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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00054717
Registration number
NCT00054717
Ethics application status
Date submitted
7/02/2003
Date registered
10/02/2003
Date last updated
2/07/2014
Titles & IDs
Public title
Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)
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Scientific title
Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low-dose Ritonavir (TPV/RTV) Verses Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients.
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Secondary ID [1]
0
0
1182.12
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Infections
0
0
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Condition category
Condition code
Infection
0
0
0
0
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tipranavir
Treatment: Drugs - Ritonavir(r)
Treatment: Drugs - Comparator Protease Inhibitor (CPI)
Other: Tipranavir(TPV)/low dose ritonavir(r) -
Other: Comparator protease inhibitor(CPI)/low dose ritonavir(r) -
Treatment: Drugs: Tipranavir
Treatment: Drugs: Ritonavir(r)
Treatment: Drugs: Comparator Protease Inhibitor (CPI)
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
0
0
Treatment Response at Week 48
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Assessment method [1]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [1]
0
0
At week 48
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Primary outcome [2]
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0
Time to Treatment Failure Through 48 Weeks of Treatment
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Assessment method [2]
0
0
Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.
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Timepoint [2]
0
0
Week 48
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Secondary outcome [1]
0
0
Treatment Response at Week 24
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Assessment method [1]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [1]
0
0
Week 24
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Secondary outcome [2]
0
0
Treatment Response at Week 2
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Assessment method [2]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [2]
0
0
week 2
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Secondary outcome [3]
0
0
Treatment Response at Week 4
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Assessment method [3]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [3]
0
0
week 4
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Secondary outcome [4]
0
0
Treatment Response at Week 8
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Assessment method [4]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [4]
0
0
week 8
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Secondary outcome [5]
0
0
Treatment Response at Week 16
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Assessment method [5]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [5]
0
0
week 16
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Secondary outcome [6]
0
0
Treatment Response at Week 32
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Assessment method [6]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [6]
0
0
Week 32
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Secondary outcome [7]
0
0
Treatment Response at Week 40
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Assessment method [7]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [7]
0
0
Week 40
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Secondary outcome [8]
0
0
Treatment Response at Week 48
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Assessment method [8]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [8]
0
0
Week 48
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Secondary outcome [9]
0
0
Treatment Response at Week 56
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Assessment method [9]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [9]
0
0
week 56
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Secondary outcome [10]
0
0
Treatment Response at Week 64
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Assessment method [10]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [10]
0
0
week 64
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Secondary outcome [11]
0
0
Treatment Response at Week 72
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Assessment method [11]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [11]
0
0
Week 72
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Secondary outcome [12]
0
0
Treatment Response at Week 80
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Assessment method [12]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [12]
0
0
Week 80
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Secondary outcome [13]
0
0
Treatment Response at Week 88
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Assessment method [13]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [13]
0
0
Week 88
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Secondary outcome [14]
0
0
Treatment Response at Week 96
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Assessment method [14]
0
0
Treatment response (TR) is defined as two consecutive VL = 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
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Timepoint [14]
0
0
Week 96
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Secondary outcome [15]
0
0
Time to Treatment Failure Through 96 Weeks of Treatment
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Assessment method [15]
0
0
time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.
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Timepoint [15]
0
0
Week 96
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Secondary outcome [16]
0
0
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
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Assessment method [16]
0
0
Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.
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Timepoint [16]
0
0
Week 48
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Secondary outcome [17]
0
0
Time to Confirmed Virologic Failure Through 96 Weeks of Treatment
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Assessment method [17]
0
0
Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.
