HIV Infections
Conditions
Brief summary
The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load \> =1000 cells/mL, and genotype indicating at least one resistance conferring protease inhibitor-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.
Interventions
DRUGTipranavir (with low dose ritonavir)
DRUGComparator protease inhibitor(CPI)/low dose ritonavir(r)
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
1. Signed informed consent prior to trial participation. 2. Human immunodeficiency virus-1 infected males or females \>=18 years of age. 3. Screening genotypic resistance report indicating both of the following: * at least one primary protease 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. 4. At least 3 consecutive months experience taking antiretrovirals from each of the classes of Nucleoside reverse transcriptase inhibitor(s), Non-nucleoside reverse transcriptase inhibitor(s), and Protease inhibitor(s) at some point in treatment history, * with at least 2 Protease inhibitor-based regimens (minimum 3 months of exposure of each), one of which must be part of the current regimen, and * current Protease inhibitor-based antiretroviral medication regimen for at least 3 months prior to randomisation. 5. Human immunodeficiency virus-1 viral load \>=1000 copies/mL at screening. 6. Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply: * Total cholesterol \<=400 mg/dl or 10,36 mm/L. * Total triglycerides \<=750 mg/dl or 8,5 mm/L. * Alanine aminotransferase \<=3x upper limit of normal and aspartate aminotransferase \<=2.5x upper limit of normal. * Any Grade gamma-glutamyl transpeptidase is acceptable. * Any Grade creatinine kinase is acceptable as long as there is no concurrent myopathy. * All other laboratory test values \<= Grade 1(Division of Acquired immune deficiency syndrome, National Institute of Health grading scale). 7. Acceptable medical history, as assessed by the investigator, with chest X-ray and electrocardiogram within 1 year of study participation. 8. Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system. 9. A prior Acquired immune deficiency syndrome-defining event is acceptable as long as it has resolved or the patient has been on stable treatment for at least 2 months (Acquired immune deficiency syndrome related complex is acceptable).
Exclusion criteria
1. Antiretroviral medication naïve. 2. Patients on recent drug holiday, defined as off antiretroviral medications for at least 7 consecutive days within the last 3 months. 3. Alanine aminotransferase \>3x upper limit of normal and aspartate aminotransferase \>2.5x upper limit of normal at either screening visit. 4. Female patients of child-bearing potential who: * have a positive serum pregnancy test at screening or during the study, * are breast feeding * are planning to become pregnant, or * are not willing to use a barrier method of contraception, or * require ethinyl estradiol administration 5. Prior tipranavir use. 6. Use of investigational medications within 30 days before study entry or during the trial. (T-20 \[enfuvirtide\] and Tenofovir (Viread), investigational at the time of writing of this protocol, will be allowed.) 7. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2). 8. Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator. 9. In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Response at Week 48 | after 48 weeks of treatment | 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 to Treatment Failure Through 48 Weeks of Treatment | after 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 Log(baseline Viral Load) - Log(on-treatment Viral Load) \< 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Response at Week 4 | week 4 | 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 |
| Treatment Response at Week 8 | week 8 | 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 |
| Treatment Response at Week 16 | week 16 | 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 |
| Treatment Response at Week 24 | Week 24 | 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 |
| Treatment Response at Week 32 | week 32 | 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 |
| Treatment Response at Week 40 | week 40 | 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 |
| Treatment Response at Week 64 | week 64 | 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 |
| Treatment Response at Week 72 | week 72 | 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 |
| Treatment Response at Week 80 | week 80 | 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 |
| Treatment Response at Week 88 | week 88 | 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 |
| Treatment Response at Week 96 | after 96 weeks of treatment | 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 to Treatment Failure Through 96 Weeks of Treatment | after 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 Log(baseline Viral Load) - Log(on-treatment Viral Load) \< 1. |
| Time to Confirmed Virologic Failure Through 48 Weeks of Treatment | after 48 weeks of treatment | 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 to Confirmed Virologic Failure Through 96 Weeks of Treatment | after 96 weeks of treatment | 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. |
