HIV Infections
Conditions
Brief summary
Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.
Interventions
DRUGTipranavir
DRUGRitonavir(r)
DRUGComparator Protease Inhibitor (CPI)
Sponsors
Boehringer Ingelheim
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients meeting the following criteria will be eligible for participation in th is study: 1. Human Immunodeficiency virus 1 (HIV-1) infected males or females \>=18 years of age. 2. Screening genotypic resistance report indicating both of the following: at least one primary protease Inhibitor (PI) mutation at the following sites: 30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M, and no more than two protease mutations on codons 33, 82, 84, or 90. 3\. At least 3 consecutive months experience taking antiretrovirals (ARVs) from each of the classes of nucleoside reverse transcriptase inhibitors(NRTI(s)), non-nucleoside reverse transcriptase inhibitors(NNRTI(s)), and protease inhibitors (PIs) at some point in treatment history,with at least 2 protease inhibitor (PI)-based regimens, one of which must be the current regimen, and current protease inhibitor (PI)-based antiretroviral (ARV) medication regimen for at least 3 months prior to randomization. 4\. Human Immunodeficiency Virus 1 (HIV-1) viral load \>=1,000 copies/mL at screening.
Exclusion criteria
Patients with any of the following criteria are excluded from participation in t he study: 1. Antiretroviral (ARV) medication naïve. 2. Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for at least 7 consecutive days within the last 3 months. 3. alanine aminotransferase (ALT) \>=3.0x upper limit of normal (ULN) and aspartate aminotransferase(AST) \>=2.5x upper limit of normal (ULN) (\>=Division of AIDS(DAIDS) Grade 1) at either screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Response at Week 48 | At week 48 | 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 to Treatment Failure Through 48 Weeks of Treatment | Week 48 | Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements \<1 log10 below baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Response at Week 24 | Week 24 | 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 |
| Treatment Response at Week 2 | week 2 | 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 |
| Treatment Response at Week 4 | week 4 | 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 |
| Treatment Response at Week 8 | week 8 | 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 |
| Treatment Response at Week 16 | week 16 | 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 |
| Treatment Response at Week 32 | Week 32 | 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 |
| Treatment Response at Week 40 | Week 40 | 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 |
| Treatment Response at Week 48 | Week 48 | 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 |
| Treatment Response at Week 56 | week 56 | 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 |
| Treatment Response at Week 64 | week 64 | 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 |
| Treatment Response at Week 72 | Week 72 | 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 |
| Treatment Response at Week 80 | Week 80 | 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 |
| Treatment Response at Week 88 | Week 88 | 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 |
| Treatment Response at Week 96 | Week 96 | 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 to Treatment Failure Through 96 Weeks of Treatment | Week 96 | time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements \<1 log10 below baseline. |
| Time to Confirmed Virologic Failure Through 48 Weeks of Treatment | Week 48 | Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log. |
| Time to Confirmed Virologic Failure Through 96 Weeks of Treatment | Week 96 | Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log. |
| Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF | Week 2 through Week 96 (at any point during trial) | Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline |
| Virologic Response (Viral Load >= 1 Log Drop) at Week 2 | Week 2 | Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline |
| Virologic Response (Viral Load >= 1 Log Drop) at Week 4 | Week 4 | Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline |