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Timepoint [17]
0
0
Week 96
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Secondary outcome [18]
0
0
Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF
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Assessment method [18]
0
0
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
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Timepoint [18]
0
0
Week 2 through Week 96 (at any point during trial)
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Secondary outcome [19]
0
0
Virologic Response (Viral Load >= 1 Log Drop) at Week 2
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Assessment method [19]
0
0
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
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Timepoint [19]
0
0
Week 2
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Secondary outcome [20]
0
0
Virologic Response (Viral Load >= 1 Log Drop) at Week 4
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Assessment method [20]
0
0
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
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Timepoint [20]
0
0
Week 4
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Secondary outcome [21]
0
0
Virologic Response (Viral Load >= 1 Log Drop) at Week 8
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Assessment method [21]
0
0
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
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Timepoint [21]
0
0
Week 8
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Secondary outcome [22]
0
0
Virologic Response (Viral Load >= 1 Log Drop) at Week 16
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Assessment method [22]
0
0
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
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Timepoint [22]
0
0
Week 16
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Secondary outcome [23]
0
0
Virologic Response (Viral Load >= 1 Log Drop) at Week 24
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Assessment method [23]
0
0
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
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Timepoint [23]
0
0
Week 24
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Secondary outcome [24]
0
0
Virologic Response (Viral Load >= 1 Log Drop) at Week 32
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Assessment method [24]
0
0
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
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Timepoint [24]
0
0
Week 32
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Secondary outcome [25]
0
0
Virologic Response (Viral Load >= 1 Log Drop) at Week 40
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Assessment method [25]
0
0
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
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Timepoint [25]
0
0
Week 40
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Secondary outcome [26]
0
0
Virologic Response (Viral Load >= 1 Log Drop) at Week 48
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Assessment method [26]
0
0
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
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Timepoint [26]
0
0
Week 48
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Secondary outcome [27]
0
0
Virologic Response (Viral Load >= 1 Log Drop) at Week 56
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Assessment method [27]
0
0
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
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Timepoint [27]
0
0
Week 56
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Secondary outcome [28]
0
0
Virologic Response (Viral Load >= 1 Log Drop) at Week 64
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Assessment method [28]
0
0
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
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Timepoint [28]
0
0
Week 64
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Secondary outcome [29]
0
0
Median Change From Baseline in Viral Load to Week 2
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Assessment method [29]
0
0
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Timepoint [29]
0
0
Baseline to Week 2
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Secondary outcome [30]
0
0
Median Change From Baseline in Viral Load to Week 4
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Assessment method [30]
0
0
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Timepoint [30]
0
0
Baseline to Week 4
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Secondary outcome [31]
0
0
Median Change From Baseline in Viral Load to Week 8
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Assessment method [31]
0
0
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Timepoint [31]
0
0
Baseline to Week 8
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Secondary outcome [32]
0
0
Median Change From Baseline in Viral Load to Week 16
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Assessment method [32]
0
0
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Timepoint [32]
0
0
Baseline to Week 16
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Secondary outcome [33]
0
0
Median Change From Baseline in Viral Load to Week 24
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Assessment method [33]
0
0
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Timepoint [33]
0
0
Baseline to Week 24
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Secondary outcome [34]
0
0
Median Change From Baseline in Viral Load to Week 32
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Assessment method [34]
0
0
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Timepoint [34]
0
0
Baseline to Week 32
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Secondary outcome [35]
0
0
Median Change From Baseline in Viral Load to Week 40
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Assessment method [35]
0
0
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Timepoint [35]
0
0
Baseline to Week 40
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Secondary outcome [36]
0
0
Median Change From Baseline in Viral Load to Week 48
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Assessment method [36]
0
0
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Timepoint [36]
0
0