| Virologic Response at Week 72 | Week 72 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Virologic Response | Week 2 through Week 96 (at any point during trial) | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Virologic Response at Week 2 | Week 2 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Virologic Response at Week 4 | week 4 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Virologic Response at Week 8 | week 8 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Virologic Response at Week 16 | week 16 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Virologic Response at Week 24 | week 24 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Virologic Response at Week 32 | week 32 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Virologic Response at Week 40 | week 40 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Virologic Response at Week 48 | week 48 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Virologic Response at Week 56 | week 56 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Virologic Response at Week 64 | week 64 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Virologic Response at Week 80 | Week 80 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Virologic Response at Week 88 | Week 88 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Virologic Response at Week 96 | Week 96 | Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1 |
| Median Change From Baseline in Viral Load (Week 2) | Baseline to Week 2 | — |
| Median Change From Baseline in Viral Load (Week 4) | Baseline to Week 4 | — |
| Median Change From Baseline in Viral Load (Week 8) | Baseline to Week 8 | — |
| Median Change From Baseline in Viral Load (Week 16) | Baseline to Week 16 | — |
| Median Change From Baseline in Viral Load (Week 24) | Baseline to Week 24 | — |
| Median Change From Baseline in Viral Load (Week 32) | Baseline to Week 32 | — |
| Median Change From Baseline in Viral Load (Week 40) | Baseline to Week 40 | — |
| Median Change From Baseline in Viral Load (Week 48) | Baseline to Week 48 | — |
| Median Change From Baseline in Viral Load (Week 56) | Baseline to Week 56 | — |
| Median Change From Baseline in Viral Load (Week 64) | Baseline to Week 64 | — |
| Median Change From Baseline in Viral Load (Week 72) | Baseline to Week 72 | — |
| Median Change From Baseline in Viral Load (Week 80) | Baseline to Week 80 | — |
| Median Change From Baseline in Viral Load (Week 88) | Baseline to Week 88 | — |
| Median Change From Baseline in Viral Load (Week 96) | Baseline to Week 96 | — |
| Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks | Week 2 through Week 96 (at any point during trial) | Virologic response defined as Viral Load\<400 copies/mL |
| Mean Change From Baseline in CD4+ Cell Count (Week 2) | Baseline to Week 2 | — |
| Mean Change From Baseline in CD4+ Cell Count (Week 4) | Baseline to Week 4 | — |
| Mean Change From Baseline in CD4+ Cell Count (Week 8) | Baseline to Week 8 | — |
| Mean Change From Baseline in CD4+ Cell Count (Week 16) | Baseline to Week 16 | — |
| Mean Change From Baseline in CD4+ Cell Count (Week 24) | Baseline to Week 24 | — |
| Mean Change From Baseline in CD4+ Cell Count (Week 32) | Baseline to Week 32 | — |
| Mean Change From Baseline in CD4+ Cell Count (Week 40) | Baseline to Week 40 | — |
| Mean Change From Baseline in CD4+ Cell Count (Week 48) | Baseline to Week 48 | — |
| Mean Change From Baseline in CD4+ Cell Count (Week 56) | Baseline to Week 56 | — |
| Treatment Response at Week 56 | week 56 | 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 |
| Mean Change From Baseline in CD4+ Cell Count (Week 72) | Baseline to Week 72 | — |
| Mean Change From Baseline in CD4+ Cell Count (Week 80) | Baseline to Week 80 | — |
| Mean Change From Baseline in CD4+ Cell Count (Week 88) | Baseline to Week 88 | — |
| Mean Change From Baseline in CD4+ Cell Count (Week 96) | Baseline to Week 96 | — |
| Time to New Centers for Disease Control (CDC) Class C Progression Event or Death. | up to 75 weeks of treatment | 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. |
| Mean Change From Baseline in CD4+ Cell Count (Week 64) | Baseline to Week 64 | — |
| Treatment Response at Week 2 | week 2 | 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 |
Countries
Argentina, Austria, Belgium, Brazil, Denmark, France, Germany, Greece, Ireland, Italy, Mexico, Netherlands, Portugal, Spain, Sweden, Switzerland, United Kingdom
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | 435 |
| Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | 428 |
| Total | 863 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 84 | 41 |
| Overall Study | Lost to Follow-up | 5 | 10 |
| Overall Study | Other reason not defined above | 211 | 316 |
| Overall Study | Protocol Violation | 23 | 16 |
| Overall Study | Withdrawal by Subject | 29 | 13 |
Baseline characteristics
| Characteristic | Tipranavir(TPV)/Low Dose Ritonavir(r) | Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Total |
|---|---|---|---|
| Age, Continuous | 42.5 years STANDARD_DEVIATION 8.4 | 42.9 years STANDARD_DEVIATION 8 | 42.7 years STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 84 Participants | 64 Participants | 148 Participants |
| Sex: Female, Male Male | 351 Participants | 364 Participants | 715 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 359 / 438 | 270 / 428 |
| serious Total, serious adverse events | 123 / 438 | 89 / 428 |
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 Log(baseline Viral Load) - Log(on-treatment Viral Load) \< 1.
