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

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

HIV Infections

Treatments

Drug: amprenavir

Drug: tipranavir

Drug: lopinavir

Drug: ritonavir

Drug: saquinavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00056641

1182.51

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.