drugset / Trial / NCT00056641
Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2003-02-18
- Primary completion
- 2004-01-27
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amprenavir | Other / unclassified | — | — |
| Subject | Lopinavir | Other / unclassified | — | — |
| Subject | Ritonavir | Other / unclassified | — | — |
| Subject | Saquinavir | Small molecule | — | — |
| Subject | Tipranavir | Small molecule | — | — |