3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study
Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects
1 other identifier
interventional
216
9 countries
62
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2003
CompletedFirst Submitted
Initial submission to the registry
January 9, 2006
CompletedFirst Posted
Study publicly available on registry
January 12, 2006
CompletedDecember 1, 2023
November 1, 2023
10 months
January 9, 2006
November 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Virologic response after 2 weeks of functional monotherapy
At week 2
Secondary Outcomes (1)
Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures.
Up to 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent prior to trial participation.
- Human immunodeficiency virus 1 (HIV-1) infected males or females \> 18 years of age.
- At least 3 months experience taking Nucleoside reverse transcriptase inhibitors (NRTIs), Non-nucleoside reverse transcriptase inhibitor (NNRTIs), and Protease inhibitors (PIs).
- Current PI-based Antiretroviral (ARV) medication regimen for at least 3 months prior to randomization, and at least 3 months experience taking at least one other PI-based regimen.
- HIV-1 viral load ≥1000 copies/mL at screening.
- Genotypic resistance report indicating one or more primary PI resistance mutation(s), including 30N, 46I/L, 48V, 50V, 82A/F/T, 84V or 90M.
- Availability of 2 or more non-PI ARV medications by genotypic resistance testing, i.e. 2 drugs tested as "no evidence of resistance" or "possible resistance".
- Acceptable screening laboratory values that indicate adequate baseline organ function.
- Laboratory values are considered to be acceptable if severity is no higher than Grade 3 Gamma glutamyl transferase (GGT), Grade 2 cholesterol or triglycerides, and no higher than Grade 1 for all other tests based on the "Division of Acquired Immune Deficiency Syndrome" of National Institute of Health, USA - DAIDS - Grading Scale. All laboratory values outside these limits are subject to approval by Boehringer Ingelheim (BI).
You may not qualify if:
- ARV medication naïve.
- Only one or no available ARV medications as determined by genotypic resistance testing.
- Female subjects 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 use two methods of contraception to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam).
- Any active opportunistic infection within 60 days before study entry.
- Active Hepatitis B (HCB) or Hepatitis C (HCV) disease defined as HBsAg positive or HCV RNA positive with Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) \> Grade 1.
- Prior tipranavir use.
- Use of investigational medications within 30 days before study entry or during the trial.Some expanded access drugs may be acceptable; must be approved by BI. Tenofovir, investigational at time of preparation of this protocol, is acceptable.
- Use of concomitant drugs which may significantly reduce plasma levels of the study medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
Living Hope Clinical Trials, Inc.
Long Beach, California, United States
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Vincent Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
1501 N.W. 9th Ave
Miami, Florida, United States
Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
Boehringer Ingelheim Investigational Site
South Miami, Florida, United States
Hillsborough County Health Dept.
Tampa, Florida, United States
Boehringer Ingelheim Investigational Site
Vero Beach, Florida, United States
Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Mercer University School of Medicine
Macon, Georgia, United States
CORE Center
Chicago, Illinois, United States
Rush-Presbytarian-St Luke's Medical Center
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
HIV Outpatient Program (H.O.P)
New Orleans, Louisiana, United States
John's Hopkins University
Baltimore, Maryland, United States
Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
Community Research Initiative of New England
Springfield, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
Boehringer Ingelheim Investigational Site
Las Vegas, Nevada, United States
ID Care
Hillsborough, New Jersey, United States
Boehringer Ingelheim Investigational Site
Santa Fe, New Mexico, United States
Albany Medical College
Albany, New York, United States
University of New York at 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
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
Boehringer Ingelheim Investigational Site
Columbia, South Carolina, United States
Boehringer Ingelheim Investigational Site
Houston, Texas, United States
Boehringer Ingelheim Investigational Site
Annandale, Virginia, United States
Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales, Australia
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia
Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Chest Institute - McGill University Health Centre
Montreal, Quebec, Canada
Hôpital de Bicêtre
Le Kremlin-Bicêtre, France
Hôpital de Chauliac
Montpellier, France
Hôpital Hôtel Dieu
Nantes, France
Hôpital Bichat Claude Bernard
Paris, France
Hôpital de la pitié Salpetrière
Paris, France
Hôpital Saint Louis
Paris, France
Epimed GmbH
Berlin, Germany
Klinik I für Innere Medizin der
Cologne, Germany
Klinikum der J.-W.-Goethe-Universität
Frankfurt am Main, Germany
Medizinische Poliklinik
München, Germany
Fondazione Centro S. Raffaele del Monte Tabor
Milan, Italy
IRCCS Policlinico San Matteo
Pavia, Italy
Academisch Medisch Centrum
Amsterdam, Netherlands
Erasmus Medical Centre
Rotterdam, Netherlands
Hospital Clínico y Provincial de Barcelona - HIV
Barcelona, Spain
Boehringer Ingelheim Investigational Site
Madrid, Spain
Hospital La Paz.
Madrid, Spain
Hospital Ramón y Cajal.
Madrid, Spain
4th Floor Research Office (St Stephens Centre)
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2006
First Posted
January 12, 2006
Study Start
March 29, 2002
Primary Completion
January 20, 2003
Last Updated
December 1, 2023
Record last verified: 2023-11