Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects
- NCT00275444
- PHASE2
- INTERVENTIONAL
Last updated: 2023-12-01
Purpose of Trial
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.
This study is for people with
HIV Infections
Interventions being studied
Tipranavir
Inclusion criteria:
* 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).
* Further inclusion criteria apply.
Exclusion criteria:
* 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.
* Further exclusion criteria apply.
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
38 Locations
Phoenix
Boehringer Ingelheim Investigational Site
Arizona, United States
Fountain Valley
Boehringer Ingelheim Investigational Site
California, United States
Long Beach
Living Hope Clinical Trials, Inc.
California, United States
Los Angeles
Boehringer Ingelheim Investigational Site
California, United States
Los Angeles
David Geffen School of Medicine at UCLA
California, United States
Washington
Vincent Lombardi Cancer Center
District of Columbia, United States
Fort Lauderdale
Therafirst Medical Center
Florida, United States
Miami
1501 N.W. 9th Ave
Florida, United States
Orlando
Boehringer Ingelheim Investigational Site
Florida, United States
South Miami
Boehringer Ingelheim Investigational Site
Florida, United States
Tampa
Hillsborough County Health Dept.
Florida, United States
Vero Beach
Boehringer Ingelheim Investigational Site
Florida, United States
Atlanta
Boehringer Ingelheim Investigational Site
Georgia, United States
Decatur
Atlanta VA Medical Center
Georgia, United States
Macon
Mercer University School of Medicine
Georgia, United States
Chicago
CORE Center
Illinois, United States
Chicago
Rush-Presbytarian-St Luke's Medical Center
Illinois, United States
Louisville
University of Louisville
Kentucky, United States
New Orleans
HIV Outpatient Program (H.O.P)
Louisiana, United States
Baltimore
John's Hopkins University
Maryland, United States
Boston
Boehringer Ingelheim Investigational Site
Massachusetts, United States
Springfield
Community Research Initiative of New England
Massachusetts, United States
Ann Arbor
University of Michigan Health System
Michigan, United States
Kansas City
Boehringer Ingelheim Investigational Site
Missouri, United States
Saint Louis
Washington University
Missouri, United States
Las Vegas
Boehringer Ingelheim Investigational Site
Nevada, United States
Hillsborough
ID Care
New Jersey, United States
Santa Fe
Boehringer Ingelheim Investigational Site
New Mexico, United States
Albany
Albany Medical College
New York, United States
Stony Brook
University of New York at Stony Brook
New York, United States
Durham
Duke University Medical Center
North Carolina, United States
Huntersville
Boehringer Ingelheim Investigational Site
North Carolina, United States
Winston-Salem
Wake Forest University Baptist Medical Center
North Carolina, United States
Columbus
Ohio State University Medical Center
Ohio, United States
Oklahoma City
Boehringer Ingelheim Investigational Site
Oklahoma, United States
Columbia
Boehringer Ingelheim Investigational Site
South Carolina, United States
Houston
Boehringer Ingelheim Investigational Site
Texas, United States
Annandale
Boehringer Ingelheim Investigational Site
Virginia, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov