This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients.

The primary objective is to determine the safety and pharmacokinetics of:

TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).

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.