SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC
Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The primary purpose of this study is to:
1. Demonstrate the safety and efficacy of tipranavir/ritonavir (TPV/r) among a racially
diverse HIV+ population (males and females) who are three-class (nucleoside reverse
transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI),
and protease inhibitor (PI)) experienced with documented resistance to more than one PI.
2. Determine pharmacokinetic data in this racially and gender diverse population.
3. Determine the potential utility of using therapeutic drug monitoring (TDM) in improving
efficacy outcomes.