CompletedPhase 3

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

United States630 participantsStarted 2003-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:

Exclusion criteria

✕. 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.

What they're measuring

Treatment Response at Week 48

Timeframe: At week 48

Time to Treatment Failure Through 48 Weeks of Treatment

Timeframe: Week 48

Trial details

NCT IDNCT00054717

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-09

Results submitted2009-09-09

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