Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440271
Status:
TERMINATED
Last Update Posted:
2014-06-27
First Post:
2007-02-26
Brief Title:
SPRING Safety Efficacy Pharmacokinetics of tipRanavirr IN RaceGender HIV Patients Randomized to TDM or SoC
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
SPRING Safety Efficacy Pharmacokinetics of tipRanavir IN RaceGender HIV Patients Randomized to Therapeutic Drug Monitoring or Standard of Care
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to
1 Demonstrate the safety and efficacy of tipranavirritonavir TPVr 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
1 Demonstrate the safety and efficacy of tipranavirritonavir TPVr 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT No 2005-005264-86 | None | None | None |