Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
NCT00144170 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 882
Last updated 2014-07-02
Summary
The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load \> =1000 cells/mL, and genotype indicating at least one resistance conferring protease inhibitor-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.
Conditions
- HIV Infections
Interventions
- DRUG
-
Tipranavir (with low dose ritonavir)
- DRUG
-
Comparator protease inhibitor(CPI)/low dose ritonavir(r)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Purpose
- TREATMENT
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-02-28
- Primary Completion
- 2008-10-31
Countries
- Argentina
- Austria
- Belgium
- Brazil
- Denmark
- France
- Germany
- Greece
- Ireland
- Italy
- Mexico
- Netherlands
- Portugal
- Spain
- Sweden
- Switzerland
- United Kingdom
Study Locations
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