| Virologic Response (Viral Load >= 1 Log Drop) at Week 8 | Week 8 | Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline |
| Virologic Response (Viral Load >= 1 Log Drop) at Week 16 | Week 16 | Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline |
| Virologic Response (Viral Load >= 1 Log Drop) at Week 24 | Week 24 | Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline |
| Virologic Response (VL < 50 Copies/ml) at Week 24 | Week 24 | Percentage of participants with Viral Load \< 50 copies/mL |
| Virologic Response (Viral Load >= 1 Log Drop) at Week 32 | Week 32 | Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline |
| Virologic Response (Viral Load >= 1 Log Drop) at Week 40 | Week 40 | Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline |
| Virologic Response (Viral Load >= 1 Log Drop) at Week 48 | Week 48 | Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline |
| Virologic Response (Viral Load >= 1 Log Drop) at Week 56 | Week 56 | Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline |
| Virologic Response (Viral Load >= 1 Log Drop) at Week 64 | Week 64 | Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline |
| Median Change From Baseline in Viral Load to Week 2 | Baseline to Week 2 | — |
| Median Change From Baseline in Viral Load to Week 4 | Baseline to Week 4 | — |
| Median Change From Baseline in Viral Load to Week 8 | Baseline to Week 8 | — |
| Virologic Response (VL < 50 Copies/ml) at Week 32 | Week 32 | Percentage of participants with Viral Load \< 50 copies/mL |
| Median Change From Baseline in Viral Load to Week 16 | Baseline to Week 16 | — |
| Median Change From Baseline in Viral Load to Week 24 | Baseline to Week 24 | — |
| Median Change From Baseline in Viral Load to Week 32 | Baseline to Week 32 | — |
| Median Change From Baseline in Viral Load to Week 40 | Baseline to Week 40 | — |
| Median Change From Baseline in Viral Load to Week 48 | Baseline to Week 48 | — |
| Median Change From Baseline in Viral Load to Week 56 | Baseline to Week 56 | — |
| Median Change From Baseline in Viral Load to Week 64 | Baseline to Week 64 | — |
| Median Change From Baseline in Viral Load to Week 72 | Baseline to Week 72 | — |
| Median Change From Baseline in Viral Load to Week 80 | Baseline to Week 80 | — |
| Median Change From Baseline in Viral Load to Week 88 | Baseline to Week 88 | — |
| Virologic Response (VL < 50 Copies/ml) at Week 40 | Week 40 | Percentage of participants with Viral Load \< 50 copies/mL |
| Median Change From Baseline in Viral Load to Week 96 | Baseline to Week 96 | — |
| Mean Change From Baseline to Week 2 in CD4+ Cell Count | Baseline to Week 2 | — |
| Mean Change From Baseline to Week 4 in CD4+ Cell Count | Baseline to Week 4 | — |
| Mean Change From Baseline to Week 8 in CD4+ Cell Count | Baseline to Week 8 | — |
| Mean Change From Baseline to Week 16 in CD4+ Cell Count | Baseline to Week 16 | — |
| Mean Change From Baseline to Week 24 in CD4+ Cell Count | Baseline to Week 24 | — |
| Mean Change From Baseline to Week 32 in CD4+ Cell Count | Baseline to Week 32 | — |
| Mean Change From Baseline to Week 40 in CD4+ Cell Count | Baseline to Week 40 | — |
| Mean Change From Baseline to Week 48 in CD4+ Cell Count | Baseline to Week 48 | — |
| Mean Change From Baseline to Week 56 in CD4+ Cell Count | Baseline to Week 56 | — |
| Mean Change From Baseline to Week 64 in CD4+ Cell Count | Baseline to Week 64 | — |
| Mean Change From Baseline to Week 72 in CD4+ Cell Count | Baseline to Week 72 | — |
| Mean Change From Baseline to Week 80 in CD4+ Cell Count | Baseline to Week 80 | — |
| Mean Change From Baseline to Week 88 in CD4+ Cell Count | Baseline to Week 88 | — |
| Mean Change From Baseline to Week 96 in CD4+ Cell Count | Baseline to Week 96 | — |
| Virologic Response (VL < 50 Copies/ml) at Week 48 | Week 48 | Percentage of participants with Viral Load \< 50 copies/mL |
| Time to New CDC Class C Progression Event or Death. | after 48 weeks of treatment | Time to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death |
| Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF | Week 2 through Week 96 (at any point during trial) | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 400 Copies/ml) at Week 2 | Week 2 | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 400 Copies/ml) at Week 4 | Week 4 | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 400 Copies/ml) at Week 8 | Week 8 | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 400 Copies/ml) at Week 16 | Week 16 | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 400 Copies/ml) at Week 24 | Week 24 | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 400 Copies/ml) at Week 32 | week 32 | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 400 Copies/ml) at Week 40 | Week 40 | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 400 Copies/ml) at Week 48 | Week 48 | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 400 Copies/ml) at Week 56 | Week 56 | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 400 Copies/ml) at Week 64 | Week 64 | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 400 Copies/ml) at Week 72 | Week 72 | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 400 Copies/ml) at Week 80 | Week 80 | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 400 Copies/ml) at Week 88 | week 88 | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 400 Copies/ml) at Week 96 | week 96 | Percentage of participants with Viral Load \< 400 copies/mL |
| Virologic Response (VL < 50 Copies/ml) at Week 56 | Week 56 | Percentage of participants with Viral Load \< 50 copies/mL |
| Virologic Response (VL < 50 Copies/ml) at Week 2 | Week 2 | Percentage of participants with Viral Load \< 50 copies/mL |
| Virologic Response (VL < 50 Copies/ml) at Week 4 | Week 4 | Percentage of participants with Viral Load \< 50 copies/mL |
| Virologic Response (VL < 50 Copies/ml) at Week 8 | Week 8 | Percentage of participants with Viral Load \< 50 copies/mL |
| Virologic Response (VL < 50 Copies/ml) at Week 16 | Week 16 | Percentage of participants with Viral Load \< 50 copies/mL |
| Virologic Response (VL < 50 Copies/ml) at Week 72 | Week 72 | Percentage of participants with Viral Load \< 50 copies/mL |
| Virologic Response (VL < 50 Copies/ml) at Week 80 | Week 80 | Percentage of participants with Viral Load \< 50 copies/mL |
| Virologic Response (VL < 50 Copies/ml) at Week 88 | Week 88 | Percentage of participants with Viral Load \< 50 copies/mL |
| Virologic Response (VL < 50 Copies/ml) at Week 96 | Week 96 | Percentage of participants with Viral Load \< 50 copies/mL |
| Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | 240 Weeks | NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004. |
| Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF | Week 2 through Week 96 (at any point during trial) | Percentage of participants with Viral Load \< 50 copies/mL |
| Virologic Response (VL < 50 Copies/ml) at Week 64 | Week 64 | Percentage of participants with Viral Load \< 50 copies/mL |
Countries
Australia, Canada, Puerto Rico, United States
Participant flow
Pre-assignment details
In the study there were 630 patients entered as stated in the protocol section. There were 10 patients not treated and are not included within the Participant Flow Module or any other analysis.
Participants by arm
| Arm | Count |
|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) TPV 500 mg / Ritonavir 200 mg, twice daily | 311 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) lopinavir, amprenavir \[or fosamprenavir\], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) | 309 |
| Total | 620 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 70 | 22 |
| Overall Study | Lost to Follow-up | 23 | 13 |
| Overall Study | Other reason not defined above | 117 | 217 |
| Overall Study | Protocol Violation | 18 | 19 |
| Overall Study | Randomized but not treated | 2 | 8 |
| Overall Study | Withdrawal by Subject | 32 | 20 |
Baseline characteristics
| Characteristic | Tipranavir(TPV)/Low Dose Ritonavir(r) | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Total |
|---|---|---|---|
| Age, Continuous | 45.6 years STANDARD_DEVIATION 7.9 | 44.5 years STANDARD_DEVIATION 7.1 | 45.1 years STANDARD_DEVIATION 7.5 |
| Sex: Female, Male Female | 33 Participants | 22 Participants | 55 Participants |
| Sex: Female, Male Male | 278 Participants | 287 Participants | 565 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 301 / 311 | 271 / 309 |
| serious Total, serious adverse events | 113 / 311 | 61 / 309 |
Outcome results
Primary
Time to Treatment Failure Through 48 Weeks of Treatment
Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements \<1 log10 below baseline.
