Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144170
First received: September 2, 2005
Last updated: June 23, 2014
Last verified: April 2014
Results First Received: September 11, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Tipranavir (with low dose ritonavir)
Drug: Comparator protease inhibitor(CPI)/low dose ritonavir(r)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The discrepancy with enrollment number in the protocol section is due to 16 patients not treated. (7 from TPV/r and 9 from CPI/r). These patients were not included in any analyses or results.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Participant Flow:   Overall Study
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
STARTED     438     428  
COMPLETED     86     32  
NOT COMPLETED     352     396  
Adverse Event                 84                 41  
Protocol Violation                 23                 16  
Lost to Follow-up                 5                 10  
Withdrawal by Subject                 29                 13  
Other reason not defined above                 211                 316  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.
Total Total of all reporting groups

Baseline Measures
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)     Total  
Number of Participants  
[units: participants]
  435     428     863  
Age [1]
[units: years]
Mean ± Standard Deviation
  42.5  ± 8.4     42.9  ± 8     42.7  ± 8.2  
Gender [1]
[units: participants]
     
Female     84     64     148  
Male     351     364     715  
[1] 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Treatment Response at Week 48   [ Time Frame: after 48 weeks of treatment ]

Measure Type Primary
Measure Title Treatment Response at Week 48
Measure Description Patients who experienced treatment response. 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
Time Frame after 48 weeks of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Treatment Response at Week 48  
[units: percentage of participants]
  34.5     15  


Statistical Analysis 1 for Treatment Response at Week 48
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0001
Risk Difference (RD) [4] 18.5
95% Confidence Interval ( 12.9 to 24.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Weighted by the size of enfuvirtide and protease inhibitor strata
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



2.  Primary:   Time to Treatment Failure Through 48 Weeks of Treatment   [ Time Frame: after 48 weeks of treatment ]

Measure Type Primary
Measure Title Time to Treatment Failure Through 48 Weeks of Treatment
Measure Description 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 Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.
Time Frame after 48 weeks of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Time to Treatment Failure Through 48 Weeks of Treatment  
[units: Days]
Median ( Inter-Quartile Range )
  112  
  ( 0 to 475 )  
  0  
  ( 0 to 112 )  


Statistical Analysis 1 for Time to Treatment Failure Through 48 Weeks of Treatment
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



3.  Secondary:   Treatment Response at Week 2   [ Time Frame: week 2 ]

Measure Type Secondary
Measure Title Treatment Response at Week 2
Measure Description Patients who experienced treatment response. 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
Time Frame week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Treatment Response at Week 2  
[units: percentage of participants]
  51     25.9  


Statistical Analysis 1 for Treatment Response at Week 2
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0001
Risk Difference (RD) [4] 24.9
95% Confidence Interval ( 18.6 to 31.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Weighted by the size of enfuvirtide and protease inhibitor strata
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



4.  Secondary:   Treatment Response at Week 4   [ Time Frame: week 4 ]

Measure Type Secondary
Measure Title Treatment Response at Week 4
Measure Description Patients who experienced treatment response. 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
Time Frame week 4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Treatment Response at Week 4  
[units: percentage of participants]
  59.1     29.9  


Statistical Analysis 1 for Treatment Response at Week 4
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0001
Risk Difference (RD) [4] 28.8
95% Confidence Interval ( 22.5 to 35.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



5.  Secondary:   Treatment Response at Week 8   [ Time Frame: week 8 ]

Measure Type Secondary
Measure Title Treatment Response at Week 8
Measure Description Patients who experienced treatment response. 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
Time Frame week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Treatment Response at Week 8  
[units: Percentage of participants]
  54.3     24.5  


Statistical Analysis 1 for Treatment Response at Week 8
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0001
Risk Difference (RD) [4] 29.4
95% Confidence Interval ( 23.2 to 35.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Weighted by the size of enfuvirtide and protease inhibitor strata
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



6.  Secondary:   Treatment Response at Week 16   [ Time Frame: week 16 ]

Measure Type Secondary
Measure Title Treatment Response at Week 16
Measure Description Patients who experienced treatment response. 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
Time Frame week 16  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Treatment Response at Week 16  
[units: percentage of participants]
  47.1     19.9  


Statistical Analysis 1 for Treatment Response at Week 16
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0001
Risk Difference (RD) [4] 26.6
95% Confidence Interval ( 20.5 to 32.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Weighted by the size of enfuvirtide and protease inhibitor strata
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



7.  Secondary:   Treatment Response at Week 24   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title Treatment Response at Week 24
Measure Description Patients who experienced treatment response. 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
Time Frame Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Treatment Response at Week 24  
[units: percentage of participants]
  40.9     18.0  


Statistical Analysis 1 for Treatment Response at Week 24
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0001
Risk Difference (RD) [4] 22.1
95% Confidence Interval ( 16.2 to 27.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Weighted by the size of enfuvirtide and protease inhibitor strata
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



8.  Secondary:   Treatment Response at Week 32   [ Time Frame: week 32 ]

Measure Type Secondary
Measure Title Treatment Response at Week 32
Measure Description Patients who experienced treatment response. 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
Time Frame week 32  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Treatment Response at Week 32  
[units: percentage of participants]
  37.2     17.3  


Statistical Analysis 1 for Treatment Response at Week 32
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0001
Risk Difference (RD) [4] 19.0
95% Confidence Interval ( 13.3 to 24.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Weighted by the size of enfuvirtide and protease inhibitor strata
[4] Other relevant estimation information:
  No text entered.