Time frame: after 48 weeks of treatment
Population: Full Analysis Set (FAS), included 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 | 112 Days |
| Comparator Protease Inhibitor(CPI)/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
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
Population: Full Analysis Set (FAS), included 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 | 34.5 percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Treatment Response at Week 48 | 15 percentage of participants |
p-value: 0.000195% CI: [12.9, 24]Cochran-Mantel-Haenszel
Secondary
Mean Change From Baseline in CD4+ Cell Count (Week 16)
Time frame: Baseline to Week 16
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 16) | 57 Cells/mm3 | Standard Deviation 90 |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 16) | 25 Cells/mm3 | Standard Deviation 77 |
Secondary
Mean Change From Baseline in CD4+ Cell Count (Week 2)
Time frame: Baseline to Week 2
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 2) | 26 Cells/mm3 | Standard Deviation 65 |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 2) | 13 Cells/mm3 | Standard Deviation 56 |
Secondary
Mean Change From Baseline in CD4+ Cell Count (Week 24)
Time frame: Baseline to Week 24
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 24) | 51 Cells/mm3 | Standard Deviation 97 |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 24) | 21 Cells/mm3 | Standard Deviation 81 |
Secondary
Mean Change From Baseline in CD4+ Cell Count (Week 32)
Time frame: Baseline to Week 32
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 32) | 46 Cells/mm3 | Standard Deviation 102 |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 32) | 17 Cells/mm3 | Standard Deviation 87 |
Secondary
Mean Change From Baseline in CD4+ Cell Count (Week 4)
Time frame: Baseline to Week 4
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 4) | 39 Cells/mm3 | Standard Deviation 77 |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 4) | 19 Cells/mm3 | Standard Deviation 64 |
Secondary
Mean Change From Baseline in CD4+ Cell Count (Week 40)
Time frame: Baseline to Week 40
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 40) | 47 Cells/mm3 | Standard Deviation 99 |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 40) | 19 Cells/mm3 | Standard Deviation 87 |
Secondary
Mean Change From Baseline in CD4+ Cell Count (Week 48)
Time frame: Baseline to Week 48
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 48) | 43 Cells/mm3 | Standard Deviation 109 |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 48) | 16 Cells/mm3 | Standard Deviation 92 |
Secondary
Mean Change From Baseline in CD4+ Cell Count (Week 56)
Time frame: Baseline to Week 56
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 56) | 39 Cells/mm3 | Standard Deviation 113 |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 56) | 16 Cells/mm3 | Standard Deviation 95 |
Secondary
Mean Change From Baseline in CD4+ Cell Count (Week 64)
Time frame: Baseline to Week 64
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 64) | 42 Cells/mm3 | Standard Deviation 125 |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 64) | 13 Cells/mm3 | Standard Deviation 92 |
Secondary
Mean Change From Baseline in CD4+ Cell Count (Week 72)
Time frame: Baseline to Week 72
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 72) | 42 Cells/mm3 | Standard Deviation 129 |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 72) | 18 Cells/mm3 | Standard Deviation 105 |
Secondary
Mean Change From Baseline in CD4+ Cell Count (Week 8)
Time frame: Baseline to Week 8
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 8) | 52 Cells/mm3 | Standard Deviation 85 |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 8) | 25 Cells/mm3 | Standard Deviation 76 |
Secondary
Mean Change From Baseline in CD4+ Cell Count (Week 80)
Time frame: Baseline to Week 80
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 80) | 39 Cells/mm3 | Standard Deviation 125 |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 80) | 19 Cells/mm3 | Standard Deviation 112 |
Secondary
Mean Change From Baseline in CD4+ Cell Count (Week 88)
Time frame: Baseline to Week 88
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 88) | 41 Cells/mm3 | Standard Deviation 138 |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 88) | 19 Cells/mm3 | Standard Deviation 109 |
Secondary
Mean Change From Baseline in CD4+ Cell Count (Week 96)
Time frame: Baseline to Week 96
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 96) | 41 Cells/mm3 | Standard Deviation 132 |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Mean Change From Baseline in CD4+ Cell Count (Week 96) | 20 Cells/mm3 | Standard Deviation 111 |
Secondary
Median Change From Baseline in Viral Load (Week 16)
Time frame: Baseline to Week 16