Time frame: Week 48
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Time to Treatment Failure Through 48 Weeks of Treatment | 113 Days |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Time to Treatment Failure Through 48 Weeks of Treatment | 0 Days |
p-value: 0.0001Log Rank
Primary
Treatment Response at Week 48
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: At week 48
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 48 | 33.80 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 48 | 16.20 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Mean Change From Baseline to Week 16 in CD4+ Cell Count
Time frame: Baseline to Week 16
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 16 in CD4+ Cell Count | 55 Cells/mm3 | Standard Deviation 92 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 16 in CD4+ Cell Count | 30 Cells/mm3 | Standard Deviation 78 |
Secondary
Mean Change From Baseline to Week 24 in CD4+ Cell Count
Time frame: Baseline to Week 24
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 24 in CD4+ Cell Count | 54 Cells/mm3 | Standard Deviation 86 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 24 in CD4+ Cell Count | 24 Cells/mm3 | Standard Deviation 77 |
Secondary
Mean Change From Baseline to Week 2 in CD4+ Cell Count
Time frame: Baseline to Week 2
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 2 in CD4+ Cell Count | 23 Cells/mm3 | Standard Deviation 48 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 2 in CD4+ Cell Count | 19 Cells/mm3 | Standard Deviation 63 |
Secondary
Mean Change From Baseline to Week 32 in CD4+ Cell Count
Time frame: Baseline to Week 32
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 32 in CD4+ Cell Count | 51 Cells/mm3 | Standard Deviation 91 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 32 in CD4+ Cell Count | 26 Cells/mm3 | Standard Deviation 87 |
Secondary
Mean Change From Baseline to Week 40 in CD4+ Cell Count
Time frame: Baseline to Week 40
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 40 in CD4+ Cell Count | 50 Cells/mm3 | Standard Deviation 100 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 40 in CD4+ Cell Count | 24 Cells/mm3 | Standard Deviation 84 |
Secondary
Mean Change From Baseline to Week 48 in CD4+ Cell Count
Time frame: Baseline to Week 48
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 48 in CD4+ Cell Count | 46 Cells/mm3 | Standard Deviation 95 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 48 in CD4+ Cell Count | 28 Cells/mm3 | Standard Deviation 86 |
Secondary
Mean Change From Baseline to Week 4 in CD4+ Cell Count
Time frame: Baseline to Week 4
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 4 in CD4+ Cell Count | 41 Cells/mm3 | Standard Deviation 69 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 4 in CD4+ Cell Count | 22 Cells/mm3 | Standard Deviation 64 |
Secondary
Mean Change From Baseline to Week 56 in CD4+ Cell Count
Time frame: Baseline to Week 56
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 56 in CD4+ Cell Count | 52 Cells/mm3 | Standard Deviation 104 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 56 in CD4+ Cell Count | 26 Cells/mm3 | Standard Deviation 88 |
Secondary
Mean Change From Baseline to Week 64 in CD4+ Cell Count
Time frame: Baseline to Week 64
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 64 in CD4+ Cell Count | 50 Cells/mm3 | Standard Deviation 107 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 64 in CD4+ Cell Count | 26 Cells/mm3 | Standard Deviation 94 |
Secondary
Mean Change From Baseline to Week 72 in CD4+ Cell Count
Time frame: Baseline to Week 72
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 72 in CD4+ Cell Count | 50 Cells/mm3 | Standard Deviation 113 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 72 in CD4+ Cell Count | 24 Cells/mm3 | Standard Deviation 96 |
Secondary
Mean Change From Baseline to Week 80 in CD4+ Cell Count
Time frame: Baseline to Week 80
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 80 in CD4+ Cell Count | 55 Cells/mm3 | Standard Deviation 122 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 80 in CD4+ Cell Count | 26 Cells/mm3 | Standard Deviation 93 |
Secondary
Mean Change From Baseline to Week 88 in CD4+ Cell Count
Time frame: Baseline to Week 88
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 88 in CD4+ Cell Count | 60 Cells/mm3 | Standard Deviation 126 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 88 in CD4+ Cell Count | 29 Cells/mm3 | Standard Deviation 100 |
Secondary
Mean Change From Baseline to Week 8 in CD4+ Cell Count
Time frame: Baseline to Week 8
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 8 in CD4+ Cell Count | 49 Cells/mm3 | Standard Deviation 72 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 8 in CD4+ Cell Count | 25 Cells/mm3 | Standard Deviation 72 |
Secondary
Mean Change From Baseline to Week 96 in CD4+ Cell Count
Time frame: Baseline to Week 96
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 96 in CD4+ Cell Count | 60 Cells/mm3 | Standard Deviation 133 |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Mean Change From Baseline to Week 96 in CD4+ Cell Count | 28 Cells/mm3 | Standard Deviation 97 |
Secondary
Median Change From Baseline in Viral Load to Week 16
Time frame: Baseline to Week 16
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 16 | -1.08 Log(Copies/mL) |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 16 | -0.32 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load to Week 2
Time frame: Baseline to Week 2
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 2 | -1.36 Log(Copies/mL) |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 2 | -0.57 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load to Week 24
Time frame: Baseline to Week 24