Baseline to Week 48
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Secondary outcome [37]
0
0
Median Change From Baseline in Viral Load to Week 56
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Assessment method [37]
0
0
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Timepoint [37]
0
0
Baseline to Week 56
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Secondary outcome [38]
0
0
Median Change From Baseline in Viral Load to Week 64
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Assessment method [38]
0
0
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Timepoint [38]
0
0
Baseline to Week 64
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Secondary outcome [39]
0
0
Median Change From Baseline in Viral Load to Week 72
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Assessment method [39]
0
0
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Timepoint [39]
0
0
Baseline to Week 72
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Secondary outcome [40]
0
0
Median Change From Baseline in Viral Load to Week 80
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Assessment method [40]
0
0
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Timepoint [40]
0
0
Baseline to Week 80
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Secondary outcome [41]
0
0
Median Change From Baseline in Viral Load to Week 88
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Assessment method [41]
0
0
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Timepoint [41]
0
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Baseline to Week 88
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Secondary outcome [42]
0
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Median Change From Baseline in Viral Load to Week 96
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Assessment method [42]
0
0
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Timepoint [42]
0
0
Baseline to Week 96
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Secondary outcome [43]
0
0
Mean Change From Baseline to Week 2 in CD4+ Cell Count
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Assessment method [43]
0
0
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Timepoint [43]
0
0
Baseline to Week 2
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Secondary outcome [44]
0
0
Mean Change From Baseline to Week 4 in CD4+ Cell Count
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Assessment method [44]
0
0
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Timepoint [44]
0
0
Baseline to Week 4
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Secondary outcome [45]
0
0
Mean Change From Baseline to Week 8 in CD4+ Cell Count
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Assessment method [45]
0
0
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Timepoint [45]
0
0
Baseline to Week 8
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Secondary outcome [46]
0
0
Mean Change From Baseline to Week 16 in CD4+ Cell Count
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Assessment method [46]
0
0
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Timepoint [46]
0
0
Baseline to Week 16
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Secondary outcome [47]
0
0
Mean Change From Baseline to Week 24 in CD4+ Cell Count
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Assessment method [47]
0
0
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Timepoint [47]
0
0
Baseline to Week 24
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Secondary outcome [48]
0
0
Mean Change From Baseline to Week 32 in CD4+ Cell Count
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Assessment method [48]
0
0
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Timepoint [48]
0
0
Baseline to Week 32
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Secondary outcome [49]
0
0
Mean Change From Baseline to Week 40 in CD4+ Cell Count
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Assessment method [49]
0
0
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Timepoint [49]
0
0
Baseline to Week 40
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Secondary outcome [50]
0
0
Mean Change From Baseline to Week 48 in CD4+ Cell Count
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Assessment method [50]
0
0
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Timepoint [50]
0
0
Baseline to Week 48
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Secondary outcome [51]
0
0
Mean Change From Baseline to Week 56 in CD4+ Cell Count
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Assessment method [51]
0
0
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Timepoint [51]
0
0
Baseline to Week 56
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Secondary outcome [52]
0
0
Mean Change From Baseline to Week 64 in CD4+ Cell Count
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Assessment method [52]
0
0
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Timepoint [52]
0
0
Baseline to Week 64
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Secondary outcome [53]
0
0
Mean Change From Baseline to Week 72 in CD4+ Cell Count
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Assessment method [53]
0
0
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Timepoint [53]
0
0
Baseline to Week 72
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Secondary outcome [54]
0
0
Mean Change From Baseline to Week 80 in CD4+ Cell Count
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Assessment method [54]
0
0
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Timepoint [54]
0
0
Baseline to Week 80
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Secondary outcome [55]
0
0
Mean Change From Baseline to Week 88 in CD4+ Cell Count
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Assessment method [55]
0
0
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Timepoint [55]
0
0
Baseline to Week 88
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Secondary outcome [56]
0
0
Mean Change From Baseline to Week 96 in CD4+ Cell Count
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Assessment method [56]
0
0
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Timepoint [56]
0
0
Baseline to Week 96
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Secondary outcome [57]
0
0
Time to New CDC Class C Progression Event or Death.
