| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | At week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Cochran-Mantel-Haenszel | Weighted by the size of enfuvirtide and protease inhibitor strata | 0.0001 | | | | | | | 95 | | | | | | No | Superiority or Other | | |
|
| 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. | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Days | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | week 2 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | week 4 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | week 8 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | week 16 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | week 24 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | Week 32 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | Week 40 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | week 56 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | week 64 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | Week 80 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | Week 88 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | percentage of participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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. | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Days | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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. | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Days | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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. | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Days | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 2 through Week 96 (at any point during trial) | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (Viral Load >= 1 Log Drop) at Week 2 | Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (Viral Load >= 1 Log Drop) at Week 4 | Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (Viral Load >= 1 Log Drop) at Week 8 | Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (Viral Load >= 1 Log Drop) at Week 16 | Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (Viral Load >= 1 Log Drop) at Week 24 | Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (Viral Load >= 1 Log Drop) at Week 32 | Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 32 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (Viral Load >= 1 Log Drop) at Week 40 | Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 40 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (Viral Load >= 1 Log Drop) at Week 48 | Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (Viral Load >= 1 Log Drop) at Week 56 | Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 56 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (Viral Load >= 1 Log Drop) at Week 64 | Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 64 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Median Change From Baseline in Viral Load to Week 2 | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Log(Copies/mL) | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Median Change From Baseline in Viral Load to Week 4 | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Log(Copies/mL) | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Median Change From Baseline in Viral Load to Week 8 | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Log(Copies/mL) | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Median Change From Baseline in Viral Load to Week 16 | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Log(Copies/mL) | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Median Change From Baseline in Viral Load to Week 24 | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Log(Copies/mL) | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Median Change From Baseline in Viral Load to Week 32 | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Log(Copies/mL) | | Baseline to Week 32 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Median Change From Baseline in Viral Load to Week 40 | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Log(Copies/mL) | | Baseline to Week 40 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Median Change From Baseline in Viral Load to Week 48 | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Log(Copies/mL) | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Median Change From Baseline in Viral Load to Week 56 | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Log(Copies/mL) | | Baseline to Week 56 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Median Change From Baseline in Viral Load to Week 64 | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Log(Copies/mL) | | Baseline to Week 64 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Median Change From Baseline in Viral Load to Week 72 | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Log(Copies/mL) | | Baseline to Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Median Change From Baseline in Viral Load to Week 80 | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Log(Copies/mL) | | Baseline to Week 80 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Median Change From Baseline in Viral Load to Week 88 | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Log(Copies/mL) | | Baseline to Week 88 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Median Change From Baseline in Viral Load to Week 96 | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Log(Copies/mL) | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Mean Change From Baseline to Week 2 in CD4+ Cell Count | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Mean | Standard Deviation | Cells/mm3 | | Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Mean Change From Baseline to Week 4 in CD4+ Cell Count | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Mean | Standard Deviation | Cells/mm3 | | Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Mean Change From Baseline to Week 8 in CD4+ Cell Count | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Mean | Standard Deviation | Cells/mm3 | | Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Mean Change From Baseline to Week 16 in CD4+ Cell Count | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Mean | Standard Deviation | Cells/mm3 | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Mean Change From Baseline to Week 24 in CD4+ Cell Count | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Mean | Standard Deviation | Cells/mm3 | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Mean Change From Baseline to Week 32 in CD4+ Cell Count | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Mean | Standard Deviation | Cells/mm3 | | Baseline to Week 32 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Mean Change From Baseline to Week 40 in CD4+ Cell Count | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Mean | Standard Deviation | Cells/mm3 | | Baseline to Week 40 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Mean Change From Baseline to Week 48 in CD4+ Cell Count | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Mean | Standard Deviation | Cells/mm3 | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Mean Change From Baseline to Week 56 in CD4+ Cell Count | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Mean | Standard Deviation | Cells/mm3 | | Baseline to Week 56 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Mean Change From Baseline to Week 64 in CD4+ Cell Count | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Mean | Standard Deviation | Cells/mm3 | | Baseline to Week 64 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Mean Change From Baseline to Week 72 in CD4+ Cell Count | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Mean | Standard Deviation | Cells/mm3 | | Baseline to Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Mean Change From Baseline to Week 80 in CD4+ Cell Count | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Mean | Standard Deviation | Cells/mm3 | | Baseline to Week 80 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Mean Change From Baseline to Week 88 in CD4+ Cell Count | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Mean | Standard Deviation | Cells/mm3 | | Baseline to Week 88 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Mean Change From Baseline to Week 96 in CD4+ Cell Count | | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Mean | Standard Deviation | Cells/mm3 | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| 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 | Safety Analysis Set (SAF), includes all patients treated with at least one dose of study medication | Posted | | Median | Inter-Quartile Range | Days | | after 48 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF | Percentage of participants with Viral Load < 400 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 2 through Week 96 (at any point during trial) | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Week 2 | Percentage of participants with Viral Load < 400 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Week 4 | Percentage of participants with Viral Load < 400 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Week 8 | Percentage of participants with Viral Load < 400 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Week 16 | Percentage of participants with Viral Load < 400 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Week 24 | Percentage of participants with Viral Load < 400 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Week 32 | Percentage of participants with Viral Load < 400 copies/mL | | Posted | | Number | | Percentage of participants | | week 32 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Week 40 | Percentage of participants with Viral Load < 400 copies/mL | | Posted | | Number | | Percentage of participants | | Week 40 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Week 48 | Percentage of participants with Viral Load < 400 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Week 56 | Percentage of participants with Viral Load < 400 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 56 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Week 64 | Percentage of participants with Viral Load < 400 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 64 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Week 72 | Percentage of participants with Viral Load < 400 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Week 80 | Percentage of participants with Viral Load < 400 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 80 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Week 88 | Percentage of participants with Viral Load < 400 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | week 88 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 400 Copies/ml) at Week 96 | Percentage of participants with Viral Load < 400 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | week 96 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 2 through Week 96 (at any point during trial) | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 50 Copies/ml) at Week 2 | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 50 Copies/ml) at Week 4 | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 50 Copies/ml) at Week 8 | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 50 Copies/ml) at Week 16 | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 50 Copies/ml) at Week 24 | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 50 Copies/ml) at Week 32 | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 32 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 50 Copies/ml) at Week 40 | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 40 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
| |
| Secondary | Virologic Response (VL < 50 Copies/ml) at Week 48 | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
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| Secondary | Virologic Response (VL < 50 Copies/ml) at Week 56 | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 56 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
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| Secondary | Virologic Response (VL < 50 Copies/ml) at Week 64 | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 64 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
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| Secondary | Virologic Response (VL < 50 Copies/ml) at Week 72 | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
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| Secondary | Virologic Response (VL < 50 Copies/ml) at Week 80 | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 80 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
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| Secondary | Virologic Response (VL < 50 Copies/ml) at Week 88 | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 88 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
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| Secondary | Virologic Response (VL < 50 Copies/ml) at Week 96 | Percentage of participants with Viral Load < 50 copies/mL | FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication | Posted | | Number | | Percentage of participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
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| 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. | 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 | Posted | | Number | | Percentage of participants | | 240 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Tipranavir(TPV)/Low Dose Ritonavir(r) | TPV 500 mg / Ritonavir 200 mg, twice daily | | OG001 | Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) | lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV) |
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