Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options

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.

Inclusion criteria

• Triple antiretroviral class experienced patients with at least two previous PI-based regimens, who had failed or are intolerant to currently approved HIV-1 treatments
• Age >= 18 years
• Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter
• Patient voluntarily provides written informed consent to participate, in compliance with local law

Exclusion criteria

• Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir
• Required use of restricted medications
• Female patients of childbearing potential who:

• Have a positive pregnancy test at baseline or
• Are breast feeding.
• Any medical condition(s) which, in the opinion of the investigator, would interfere with the patient´s ability to participate in or adhere to the requirements of this protocol.
• Use of other investigational drugs, within 30 days prior to TPV/r initiation and for the duration of study participation.
• Hepatic impairment(*) evidenced by the following baseline laboratory findings:

• AST or ALT >5X upper limit of normal (ULN) or total bilirubin >3.5X ULN or
• AST or ALT >2.5X ULN and total bilirubin >2X ULN

(*) Patients with liver enzymes outside this range will be restricted from participation in this safety study until more data become available from ongoing phase III clinical studies.