Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00056641

Run by

Boehringer Ingelheim

People needed

328

Starts

2003-02-18

Last updated by the study team

2023-12-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Boehringer Ingelheim Investigational Site — Berkeley, California, United States
• Boehringer Ingelheim Investigational Site — Fountain Valley, California, United States
• Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• Boehringer Ingelheim Investigational Site — San Francisco, California, United States
• Kaiser Permanente Medical Center — San Francisco, California, United States
• San Francisco VAMC — San Francisco, California, United States
• Boehringer Ingelheim Investigational Site — Norwalk, Connecticut, United States
• Washington DC VA Medical Center — Washington D.C., District of Columbia, United States
• North Broward Hospital District — Fort Lauderdale, Florida, United States
• Boehringer Ingelheim Investigational Site — Fort Myers, Florida, United States
• Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• Boehringer Ingelheim Investigational Site — Orlando, Florida, United States
• Boehringer Ingelheim Investigational Site — Sarasota, Florida, United States
• Boehringer Ingelheim Investigational Site — Tampa, Florida, United States
• Boehringer Ingelheim Investigational Site — Vero Beach, Florida, United States
• Boehringer Ingelheim Investigational Site — Atlanta, Georgia, United States
• Mercer University School of Medicine — Macon, Georgia, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Boehringer Ingelheim Investigational Site — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Boehringer Ingelheim Investigational Site — Springfield, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Boehringer Ingelheim Investigational Site — Santa Fe, New Mexico, United States
• Albany Medical College — Albany, New York, United States
• Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.