Population: Full Analysis Set (FAS), included 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 (Week 16) | -1.03 Log(Copies/mL) |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load (Week 16) | -0.3 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load (Week 2)
Time frame: Baseline to Week 2
Population: Full Analysis Set (FAS), included 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 (Week 2) | -1.27 Log(Copies/mL) |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load (Week 2) | -0.56 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load (Week 24)
Time frame: Baseline to Week 24
Population: Full Analysis Set (FAS), included 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 (Week 24) | -0.69 Log(Copies/mL) |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load (Week 24) | -0.21 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load (Week 32)
Time frame: Baseline to Week 32
Population: Full Analysis Set (FAS), included 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 (Week 32) | -0.63 Log(Copies/mL) |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load (Week 32) | -0.24 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load (Week 4)
Time frame: Baseline to Week 4
Population: Full Analysis Set (FAS), included 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 (Week 4) | -1.47 Log(Copies/mL) |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load (Week 4) | -0.42 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load (Week 40)
Time frame: Baseline to Week 40
Population: Full Analysis Set (FAS), included 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 (Week 40) | -0.65 Log(Copies/mL) |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load (Week 40) | -0.2 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load (Week 48)
Time frame: Baseline to Week 48
Population: Full Analysis Set (FAS), included 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 (Week 48) | -0.65 Log(Copies/mL) |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load (Week 48) | -0.2 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load (Week 56)
Time frame: Baseline to Week 56
Population: Full Analysis Set (FAS), included 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 (Week 56) | -0.64 Log(Copies/mL) |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load (Week 56) | -0.22 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load (Week 64)
Time frame: Baseline to Week 64
Population: Full Analysis Set (FAS), included 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 (Week 64) | -0.63 Log(Copies/mL) |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load (Week 64) | -0.21 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load (Week 72)
Time frame: Baseline to Week 72
Population: Full Analysis Set (FAS), included 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 (Week 72) | -0.52 Log(Copies/mL) |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load (Week 72) | -0.2 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load (Week 8)
Time frame: Baseline to Week 8
Population: Full Analysis Set (FAS), included 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 (Week 8) | -1.4 Log(Copies/mL) |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load (Week 8) | -0.33 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load (Week 80)
Time frame: Baseline to Week 80
Population: Full Analysis Set (FAS), included 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 (Week 80) | -0.55 Log(Copies/mL) |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load (Week 80) | -0.2 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load (Week 88)
Time frame: Baseline to Week 88
Population: Full Analysis Set (FAS), included 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 (Week 88) | -0.56 Log(Copies/mL) |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load (Week 88) | -0.2 Log(Copies/mL) |
Secondary
Median Change From Baseline in Viral Load (Week 96)
Time frame: Baseline to Week 96
Population: Full Analysis Set (FAS), included 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 (Week 96) | -0.56 Log(Copies/mL) |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Median Change From Baseline in Viral Load (Week 96) | -0.2 Log(Copies/mL) |
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 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
Population: Full Analysis Set (FAS), included 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 | 117 Days |
| Comparator Protease Inhibitor(CPI)/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 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
Population: Full Analysis Set (FAS), included 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 | 117 Days |
| Comparator Protease Inhibitor(CPI)/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 Centers for Disease Control (CDC) Class C Progression Event or Death.
