Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI

• Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure). [ Time Frame: 48 weeks of treatment ]
• Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug. [ Time Frame: 48 weeks of treatment ]
• Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion. [ Time Frame: 48 weeks of treatment ]
• Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored [ Time Frame: up to 48 weeks ]
• Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF [ Time Frame: up to 48 weeks ]
• Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat [ Time Frame: up to 48 weeks ]
• Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored [ Time Frame: up to 48 weeks ]
• Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF [ Time Frame: up to 48 weeks ]
• Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat [ Time Frame: up to 48 weeks ]
• Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored [ Time Frame: up to 48 weeks ]
• Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using NCF [ Time Frame: up to 48 weeks ]
• Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat [ Time Frame: up to 48 weeks ]
• Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8 [ Time Frame: up to week 8 ]
• Daily Average in CD4+ Cell Count Change From Baseline up to Week 24 [ Time Frame: up to week 24 ]
• Daily Average in CD4+ Cell Count Change From Baseline up to Week 48 [ Time Frame: up to week 48 ]
• Daily Average in Viral Load Change From Baseline up to Week 8 [ Time Frame: up to week 8 ]
• Daily Average in Viral Load Change From Baseline up to Week 24 [ Time Frame: up to week 24 ]
• Daily Average in Viral Load Change From Baseline up to Week 48 [ Time Frame: up to week 48 ]
• Change From Baseline in CD4+ Cell Count up to Week 48 [ Time Frame: up to week 48 ]
• Change From Baseline in log10 Viral Load up to Week 48 [ Time Frame: up to week 48 ]
• Occurrence of New AIDS Progression Events or Death [ Time Frame: through 48 weeks of treatment ]

The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.

• Drug: Tipranavir
• Drug: Darunavir
• Drug: Ritonavir

Inclusion Criteria:

1. Three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced patients (a minimum of 3-months duration for each class) with resistance to more than one protease inhibitor on the screening virtual phenotype resistance testing.
2. Patients optimized background regimen must contain at least two active antiretrovirals including Efuvirtide, Maraviroc and integrase inhibitors.
3. Patient has been on their current (failing) protease inhibitor-containing regimen for at least 8 weeks prior to randomization.
4. An HIV-1 viral load of at least 1,000 copies/mL at screening.
5. A CD4+ cell count of at least 50 cells/mm3 at screening.

9. Acceptable screening laboratory values that indicate adequate baseline organ function.

Exclusion Criteria:

1. Previous use of Tipranavir (TPV) or Darunavir (DRV).
2. Full genotypic resistance (reported as minimal response) to Tipranavir (TPV) or Darunavir (DRV) on screening virtual phenotype:

3. Female patient of child-bearing potential who:

   has a positive serum pregnancy test at screening or during the study, is breast feeding, is planning to become pregnant, is not willing to use barrier methods of contraception or requires ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, condom for females, cervical caps and condoms.

4. History of Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any malignancy.
5. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit.
6. Use of immunomodulatory drugs (such as interferon, cyclosporin, hydroxyurea and interleukin 2) within 30 days prior to randomization.
7. Current use of systemic cytotoxic chemotherapy.
8. All contraindications listed in the product monographs of Aptivus, Prezista and Norvir.