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 24 | -0.81 Log(Copies/mL) |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 24 | -0.3 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load to Week 32
Time frame: Baseline to Week 32
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 32 | -0.73 Log(Copies/mL) |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 32 | -0.24 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load to Week 4
Time frame: Baseline to Week 4
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 4 | -1.56 Log(Copies/mL) |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 4 | -0.46 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load to Week 40
Time frame: Baseline to Week 40
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 40 | -0.74 Log(Copies/mL) |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 40 | -0.23 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load to Week 48
Time frame: Baseline to Week 48
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 48 | -0.61 Log(Copies/mL) |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 48 | -0.24 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load to Week 56
Time frame: Baseline to Week 56
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 56 | -0.57 Log(Copies/mL) |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 56 | -0.23 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load to Week 64
Time frame: Baseline to Week 64
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 64 | -0.6 Log(Copies/mL) |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 64 | -0.23 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load to Week 72
Time frame: Baseline to Week 72
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 72 | -0.65 Log(Copies/mL) |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 72 | -0.21 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load to Week 8
Time frame: Baseline to Week 8
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 8 | -1.6 Log(Copies/mL) |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 8 | -0.43 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load to Week 80
Time frame: Baseline to Week 80
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 80 | -0.64 Log(Copies/mL) |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 80 | -0.21 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load to Week 88
Time frame: Baseline to Week 88
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 88 | -0.64 Log(Copies/mL) |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 88 | -0.21 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load to Week 96
Time frame: Baseline to Week 96
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 96 | -0.6 Log(Copies/mL) |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load to Week 96 | -0.21 Log(Copies/mL) |
Secondary
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities
NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Time frame: 240 Weeks
Population: Safety Analysis Set with On-Treatment data (SAF-OT), all patients treated with at least one dose of study drug and have on-treatment laboratory values
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | White Blood Cell Count Increase | 0 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Alkaline phosphatase | 1.0 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Alanine Transaminase (ALT) | 13.5 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Amylase | 11.8 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Platelets | 2.0 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Lipase | 2.0 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Aspartate Transaminase (AST) | 7.9 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Cholesterol | 23.7 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | White Blood Cell Count Decrease | 5.3 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Triglycerides | 29.3 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | ALT or AST | 15.1 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Glucose, increase | 3.3 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Prothrombin Time | 1.6 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Glucose, decrease | 0 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Bilirubin, Total | 1.0 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Creatinine | 2.0 Percentage of participants |
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Haemoglobin | 1.3 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Creatinine | 2.3 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Haemoglobin | 0.7 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | White Blood Cell Count Increase | 0 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | White Blood Cell Count Decrease | 5.3 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Platelets | 0.7 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Prothrombin Time | 2.0 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Alanine Transaminase (ALT) | 1.6 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Aspartate Transaminase (AST) | 1.6 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | ALT or AST | 2.6 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Bilirubin, Total | 0.7 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Alkaline phosphatase | 0 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Amylase | 9.2 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Lipase | 1.3 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Cholesterol | 8.6 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Triglycerides | 15.5 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Glucose, increase | 2.0 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities | Glucose, decrease | 1.0 Percentage of participants |
Secondary
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.