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
Population: Safety Set (SAF), included all patients treated with at least one dose of study medication
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Time to New Centers for Disease Control (CDC) Class C Progression Event or Death. | 528 Days |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Time to New Centers for Disease Control (CDC) Class C Progression Event or Death. | 332 Days |
p-value: 0.1026Log 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 Log(baseline Viral Load) - Log(on-treatment Viral Load) \< 1.
Time frame: after 96 weeks of treatment
Population: Full Analysis Set (FAS), included 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 | 115 Days |
| Comparator Protease Inhibitor(CPI)/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
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
Population: Full Analysis Set (FAS), included 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 | 47.1 percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Treatment Response at Week 16 | 19.9 percentage of participants |
p-value: 0.000195% CI: [20.5, 32.6]Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 2
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
Population: Full Analysis Set (FAS), included 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 | 51 percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Treatment Response at Week 2 | 25.9 percentage of participants |
p-value: 0.000195% CI: [18.6, 31.1]Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 24
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
Population: Full Analysis Set (FAS), included 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 | 40.9 percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Treatment Response at Week 24 | 18.0 percentage of participants |
p-value: 0.000195% CI: [16.2, 27.9]Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 32
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
Population: Full Analysis Set (FAS), included 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 | 37.2 percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Treatment Response at Week 32 | 17.3 percentage of participants |
p-value: 0.000195% CI: [13.3, 24.7]Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 4
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
Population: Full Analysis Set (FAS), included 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 | 59.1 percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Treatment Response at Week 4 | 29.9 percentage of participants |
p-value: 0.000195% CI: [22.5, 35.1]Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 40
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
Population: Full Analysis Set (FAS), included 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 | 36.3 percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Treatment Response at Week 40 | 16.6 percentage of participants |
p-value: 0.000195% CI: [13, 24.4]Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 56
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
Population: Full Analysis Set (FAS), included 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 | 32.6 percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Treatment Response at Week 56 | 14.5 percentage of participants |
p-value: 0.000195% CI: [11.7, 22.7]Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 64
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
Population: Full Analysis Set (FAS), included 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 percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Treatment Response at Week 64 | 13.3 percentage of participants |
p-value: 0.000195% CI: [11.7, 22.4]Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 72
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
Population: Full Analysis Set (FAS), included 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 | 30.1 percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Treatment Response at Week 72 | 12.1 percentage of participants |
p-value: 0.000195% CI: [12, 22.5]Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 8
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
Population: Full Analysis Set (FAS), included 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 | 54.3 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Treatment Response at Week 8 | 24.5 Percentage of participants |
p-value: 0.000195% CI: [23.2, 35.7]Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 80
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
Population: Full Analysis Set (FAS), included 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 | 28.5 percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Treatment Response at Week 80 | 11.4 percentage of participants |
p-value: 0.000195% CI: [11.2, 21.5]Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 88
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
Population: Full Analysis Set (FAS), included 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 | 27.8 percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Treatment Response at Week 88 | 11 percentage of participants |
p-value: 0.000195% CI: [11.1, 21.3]Cochran-Mantel-Haenszel
Secondary
Treatment Response at Week 96
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
Population: Full Analysis Set (FAS), included 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 | 26.2 percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Treatment Response at Week 96 | 10 percentage of participants |
p-value: 0.000195% CI: [10.6, 20.6]Cochran-Mantel-Haenszel
Secondary
Virologic Response
Virologic response defined as Viral Load\<50 copies/mL
Time frame: Week 2 through Week 96 (at any point during trial)
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response | 36.6 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response | 16.8 Percentage of participants |
Secondary
Virologic Response