9.  Secondary:   Treatment Response at Week 40   [ Time Frame: week 40 ]

Measure Type Secondary
Measure Title Treatment Response at Week 40
Measure Description Patients who experienced treatment response. 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
Time Frame week 40  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Treatment Response at Week 40  
[units: percentage of participants]
  36.3     16.6  


Statistical Analysis 1 for Treatment Response at Week 40
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0001
Risk Difference (RD) [4] 18.7
95% Confidence Interval ( 13.0 to 24.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Weighted by the size of enfuvirtide and protease inhibitor strata
[4] Other relevant estimation information:
  No text entered.



10.  Secondary:   Treatment Response at Week 56   [ Time Frame: week 56 ]

Measure Type Secondary
Measure Title Treatment Response at Week 56
Measure Description Patients who experienced treatment response. 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
Time Frame week 56  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Treatment Response at Week 56  
[units: percentage of participants]
  32.6     14.5  


Statistical Analysis 1 for Treatment Response at Week 56
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0001
Risk Difference (RD) [4] 17.2
95% Confidence Interval ( 11.7 to 22.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Weighted by the size of enfuvirtide and protease inhibitor strata
[4] Other relevant estimation information:
  No text entered.



11.  Secondary:   Treatment Response at Week 64   [ Time Frame: week 64 ]

Measure Type Secondary
Measure Title Treatment Response at Week 64
Measure Description Patients who experienced treatment response. 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
Time Frame week 64  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Treatment Response at Week 64  
[units: percentage of participants]
  31     13.3  


Statistical Analysis 1 for Treatment Response at Week 64
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0001
Risk Difference (RD) [4] 17.1
95% Confidence Interval ( 11.7 to 22.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Weighted by the size of enfuvirtide and protease inhibitor strata
[4] Other relevant estimation information:
  No text entered.



12.  Secondary:   Treatment Response at Week 72   [ Time Frame: week 72 ]

Measure Type Secondary
Measure Title Treatment Response at Week 72
Measure Description Patients who experienced treatment response. 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
Time Frame week 72  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Treatment Response at Week 72  
[units: percentage of participants]
  30.1     12.1  


Statistical Analysis 1 for Treatment Response at Week 72
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0001
Risk Difference (RD) [4] 17.3
95% Confidence Interval ( 12.0 to 22.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Weighted by the size of enfuvirtide and protease inhibitor strata
[4] Other relevant estimation information:
  No text entered.



13.  Secondary:   Treatment Response at Week 80   [ Time Frame: week 80 ]

Measure Type Secondary
Measure Title Treatment Response at Week 80
Measure Description Patients who experienced treatment response. 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
Time Frame week 80  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Treatment Response at Week 80  
[units: percentage of participants]
  28.5     11.4  


Statistical Analysis 1 for Treatment Response at Week 80
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0001
Risk Difference (RD) [4] 16.4
95% Confidence Interval ( 11.2 to 21.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Weighted by the size of enfuvirtide and protease inhibitor strata
[4] Other relevant estimation information:
  No text entered.



14.  Secondary:   Treatment Response at Week 88   [ Time Frame: week 88 ]

Measure Type Secondary
Measure Title Treatment Response at Week 88
Measure Description Patients who experienced treatment response. 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
Time Frame week 88  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Treatment Response at Week 88  
[units: percentage of participants]
  27.8     11  


Statistical Analysis 1 for Treatment Response at Week 88
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0001
Risk Difference (RD) [4] 16.2
95% Confidence Interval ( 11.1 to 21.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Weighted by the size of enfuvirtide and protease inhibitor strata
[4] Other relevant estimation information:
  No text entered.



15.  Secondary:   Treatment Response at Week 96   [ Time Frame: after 96 weeks of treatment ]

Measure Type Secondary
Measure Title Treatment Response at Week 96
Measure Description Patients who experienced treatment response. 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
Time Frame after 96 weeks of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Treatment Response at Week 96  
[units: percentage of participants]
  26.2     10  


Statistical Analysis 1 for Treatment Response at Week 96
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0001
Risk Difference (RD) [4] 15.6
95% Confidence Interval ( 10.6 to 20.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Weighted by the size of enfuvirtide and protease inhibitor strata
[4] Other relevant estimation information:
  No text entered.