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Assessment method [57]
0
0
Time to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death
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Timepoint [57]
0
0
after 48 weeks of treatment
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Secondary outcome [58]
0
0
Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF
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Assessment method [58]
0
0
Percentage of participants with Viral Load < 400 copies/mL
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Timepoint [58]
0
0
Week 2 through Week 96 (at any point during trial)
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Secondary outcome [59]
0
0
Virologic Response (VL < 400 Copies/ml) at Week 2
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Assessment method [59]
0
0
Percentage of participants with Viral Load < 400 copies/mL
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Timepoint [59]
0
0
Week 2
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Secondary outcome [60]
0
0
Virologic Response (VL < 400 Copies/ml) at Week 4
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Assessment method [60]
0
0
Percentage of participants with Viral Load < 400 copies/mL
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Timepoint [60]
0
0
Week 4
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Secondary outcome [61]
0
0
Virologic Response (VL < 400 Copies/ml) at Week 8
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Assessment method [61]
0
0
Percentage of participants with Viral Load < 400 copies/mL
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Timepoint [61]
0
0
Week 8
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Secondary outcome [62]
0
0
Virologic Response (VL < 400 Copies/ml) at Week 16
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Assessment method [62]
0
0
Percentage of participants with Viral Load < 400 copies/mL
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Timepoint [62]
0
0
Week 16
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Secondary outcome [63]
0
0
Virologic Response (VL < 400 Copies/ml) at Week 24
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Assessment method [63]
0
0
Percentage of participants with Viral Load < 400 copies/mL
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Timepoint [63]
0
0
Week 24
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Secondary outcome [64]
0
0
Virologic Response (VL < 400 Copies/ml) at Week 32
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Assessment method [64]
0
0
Percentage of participants with Viral Load < 400 copies/mL
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Timepoint [64]
0
0
week 32
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Secondary outcome [65]
0
0
Virologic Response (VL < 400 Copies/ml) at Week 40
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Assessment method [65]
0
0
Percentage of participants with Viral Load < 400 copies/mL
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Timepoint [65]
0
0
Week 40
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Secondary outcome [66]
0
0
Virologic Response (VL < 400 Copies/ml) at Week 48
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Assessment method [66]
0
0
Percentage of participants with Viral Load < 400 copies/mL
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Timepoint [66]
0
0
Week 48
Query!
Secondary outcome [67]
0
0
Virologic Response (VL < 400 Copies/ml) at Week 56
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Assessment method [67]
0
0
Percentage of participants with Viral Load < 400 copies/mL
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Timepoint [67]
0
0
Week 56
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Secondary outcome [68]
0
0
Virologic Response (VL < 400 Copies/ml) at Week 64
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Assessment method [68]
0
0
Percentage of participants with Viral Load < 400 copies/mL
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Timepoint [68]
0
0
Week 64
Query!
Secondary outcome [69]
0
0
Virologic Response (VL < 400 Copies/ml) at Week 72
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Assessment method [69]
0
0
Percentage of participants with Viral Load < 400 copies/mL
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Timepoint [69]
0
0
Week 72
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Secondary outcome [70]
0
0
Virologic Response (VL < 400 Copies/ml) at Week 80
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Assessment method [70]
0
0
Percentage of participants with Viral Load < 400 copies/mL
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Timepoint [70]
0
0
Week 80
Query!
Secondary outcome [71]
0
0
Virologic Response (VL < 400 Copies/ml) at Week 88
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Assessment method [71]
0
0
Percentage of participants with Viral Load < 400 copies/mL
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Timepoint [71]
0
0
week 88
Query!
Secondary outcome [72]
0
0
Virologic Response (VL < 400 Copies/ml) at Week 96
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Assessment method [72]
0
0
Percentage of participants with Viral Load < 400 copies/mL
Query!
Timepoint [72]
0
0
week 96
Query!
Secondary outcome [73]
0
0
Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF
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Assessment method [73]
0
0
Percentage of participants with Viral Load < 50 copies/mL
Query!
Timepoint [73]
0
0
Week 2 through Week 96 (at any point during trial)
Query!
