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NCT00440271 · ClinicalTrials.gov registry record · Phase 3
SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 3
- Development phase
- 33
- Enrollment target
NCT00440271: Clinical Trial Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00440271 is a Phase 3 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 33 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00440271, a Phase 3 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 33 participants
- Enrollment target
Study 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.
Primary Outcome
percentage of participants whose viral load \<50 copies/mL at Week 48
Interventions
- DRUG Optimized Background Regimen (OBR)
- DRUG ritonavir
- DRUG tipranavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2007-02 |
| Phase | Phase 3 |
Why NCT00440271 stopped before completion
NCT00440271 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Optimized Background Regimen (OBR) is the first listed.
NCT00440271 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00440271 about?
NCT00440271 is a clinical study titled "SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC". 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)...
What is the current status of trial NCT00440271?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2007-02.
What interventions are being tested in trial NCT00440271?
The interventions under investigation include: Optimized Background Regimen (OBR) (DRUG), ritonavir (DRUG), tipranavir (DRUG).
Who is sponsoring clinical trial NCT00440271?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00440271's enrollment target sits among peer trials
33 1907th of 2000 higher than 92 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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