16.  Secondary:   Time to Treatment Failure Through 96 Weeks of Treatment   [ Time Frame: after 96 weeks of treatment ]

Measure Type Secondary
Measure Title Time to Treatment Failure Through 96 Weeks of Treatment
Measure Description 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 Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.
Time Frame after 96 weeks of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Time to Treatment Failure Through 96 Weeks of Treatment  
[units: Days]
Median ( Inter-Quartile Range )
  115  
  ( 0 to 811 )  
  0  
  ( 0 to 112 )  


Statistical Analysis 1 for Time to Treatment Failure Through 96 Weeks of Treatment
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



17.  Secondary:   Time to Confirmed Virologic Failure Through 48 Weeks of Treatment   [ Time Frame: after 48 weeks of treatment ]

Measure Type Secondary
Measure Title Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
Measure Description Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.
Time Frame after 48 weeks of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment  
[units: Days]
Median ( Inter-Quartile Range )
  117  
  ( 0 to 475 )  
  0  
  ( 0 to 112 )  


Statistical Analysis 1 for Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



18.  Secondary:   Time to Confirmed Virologic Failure Through 96 Weeks of Treatment   [ Time Frame: after 96 weeks of treatment ]

Measure Type Secondary
Measure Title Time to Confirmed Virologic Failure Through 96 Weeks of Treatment
Measure Description Time to virologic failure is defined as the time from the start of treatment to the last measurement where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.
Time Frame after 96 weeks of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Time to Confirmed Virologic Failure Through 96 Weeks of Treatment  
[units: Days]
Median ( Inter-Quartile Range )
  117  
  ( 0 to 756 )  
  0  
  ( 0 to 112 )  


Statistical Analysis 1 for Time to Confirmed Virologic Failure Through 96 Weeks of Treatment
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



19.  Secondary:   Virologic Response   [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

Measure Type Secondary
Measure Title Virologic Response
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame Week 2 through Week 96 (at any point during trial)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response  
[units: Percentage of participants]
  75.6     48.6  

No statistical analysis provided for Virologic Response



20.  Secondary:   Virologic Response at Week 2   [ Time Frame: Week 2 ]

Measure Type Secondary
Measure Title Virologic Response at Week 2
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 2  
[units: Percentage of participants]
  60.5     36  

No statistical analysis provided for Virologic Response at Week 2



21.  Secondary:   Virologic Response at Week 4   [ Time Frame: week 4 ]

Measure Type Secondary
Measure Title Virologic Response at Week 4
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame week 4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 4  
[units: Percentage of participants]
  62.3     33.4  

No statistical analysis provided for Virologic Response at Week 4



22.  Secondary:   Virologic Response at Week 8   [ Time Frame: week 8 ]

Measure Type Secondary
Measure Title Virologic Response at Week 8
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 8  
[units: Percentage of participants]
  56.3     26.6  

No statistical analysis provided for Virologic Response at Week 8



23.  Secondary:   Virologic Response at Week 16   [ Time Frame: week 16 ]

Measure Type Secondary
Measure Title Virologic Response at Week 16
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame week 16  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 16  
[units: Percentage of participants]
  47.1     20.8  

No statistical analysis provided for Virologic Response at Week 16



24.  Secondary:   Virologic Response at Week 24   [ Time Frame: week 24 ]

Measure Type Secondary
Measure Title Virologic Response at Week 24
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 24  
[units: Percentage of participants]
  42.8     19.2  

No statistical analysis provided for Virologic Response at Week 24



25.  Secondary:   Virologic Response at Week 32   [ Time Frame: week 32 ]

Measure Type Secondary
Measure Title Virologic Response at Week 32
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame week 32  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 32  
[units: Percentage of participants]
  38.6     19.4  

No statistical analysis provided for Virologic Response at Week 32



26.  Secondary:   Virologic Response at Week 40   [ Time Frame: week 40 ]

Measure Type Secondary
Measure Title Virologic Response at Week 40
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame week 40  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 40  
[units: Percentage of participants]
  37     17.3  

No statistical analysis provided for Virologic Response at Week 40



27.  Secondary:   Virologic Response at Week 48   [ Time Frame: week 48 ]

Measure Type Secondary
Measure Title Virologic Response at Week 48
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 48  
[units: Percentage of participants]
  36.8     16.6  

No statistical analysis provided for Virologic Response at Week 48



28.  Secondary:   Virologic Response at Week 56   [ Time Frame: week 56 ]

Measure Type Secondary
Measure Title Virologic Response at Week 56
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame week 56  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 56  
[units: Percentage of participants]
  35.2     15.2  

No statistical analysis provided for Virologic Response at Week 56



29.  Secondary:   Virologic Response at Week 64   [ Time Frame: week 64 ]

Measure Type Secondary
Measure Title Virologic Response at Week 64
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame week 64  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 64  
[units: Percentage of participants]
  33.6     14  

