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 Patients.
- NCT00056641
- PHASE2
- INTERVENTIONAL
Last updated: 2023-12-01
Purpose of Trial
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).
This study is for people with
HIV Infections
Interventions being studied
tipranavir
ritonavir
saquinavir
amprenavir
lopinavir
Inclusion criteria:
* Signed informed consent prior to trial participation.
* 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.
* Further inclusion criteria apply.
Exclusion criteria:
* Anti-retroviral (ARV) medication naïve.
* 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.
* Further exclusion criteria apply.
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
34 Locations
Phoenix
Boehringer Ingelheim Investigational Site
Arizona, United States
Berkeley
Boehringer Ingelheim Investigational Site
California, United States
Fountain Valley
Boehringer Ingelheim Investigational Site
California, United States
Los Angeles
Boehringer Ingelheim Investigational Site
California, United States
San Francisco
Boehringer Ingelheim Investigational Site
California, United States
San Francisco
Kaiser Permanente Medical Center
California, United States
San Francisco
San Francisco VAMC
California, United States
Norwalk
Boehringer Ingelheim Investigational Site
Connecticut, United States
Washington
Washington DC VA Medical Center
District of Columbia, United States
Fort Lauderdale
North Broward Hospital District
Florida, United States
Fort Myers
Boehringer Ingelheim Investigational Site
Florida, United States
Miami
Boehringer Ingelheim Investigational Site
Florida, United States
Orlando
Boehringer Ingelheim Investigational Site
Florida, United States
Sarasota
Boehringer Ingelheim Investigational Site
Florida, United States
Tampa
Boehringer Ingelheim Investigational Site
Florida, United States
Vero Beach
Boehringer Ingelheim Investigational Site
Florida, United States
Atlanta
Boehringer Ingelheim Investigational Site
Georgia, United States
Macon
Mercer University School of Medicine
Georgia, United States
Lexington
University of Kentucky Medical Center
Kentucky, United States
Boston
Boehringer Ingelheim Investigational Site
Massachusetts, United States
Boston
Brigham and Women's Hospital
Massachusetts, United States
Springfield
Boehringer Ingelheim Investigational Site
Massachusetts, United States
Detroit
Henry Ford Hospital
Michigan, United States
Santa Fe
Boehringer Ingelheim Investigational Site
New Mexico, United States
Albany
Albany Medical College
New York, United States
New York
Boehringer Ingelheim Investigational Site
New York, United States
Stony Brook
University of New York, Stony Brook
New York, United States
Durham
Duke University Medical Center
North Carolina, United States
Huntersville
Boehringer Ingelheim Investigational Site
North Carolina, United States
Philadelphia
University of Pennsylvania
Pennsylvania, United States
Dallas
UT Southwestern
Texas, United States
Houston
Boehringer Ingelheim Investigational Site
Texas, United States
Annandale
Boehringer Ingelheim Investigational Site
Virginia, United States
Tacoma
Boehringer Ingelheim Investigational Site
Washington, 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