Secondary outcome [74]
0
0
Virologic Response (VL < 50 Copies/ml) at Week 2
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Assessment method [74]
0
0
Percentage of participants with Viral Load < 50 copies/mL
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Timepoint [74]
0
0
Week 2
Query!
Secondary outcome [75]
0
0
Virologic Response (VL < 50 Copies/ml) at Week 4
Query!
Assessment method [75]
0
0
Percentage of participants with Viral Load < 50 copies/mL
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Timepoint [75]
0
0
Week 4
Query!
Secondary outcome [76]
0
0
Virologic Response (VL < 50 Copies/ml) at Week 8
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Assessment method [76]
0
0
Percentage of participants with Viral Load < 50 copies/mL
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Timepoint [76]
0
0
Week 8
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Secondary outcome [77]
0
0
Virologic Response (VL < 50 Copies/ml) at Week 16
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Assessment method [77]
0
0
Percentage of participants with Viral Load < 50 copies/mL
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Timepoint [77]
0
0
Week 16
Query!
Secondary outcome [78]
0
0
Virologic Response (VL < 50 Copies/ml) at Week 24
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Assessment method [78]
0
0
Percentage of participants with Viral Load < 50 copies/mL
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Timepoint [78]
0
0
Week 24
Query!
Secondary outcome [79]
0
0
Virologic Response (VL < 50 Copies/ml) at Week 32
Query!
Assessment method [79]
0
0
Percentage of participants with Viral Load < 50 copies/mL
Query!
Timepoint [79]
0
0
Week 32
Query!
Secondary outcome [80]
0
0
Virologic Response (VL < 50 Copies/ml) at Week 40
Query!
Assessment method [80]
0
0
Percentage of participants with Viral Load < 50 copies/mL
Query!
Timepoint [80]
0
0
Week 40
Query!
Secondary outcome [81]
0
0
Virologic Response (VL < 50 Copies/ml) at Week 48
Query!
Assessment method [81]
0
0
Percentage of participants with Viral Load < 50 copies/mL
Query!
Timepoint [81]
0
0
Week 48
Query!
Secondary outcome [82]
0
0
Virologic Response (VL < 50 Copies/ml) at Week 56
Query!
Assessment method [82]
0
0
Percentage of participants with Viral Load < 50 copies/mL
Query!
Timepoint [82]
0
0
Week 56
Query!
Secondary outcome [83]
0
0
Virologic Response (VL < 50 Copies/ml) at Week 64
Query!
Assessment method [83]
0
0
Percentage of participants with Viral Load < 50 copies/mL
Query!
Timepoint [83]
0
0
Week 64
Query!
Secondary outcome [84]
0
0
Virologic Response (VL < 50 Copies/ml) at Week 72
Query!
Assessment method [84]
0
0
Percentage of participants with Viral Load < 50 copies/mL
Query!
Timepoint [84]
0
0
Week 72
Query!
Secondary outcome [85]
0
0
Virologic Response (VL < 50 Copies/ml) at Week 80
Query!
Assessment method [85]
0
0
Percentage of participants with Viral Load < 50 copies/mL
Query!
Timepoint [85]
0
0
Week 80
Query!
Secondary outcome [86]
0
0
Virologic Response (VL < 50 Copies/ml) at Week 88
Query!
Assessment method [86]
0
0
Percentage of participants with Viral Load < 50 copies/mL
Query!
Timepoint [86]
0
0
Week 88
Query!
Secondary outcome [87]
0
0
Virologic Response (VL < 50 Copies/ml) at Week 96
Query!
Assessment method [87]
0
0
Percentage of participants with Viral Load < 50 copies/mL
Query!
Timepoint [87]
0
0
Week 96
Query!
Secondary outcome [88]
0
0
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities
Query!
Assessment method [88]
0
0
NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Query!
Timepoint [88]
0
0
240 Weeks
Query!