No statistical analysis provided for Virologic Response at Week 64



30.  Secondary:   Virologic Response at Week 72   [ Time Frame: Week 72 ]

Measure Type Secondary
Measure Title Virologic Response at Week 72
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame Week 72  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 72  
[units: Percentage of participants]
  32.2     13.8  

No statistical analysis provided for Virologic Response at Week 72



31.  Secondary:   Virologic Response at Week 80   [ Time Frame: Week 80 ]

Measure Type Secondary
Measure Title Virologic Response at Week 80
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame Week 80  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 80  
[units: Percentage of participants]
  32.6     13.6  

No statistical analysis provided for Virologic Response at Week 80



32.  Secondary:   Virologic Response at Week 88   [ Time Frame: Week 88 ]

Measure Type Secondary
Measure Title Virologic Response at Week 88
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame Week 88  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 88  
[units: Percentage of participants]
  31     12.1  

No statistical analysis provided for Virologic Response at Week 88



33.  Secondary:   Virologic Response at Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Virologic Response at Week 96
Measure Description Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Time Frame Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 96  
[units: Percentage of participants]
  30.1     11.4  

No statistical analysis provided for Virologic Response at Week 96



34.  Secondary:   Median Change From Baseline in Viral Load (Week 2)   [ Time Frame: Baseline to Week 2 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Viral Load (Week 2)
Measure Description No text entered.
Time Frame Baseline to Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Median Change From Baseline in Viral Load (Week 2)  
[units: Log(Copies/mL)]
Median ( Inter-Quartile Range )
  -1.27  
  ( -1.78 to -0.55 )  
  -0.56  
  ( -1.28 to 0 )  

No statistical analysis provided for Median Change From Baseline in Viral Load (Week 2)



35.  Secondary:   Median Change From Baseline in Viral Load (Week 4)   [ Time Frame: Baseline to Week 4 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Viral Load (Week 4)
Measure Description No text entered.
Time Frame Baseline to Week 4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Median Change From Baseline in Viral Load (Week 4)  
[units: Log(Copies/mL)]
Median ( Inter-Quartile Range )
  -1.47  
  ( -2.03 to -0.4 )  
  -0.42  
  ( -1.35 to 0 )  

No statistical analysis provided for Median Change From Baseline in Viral Load (Week 4)



36.  Secondary:   Median Change From Baseline in Viral Load (Week 8)   [ Time Frame: Baseline to Week 8 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Viral Load (Week 8)
Measure Description No text entered.
Time Frame Baseline to Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Median Change From Baseline in Viral Load (Week 8)  
[units: Log(Copies/mL)]
Median ( Inter-Quartile Range )
  -1.4  
  ( -2.25 to -0.22 )  
  -0.33  
  ( -1.23 to 0 )  

No statistical analysis provided for Median Change From Baseline in Viral Load (Week 8)



37.  Secondary:   Median Change From Baseline in Viral Load (Week 16)   [ Time Frame: Baseline to Week 16 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Viral Load (Week 16)
Measure Description No text entered.
Time Frame Baseline to Week 16  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Median Change From Baseline in Viral Load (Week 16)  
[units: Log(Copies/mL)]
Median ( Inter-Quartile Range )
  -1.03  
  ( -2.35 to -0.17 )  
  -0.3  
  ( -0.93 to -0.02 )  

No statistical analysis provided for Median Change From Baseline in Viral Load (Week 16)



38.  Secondary:   Median Change From Baseline in Viral Load (Week 24)   [ Time Frame: Baseline to Week 24 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Viral Load (Week 24)
Measure Description No text entered.
Time Frame Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Median Change From Baseline in Viral Load (Week 24)  
[units: Log(Copies/mL)]
Median ( Inter-Quartile Range )
  -0.69  
  ( -2.28 to -0.11 )  
  -0.21  
  ( -0.86 to 0.06 )  

No statistical analysis provided for Median Change From Baseline in Viral Load (Week 24)



39.  Secondary:   Median Change From Baseline in Viral Load (Week 32)   [ Time Frame: Baseline to Week 32 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Viral Load (Week 32)
Measure Description No text entered.
Time Frame Baseline to Week 32  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Median Change From Baseline in Viral Load (Week 32)  
[units: Log(Copies/mL)]
Median ( Inter-Quartile Range )
  -0.63  
  ( -2.29 to -0.09 )  
  -0.24  
  ( -0.84 to 0.06 )  

No statistical analysis provided for Median Change From Baseline in Viral Load (Week 32)



40.  Secondary:   Median Change From Baseline in Viral Load (Week 40)   [ Time Frame: Baseline to Week 40 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Viral Load (Week 40)
Measure Description No text entered.
Time Frame Baseline to Week 40  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Median Change From Baseline in Viral Load (Week 40)  
[units: Log(Copies/mL)]
Median ( Inter-Quartile Range )
  -0.65  
  ( -2.27 to -0.07 )  
  -0.2  
  ( -0.73 to 0.1 )  

