Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients

Inclusion criteria

• Signed informed consent prior to trial participation.
• Human Immunodeficiency Virus type 1 (HIV-1) infected males or females ≥18 years of age.
• Acceptable laboratory screening values in Trial 1182.12 (RESIST 1) or 1182.48 (RESIST 2), excluding genotype.
• Genotypic resistance report from screening visit of study RESIST 1 or RESIST 2 indicating at least three mutations at protease codons 33, 82, 84, and 90.
• At least 3 consecutive months experience taking ARVs from each of the classes of Nucleoside reverse transcriptase inhibitors (NRTI), Non-nucleoside reverse transcriptase inhibitor 1 (NNRTI), and Protease Inhibitor (PI) at some point in treatment history, with at least 2 PI-based regimens, one of which must be part of the current regimen, and current PI-based Anti-retroviral (ARV) medication regimen for at least 3 months prior to randomization.
• HIV-1 viral load ≥1000 copies/mL at screening.
• Further inclusion criteria apply.

Exclusion criteria

• Anti-retroviral (ARV) medication naïve.
• Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the last 3 months.
• Female patients of child-bearing potential who:

• have a positive serum pregnancy test at screening or during the study,
• are breast feeding,
• are planning to become pregnant,
• are not willing to a use barrier method of contraception, or
• require ethinyl estradiol administration.
• Prior tipranavir use.
• Use of investigational medications within 30 days before study entry or during the trial.
• Further exclusion criteria apply.