Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)

Completed · Phase 3

Conditions studied: HIV Infections

In brief

Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.

Key facts

Study ID

NCT00054717

Run by

Boehringer Ingelheim

People needed

630

Starts

2003-01-01

Last updated by the study team

2014-07-02

Who can join

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

You may qualify if…

• Patients meeting the following criteria will be eligible for participation in th is study:
• Human Immunodeficiency virus 1 (HIV-1) infected males or females >=18 years of age.
• Screening genotypic resistance report indicating both of the following: at least one primary protease Inhibitor (PI) mutation at the following sites:
• 30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M, and no more than two protease mutations on codons 33, 82, 84, or 90.
• At least 3 consecutive months experience taking antiretrovirals (ARVs) from each of the classes of nucleoside reverse transcriptase inhibitors(NRTI(s)), non-nucleoside reverse transcriptase inhibitors(NNRTI(s)), and protease inhibitors (PIs) at some point in treatment history,with at least 2 protease inhibitor (PI)-based regimens, one of which must be the current regimen, and current protease inhibitor (PI)-based antiretroviral (ARV) medication regimen for at least 3 months prior to randomization.
• Human Immunodeficiency Virus 1 (HIV-1) viral load >=1,000 copies/mL at screening.

You may not qualify if…

• Patients with any of the following criteria are excluded from participation in t he study:
• Antiretroviral (ARV) medication naïve.
• Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for at least 7 consecutive days within the last 3 months.
• alanine aminotransferase (ALT) >=3.0x upper limit of normal (ULN) and aspartate aminotransferase(AST) >=2.5x upper limit of normal (ULN) (>=Division of AIDS(DAIDS) Grade 1) at either screening visit.

Where it is running

• 1182.12.108 El Rio SIA — Tucson, Arizona, United States
• 1182.12.9 Boehringer Ingelheim Investigational Site — Berkeley, California, United States
• 1182.12.23 Boehringer Ingelheim Investigational Site — Beverly Hills, California, United States
• 1182.12.12 Boehringer Ingelheim Investigational Site — Fountain Valley, California, United States
• 1182.12.76 Boehringer Ingelheim Investigational Site — Long Beach, California, United States
• 1182.12.1 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1182.12.59 David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• 1182.12.82 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1182.12.97 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1182.12.69 UC Davis Medical Center — Sacramento, California, United States
• 1182.12.89 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1182.12.99 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 1182.12.25 Boehringer Ingelheim Investigational Site — San Francisco, California, United States
• 1182.12.5 Boehringer Ingelheim Investigational Site — San Francisco, California, United States
• 1182.12.53 Boehringer Ingelheim Investigational Site — San Francisco, California, United States
• 1182.12.98 University of Colorado Health Sciences Center — Denver, Colorado, United States
• 1182.12.7 Boehringer Ingelheim Investigational Site — Norwalk, Connecticut, United States
• 1182.12.103 Boehringer Ingelheim Investigational Site — Washington D.C., District of Columbia, United States
• 1182.12.52 Boehringer Ingelheim Investigational Site — Washington D.C., District of Columbia, United States
• 1182.12.70 — Washington D.C., District of Columbia, United States
• 1182.12.79 Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
• 1182.12.77 Boehringer Ingelheim Investigational Site — Fort Myers, Florida, United States
• 1182.12.45 Boehringer Ingelheim Investigational Site — Miami, Florida, United States
• 1182.12.75 CARES Resource — Miami, Florida, United States
• 1182.12.62 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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