No statistical analysis provided for Median Change From Baseline in Viral Load (Week 40)



41.  Secondary:   Median Change From Baseline in Viral Load (Week 48)   [ Time Frame: Baseline to Week 48 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Viral Load (Week 48)
Measure Description No text entered.
Time Frame Baseline to Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Median Change From Baseline in Viral Load (Week 48)  
[units: Log(Copies/mL)]
Median ( Inter-Quartile Range )
  -0.65  
  ( -2.17 to -0.07 )  
  -0.2  
  ( -0.75 to 0.11 )  

No statistical analysis provided for Median Change From Baseline in Viral Load (Week 48)



42.  Secondary:   Median Change From Baseline in Viral Load (Week 56)   [ Time Frame: Baseline to Week 56 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Viral Load (Week 56)
Measure Description No text entered.
Time Frame Baseline to Week 56  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Median Change From Baseline in Viral Load (Week 56)  
[units: Log(Copies/mL)]
Median ( Inter-Quartile Range )
  -0.64  
  ( -2.16 to -0.07 )  
  -0.22  
  ( -0.74 to 0.11 )  

No statistical analysis provided for Median Change From Baseline in Viral Load (Week 56)



43.  Secondary:   Median Change From Baseline in Viral Load (Week 64)   [ Time Frame: Baseline to Week 64 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Viral Load (Week 64)
Measure Description No text entered.
Time Frame Baseline to Week 64  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Median Change From Baseline in Viral Load (Week 64)  
[units: Log(Copies/mL)]
Median ( Inter-Quartile Range )
  -0.63  
  ( -2.12 to -0.07 )  
  -0.21  
  ( -0.71 to 0.12 )  

No statistical analysis provided for Median Change From Baseline in Viral Load (Week 64)



44.  Secondary:   Median Change From Baseline in Viral Load (Week 72)   [ Time Frame: Baseline to Week 72 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Viral Load (Week 72)
Measure Description No text entered.
Time Frame Baseline to Week 72  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Median Change From Baseline in Viral Load (Week 72)  
[units: Log(Copies/mL)]
Median ( Inter-Quartile Range )
  -0.52  
  ( -2.14 to -0.05 )  
  -0.2  
  ( -0.7 to 0.11 )  

No statistical analysis provided for Median Change From Baseline in Viral Load (Week 72)



45.  Secondary:   Median Change From Baseline in Viral Load (Week 80)   [ Time Frame: Baseline to Week 80 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Viral Load (Week 80)
Measure Description No text entered.
Time Frame Baseline to Week 80  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Median Change From Baseline in Viral Load (Week 80)  
[units: Log(Copies/mL)]
Median ( Inter-Quartile Range )
  -0.55  
  ( -2.14 to -0.06 )  
  -0.2  
  ( -0.72 to 0.11 )  

No statistical analysis provided for Median Change From Baseline in Viral Load (Week 80)



46.  Secondary:   Median Change From Baseline in Viral Load (Week 88)   [ Time Frame: Baseline to Week 88 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Viral Load (Week 88)
Measure Description No text entered.
Time Frame Baseline to Week 88  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Median Change From Baseline in Viral Load (Week 88)  
[units: Log(Copies/mL)]
Median ( Inter-Quartile Range )
  -0.56  
  ( -2.12 to -0.03 )  
  -0.2  
  ( -0.7 to 0.11 )  

No statistical analysis provided for Median Change From Baseline in Viral Load (Week 88)



47.  Secondary:   Median Change From Baseline in Viral Load (Week 96)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Median Change From Baseline in Viral Load (Week 96)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Median Change From Baseline in Viral Load (Week 96)  
[units: Log(Copies/mL)]
Median ( Inter-Quartile Range )
  -0.56  
  ( -2.14 to -0.05 )  
  -0.2  
  ( -0.67 to 0.11 )  

No statistical analysis provided for Median Change From Baseline in Viral Load (Week 96)



48.  Secondary:   Virologic Response at Week 40   [ Time Frame: Week 40 ]

Measure Type Secondary
Measure Title Virologic Response at Week 40
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame Week 40  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 40  
[units: Percentage of participants]
  31.5     15  

No statistical analysis provided for Virologic Response at Week 40



49.  Secondary:   Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks   [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

Measure Type Secondary
Measure Title Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame Week 2 through Week 96 (at any point during trial)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks  
[units: Percentage of participants]
  52.2     25.7  

No statistical analysis provided for Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks



50.  Secondary:   Virologic Response at Week 2   [ Time Frame: Week 2 ]

Measure Type Secondary
Measure Title Virologic Response at Week 2
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 2  
[units: Percentage of participants]
  14.5     8.2  

No statistical analysis provided for Virologic Response at Week 2



51.  Secondary:   Virologic Response at Week 4   [ Time Frame: Week 4 ]

Measure Type Secondary
Measure Title Virologic Response at Week 4
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame Week 4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 4  
[units: Percentage of participants]
  26.2     15.2  

