The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
40
1182.71.1109 Boehringer Ingelheim Investigational Site
Beverly Hills, California, United States
1182.71.1101 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1182.71.1104 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1182.71.1115 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1182.71.1108 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion.
Time frame: 48 weeks of treatment
Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure).
Time frame: 48 weeks of treatment
Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug.
Time frame: 48 weeks of treatment
Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion.
Time frame: 48 weeks of treatment
Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored
Time frame: up to 48 weeks
Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF
Time frame: up to 48 weeks
Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat
Time frame: up to 48 weeks
Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored
Time frame: up to 48 weeks
Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF
Time frame: up to 48 weeks
Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat
Time frame: up to 48 weeks
Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored
Time frame: up to 48 weeks
Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using NCF
Time frame: up to 48 weeks
Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat
Time frame: up to 48 weeks
Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8
Time frame: up to week 8
Daily Average in CD4+ Cell Count Change From Baseline up to Week 24
Time frame: up to week 24
Daily Average in CD4+ Cell Count Change From Baseline up to Week 48
Time frame: up to week 48
Daily Average in Viral Load Change From Baseline up to Week 8
Time frame: up to week 8
Daily Average in Viral Load Change From Baseline up to Week 24
Time frame: up to week 24
Daily Average in Viral Load Change From Baseline up to Week 48
Time frame: up to week 48
Change From Baseline in CD4+ Cell Count up to Week 48
Time frame: up to week 48
Change From Baseline in log10 Viral Load up to Week 48
Time frame: up to week 48
Occurrence of New AIDS Progression Events or Death
Time frame: through 48 weeks of treatment
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1182.71.1126 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
1182.71.1124 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
1182.71.1116 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1182.71.1118 Boehringer Ingelheim Investigational Site
Longview, Texas, United States
1182.71.3202 Boehringer Ingelheim Investigational Site
Brussels, Belgium
...and 44 more locations