Who is sponsoring NCT00440271?

NCT00440271 is sponsored by Boehringer Ingelheim.

What condition does NCT00440271 study?

NCT00440271 studies HIV Infections.

What drugs are being tested in NCT00440271?

Interventions: tipranavir, ritonavir, Optimized Background Regimen (OBR).

What is the status of NCT00440271?

NCT00440271 is currently TERMINATED.

Last reviewed 2014-06-17 · How we verify

SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavi/r IN Race/Gender HIV+ Patients Randomized to Therapeutic Drug Monitoring or Standard of Care

NCT00440271 Phase 3 TERMINATED Results posted

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.

Details

Lead sponsor	Boehringer Ingelheim
Phase	Phase 3
Status	TERMINATED
Enrolment	33
Start date	2007-02

Conditions

HIV Infections

Interventions

tipranavir
ritonavir
Optimized Background Regimen (OBR)

Primary outcomes

Treatment Response at Week 48 — after 48 weeks of treatment
percentage of participants whose viral load \<50 copies/mL at Week 48

Countries

United States, Argentina, Brazil, Canada, Germany, Italy, Spain