No statistical analysis provided for Virologic Response at Week 4



52.  Secondary:   Virologic Response at Week 8   [ Time Frame: Week 8 ]

Measure Type Secondary
Measure Title Virologic Response at Week 8
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 8  
[units: Percentage of participants]
  33.3     17.5  

No statistical analysis provided for Virologic Response at Week 8



53.  Secondary:   Virologic Response at Week 16   [ Time Frame: Week 16 ]

Measure Type Secondary
Measure Title Virologic Response at Week 16
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame Week 16  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 16  
[units: Percentage of participants]
  35.2     17.5  

No statistical analysis provided for Virologic Response at Week 16



54.  Secondary:   Virologic Response at Week 24   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title Virologic Response at Week 24
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 24  
[units: Percentage of participants]
  32.6     15.4  

No statistical analysis provided for Virologic Response at Week 24



55.  Secondary:   Virologic Response at Week 32   [ Time Frame: Week 32 ]

Measure Type Secondary
Measure Title Virologic Response at Week 32
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame Week 32  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 32  
[units: Percentage of participants]
  32.4     16.1  

No statistical analysis provided for Virologic Response at Week 32



56.  Secondary:   Virologic Response at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Virologic Response at Week 48
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 48  
[units: Percentage of participants]
  30.1     13.6  

No statistical analysis provided for Virologic Response at Week 48



57.  Secondary:   Virologic Response at Week 56   [ Time Frame: Week 56 ]

Measure Type Secondary
Measure Title Virologic Response at Week 56
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame Week 56  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 56  
[units: Percentage of participants]
  30.6     12.4  

No statistical analysis provided for Virologic Response at Week 56



58.  Secondary:   Virologic Response at Week 64   [ Time Frame: Week 64 ]

Measure Type Secondary
Measure Title Virologic Response at Week 64
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame Week 64  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 64  
[units: Percentage of participants]
  28.7     12.1  

No statistical analysis provided for Virologic Response at Week 64



59.  Secondary:   Virologic Response at Week 72   [ Time Frame: Week 72 ]

Measure Type Secondary
Measure Title Virologic Response at Week 72
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame Week 72  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 72  
[units: Percentage of participants]
  28     11.4  

No statistical analysis provided for Virologic Response at Week 72



60.  Secondary:   Virologic Response at Week 80   [ Time Frame: Week 80 ]

Measure Type Secondary
Measure Title Virologic Response at Week 80
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame Week 80  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 80  
[units: Percentage of participants]
  28.7     11  

No statistical analysis provided for Virologic Response at Week 80



61.  Secondary:   Virologic Response at Week 88   [ Time Frame: week 88 ]

Measure Type Secondary
Measure Title Virologic Response at Week 88
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame week 88  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 88  
[units: Percentage of participants]
  27.8     11.2  

No statistical analysis provided for Virologic Response at Week 88



62.  Secondary:   Virologic Response at Week 96   [ Time Frame: week 96 ]

Measure Type Secondary
Measure Title Virologic Response at Week 96
Measure Description Virologic response defined as Viral Load<400 copies/mL
Time Frame week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 96  
[units: Percentage of participants]
  27.1     10.3  

No statistical analysis provided for Virologic Response at Week 96



63.  Secondary:   Virologic Response   [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

Measure Type Secondary
Measure Title Virologic Response
Measure Description Virologic response defined as Viral Load<50 copies/mL
Time Frame Week 2 through Week 96 (at any point during trial)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response  
[units: Percentage of participants]
  36.6     16.8  

No statistical analysis provided for Virologic Response



64.  Secondary:   Virologic Response at Week 2   [ Time Frame: Week 2 ]

Measure Type Secondary
Measure Title Virologic Response at Week 2
Measure Description Virologic response defined as Viral Load<50 copies/mL
Time Frame Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 2  
[units: Percentage of participants]
  0.9     1.4  

No statistical analysis provided for Virologic Response at Week 2



65.  Secondary:   Virologic Response at Week 4   [ Time Frame: Week 4 ]

Measure Type Secondary
Measure Title Virologic Response at Week 4
Measure Description Virologic response defined as Viral Load<50 copies/mL
Time Frame Week 4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 4  
[units: Percentage of participants]
  4.4     3.5  

No statistical analysis provided for Virologic Response at Week 4



66.  Secondary:   Virologic Response at Week 8   [ Time Frame: Week 8 ]

Measure Type Secondary
Measure Title Virologic Response at Week 8
Measure Description Virologic response defined as Viral Load<50 copies/mL
Time Frame Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 8  
[units: Percentage of participants]
  11     6.8  

No statistical analysis provided for Virologic Response at Week 8



67.  Secondary:   Virologic Response at Week 16   [ Time Frame: Week 16 ]

Measure Type Secondary
Measure Title Virologic Response at Week 16
Measure Description Virologic response defined as Viral Load<50 copies/mL
Time Frame Week 16  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 16  
[units: Percentage of participants]
  20.5     10.5  