Eligibility
Key inclusion criteria
Patients meeting the following criteria will be eligible for participation in th is study:
1. Human Immunodeficiency virus 1 (HIV-1) infected males or females >=18 years of age.
2. 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.
3. 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.
4. Human Immunodeficiency Virus 1 (HIV-1) viral load >=1,000 copies/mL at screening.
Query!
Minimum age
18
Years
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Query!
Maximum age
No limit
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Query!
Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
Patients with any of the following criteria are excluded from participation in t he study:
1. Antiretroviral (ARV) medication naïve.
2. Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for
at least 7 consecutive days within the last 3 months.
3. 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.
Query!
Study design
Purpose of the study
Treatment
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Allocation to intervention
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Query!
Query!
Query!
Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
Query!
Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
630
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
0
0
1182.12.1401 St. Vincent's Hospital - Darlinghurst
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Recruitment hospital [2]
0
0
1182.12.1405 AIDS Research Initiative / Ground Zero - Darlinghurst
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Recruitment hospital [3]
0
0
1182.12.1407 Holdsworth House General Practice - Darlinghurst
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Recruitment hospital [4]
0
0
1182.12.1408 407 Doctors Pty Ltd. - Darlinghurst
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Recruitment hospital [5]
0
0
1182.12.1403 Albion Street Centre - Surry Hills
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Recruitment hospital [6]
0
0
1182.12.1406 Gold Coast Sexual Health Clinic - Miami
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Recruitment hospital [7]
0
0
1182.12.1404 Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
0
0
- Darlinghurst
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Recruitment postcode(s) [2]
0
0
- Surry Hills
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Recruitment postcode(s) [3]
0
0
- Miami
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Recruitment postcode(s) [4]
0
0
- Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Colorado
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Connecticut
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Country [5]
0
0
United States of America
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State/province [5]
0
0
District of Columbia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Florida
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Georgia
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Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Illinois
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Indiana
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Kentucky
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Louisiana
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Maine
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Maryland
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Massachusetts
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Michigan
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Minnesota
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Missouri
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Nevada
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Country [20]
0
0
United States of America
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State/province [20]
0
0
New Jersey
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Country [21]
0
0
United States of America
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State/province [21]
0
0
New Mexico
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Country [22]
0
0
United States of America
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State/province [22]
0
0
New York
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Country [23]
0
0
United States of America
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State/province [23]
0
0
North Carolina
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Country [24]
0
0
United States of America
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State/province [24]
0
0
Ohio
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Country [25]
0
0
United States of America
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State/province [25]
0
0
Oklahoma
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Country [26]
0
0
United States of America
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State/province [26]
0
0
Pennsylvania
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Country [27]
0
0
United States of America
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State/province [27]
0
0
Rhode Island
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Country [28]
0
0
United States of America
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State/province [28]
0
0
South Carolina
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Country [29]
0
0
United States of America
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State/province [29]
0
0
Tennessee
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Country [30]
0
0
United States of America
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State/province [30]
0
0
Texas
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Country [31]
0
0
United States of America
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State/province [31]
0
0
Virginia
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Country [32]
0
0
United States of America
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State/province [32]
0
0
Washington
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Country [33]
0
0
United States of America
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State/province [33]
0
0
Wisconsin
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Country [34]
0
0
Canada
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State/province [34]
0
0
British Columbia
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Country [35]
0
0
Canada
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State/province [35]
0
0
Manitoba
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Country [36]
0
0
Canada
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State/province [36]
0
0
Nova Scotia
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Country [37]
0
0
Canada
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State/province [37]
0
0
Ontario
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Country [38]
0
0
Canada
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State/province [38]
0
0
Quebec
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Country [39]
0
0
Puerto Rico
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State/province [39]
0
0
Santurce
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00054717
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Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
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Address
0
0
Boehringer Ingelheim
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Country
0
0
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Phone
0
0
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Fax
0
0
Query!
Email
0
0
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Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00054717
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