Primary Outcome Measures:
- The frequency of treatment-emergent adverse events (AEs), all serious AEs, and additional safety laboratory parameters
- The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash
Secondary Outcome Measures:
- The quantity of HIV-1 RNA
- The CD4 cell count
The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir (500 mg tipranavir/200 mg ritonavir BID) in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens.
The safety assessment will be performed by evaluating:
- The frequency of treatment-emergent adverse events (AEs) , all serious adverse events (SAEs), and additional safety laboratory parameters.
- The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash.
The efficacy assessment will be performed by evaluating:
- The quantity of HIV-1 RNA
- The CD4 cell count.
Study Hypothesis:
The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir (500 mg tipranavir/200 mg ritonavir BID) in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens.
Comparison(s):
N.A.