚜馃嚫Barcelona, Spain
Hospital Ram贸n y Cajal.
馃嚜馃嚫Madrid, Spain
4th Floor Research Office (St Stephens Centre)
馃嚞馃嚙London, United Kingdom
Hospital La Paz.
馃嚜馃嚫Madrid, Spain
University of Michigan Health System
馃嚭馃嚫Ann Arbor, Michigan, United States
Living Hope Clinical Trials, Inc.
馃嚭馃嚫Long Beach, California, United States
Boehringer Ingelheim Investigational Site
馃嚜馃嚫Madrid, Spain
David Geffen School of Medicine at UCLA
馃嚭馃嚫Los Angeles, California, United States
Atlanta VA Medical Center
馃嚭馃嚫Decatur, Georgia, United States
Hillsborough County Health Dept.
馃嚭馃嚫Tampa, Florida, United States
CORE Center
馃嚭馃嚫Chicago, Illinois, United States
University of New York at Stony Brook
馃嚭馃嚫Stony Brook, New York, United States
Duke University Medical Center
馃嚭馃嚫Durham, North Carolina, United States
Wake Forest University Baptist Medical Center
馃嚭馃嚫Winston-Salem, North Carolina, United States
Ohio State University Medical Center
馃嚭馃嚫Columbus, Ohio, United States
H么pital de Bic锚tre
馃嚝馃嚪Le Kremlin Bic锚tre cedex, France
Toronto General Hospital
馃嚚馃嚘Toronto, Ontario, Canada
St. Vincent's Hospital
馃嚘馃嚭Darlinghurst, New South Wales, Australia
Montreal Chest Institute - McGill University Health Centre
馃嚚馃嚘Montreal, Quebec, Canada
H么pital H么tel Dieu
馃嚝馃嚪Nantes cedex 1, France
Epimed GmbH
馃嚛馃嚜Berlin, Germany
H么pital de la piti茅 Salpetri猫re
馃嚝馃嚪Paris cedex 13, France
Fondazione Centro S. Raffaele del Monte Tabor
馃嚠馃嚬Milano, Italy
Erasmus Medical Centre
馃嚦馃嚤Rotterdam, Netherlands