Time frame: Week 48
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Time to Confirmed Virologic Failure Through 48 Weeks of Treatment | 113 Days |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Time to Confirmed Virologic Failure Through 48 Weeks of Treatment | 0 Days |
p-value: 0.0001Log Rank
Secondary
Time to Confirmed Virologic Failure Through 96 Weeks of Treatment
Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.
Time frame: Week 96
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Time to Confirmed Virologic Failure Through 96 Weeks of Treatment | 116 Days |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Time to Confirmed Virologic Failure Through 96 Weeks of Treatment | 0 Days |
p-value: 0.0001Log Rank
Secondary
Time to New CDC Class C Progression Event or Death.
Time to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death
Time frame: after 48 weeks of treatment
Population: Safety Analysis Set (SAF), includes all patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Time to New CDC Class C Progression Event or Death. | 448 Days |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Time to New CDC Class C Progression Event or Death. | 284 Days |
p-value: 0.9894Log Rank
Secondary
Time to Treatment Failure Through 96 Weeks of Treatment
time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements \<1 log10 below baseline.
Time frame: Week 96
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Time to Treatment Failure Through 96 Weeks of Treatment | 114 Days |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Time to Treatment Failure Through 96 Weeks of Treatment | 0 Days |
p-value: 0.0001Log Rank
Secondary
Treatment Response at Week 16
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
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 16 | 45.7 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 16 | 27.5 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 2
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
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 2 | 53.1 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 2 | 34.3 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 24
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
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 24 | 41.8 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 24 | 23.9 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 24
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
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 24 | 42.1 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 24 | 23.6 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 32
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
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 32 | 37.9 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 32 | 19.4 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 4
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
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 4 | 52.4 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 4 | 33.3 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 40
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
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 40 | 35.4 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 40 | 17.8 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 48
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 48
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 48 | 33.8 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 48 | 16.2 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 56
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
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 56 | 32.5 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 56 | 15.9 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 64
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
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 64 | 31.3 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 64 | 15.5 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 72
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
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 72 | 29.6 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 72 | 14.9 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 8
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
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 8 | 52.4 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 8 | 33.3 Percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 80
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
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 80 | 28 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 80 | 14.2 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 88
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
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 88 | 27.3 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 88 | 12.9 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 96
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 96
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Treatment Response at Week 96 | 26.7 percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Treatment Response at Week 96 | 11.7 percentage of participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF
Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline
Time frame: Week 2 through Week 96 (at any point during trial)
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF | 79.1 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF | 50.5 Percentage of participants |
Secondary
Virologic Response (Viral Load >= 1 Log Drop) at Week 16
Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline
Time frame: Week 16
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 16 | 47.3 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 16 | 26.5 Percentage of participants |
Secondary
Virologic Response (Viral Load >= 1 Log Drop) at Week 2
Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline
Time frame: Week 2
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 2 | 63.3 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 2 | 40.1 Percentage of participants |
Secondary
Virologic Response (Viral Load >= 1 Log Drop) at Week 24
Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline
Time frame: Week 24
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 24 | 43.1 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 24 | 22.3 Percentage of participants |
Secondary
Virologic Response (Viral Load >= 1 Log Drop) at Week 32
Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline
Time frame: Week 32
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 32 | 38.9 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 32 | 19.1 Percentage of participants |
Secondary
Virologic Response (Viral Load >= 1 Log Drop) at Week 4
Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline
Time frame: Week 4
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 4 | 63.3 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 4 | 40.1 Percentage of participants |
Secondary
Virologic Response (Viral Load >= 1 Log Drop) at Week 40
Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline
Time frame: Week 40
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 40 | 36.7 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 40 | 17.5 Percentage of participants |
Secondary
Virologic Response (Viral Load >= 1 Log Drop) at Week 48
Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline
Time frame: Week 48
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 48 | 36.3 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 48 | 16.2 Percentage of participants |
Secondary
Virologic Response (Viral Load >= 1 Log Drop) at Week 56
Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline
Time frame: Week 56
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 56 | 34.1 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 56 | 15.5 Percentage of participants |
Secondary
Virologic Response (Viral Load >= 1 Log Drop) at Week 64
Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline
Time frame: Week 64
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 64 | 34.1 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 64 | 16.2 Percentage of participants |
Secondary
Virologic Response (Viral Load >= 1 Log Drop) at Week 8
Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline
Time frame: Week 8
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 8 | 55.9 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (Viral Load >= 1 Log Drop) at Week 8 | 34.3 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: Week 2 through Week 96 (at any point during trial)
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF | 53.4 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF | 32.4 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Week 16
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: Week 16
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 16 | 35.7 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 16 | 20.7 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Week 2
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: Week 2
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 2 | 14.8 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 2 | 13.6 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Week 24
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: Week 24
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 24 | 34.4 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 24 | 16.5 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Week 32
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: week 32
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 32 | 32.8 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 32 | 14.9 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Week 4
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: Week 4
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 4 | 28.3 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 4 | 19.1 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Week 40
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: Week 40
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 40 | 32.8 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 40 | 14.6 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Week 48
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: Week 48
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 48 | 30.5 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 48 | 13.6 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Week 56
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: Week 56
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 56 | 29.6 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 56 | 13.9 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Week 64
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: Week 64
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 64 | 28.6 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 64 | 13.3 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Week 72
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: Week 72
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 72 | 28.9 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 72 | 12.9 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Week 8
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: Week 8
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 8 | 37.3 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 8 | 23.6 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Week 80
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: Week 80
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 80 | 27.7 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 80 | 13.6 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Week 88
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: week 88
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 88 | 27.7 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 88 | 12.6 Percentage of participants |
Secondary
Virologic Response (VL < 400 Copies/ml) at Week 96
Percentage of participants with Viral Load \< 400 copies/mL
Time frame: week 96
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 96 | 26.7 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 400 Copies/ml) at Week 96 | 11.7 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 2 through Week 96 (at any point during trial)
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF | 37.9 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF | 20.4 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Week 16
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 16
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 16 | 23.5 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 16 | 9.4 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Week 2
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 2
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 2 | 1.9 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 2 | 1.9 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Week 24
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 24
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 24 | 24.8 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 24 | 10 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Week 32
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 32
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 32 | 24.8 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 32 | 10 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Week 4
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 4
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 4 | 6.4 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 4 | 4.2 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Week 40
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 40
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 40 | 23.5 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 40 | 8.4 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Week 48
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 48
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 48 | 22.5 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 48 | 9.7 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Week 56
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 56
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 56 | 21.5 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 56 | 10 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Week 64
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 64
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 64 | 22.8 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 64 | 10.7 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Week 72
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 72
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 72 | 21.2 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 72 | 11.3 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Week 8
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 8
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 8 | 16.1 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 8 | 8.1 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Week 80
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 80
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 80 | 20.6 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 80 | 10.7 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Week 88
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 88
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 88 | 22.2 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 88 | 9.7 Percentage of participants |
Secondary
Virologic Response (VL < 50 Copies/ml) at Week 96
Percentage of participants with Viral Load \< 50 copies/mL
Time frame: Week 96
Population: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 96 | 20.9 Percentage of participants |
| Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | Virologic Response (VL < 50 Copies/ml) at Week 96 | 9.4 Percentage of participants |