No statistical analysis provided for Virologic Response at Week 16



68.  Secondary:   Virologic Response at Week 24   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title Virologic Response at Week 24
Measure Description Viral Load < 50 copies/mL
Time Frame Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 24  
[units: Percentage of participants]
  21.1     11.9  

No statistical analysis provided for Virologic Response at Week 24



69.  Secondary:   Virologic Response at Week 32   [ Time Frame: Week 32 ]

Measure Type Secondary
Measure Title Virologic Response at Week 32
Measure Description Virologic response defined as Viral Load<50 copies/mL
Time Frame Week 32  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 32  
[units: Percentage of participants]
  22.1     12.1  

No statistical analysis provided for Virologic Response at Week 32



70.  Secondary:   Virologic Response at Week 40   [ Time Frame: Week 40 ]

Measure Type Secondary
Measure Title Virologic Response at Week 40
Measure Description Virologic response defined as Viral Load<50 copies/mL
Time Frame Week 40  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 40  
[units: Percentage of participants]
  22.3     11.9  

No statistical analysis provided for Virologic Response at Week 40



71.  Secondary:   Virologic Response at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Virologic Response at Week 48
Measure Description Virologic response defined as Viral Load<50 copies/mL
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 48  
[units: Percentage of participants]
  22.8     10.5  

No statistical analysis provided for Virologic Response at Week 48



72.  Secondary:   Virologic Response at Week 56   [ Time Frame: Week 56 ]

Measure Type Secondary
Measure Title Virologic Response at Week 56
Measure Description Virologic response defined as Viral Load<50 copies/mL
Time Frame Week 56  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 56  
[units: Percentage of participants]
  22.5     8.9  

No statistical analysis provided for Virologic Response at Week 56



73.  Secondary:   Virologic Response at Week 64   [ Time Frame: Week 64 ]

Measure Type Secondary
Measure Title Virologic Response at Week 64
Measure Description Virologic response defined as Viral Load<50 copies/mL
Time Frame Week 64  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 64  
[units: Percentage of participants]
  21.6     8.2  

No statistical analysis provided for Virologic Response at Week 64



74.  Secondary:   Virologic Response at Week 72   [ Time Frame: Week 72 ]

Measure Type Secondary
Measure Title Virologic Response at Week 72
Measure Description Virologic response defined as Viral Load<50 copies/mL
Time Frame Week 72  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 72  
[units: Percentage of participants]
  21.1     8.2  

No statistical analysis provided for Virologic Response at Week 72



75.  Secondary:   Virologic Response at Week 80   [ Time Frame: Week 80 ]

Measure Type Secondary
Measure Title Virologic Response at Week 80
Measure Description Virologic response defined as Viral Load<50 copies/mL
Time Frame Week 80  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 80  
[units: Percentage of participants]
  21.8     8.9  

No statistical analysis provided for Virologic Response at Week 80



76.  Secondary:   Virologic Response at Week 88   [ Time Frame: Week 88 ]

Measure Type Secondary
Measure Title Virologic Response at Week 88
Measure Description Virologic response defined as Viral Load<50 copies/mL
Time Frame Week 88  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 88  
[units: Percentage of participants]
  20.7     8.9  

No statistical analysis provided for Virologic Response at Week 88



77.  Secondary:   Virologic Response at Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Virologic Response at Week 96
Measure Description Virologic response defined as Viral Load<50 copies/mL
Time Frame Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Virologic Response at Week 96  
[units: Percentage of participants]
  20     8.9  

No statistical analysis provided for Virologic Response at Week 96



78.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 2)   [ Time Frame: Baseline to Week 2 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count (Week 2)
Measure Description No text entered.
Time Frame Baseline to Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  430     418  
Mean Change From Baseline in CD4+ Cell Count (Week 2)  
[units: Cells/mm3]
Mean ± Standard Deviation
  26  ± 65     13  ± 56  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count (Week 2)



79.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 4)   [ Time Frame: Baseline to Week 4 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count (Week 4)
Measure Description No text entered.
Time Frame Baseline to Week 4  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  430     418  
Mean Change From Baseline in CD4+ Cell Count (Week 4)  
[units: Cells/mm3]
Mean ± Standard Deviation
  39  ± 77     19  ± 64  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count (Week 4)



80.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 8)   [ Time Frame: Baseline to Week 8 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count (Week 8)
Measure Description No text entered.
Time Frame Baseline to Week 8  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  430     418  
Mean Change From Baseline in CD4+ Cell Count (Week 8)  
[units: Cells/mm3]
Mean ± Standard Deviation
  52  ± 85     25  ± 76  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count (Week 8)



81.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 16)   [ Time Frame: Baseline to Week 16 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count (Week 16)
Measure Description No text entered.
Time Frame Baseline to Week 16  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  430     418  
Mean Change From Baseline in CD4+ Cell Count (Week 16)  
[units: Cells/mm3]
Mean ± Standard Deviation
  57  ± 90     25  ± 77  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count (Week 16)