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)
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response | 75.6 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response | 48.6 Percentage of participants |
Secondary
Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks
Virologic response defined as Viral Load\<400 copies/mL
Time frame: Week 2 through Week 96 (at any point during trial)
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks | 52.2 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks | 25.7 Percentage of participants |
Secondary
Virologic Response at Week 16
Virologic response defined as Viral Load\<50 copies/mL
Time frame: Week 16
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 16 | 20.5 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 16 | 10.5 Percentage of participants |
Secondary
Virologic Response at Week 16
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1
Time frame: week 16
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 16 | 47.1 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 16 | 20.8 Percentage of participants |
Secondary
Virologic Response at Week 16
Virologic response defined as Viral Load\<400 copies/mL
Time frame: Week 16
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 16 | 35.2 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 16 | 17.5 Percentage of participants |
Secondary
Virologic Response at Week 2
Virologic response defined as Viral Load\<50 copies/mL
Time frame: Week 2
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 2 | 0.9 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 2 | 1.4 Percentage of participants |
Secondary
Virologic Response at Week 2
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1
Time frame: Week 2
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 2 | 60.5 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 2 | 36 Percentage of participants |
Secondary
Virologic Response at Week 2
Virologic response defined as Viral Load\<400 copies/mL
Time frame: Week 2
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 2 | 14.5 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 2 | 8.2 Percentage of participants |
Secondary
Virologic Response at Week 24
Virologic response defined as Viral Load\<400 copies/mL
Time frame: Week 24
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 24 | 32.6 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 24 | 15.4 Percentage of participants |
Secondary
Virologic Response at Week 24
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1
Time frame: week 24
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 24 | 42.8 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 24 | 19.2 Percentage of participants |
Secondary
Virologic Response at Week 24
Viral Load \< 50 copies/mL
Time frame: Week 24
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 24 | 21.1 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 24 | 11.9 Percentage of participants |
Secondary
Virologic Response at Week 32
Virologic response defined as Viral Load\<400 copies/mL
Time frame: Week 32
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 32 | 32.4 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 32 | 16.1 Percentage of participants |
Secondary
Virologic Response at Week 32
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1
Time frame: week 32
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 32 | 38.6 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 32 | 19.4 Percentage of participants |
Secondary
Virologic Response at Week 32
Virologic response defined as Viral Load\<50 copies/mL
Time frame: Week 32
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 32 | 22.1 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 32 | 12.1 Percentage of participants |
Secondary
Virologic Response at Week 4
Virologic response defined as Viral Load\<400 copies/mL
Time frame: Week 4
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 4 | 26.2 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 4 | 15.2 Percentage of participants |
Secondary
Virologic Response at Week 4
Virologic response defined as Viral Load\<50 copies/mL
Time frame: Week 4
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 4 | 4.4 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 4 | 3.5 Percentage of participants |
Secondary
Virologic Response at Week 4
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1
Time frame: week 4
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 4 | 62.3 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 4 | 33.4 Percentage of participants |
Secondary
Virologic Response at Week 40
Virologic response defined as Viral Load\<50 copies/mL
Time frame: Week 40
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 40 | 22.3 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 40 | 11.9 Percentage of participants |
Secondary
Virologic Response at Week 40
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1
Time frame: week 40
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 40 | 37 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 40 | 17.3 Percentage of participants |
Secondary
Virologic Response at Week 40
Virologic response defined as Viral Load\<400 copies/mL
Time frame: Week 40
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 40 | 31.5 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 40 | 15 Percentage of participants |
Secondary
Virologic Response at Week 48
Virologic response defined as Viral Load\<50 copies/mL
Time frame: Week 48
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 48 | 22.8 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 48 | 10.5 Percentage of participants |
Secondary
Virologic Response at Week 48
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1
Time frame: week 48
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 48 | 36.8 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 48 | 16.6 Percentage of participants |
Secondary
Virologic Response at Week 48
Virologic response defined as Viral Load\<400 copies/mL
