| Primary | Adverse Events | The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms. | Full Analysis Set (FAS), all patients entered and treated | Posted | | Number | | Number of patients with adverse events | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Secondary | Change in Viral Load | Log10 change from baseline in viral load over time | Full Analysis Set (FAS), all patients entered and treated | Posted | | Median | Inter-Quartile Range | log10 copies/ml | | Baseline and 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | |
| Secondary | CD4+ Cell Count | Change from baseline in CD4+ count over time | Full Analysis Set (FAS), all patients entered and treated | Posted | | Median | Inter-Quartile Range | cells/mm3 | | Baseline and 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | |
| Secondary | Subjective Well-being | Investigator's opinion of patient's general condition (quality of life) | Full Analysis Set (FAS), all patients entered and treated | Posted | | Number | | participants | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | |
| Secondary | Serious Adverse Events | The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms. | Full Analysis Set (FAS), all patients entered and treated | Posted | | Number | | Number of patients | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | |
| Secondary | Deaths | The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms. | Full Analysis Set (FAS), all patients entered and treated | Posted | | Number | | Number of patients | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | |
| Secondary | Discontinuations Due to an Adverse Event | The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms. | Full Analysis Set (FAS), all patients entered and treated | Posted | | Number | | Number of patients | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | |
| Secondary | Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion | The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms. | Full Analysis Set (FAS), all patients entered and treated | Posted | | Number | | Number of patients | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| |
| Secondary | Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir | | Full Analysis Set (FAS), all patients entered and treated | Posted | | Number | | participants | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | |
| Secondary | Use of Lipid Lowering Agents During the Study | | Full Analysis Set (FAS), all patients entered and treated | Posted | | Number | | participants | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | | Title | Denominators | Categories |
|---|
|
| Secondary | Body Mass Index Class (Kilograms/Square Meter) | | Full Analysis Set (FAS), all patients entered and treated | Posted | | Number | | participants | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | | Title | Denominators | Categories |
|---|
|
| Secondary | Total Cholesterol Over Time | | Full Analysis Set (FAS), all patients entered and treated | Posted | | Median | Inter-Quartile Range | mg/dl | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | | Title | Denominators | Categories |
|---|
|
| Secondary | High Density Lipoprotein (HDL) Cholesterol Over Time | | Full Analysis Set (FAS), all patients entered and treated | Posted | | Median | Inter-Quartile Range | mg/dl | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | |
| Secondary | Low Density Lipoprotein (HDL) Cholesterol Over Time | | Full Analysis Set (FAS), all patients entered and treated | Posted | | Median | Inter-Quartile Range | mg/dl | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | |
| Secondary | Triglycerides Over Time | | Full Analysis Set (FAS), all patients entered and treated | Posted | | Median | Inter-Quartile Range | mg/dl | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | | Title | Denominators | Categories |
|---|
|
| Secondary | Alanine Aminotransferase (ALT) Over Time | | Full Analysis Set (FAS), all patients entered and treated | Posted | | Median | Inter-Quartile Range | international units/liter | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | |
| Secondary | Aspartate Aminotransferase (ALT) Over Time | | Full Analysis Set (FAS), all patients entered and treated | Posted | | Median | Inter-Quartile Range | international units/liter | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | |
| Secondary | Gamma-glutamyl Transpeptidase (GGT) Over Time | | Full Analysis Set (FAS), all patients entered and treated | Posted | | Median | Inter-Quartile Range | international units/liter | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | |
| Secondary | Creatinine Over Time | | Full Analysis Set (FAS), all patients entered and treated | Posted | | Median | Inter-Quartile Range | mg/dl | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | | Title | Denominators | Categories |
|---|
|
| Secondary | Total Bilirubin Over Time | | Full Analysis Set (FAS), all patients entered and treated | Posted | | Median | Inter-Quartile Range | mg/dl | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | | Title | Denominators | Categories |
|---|
|
| Secondary | Alkaline Phosphatase Over Time | | Full Analysis Set (FAS), all patients entered and treated | Posted | | Median | Inter-Quartile Range | international units/liter | | 52 weeks | | | | ID | Title | Description |
|---|
| OG000 | Aptivus® in Combination With Low-dose Norvir® | Aptivus® in combination with low-dose Norvir® and optimised backbone therapy |
| | |