82.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 24)   [ Time Frame: Baseline to Week 24 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count (Week 24)
Measure Description No text entered.
Time Frame Baseline to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  430     418  
Mean Change From Baseline in CD4+ Cell Count (Week 24)  
[units: Cells/mm3]
Mean ± Standard Deviation
  51  ± 97     21  ± 81  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count (Week 24)



83.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 32)   [ Time Frame: Baseline to Week 32 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count (Week 32)
Measure Description No text entered.
Time Frame Baseline to Week 32  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  430     418  
Mean Change From Baseline in CD4+ Cell Count (Week 32)  
[units: Cells/mm3]
Mean ± Standard Deviation
  46  ± 102     17  ± 87  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count (Week 32)



84.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 40)   [ Time Frame: Baseline to Week 40 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count (Week 40)
Measure Description No text entered.
Time Frame Baseline to Week 40  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  430     418  
Mean Change From Baseline in CD4+ Cell Count (Week 40)  
[units: Cells/mm3]
Mean ± Standard Deviation
  47  ± 99     19  ± 87  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count (Week 40)



85.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 48)   [ Time Frame: Baseline to Week 48 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count (Week 48)
Measure Description No text entered.
Time Frame Baseline to Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  430     418  
Mean Change From Baseline in CD4+ Cell Count (Week 48)  
[units: Cells/mm3]
Mean ± Standard Deviation
  43  ± 109     16  ± 92  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count (Week 48)



86.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 56)   [ Time Frame: Baseline to Week 56 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count (Week 56)
Measure Description No text entered.
Time Frame Baseline to Week 56  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  430     418  
Mean Change From Baseline in CD4+ Cell Count (Week 56)  
[units: Cells/mm3]
Mean ± Standard Deviation
  39  ± 113     16  ± 95  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count (Week 56)



87.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 64)   [ Time Frame: Baseline to Week 64 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count (Week 64)
Measure Description No text entered.
Time Frame Baseline to Week 64  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  430     418  
Mean Change From Baseline in CD4+ Cell Count (Week 64)  
[units: Cells/mm3]
Mean ± Standard Deviation
  42  ± 125     13  ± 92  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count (Week 64)



88.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 72)   [ Time Frame: Baseline to Week 72 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count (Week 72)
Measure Description No text entered.
Time Frame Baseline to Week 72  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  430     418  
Mean Change From Baseline in CD4+ Cell Count (Week 72)  
[units: Cells/mm3]
Mean ± Standard Deviation
  42  ± 129     18  ± 105  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count (Week 72)



89.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 80)   [ Time Frame: Baseline to Week 80 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count (Week 80)
Measure Description No text entered.
Time Frame Baseline to Week 80  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  430     418  
Mean Change From Baseline in CD4+ Cell Count (Week 80)  
[units: Cells/mm3]
Mean ± Standard Deviation
  39  ± 125     19  ± 112  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count (Week 80)



90.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 88)   [ Time Frame: Baseline to Week 88 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count (Week 88)
Measure Description No text entered.
Time Frame Baseline to Week 88  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  430     418  
Mean Change From Baseline in CD4+ Cell Count (Week 88)  
[units: Cells/mm3]
Mean ± Standard Deviation
  41  ± 138     19  ± 109  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count (Week 88)



91.  Secondary:   Mean Change From Baseline in CD4+ Cell Count (Week 96)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4+ Cell Count (Week 96)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set having baseline CD4 (FAS CD4), included all randomized patients treated with at least one dose of study medication having baseline CD4 count

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  430     418  
Mean Change From Baseline in CD4+ Cell Count (Week 96)  
[units: Cells/mm3]
Mean ± Standard Deviation
  41  ± 132     20  ± 111  

No statistical analysis provided for Mean Change From Baseline in CD4+ Cell Count (Week 96)



92.  Secondary:   Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.   [ Time Frame: up to 75 weeks of treatment ]

Measure Type Secondary
Measure Title Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.
Measure Description

Time to death or occurrence of AIDS-defining condition according to the US Centers for Disease Control and Prevention case definition.

The median and quartiles are underestimated since more than 92% of the observations (in both treatment arms) were censored and the estimation was restricted to the largest observed event time.

Time Frame up to 75 weeks of treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Set (SAF), included all patients treated with at least one dose of study medication

Reporting Groups
  Description
Tipranavir(TPV)/Low Dose Ritonavir(r) No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) No text entered.

Measured Values
    Tipranavir(TPV)/Low Dose Ritonavir(r)     Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)  
Number of Participants Analyzed  
[units: participants]
  435     428  
Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.  
[units: Days]
Median ( Inter-Quartile Range )
  528  
  ( 528 to 528 )  
  332  
  ( 332 to 332 )  


Statistical Analysis 1 for Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.1026
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


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