Time frame: Week 48
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 48 | 30.1 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 48 | 13.6 Percentage of participants |
Secondary
Virologic Response at Week 56
Virologic response defined as Viral Load\<400 copies/mL
Time frame: Week 56
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 56 | 30.6 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 56 | 12.4 Percentage of participants |
Secondary
Virologic Response at Week 56
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1
Time frame: week 56
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 56 | 35.2 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 56 | 15.2 Percentage of participants |
Secondary
Virologic Response at Week 56
Virologic response defined as Viral Load\<50 copies/mL
Time frame: Week 56
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 56 | 22.5 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 56 | 8.9 Percentage of participants |
Secondary
Virologic Response at Week 64
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1
Time frame: week 64
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 64 | 33.6 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 64 | 14 Percentage of participants |
Secondary
Virologic Response at Week 64
Virologic response defined as Viral Load\<400 copies/mL
Time frame: Week 64
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 64 | 28.7 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 64 | 12.1 Percentage of participants |
Secondary
Virologic Response at Week 64
Virologic response defined as Viral Load\<50 copies/mL
Time frame: Week 64
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 64 | 21.6 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 64 | 8.2 Percentage of participants |
Secondary
Virologic Response at Week 72
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1
Time frame: Week 72
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 72 | 32.2 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 72 | 13.8 Percentage of participants |
Secondary
Virologic Response at Week 72
Virologic response defined as Viral Load\<50 copies/mL
Time frame: Week 72
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 72 | 21.1 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 72 | 8.2 Percentage of participants |
Secondary
Virologic Response at Week 72
Virologic response defined as Viral Load\<400 copies/mL
Time frame: Week 72
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 72 | 28 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 72 | 11.4 Percentage of participants |
Secondary
Virologic Response at Week 8
Virologic response defined as Viral Load\<400 copies/mL
Time frame: Week 8
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 8 | 33.3 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 8 | 17.5 Percentage of participants |
Secondary
Virologic Response at Week 8
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1
Time frame: week 8
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 8 | 56.3 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 8 | 26.6 Percentage of participants |
Secondary
Virologic Response at Week 8
Virologic response defined as Viral Load\<50 copies/mL
Time frame: Week 8
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 8 | 11 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 8 | 6.8 Percentage of participants |
Secondary
Virologic Response at Week 80
Virologic response defined as Viral Load\<50 copies/mL
Time frame: Week 80
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 80 | 21.8 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 80 | 8.9 Percentage of participants |
Secondary
Virologic Response at Week 80
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1
Time frame: Week 80
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 80 | 32.6 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 80 | 13.6 Percentage of participants |
Secondary
Virologic Response at Week 80
Virologic response defined as Viral Load\<400 copies/mL
Time frame: Week 80
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 80 | 28.7 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 80 | 11 Percentage of participants |
Secondary
Virologic Response at Week 88
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1
Time frame: Week 88
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 88 | 31 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 88 | 12.1 Percentage of participants |
Secondary
Virologic Response at Week 88
Virologic response defined as Viral Load\<400 copies/mL
Time frame: week 88
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 88 | 27.8 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 88 | 11.2 Percentage of participants |
Secondary
Virologic Response at Week 88
Virologic response defined as Viral Load\<50 copies/mL
Time frame: Week 88
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 88 | 20.7 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 88 | 8.9 Percentage of participants |
Secondary
Virologic Response at Week 96
Virologic response defined as Viral Load\<400 copies/mL
Time frame: week 96
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 96 | 27.1 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 96 | 10.3 Percentage of participants |
Secondary
Virologic Response at Week 96
Virologic response defined as Viral Load\<50 copies/mL
Time frame: Week 96
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 96 | 20 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 96 | 8.9 Percentage of participants |
Secondary
Virologic Response at Week 96
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)\>=1
Time frame: Week 96
Population: Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tipranavir(TPV)/Low Dose Ritonavir(r) | Virologic Response at Week 96 | 30.1 Percentage of participants |
| Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) | Virologic Response at Week 96 | 11.4 Percentage of participants |