drugset / Trial / NCT00440271
SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-02
- Primary completion
- 2008-10
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ritonavir | Other / unclassified | 200 mg | Oral |
| Subject | Tipranavir | Small molecule | 500 mg | Oral |
| Background | Enfuvirtide | Peptide | — | — |
| Background | Maraviroc | Other / unclassified | — | — |
| Background | Raltegravir | Other / unclassified | — | — |